Neovacs obtains FDA “Fast Track” designation for IFNα Kinoid in Lupus (SLE)

Paris and Boston, December 7, 2016 – Neovacs (Alternext Paris: ALNEV), a leader in active immunotherapies for the treatment of autoimmune diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted “Fast Track” status to IFNα Kinoid in Lupus, the most advanced therapeutic vaccine issued from Neovacs R&D.

 

The FDA’s “Fast Track” designation is granted to therapies in development that target severe diseases or those that are life threatening and which have shown their ability to address an unmet medical need, based on clinical data. This status facilitates exchanges with the FDA, accelerates the further product development and allows for a priority review of the product registration file. As a result of this designation, Neovacs has the best conditions to allow faster access to the IFNα Kinoid for American patients.

Neovacs signs production partnership with 3P Biopharmaceuticals, a leading GMP producer of biological drugs

Agreement addresses future production needs of IFNα,

key component of IFN Kinoid[1]

 

Paris and Boston, November 23, 2016 – Neovacs (Alternext Paris: ALNEV), a leader in active immunotherapies for the treatment of autoimmune diseases, today announced a partnership with 3P Biopharmaceuticals, a leader in the production of biological drugs, for the manufacture of interferon alpha (IFNα). Today’s collaboration follows the recent acquisition of the technology for the manufacture of IFNα by Neovacs from AMEGABIOTECH.



[1]IFNα Kinoid: Therapeutic vaccine from Neovacs technology, which is composed of the targeted cytokine IFNα, conjugated with a carrier protein, Keyhole Limpet Hemocyanin.

NEOVACS ACQUIRES INTERFERON ALPHA MANUFACTURING TECHNOLOGY FROM AMEGABIOTECH

Acquisition significantly strengthens the strategy for commercialization of its most advanced product: IFNα Kinoid therapeutic vaccine for lupus


Paris and Boston, November 15, 2016 – Neovacs (Alternext Paris: ALNEV), a leader in active immunotherapies for the treatment of autoimmune diseases, today announced an agreement with the Argentinean company AMEGABIOTECH to acquire its Interferon Alpha (IFNα) manufacturing license. IFNα is a key component of Neovacs’ lead therapeutic candidate, IFNα Kinoid, which is composed of inactivated IFNα coupled with a carrier protein, keyhole limpet hemocyanin.

Neovacs enrolls the first U.S. Patient in Phase IIb study of IFNa Kinoid for treatment of Systemic Lupus Erythematosus (SLE)

Strong interest from U.S. clinical investigation centers trial

 

Paris and Boston, November 7th 2016 – Neovacs (Alternext Paris: ALNEV, PEA-eligible SMEs), a leader in active immunotherapy for the treatment of autoimmune diseases, today announced the enrolment of the first U.S. patient in its international phase IIb clinical study of IFNα Kinoid in lupus.

 

A first clinical center has started to enrol patients in this study, initially planned to include 5 investigation centers.  The study has attracted interest from a large number of American sites and autoimmune disease specialists. Due to this high demand, Neovacs will open additional centers, increasing the total number of trial sites to 15.

 

Neovacs to attend Jefferies 2016 London Healthcare Conference November 16 & 17, 2016

Paris and Boston, November 3, 2016 – Neovacs (Alternext Paris: ALNEV) a leader in active immunotherapy for the treatment of autoimmune diseases, today announced its participation at the Jefferies 2016 London Healthcare Conference taking place November 16-17 at the Waldorf Hilton in London, UK.

This Conference is the largest healthcare meeting in Europe dedicated to companies from around the world from the biotechnology, pharmaceutical, generic, consumer health, medical technology and Healthcare Service sectors. Last year, the Jefferies conference hosted over 300 participating companies, 1,200 attendees and 3,700 business-to-business and investor meetings.

NEOVACS SIGNS A COOPERATION AGREEMENT WITH THE DEPARTMENT IMMUNOLOGY OF DIABETES AT THE REPUTED HOSPITAL COCHIN IN PARIS

To collaborate on development of new diabetes treatment using Neovacs’ Kinoid Technology

Paris, October 12, 2016 – NEOVACS (Alternext Paris: ALNEV PEA-PME eligible), a leader in active immunotherapies for the treatment of autoimmune diseases, today announceda collaboration with Doctor Agnès Lehuen and Professor Christian Boitard, who are leading the laboratory for Research in Immunology of Diabetes at the reputed Cochin Hospital in Paris. The goal of this collaboration is to achieve proof of concept for the use of Neovacs’ IFNa Kinoid in the treatment of Type 1 diabetes.

 

As part of this collaboration, Doctor Lehuen and Professor Boitard’s teams will jointly conduct research with scientists from Neovacs on INFa Kinoid in NOD models (Non-Obese Diabetic mice – the most relevant mouse model for this disorder). Existing scientific publications offer a significant body of evidence to support the involvement of IFNa in Type 1 diabetes[1]. This preclinical study aims to determine whether the use of the IFNa Kinoid vaccine can control this disorder by producing polyclonal neutralizing antibodies to Interferon alpha.

 



[1] Cf. Publications scientifiques :

Meyer et al., 2016, Cell 166, 582–595, July 28, 2016

Ferreira et al., Diabetes Volume 63, July 2014

Diana et al., Nature Medicine Volume 19, January 2013

 

HALF-YEAR RESULTS 2016 AND UPDATE ON OPERATIONAL DEVELOPMENT

·         Cash position significantly strengthened by successful capital increase

·         Phase IIb clinical trial in lupus expanded into the United States

 

Paris, September 30, 2016 – NEOVACS (Alternext Paris: ALNEV PEA-PME eligible), a leader in active immunotherapies for the treatment of autoimmune diseases, today announced its 2016 first half financial results, as approved by its Board of Directors on September 29, 2016.

 

Miguel Sieler, CEO of Neovacs, said: “During the first half of 2016, Neovacs completed a successful capital increase that significantly strengthened the company’s financial position and enabled us to continue our work in lupus and dermatomyositis. Indeed, in the first half of the year, Neovacs advanced its Phase IIb clinical study in lupus, accelerating patient enrollment and obtaining two important approvals from health authorities in South Korea and the United States, enabling us to expand the study into these two countries. Moreover, to be prepared for the eventual submission for regulatory approval of our product for lupus, we have created, in collaboration with Stellar Biotechnologies, the production company Neostell. We have already initiated the necessary studies to move from clinical-scale production to larger commercial-scale batches.”

Neovacs to present at two major Investor Conferences: The 18th Annual Rodman & Renshaw Global Investment Conference & Bio Europe 2016

Paris and Boston, August 30, 2016 – Neovacs (Alternext Paris: ALNEV) a leader in active immunotherapy for the treatment of autoimmune diseases, today announced CEO Miguel Sieler will present at the 18th Annual Rodman & Renshaw Global Investment Conference and Bio Europe 2016. The Rodman & Renshaw Global Investment Conference, being held September 11-13 in New York, NY, will host over 265 public and private companies, and several thousand attendees. The conference will bring together a vast audience of financial and strategic investors with growth companies in the fields of healthcare, natural resources, technology, media and telecommunications, and cleantech. In addition to corporate presentations, the conference facilitates one-on-one meetings with members of the investment community.

 

 

Miguel Sieler, CEO of Neovacs, will present the company at Rodman & Renshaw on Monday September 12, from 10:50 to 11:15 am ET at the New York Palace Hotel, on the fourth floor in the Louis Room.

 

 

Neovacs will also present at Bio Europe, which will take place November 7-9 in Cologne, Germany. This conference is one of the world’s most important meeting for the biotech Industry. This year Bio Europe event will draw over 3,500 attendees from 60 countries, representing 1,800 companies. It will provide Neovacs with the opportunity to meet with a vast audience of financial and strategic investors, as well as potential high-level partners.

Neovacs and Stellar Biotechnologies Announce Launch of Neostell, Joint Venture to Manufacture Kinoids

Administrative Board and Management Team Appointed

 

Paris (France), Boston, MA (USA) and Port Hueneme, CA (USA), July 19, 2016 – NEOVACS (Alternext Paris: ALNEV) and STELLAR BIOTECHNOLOGIES Inc. (Nasdaq: SBOT) today announced the start of their joint venture company, Neostell SAS, with the holding of its first general assembly.  At the meeting, the bylaws for Neostell were approved and the Administrative Board and management team were appointed.

EUR 8 million capital increase successfully completed

  • Total gross proceeds of 8, 045, 102.95Euros

  • 9, 464, 827 new shares issued

  • Rights issue fully subscribed

 Paris, June 22 , 2016 – NEOVACS (Alternext Paris: ALNEV), a leader in active immunotherapies for the treatment of autoimmune diseases, is pleased to announce the successful completion of its capital increase with preferential subscription rights (PSRs), which took place June 1-22, 2016. 

 

Neovacs is focused on clinical, preclinical and pharmaceutical development of IFNα Kinoid

 As previously mentioned, the funds raised will enable the Company to strengthen its financial base and fund its future programmes. In particular, funds will be deployed for external costs related to the clinical and preclinical trials, the preparation, development and production of IFNα-K clinical lots in anticipation of a Korean market entry and the launch of phase III trial with the IFNα-K for the treatment of Lupus. The Company will also initiate a phase IIa study with IFNα Kinoid  in Dermatomyositis with a part of the proceeds.

Miguel Sieler, CEO of Neovacs said:

Following IND approval from the FDA in the United States, the signing of two important partnerships and the recent approval by the European authorities of our Phase IIa study in Dermatomyositis , Neovacs has achieved with this successful financing another milestone in the pursuit of its near-term objectives. I want to thank all of our individual and institutional shareholders for their confidence and support. The success of this financing, despite a challenging market environment, provides Neovacs the funds to continue to implement our development plan and thus increase the chances of success.”

 

Neovacs and Stellar Biotechnologies sign joint venture agreement to create Neostell SAS

Paris and Boston, May 12th, 2016 – Neovacs (Alternext Paris: ALNEV)a leader in active immunotherapy for the treatment of autoimmune diseases, today announced that the Company has finalized the terms of its partnership with US company Stellar Biotechnologies Inc. (“Stellar”) (Nasdaq: SBOT), to determine the creation of the production company Neostell SAS under a form of a joint venture, based in the Paris area and owned 70% by Neovacs and 30% by Stellar Biotechnologies.

10th May is World Lupus Day

Paris May 3rd , Neovacs have organized a Press Conference to support this event and spread awareness about Lupus impact in patient’s life.  Thanks to Pr Eric Hachulla, Pr Jean Sibilia , Lupus France and AFL+   for their participation and to share their experiences with us.

Press kit available on our website

Neovacs obtains FDA approval to extend its Phase IIb clinical trial in Lupus to United States

Paris and Boston, April 28th, 2016 – Neovacs (Alternext Paris: ALNEV)a leader in active immunotherapy for the treatment of autoimmune diseases, today announced that the Company has received the approval “Investigational New Drug” (IND), from the Food and Drug Administration (FDA), to extend its ongoing Phase IIb clinical trial of IFNα Kinoid for the treatment of Lupus to the United States.

NEOVACS REPORTS FULL YEAR 2015 FINANCIAL RESULTS

Paris,  March 7, 2016 – NEOVACS (Alternext Paris: ALNEV), a leader in active immunotherapies for the treatment of autoimmune diseases, today announced its full-year 2015 financial results, as approved by its Board of Directors on March 4, 2016.

The year 2015 has been an important year for Neovacs for several reasons: We have concluded and prepared partnering agreements of strategic importance. Following the recommendation of our Scientific Advisory Board we have refocused on the clinical development of IFNα Kinoid in Lupus and added a new indication in the orphan disease Dermatomyositis. This year has also been marked by our new engagement in cancer immunotherapy with our Kinoid technology. We enter 2016 with the keys to pursue the preclinical, clinical and industrial development of our products,” said Miguel Sieler, CEO of Neovacs.

Today is #RareDiseaseDay, Join the movement in making voice of Rare Diseases Heard!

This is the official video for #RareDiseaseDay 2016!

click on the logo to watch the official video

Join us in making the voice of rare diseases heard! Read more http://www.rarediseaseday.org//

 

 

Neovacs will be at BIO Trinity 2016

As Europe’s leading investment and biopartnering conference, BioTrinity is the nexus of a booming life sciences innovation ecosystem and provides a unique platform for R&D, global pharma and investor companies across the life sciences industry to achieve their business objectives; to secure funding, seek acquisition and in-licensing deals and grow their network.

BioTrinity is celebrating its 10 year anniversary in April 2016. To reflect the importance of this key industry event, the theme running through the programme is the ‘Vision for Life Sciences 2030’. The dedicated MediTrinity stream will also address the ‘Vision for Medtech 2030’.

Meet us at BIO CEO & Investor, NYC

Miguel Sieler, Neovacs’ CEO will be presenting at the 18th Annual BIO CEO & Investor Conference on Monday, February 8, 2016, at 11:30 a.m. (ET). The conference is being held at The Waldorf Astoria hotel in New York City (US).

Neovacs associates Stellar Biotechnologies in its industrial Project

Paris and Boston, January 21, 2016Neovacs (Alternext Paris: ALNEV)a leader in active immunotherapies for the treatment of autoimmune diseases, today signed a partnering agreement with the American company Stellar Biotechnologies, Inc.(Nasdaq : SBOT TSX-V: KLH). This joint venture will operate under the name of Neostell SAS, and it will be owned 30% by Stellar and 70% by Neovacs.

photo

Neovacs secures €5 million from the public funding program «Investments for the Future»

Paris and Boston, January 6th 2016 – NEOVACS (Alternext Paris: ALNEV), has concluded an agreement which provides non-dilutive funding of five million euros for over the next four years, in the form of grants and repayable advances. 

 

This funding decision made by The General Commission for Investment and operated by Bpifrance*, is part of the program: «PIAVE- Industrial project for the future» and will be used to finalize clinical development and to initiate the industrialization process for the therapeutic vaccine IFNα Kinoid.                       

 

                   

 

                     

Neovacs announces its participation in upcoming investor conferences

Paris and Boston, October 28, 2015 – NEOVACS (Alternext Paris: ALNEV), a leader in active immunotherapies for the treatment of autoimmune diseases, announced today its participation in several investor conferences during the fourth quarter 2015. Miguel Sieler, CEO of Neovacs, will present Neovacs’ current development program and strategy at the following meetings:

 

BIO Europe 2015 Conference

Date: November 2-4, 2015 (conference on November 3 at 10:15 AM)

Location: Munich, Germany

 

Jefferies – 2015 Global Health Care Conference

Date: November 18, 2015

Location: London, United-Kingdom

 

Deutsches Eigenkapitalforum

Date: November 23-24, 2015 (conference on November 24 at 04:00 PM)

Location: Frankfurt, Germany

 

Neovacs will also be present at Actionaria, a conference dedicated to retail investors :

Salon Actionaria

Date: November 20-21, 2015

Location: Paris, France

As part of this exhibition, Miguel Sieler, CEO, will present at the “Agora des Présidents” on November 20 at 10:45 AM.

CEO Miguel Sieler commented, “I am looking forward to introducing Neovacs to a new audience through our participation at these events. It is also a great opportunity for us to connect with current and prospective investors and update them on the progress that our Company is making toward advancing our lead immunotherapy candidate, IFNα-Kinoid.”

Neovacs Reports First-Half 2015 Financial Results

Paris and Boston, October 2, 2015 – NEOVACS (Alternext Paris: ALNEV), a leader in active immunotherapies for the treatment of autoimmune diseases, today announced its results for the six months ended June 30, 2015, as approved by the Board of Directors on October 1, 2015.

 

MAIN OPERATIONAL MILESTONES SINCE JANUARY 2015

  •  Initiation of Phase IIb clinical trial of IFNα-Kinoid to treat Systemic Lupus Erythematosus (« SLE ») or lupus, based on promising preclinical and clinical results to-date;
  • Extension of IFNα-Kinoid development program to include dermatomyositis, an orphan condition where a positive IFNα signature plays a decisive role, following a recommendation by Neovacs’ Scientific Advisory Board (SAB);
  • Formation of a Neovacs U.S. subsidiary  to strengthen the Company’s presence in the country and expand clinical activity beyond the EU to the U.S. market;
  • Significant strengthing of Company’s cash position following a successful capital increase subscribed by U.S. institutional investors. Cash and cash equivalents totaled €12.3 million as of June 30, 2015.

 

“In first half of 2015, we actively pursued the development of IFNα-Kinoid, our lead active immunotherapy product while maintaining tight control on expenses. The funds we raised during June in the U.S. have strengthened our cash position and given us the means to move forward on two key programs for IFNα-Kinoid: first in SLE with the launch of IFN-K-002, a Phase IIb clinical trial of IFNα‑Kinoid ; secondly in dermatomyositis with a Phase I/IIa trial expected to commence in the first half of 2016.” commented Miguel Sieler, CEO of Neovacs.


 

HALF-YEAR 2015 FINANCIAL HIGHLIGHTS

 

in K€

June 30, 2015

June 30, 2014

Revenues

94

57

Operating costs

5,714

4,576

Of which R&D

4,724

3,594

Operating profit/loss

-5,620

-4,518

Net financial income/expense

-205

-64

Pretax profit/loss

-5,825

-4,582

Exceptional items

-48

49

Research Tax Credit

1,003

673

Net profit/loss

-4,870

-3,861

 

Anticipated increase in R&D costs with the inititation of IFN-K-002 clinical trial in SLE

 

Operating costs were €5.7 million for the six months ended June 30, 2015, a 25% increase compared to the period ended June 30, 2014. This increase was primarily the result of the initiation of the Phase IIb clinical trial of IFNα‑Kinoid in SLE. R&D expenses were 82% of the Company’s total operating costs for the first half of 2015, totaling €4.7 million compared to €3.6 million in the same period last year. General and administrative expenditures remained under tight control while Neovacs increased  focus on its emerging R&D effort.

 

Consequently, half-year operating losses increased 24% to €5.6 million, in line with Company expectations. This compares to €4.5 million in operating losses in the first half of 2014.

 

 After taking into account €1 million in Research Tax Credit, the net loss for the six months ended June, 30 2015 was €4.8 million compared to €3.9 million for the same period in 2014.

 

 

Significant strengthening of financial resources

 

Neovacs raised €7.5 million in June 2015 through a capital increase subscribed by three U.S. institutional investors. The funds raised significantly improved the Company’s cash position and strengthened its financial visibility.

 

To address its long term financing needs, Neovacs secured a flexible, multiyear equity financing with Kepler Cheuvreux in November 2014. As stated previously, this equity line, through which Neovacs can access up to €20 million is arranged in three tranches of optional equity financing, one of €7 million and two of €6.5 million each. However, Neovacs has committed not to use this equity financing until after December 31, 2015.

 

As a result, available cash balances as of June 30, 2015 were €12.3 million, compared to €2.9 million as of June 30, 2015. Neovacs believes it has the financial resources to cover its expenditures until September 2016. To increase its cash runway, the Company reserves the possibility to utilize the 3rd tranche of optional equity financing set up with Kepler Cheuvreux.

 

 

 

HALF-YEAR 2015 CLINICAL AND OPERATIONAL HIGHLIGHTS

 

-          New members joined Neovacs’ Scientific Advisory Board (SAB) to support the shift in therapeutic focus, with a greater emphasis on pathologies targeted by IFNα-Kinoid and VEGFα‑Kinoid. Professor Banchereau, Ph.D., remained SAB chairman. The SAB guides Neovacs’ clinical development strategy.

 

-          Preparation of IFN-K-002, a Phase IIb trial to assess the biological efficacy and clinical response of IFNα-Kinoid in moderate to severe forms of SLE in 19 countries in Europe, Asia and Latin America. The Company plans to file an IND for a trial in SLE with IFNα-Kinoid (Phase IIa) in the U.S. in early 2016.

 

-          Expansion IFNα-Kinoid’s clinical program to dermatomyositis, an orphan indication in which a positive IFNα signature plays a decisive role. Neovacs plans to conduct a multi-center Phase I/IIa trial of IFNα-Kinoid in adult dermatomyositis in 30 patients in 2016.

 

-          Strengthening of U.S. presence with the formation of a wholly-owned U.S. subsidiary, Neovacs, Inc., headquartered in Boston. The role of Neovacs, Inc. will be to raise the profile of the Company within the medical and financial communities in the U.S.. Neovacs, Inc. will work directly with the U.S. Food and Drug Administration as the Company prepares to initiate clinical trials in the U.S.

 

-          Collaboration agreement with Stellar Biotechnologies. The two companies entered into an expanded supply agreement to meet Neovacs’ requirements for Keyhole Limpet Hemocyanin (KLH), a primary component of Neovacs’ proprietary Kinoid immunotherapy technology, for its planned clinical trials and for expected commercial manufacturing of IFNα-Kinoid.

 

 

SUBSEQUENT EVENTS AND OUTLOOK

 

-          Initiation of Phase IIb clinical trial in SLE. Neovacs has begun enrolling patients in IFN-K-002, a Phase IIb clinical trial to evaluate the efficacy of IFNα-Kinoid in SLE, after being granted first approvals by regulatory agencies and ethics commitees in several European countries. The first centers of the trial are now active. Results of the clinical trial are expected in the first quarter of 2017.

 

-          Presentation of extended follow-up data of IFNα-Kinoid in SLE during Lupus 2015, the 11th International Congress on Systemic Lupus Erythematosus (SLE), which took place from September 2-6, 2015 in Vienna, Austria[1]. Collected as part of the extended follow-up study of the Phase I/IIa trial of IFNα-Kinoid in lupus, this new data demonstrates that IFNα-Kinoid induces a lasting, polyclonal, neutralizing anti-IFNα response in SLE patients.



[1]J. Ducreux, et Al, Lupus 2015, Poster Session P04 Treatment.

Neovacs initiates phase IIb trial of IFNα-Kinoid for the treatment of lupus

Paris and Boston, September 24, 2015 – NEOVACS (Alternext Paris: ALNEV), a leader in active immunotherapies for the treatment of autoimmune diseases, announced today it has begun enrolling patients in IFN-K-002, a Phase IIb clinical trial to evaluate the efficacy of IFNα-Kinoid, Neovacs’ lead active immunotherapy product candidate, to treat Systemic Lupus Erythematosus (“SLE” or “lupus”).

 

“With the initiation of this Phase IIb study, we have reached an important milestone in the development of IFNα-Kinoid. The first centers of the trial are now up and running, with more centers planned to open in the coming weeks, which will accelerate the recruitment for the study. IFN-K-002 is a key trial for Neovacs, and for our active immunotherapy approach to the treatment of lupus. Lupus affects millions of patients worldwide, most of whom have no access to biological treatments” commented Miguel Sieler, CEO of Neovacs.

 

Phase IIB trial design for IFN-K-002 in SLE


IFN-K-002 is a double-blind, randomized, placebo-controlled, multi-center Phase IIb clinical study to assess the biological and clinical efficacy of IFNα-Kinoid in patients suffering from SLE. The study aims to enroll 166 patients in Europe, Asia and Latin America. The co-primary endpoints for the trial are biogical efficacy and clinical efficacy nine months after first treatment with IFNα-Kinoid. Biological efficacy is defined as IFNα-signature neutralization, while  clinical efficacy will be measured by the BILAG-based[1] Composite Lupus Assessment (BICLA) response.

 

Results of the clinical trial are expected in the first quarter of 2017.



[1] The British Isles Lupus Assessment Group (BILAG) is a validated index to measure lupus disease activity listed in FDA guidance on lupus. See FDA Systemic Lupus Erythematosus working group report at : www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM072063.pdf#sthash.qR2f2REj.dpuf

Neovacs confirms potent and long-lasting biological activity of IFNα-Kinoid 4 years after patient dosing in phase I/IIa trial

Paris and Boston, September 9, 2015 – NEOVACS (Alternext Paris : ALNEV), a leader in active immunotherapies for the treatment of autoimmune diseases, today announced that it presented extended follow-up data from the Phase I/IIa clinical trial of IFNα-Kinoid during Lupus 2015, the 11th International Congress on Systemic Lupus Erythematosus (SLE), which took place from 2 to 6 September 2015 in Vienna, Austria.

The results we presented at Lupus 2015 show that our lead product candidate induces a lasting, polyclonal, neutralizing anti-IFNα response in SLE patients. This is an extremely positive sign as we are about to launch the Phase IIb trial of IFNα-Kinoid in SLE” commented Thérèse Croughs, M.D., Chief Medical Officer of Neovacs.  

This new data[1], collected as part of the Phase I/IIa extended follow-up study of six IFNα-Kinoid-treated patients, demonstrates that anti-IFNα neutralizing antibodies generated by IFNα-Kinoid continue to be present four years after the first immunization, and maintain the normalization of the IFNα signature. This confirms previously reported results[2]

The study also highlights the association between anti-IFNα neutralizing antibodies and the decreased expression of induced genes associated with B cell activation. B-cell activation, like the IFNα-signature, has been linked to the pathogenesis of SLE lupus.[3]

Follow up data from the Phase I/IIa clinical trial was presented in the poster “IFNα-kinoid (IFN-K) induces neutralizing anti-IFNα antibodies that decrease the expression of IFN-induced and B cell activation associated transcripts : Analysis of extended follow-up data from the IFN-K Phase I/IIa study”1 on Friday, September 4, 2015 in Vienna.

 

About the extended follow-up study of Phase I/IIa of IFNα-Kinoid in Lupus

Data was collected on six IFNα-Kinoid-treated patients included in the Phase I/IIa clinical trial of IFNα-Kinoid in SLE or lupus. Five of the six patients presented a positive IFN-signature at baseline. The same level of normalization of the IFN-signature as previously reported was observed in two out of five patients who developed neutralizing antibodies. Correlation in the increase of C3 serum level and neutralizing anti-IFNα antibodies also persisted in the same two patients, confirming previously reported results.



[1]J. Ducreux, et Al, Lupus 2015, Poster Session P04 Treatment.

[2]Neovacs has previously reported the strong level of biological activity of IFNα-Kinoid at 6 months after first immunization with IFNα-Kinoid. See Bernard Lauwerys et al., Down-Regulation of Interferon Signature in Systemic Lupus Erythematosus Patients by Active Immunization With Interferon –Kinoid, Arthritis & Rheumatism Vol. 65, No. 2, February 2013.

[3] Kiefer K, Oropallo MA, Cancro MP, et al. Role of type I interferons in the activation of autoreactive B cells. Immunol Cell Biol 2012

Neovacs receives first regulatory approvals for a phase IIb trial in lupus

Paris and Boston, September 1, 2015 – NEOVACS (Alternext Paris: ALNEV), a leader in active immunotherapies for the treatment of autoimmune diseases, today announced that it has been granted first approvals by regulatory agencies and ethics commitees in several European countries for a Phase IIb clinical trial of IFNα-Kinoid in Systemic Lupus Erythematosus (SLE) or lupus.

The upcoming trial was notably assessed favorably using the Voluntary Harmonization Procedure (VHP) of Europe’s Heads of Medicine Agencies, which allows for a harmonized assessement of clinical trials by relevant national health authorities.  

Acceptance by competent authorities enables Neovacs to initiate IFN-K-002, a Phase IIb clinical study to assess the biological and clinical efficacy of Neovacs’ lead active immunotherapy product candidate IFNα-Kinoid in patients suffering from lupus. Inclusion of first patients is expected to begin in the coming weeks. Approvals from other European, Asian and Latin American countries are expected in the second half of 2015.

Phase IIB trial design for IFN-K-002 in SLE

IFN-K-002 is a double-blind, randomized, placebo-controlled multicentric Phase IIb clinical trial designed to assess the efficacy and safety of IFNα-Kinoid in moderate to severe lupus patients. The study will recruit 166 patients across 19 countries in Europe, Asia and Latin America.

The co-primary endpoints for the trial are biogical efficacy and clinical efficacy nine months after first immunization with IFNα-Kinoid. Biological efficacy is defined as IFNα-signature neutralization, while  clinical efficacy will be measured by the BILAG-based[1] Composite Lupus Assessment (BICLA) response.   

Timelines for the study

Regulatory and ethics committee approvals pave the way for a rapid initiation of the study IFN-K-002. These centers will begin screening and immunizing patients in the coming weeks. Results of the clinical trial are expected in the first quarter of 2017.



[1] The British Isles Lupus Assessment Group (BILAG) is a validated index to measure lupus disease activity listed in FDA guidance on lupus. See FDA Systemic Lupus Erythematosus working group report at : www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM072063.pdf#sthash.qR2f2REj.dpuf

Neovacs announces closing of 7.5 M Euro capital increase with U.S. investors

Paris and Boston, July 2, 2015 – Neovacs (Alternext Paris: ALNEV), (the “Company”) a leader in active immunotherapies for the treatment of autoimmune diseases, today announced the successful closing of the 7.5 million euros share capital increase subscribed by U.S. institutional investors on June 25, 2015.

Following this transaction, Neovacs’ share capital totals 4,808,446.50 euros divided into 32,056,310 shares, representing a dilution of 23.40% for existing shareholders.

The proceeds of the capital increase will provide additional funding to the Company to finance the development plan of IFNα-Kinoid, including:

  • A phase IIb clinical trial of IFNα-Kinoid in lupus conducted in Europe, Latin America and Asia, to begin in the second half of 2015; and
  • A phase IIa clinical trial of IFNα-Kinoid in lupus conducted in the United States. This study is expected to begin six months after initiation of the phase IIb clinical trial of IFNα-Kinoid, and will provide additional, U.S.-specific, data to the results previously obtained in Europe[1].

Maxim Group LLC acted as sole placement agent in connection with the capital increase.



[1] Results of a Phase I/II clinical trial of IFNα-Kinoid were published in November 2011 at ACR and published in 2013 in Rheumatoid & Arthritis (Lauwerys, 2013)

Neovacs raises 7.5 million euros in capital increase with U.S. investors

Paris and Boston, June 26, 2015 – Neovacs (Alternext Paris: ALNEV), (the “Company”) a leader in active immunotherapies for the treatment of autoimmune diseases, today announced that it has received commitments from three U.S. institutional investors for a capital increase totaling 7,500,000 euros.

 

Participation in the capital increase is limited to biotechnology-focused institutional investors. Neovacs will issue a total of 7,500,000 securities at a price of one euro (premium included). Each security is composed of one ordinary share and one warrant. The warrants will be immediately detached from the shares.

 

This capital increase is in line with our development strategy in the United States, a country which has a very high prevalence of lupus and is the reference market for this indication. The funds raised will enable us to move forward with the development of our product portfolio including lead product, IFNα-Kinoid, with new trials starting both in lupus and dermatomyositis. The subscription commitments made by specialists funds in biotechnology are a strong signal in support of our Kinoid technology and our strategy based on the development of active immunotherapies for the treatment of severe and orphan auto-immune diseases with significant medical need commented Miguel Sieler, CEO of Neovacs.  

   

Use of Proceeds       

 

The proceeds of the capital increase will provide additional funding to the Company to finance the development plan of IFNα-Kinoid, including:

  • A phase IIb clinical trial of IFNα-Kinoid in lupus conducted in Europe, Latin America and Asia, to begin in the second half of 2015; and

  • A phase IIa clinical trial of IFNα-Kinoid in lupus conducted in the United States. This study is expected to begin six months after initiation of the phase IIb clinical trial of IFNα-Kinoid, and will provide additional, U.S.-specific, data to the results previously obtained in Europe[1].

 

 

Terms of the capital increase

 

The capital increase was approved by the Company’s Board of Directors on June 24, 2015. It will be carried out without preferential subscription rights and reserved to the benefits of foreign institutional investors investing in biotechnology companies on a regular basis, in accordance with the eleventh resolution of the Company’s Annual General Meeting of Shareholders held on April 8, 2015.

 

The capital increase amounts to 30.54% of the share capital of the Company to date and represents a dilution of approximately 23.40% for existing shareholders.

 

The settlement of the new shares should take place (subject to usual market conditions) no later than July 3, 2015.

 

In accordance with Article 211-3 of the General Regulation of the French Financial Market Authority (AMF), the capital increase does not require a prospectus to be submitted for approval to the AMF.

 

Characteristics of the warrants

 

One warrant will give the right to subscribe to 0.37732 ordinary share of the Company, that is a potential dilution of 10.33% for existing shareholders.

 

The warrants shall be exercisable within 60 months of their issuance. They will not be listed on the Alternext Paris market.

 

The warrants shall be exercisable at 1.25 euros per ordinary share.

 

If all the warrants are exercised, the Company would receive an additional 3,537,500 euros of proceeds.

 

Listing of the new shares

 

The new shares, with a par value of 0.15 euro, will be of the same category as the existing shares of the Company and will be listed on the same line as the existing shares of the Company under ISIN code FR0004032746. They will carry the same dividend rights as the existing shares and will be entitled, after issuance, to all dividends declared by the Company from that date.

 

Lock-up agreement of the Company

 

In connection with the capital increase, the Company has agreed to a lock‐up period of 90 days following the issuance of the new shares, subject to standard exemptions. The Company has further undertaken not to use the equity financing agreed in October 2014 between Kepler Chevreux and the Company, until after December 31, 2015.

 

Equity line of Kepler Chevreux

 

Neovacs could utilize, when needed, two additional tranches of equity financing, totaling 6,500,000 euros each, as from January 1, 2016 and over a fixed period of 17 months, based on the same terms as the equity line previously announced. As previously announced, Neovacs intends to draw down on these purely optional equity lines only if needed, in the best interest of the Company and its shareholders.

Lock-up agreements of certain managers of the Company

 

Mr. Miguel Sieler (CEO) and the directors holding shares and warrants[2] of the Company have entered into lock-up undertakings for 90 days following the issuance of the new securities with respect to 100% of the securities of the Company they hold (including the shares resulting from the exercise of their warrants).

 

Risk factors

 

Neovacs draws investors’ attention to the June 2015 update to the risk factors of the Reference Document registered under the number R-14.074 of December 11, 2014, available on the website of the Company at the following address: http://neovacs.fr/investors/investors-documentation/.

 

Advisors

 

Maxim Group LLC acted as sole placement agent in connection with the capital increase.



[1] Results of a Phase I/II clinical trial of IFNα-Kinoid were published in November 2011 at ACR and published in 2013 in Rheumatoid & Arthritis (Lauwerys, 2013)

[2] “BSPCE 2007”, “BSA 2014-1” or “BSA 2015-1” depending on the director

Neovacs initiates clinical program in Dermatomyositis

  • Extension of IFNα-Kinoid program to include Dermatomyositis
  • Formation of Clinical Advisory Board
  • Anticipated trial launch early 2016

 

Paris and Boston, June 16, 2015 – NEOVACS (Alternext Paris: ALNEV), a leader in active immunotherapies for the treatment of autoimmune diseases, today announced the launch of its clinical development program in Dermatomyositis (DM), an orphan skin and muscular condition with significant unmet medical need.

Neovacs is extending its IFNα-Kinoid clinical program beyond  lupus to include adult and pediatric DM – an indication where a positive IFNα signature plays a decisive role[1]. The decision follows a recommendation earlier this year by the Company’s Scientific Advisory Board to pursue IFNα-Kinoid as a potential treatment for DM and extensive due diligence in researching IFN-related diseases that could benefit from this treatment modality. Neovacs plans to conduct a multicentric phase I/IIa trial of IFNα-Kinoid in adult DM in 15 patients which is anticipated to launch in early 2016 in France and other European countries.

“Dermatomyositis demonstrates a promising therapeutic candidate pipeline expansion, given the demonstrated role of IFNα in this auto-immune disease. As DM is an orphan condition, this is also an opportunity to bring needed relief to thousands of patients, most of them children, for whom there is currently no satisfactory biotherapy,” commented Miguel Sieler, CEO of Neovacs. “We believe that the IFNα-Kinoid in DM will be a development driver for Neovacs, with a limited impact on expenditures. Neovacs will apply for grants dedicated to rare diseases to support the funding of the DM program.”

DM is an inflammatory disease characterized by severe skin lesions and muscle weakness with a variable impact on physical capacities. DM can also affect the vascular, pulmonary, gastrointestinal and cardiac systems. Approximately one third of DM patients will develop cancer within three years[2]. DM affects primarily children, and mostly females. No biological treatment has been registered to date in this indication.

With a prevalence between 1 in 50,000 and 1 in 10,000 cases[3], DM is considered an orphan disease both in North America and in Europe. It is estimated that there are currently approximately 87,000 patients[4] with DM in the EU. Because of the recognized orphan status of DM, Neovacs estimates that clinical development of IFNα‑Kinoid in this indication could be considerably shortened, with the potential to bring a treatment to patients in a few years.


Formation of a Clinical Advisory Board

To sustain and support it in this endeavor, Neovacs has formed a cross disciplinary Clinical Advisory Board (CAB) composed of leading experts in DM:

  • Prof. Olivier Benveniste, M.D., Ph.D.,
    Hôpital Pitié-Salpêtrière, Paris
  • Prof. Eric Hachulla, M.D., Ph.D.,
    Centre Hospitalier Regional Universitaire de Lille, France
  • Dr. Jean-David Bouaziz, M.D.,Ph.D.,
    Hôpital Saint-Louis, Paris
  • Prof. Werner Stenzel, M.D. ,Ph.D.,
    Charité Universitätmedizin Berlin
  • Prof. Ingrid Lundberg, M.D.,
    Karolinska Universitetssjukhuset, Stockholm

These board members will be instrumental not only in bringing their expertise to Neovacs in preparing for and defining the metholodology, target population, and evaluation criteriafor the DM trial; but also in assisting with trial development and patient recruitment.

The IFNα-Kinoid program in DM could be initiated as early as 2016.



[1] Baechler, ART 2011; Wong, Plos One 2012; Greenberg, Genes immun 2012; Shiba, Rheumatol Int 2014

[2] http://www.orpha.net/consor/cgi-bin/OC_Exp.php?Expert=221

[3] Ibid

[4] Estimated population assessed taking into account a 1.7/10,000 prevalence in the European Union, and a total EU population of 511,100,000 (Eurostat 2014). Source: EMA/COMP/660609/2014, 12 January 2015

Neovacs to present at 2015 BIO International Convention

Company to Highlight Active Immunotherapy Platform Focused on  Autoimmune Diseases and Cancer

 

 

Paris and Boston, June 3, 2015 – NEOVACS (Alternext Paris: ALNEV), a leader in active immunotherapies for the treatment of autoimmune diseases and solid tumors, announced today that it has been selected to present at the 2015 BIO International Convention to be held in Philadelphia, June 15-18, 2015.

 

Neovacs has strengthened its position in the U.S. since 2014, notably with :

-          The installation of its Scientific Advisory Board in New York City;

-          The creation of a U.S. subsidiary, Neovacs, Inc, in Boston;

-          The preparation of U.S.-based clinical trials with IFNα-Kinoid;

-          Participation in key U.S. investor conferences

 

Neovacs‘ participation at BIO 2015 corresponds with these U.S. expansion efforts. Neovacs will have its own booth within the French Pavillion[1] where CEO Miguel Sieler will present recent information on the Company’s proprietary active immunotherapy platform for the treatment of auto-immune diseases and solid tumors on Tues., June 16 at 4:15 p.m. EDT.

 

BIO International Convention is the world’s largest biotechnology convention, gathering several thousand companies from the global biotechnology and pharmaceutical industry. More information on BIO 2015 is available at http://convention.bio.org/2015/.



[1] http://convention.bio.org/pavilions/

BioEquity 2015

Néovacs has been selected to present at BioEquity Europe 2015 to be held in Vienna, on May 19 and 20, 2015.

Miguel Sieler, CEO of Neovacs, will present recent information on Neovacs’ proprietary active immunotherapy platform on May 20, 2015 at 2:20 pm CET (Central European Time).

Neovacs granted 1.8 million euros in research tax credit

Paris and Boston,  May 13, 2015 – NEOVACS (Alternext Paris : ALNEV), ), a leader in active immunotherapies for the treatment of autoimmune diseases, today announced that it has received €1.8 million in research tax credit for R&D expenses incurred in 2014.

 

The funds received through the tax credit will be used to fund the clinical and pre-clinical development of Neovacs’ therapeutic vaccines portfolio.

 

“We are actively pursuing the clinical development of IFNα-Kinoid in lupus and dermatomyositis, while carefully controlling our expenditures. The phase IIb clinical trial of IFNα-Kinoid in lupus will be initiated in the coming months in Europe, Asia and Latin America; it will be followed by a phase I/II trial in the U.S. in early 2016” commented Miguel Sieler, Chief Executive Officer of Neovacs.

 

The anticipated paiement of the research tax credit for 2014 was obtained through a pre-financing mechanism put in place with NEFTYS Conseil.

ChinaBio Partnering Forum

Néovacs has been selected to present at the seventh annual ChinaBio® Partnering Forum 2015 to be held in Shanghai, April 15 and 16, 2015.

Miguel Sieler, CEO of Neovacs, will present recent information on Neovacs’ proprietary active immunotherapy platform on April 15, 2015 at 2:30 pm CST (China Standard Time).

Neovacs to Present at China BIO Partnering Forum

Paris and Boston,  April 14, 2015 – NEOVACS (Alternext Paris: ALNEV), a leader in active immunotherapies for the treatment of autoimmune diseases, announced today that is has been selected to present at the seventh annual ChinaBio® Partnering Forum 2015 to be held in Shanghai, April 15 and 16, 2015.

This life science industry event is expected to attract over 800 attendees from around the world focused on partnering opportunities and cross-border relationships in China.

Miguel Sieler, CEO of Neovacs, will present recent information on Neovacs’ proprietary active immunotherapy platform on April 15, 2015 at 2:30 pm CST (China Standard Time).  China has a high prevalence of Systemic Lupus Erythematosus (SLE) or lupus, an autoimmune  disease characterized by a significant unmet medical need. Several Chinese pharmaceutical companies have shown interest in the potential for an innovative, affordable biological treatment option, such as Neovacs’ lead product candidate, IFNα-Kinoid.

Stellar Biotechnologies and Neovacs S.A. Expand KLH Supply Relationship

 PORT HUENEME, CA and PARIS, FRANCE, April 1st, 2015 — Stellar Biotechnologies, Inc. (“Stellar” or the “Company”) (OTCQB: SBOTF) (TSX-V: KLH) and Neovacs S.A., (“Neovacs”) (Alternext Paris: ALNEV) today announced that the Companies have entered into an expanded supply agreement to meet Neovacs’ requirements for Keyhole Limpet Hemocyanin (KLH), a primary component of Neovacs’ proprietary Kinoid immunotherapy technology.

 

The new agreement extends and expands the supply contracts previously in place between the Companies, in order to ensure the continued supply of Stellar KLH™ to Neovacs during its Kinoid clinical trials and to support the expected commercial roll-out of Neovacs’ lead product candidate IFNα-Kinoid, an immunotherapy being developed for the treatment of systemic lupus erythematosus (“lupus”).

 

Stellar is a leader in the sustainable manufacture of KLH, an immune-stimulating protein widely used as a carrier molecule in immunotherapies under development for a variety of disease indications. Immunotherapy uses a patient’s own immune system to target and treat diseases. KLH can only be produced from a scarce marine source. Stellar believes it is the only company with the proprietary technology to manage sustainable, scalable production of GMP quality KLH to meet future pharmaceutical industry demands.

 

Neovacs is a leader in the development of active immunotherapies for the treatment of chronic autoimmune diseases. Neovacs’ patented Kinoid technology combines a select cytokine of interest attached to KLH as the immune-stimulating carrier protein. The resulting immunotherapy uses the patient’s immune system to generate antibodies against the targeted disease.

 

Neovacs’ lead product candidate, IFNa-Kinoid, has successfully completed a Phase I/IIa clinical trial for lupus. The Company’s Scientific Advisory Board (SAB) members have announced their full support for the planned Phase IIb trial of IFNα-Kinoid in approximately 160 patients in Europe, Latin America and Asia. This Phase IIb study is expected to begin mid-2015. A U.S. Phase IIa trial of IFNα‑Kinoid for the treatment of lupus in the U.S. is expected to commence by early 2016.

 

We have enjoyed a long-standing and successful relationship with Stellar Biotechnologies as our key KLH supplier,” said Miguel Sieler, Chief Executive Officer of Neovacs. “This new agreement with Stellar comes at a pivotal point for Neovacs, as we are preparing to launch multicenter clinical trials with IFNα‑Kinoid and are strengthening our U.S. operations through the recent formation of a wholly-owned subsidiary, Neovacs, Inc. The new supply agreement will ensure that Neovacs has access to a scalable, stable supply of GMP grade KLH as our Kinoid products advance through clinical development and we prepare for the expected commercial launch.

 

Expanding our supply commitment to Neovacs to include late-stage clinical trials and expected initial commercialization is an excellent demonstration of the growing commercial prospects for our core KLH business,” said Frank Oakes, President and CEO of Stellar Biotechnologies. “We also see this is as positive validation for the use of Stellar KLH™ in the development of new immunotherapy treatments.”

 

Under the terms of the agreement, Neovacs will purchase Stellar KLH™ for use in its proprietary KLH‑based Kinoid immunotherapies in the European Union, Latin America, Asia, the U.S. and Canada. Neovacs will use Stellar KLH™ for its planned Phase II and Phase III clinical trials and for expected commercial manufacturing of its products for up to one year following market approval. Neovacs will manage and fund all product development and regulatory submissions for its immunotherapy products and act as the sponsor company for the future clinical trials. Stellar will supply GMP grade KLH to Neovacs according to agreed specifications, quantities, and pricing, as well as maintain a master file with the U.S. FDA for the KLH product. Stellar will also provide professional, technical, and regulatory support to Neovacs. The agreement has an initial five-year term, which may be renewed by Neovacs in one-year increments.

Néovacs renforce son engagement américain avec sa filiale, Néovacs, Inc.

Paris, le 23 mars 2015 – NEOVACS (Alternext Paris : ALNEV, FR0004032746, éligible PEA-PME), acteur majeur de la vaccination thérapeutique pour le traitement des maladies auto-immunes, annonce aujourd’hui la création à Boston de sa filiale américaine, Neovacs, Inc. La création de cette société américaine s’inscrit dans la dynamique stratégique d’extension des programmes de recherche clinique de Néovacs sur le marché américain. Elle intervient quelques mois seulement après la formation d’un Comité Scientifique International à New York en octobre 2013.


Neovacs, Inc. aura pour Présidente Arlène Morris, membre du Conseil d’Administration de Néovacs S.A. et Directeur Général de Syndax Pharmaceuticals. Miguel Sieler, Directeur Général de Néovacs S.A., assumera également cette fonction auprès de la filiale américaine.

 

« La création de notre filiale américaine est une étape essentielle dans la mise en place des prochains essais cliniques de l’IFNα-Kinoïde dans le lupus et la dermatomyosite aux États-Unis. La prévalence de lupus y est en effet la plus élevée au monde, avec plus d’1,5 million de cas recensés[1]. Le besoin médical insatisfait dans cette pathologie y crée une opportunité de marché unique pour le développement de l’IFNα-Kinoïde, qui a, d’après les données cliniques que nous avons obtenues à ce jour, le potentiel pour devenir le traitement de référence dans le lupus, à même d’apporter une solution thérapeutique à des milliers de patients » commente Miguel Sieler, Directeur Général de Néovacs.

 

Néovacs devrait initier aux États-Unis début 2016, un essai clinique de phase IIa de l’IFNα-Kinoïde dans le lupus. Les prochaines études de l’IFNα-Kinoïde dans la dermatomyosite, actuellement en cours de préparation et qui seront initiés à court-moyen terme, comporteront également un volet américain. La dermatomyosite est une maladie orpheline caractérisée par des inflammations dermatologiques et musculaires graves.

 

Le rôle de la filiale américaine de Néovacs sera d’accroître la visibilité de Néovacs auprès de la communauté médicale et financière. Sa première mission consistera à introduire auprès de la FDA les demandes d’autorisations règlementaires pour mener les prochains essais cliniques de l’IFNα-Kinoïde, et notamment la demande de statut de médicament orphelin pour son traitement contre la dermatomyosite. Neovacs, Inc. sera également chargée de co-diriger, en collaboration avec Néovacs S.A., ces études cliniques avec la société de recherche clinique et les centres investigateurs américains, ainsi que de renforcer l’engagement de Néovacs auprès des investisseurs américains suite aux différentes réunions investisseurs réalisées à New York ces 12 derniers mois.

 

Neovacs, Inc. sera basée au cœur du secteur de la biotechnologie à Boston, au sein du French Tech Hub.



[1] Source : Lupus Foundation of America

Neovacs strengthens american presence with formation of U.S. subsidiary

Paris, March 23, 2015 – NEOVACS (Alternext Paris : ALNEV, FR0004032746), a leader in active immunotherapies for the treatment of autoimmune diseases, is proud to announce the establishment of its wholly-owned U.S. subsidiary, Neovacs, Inc. Neovacs, Inc. is headquartered in Boston and has been incorporated in Delaware. The creation of this U.S. subsidiary marks an important strategic step for Neovacs, as the Company extends its clinical initiatives for lead product candidate, IFNα-Kinoid, beyond the EU to the U.S. market. The establishment of this subsidiary follows the formation of a U.S. Scientific Advisory Board in October 2013.

 

Arlene Morris, Director of Neovacs and CEO of Syndax Pharmaceuticals, has been named Chairman of Neovacs, Inc. Miguel Sieler, current CEO of Neovacs will also hold the position of CEO of the subsidiary.

 

“We are thrilled to expand our U.S. operations through the formation of Neovacs, Inc., and believe that the subsidiary will be instrumental to our ongoing clinical and regulatory efforts in support of IFNα‑Kinoid in systemic lupus erythematosus (“lupus”) and dermatomyositis. The United States has the world’s highest lupus prevalence, totaling over 1.5 million reported cases[1], and the unsatisfactory treatment options create a substantive opportunity for Neovacs as we continue to advance IFNα-Kinoid for this indication. Based on our analysis of IFNα-Kinoid to date, we believe the compound has significant potential in the treatment of lupus, and look forward to the ongoing development of the product as we work to bring potential relief to this large patient population,” commented Miguel Sieler, CEO of Neovacs.

 

Neovacs plans to launch a phase IIa clinical trial of IFNα-Kinoid in this indication in early 2016. The Company is also planning to launch further U.S. trials of IFNα-Kinoid in dermatomyositis, an orphan skin and muscular disease, in the short-to-mid term.

 

The role of Neovacs, Inc. will be to raise the profile of Neovacs with the medical and financial communities in the U.S.. Neovacs, Inc. will work directly with the U.S. Food and Drug Administration as the Company prepares to initiate its planned lupus and dermatomyositis trials, including securing all regulatory approvals and potential orphan drug status for IFNα-Kinoid in dermatomyositis. Additionally, Neovacs, Inc. will co-lead with Neovacs all U.S. clinical trials, in coordination with contractors and research centers, and strengthen also Neovacs’ engagement with American investors.

 

Neovacs, Inc. will be located in Boston within the French Tech Hub.



[1] Source: Lupus Foundation of America

Neovacs strengthens scientific leadership through executive appointments

  • Therese Croughs, M.D., named Chief Medical Officer
  • Géraldine Grouard-Vogel, Pharm.D., Ph.D., appointed Chief Scientific Officer

Paris, March 11, 2015 – NEOVACS (Alternext Paris : ALNEV – FR0004032746), a leader in active immunotherapies for the treatment of autoimmune diseases, today announced the enhancement of its scientific leadership team with the appointment of Therese Croughs, M.D., as Chief Medical Officer, effective immediately. Dr. Croughs replaces Pierre Vandepapeliere who is leaving the Company to pursue other opportunities. Additionally, Géraldine Grouard-Vogel, Pharm.D., Ph.D., has been promoted from Head of Research and Preclinical Development to Chief Scientific Officer.

 

Jean-Jacques Bertrand, Chairman of Neovacs, commented, “We are  proud to welcome Therese to the Neovacs team. Her expertise in immunology and oncology, and extensive experience in defining worldwide clinical development programs for immunotherapies and biologics will be instrumental for Neovacs at such a critical time in our clinical development. We plan to launch two clinical trials in lupus with IFNα-Kinoid in the coming months, and we are preparing to initiate the development of IFNα-Kinoid in dermatomyositis, with every intention of a rapid entry into the clinic.”

 

 “Therese will be supported in this effort by Géraldine Grouard-Vogel, our new Chief Scientific Officer, who has been a cornerstone of our R&D initiatives for the last 10 years. I am particularly pleased to see her take an even greater strategic role within our company, and have the utmost faith that she will thrive in this new position. We thank Pierre for his dedication to the Company and his contributions to strengthening Neovacs’ scientific capabilities over the last seven years. We wish him the best in his future endeavors,” Bertrand said.

 

Dr. Croughs brings more than 20 years of drug development and regulatory affairs experience to the CMO position at Neovacs. Her experience includes work with companies of a variety of sizes in various stages of clinical development in the pharmaceutical and biotechnology industries across Europe, North America and Asia. Dr. Croughs will lead the clinical development programs for IFNα-Kinoid in lupus and dermatomyositis, while and preparing for the launch of the VEGF-Kinoid development program.

 

Dr. Croughs began her career in the pharmaceutical industry at Bayer, where she worked on the design, implementation and oversight of clinical trials and product registrations, notably r-FVIII for haemophiliac patients. After 10 years at Bayer, she joined Novo Nordisk where she served as international medical adviser for EU clinical developments of r-FVIIa in severe haemorrhages. Dr.Croughs entered the biotechnology industry in 2004 as the Director of the Adhesive Technology and New Projects Business Units of BioAlliance Pharma. Prior to joining Neovacs, Dr. Croughs was Chief Medical Officer at Cytheris for over six years, where she  notably defined the R&D strategy for the worldwide development plan of Cytheris’ immunotherapy program r-hIL-7 (growth factor for the immune system). Dr. Croughs has a medical degree from the Catholic University of Louvain, Brussels, Belgium.

 

Géraldine Grouard-Vogel, Pharm.D., Ph.D., who is currently the Director of R&D and preclinical development, has been promoted to the role of Chief Scientific Officer of Neovacs. Dr. Grouard-Vogel’s new role as CSO, will allow her to oversee all scientific developments for Neovacs and play a greater role in promoting Neovacs’ preclinical and clinical portfolio candidates.

 

Dr. Grouard-Vogel joined Neovacs in 2005 and has more than 12 years of pharmaceutical development experience in the U.S. She previously worked at Sanofi-Pasteur USA in bacterial vaccine development. Prior to entering the biotechnology industry, Dr. Grouard-Vogel worked at the Walter Reed Army Institute of Research on dengue vaccine development[1] and at Seattle University studying HIV-dendritic cells interactions. She holds a Degree in Pharmacy from Angers University (France) and a Ph.D. in immunology – conducted with Pr. Jacques Banchereau at Schering-Plough Lyon (France). Dr. Grouard-Vogel has authored several scientific publications in peer-reviewed journals and patents. She discovered the plasmacytoid dendritic cell[2] and demonstrated the presence of dendritic cells in germinal center[3] and dendritic cells as the first target for dengue virus1. She has also authored several patents regarding the Kinoid technology.



[1] Nature medicine 2000

[2] Grouard et al., Journal of experimental medicine, 1997

[3] Grouard, Nature, 1996

Neovacs Scientific Advisory Board endorses company’s updated IFNα-Kinoid development plan

  • IFNα-Kinoid program to target Systemic Lupus Erythematosus (SLE) as first indication

 

  • Important pipeline extension to dermatomyositis, an orphan condition linked to IFNα

 

  • SAB concludes final review of TNF-Kinoid Phase IIb data

 

Paris,  March 4, 2015 – NEOVACS (Alternext Paris : ALNEV), a leader in active immunotherapies for the treatment of autoimmune diseases, today provided details about its updated clinical path forward, focusing on IFNα-Kinoid. The Company’s decision to focus on IFNα-Kinoid was based on conclusions from its international Scientific Advisory Board (SAB) meeting, which took place in New York on February 12, 2015.

 

Neovacs’ international SAB, comprised of leaders in immune therapy, chronic inflammatory and autoimmune diseases, reviewed the Company’s clinical results and development plans, and made the following recommendations to the management.

 

Moving forward with IFNα-Kinoid in Systemic Lupus Erythematosus (SLE)


Neovacs’ SAB reviewed the pre-clinical trials of IFNα-Kinoid, conducted from 2005-2009, as well as the results of the Phase I/IIa trial on 28 patients which concluded in 2011 (Lauwerys et al., Arthritis & Rheumatism, 2013).  Study results demonstrated:

 

-          The Kinoid was well tolerated by patients;

-          Patients experienced a strong immune response with a significantly higher production of binding antibodies than that observed with the TNF Kinoid in humans;

-           significant production of antibodies with strong neutralizing capacity.

 

The SAB further reviewed a comparative analysis conducted by Neovacs in 2013, evaluating IFNα-Kinoid against ann anti-IFNα monoclonal antibody under clinical development. In this comparative trial, Neovacs’ IFNα-Kinoid achieved strong neutralization of all 13 subtypes of IFNα, while the monoclonal antibody used in the study strongly neutralized only two of these subtypes.[1]

 

Based on these findings, SAB members expressed full support for the forthcoming Phase IIb trial of IFNα-Kinoid in approximatively 160 patients in Europe, Latin-America and Asia. The SAB also made recommendations regarding trial protocol and recruitment criteria, which have been discussed with the Clinical Lupus Board and integrated into the study design. This Phase IIb study is expected to begin mid 2015. A second Phase I/IIa trial for SLE using IFNα-Kinoid in the U.S. is planned to commence by early 2016.

 

Extension of IFNα-Kinoid development program to include dermatomyositis

 

As a result of the positive safety profile and encouraging results from IFNα-Kinoid thus far, the SAB recommended broadening Neovacs’ scope of IFNα-Kinoid treatment targets to dermatomyositis, another indication where a positive IFNα signature plays a decisive role. Clinical trials conducted in this indication further validate the scientific consensus in this matter.

 

Dermatomyositis (DM) is a severe, sometimes fatal, disease affecting mainly children (60 percent of the patient population), with significant unmet medical need as no biological treatment has been registered to date in this indication. Dermatomyositis is considered an orphan disease both in North America and in Europe, where there are fewer than 20,000 affected patients respectively.

 

Following this recommendation, Neovacs is working to rapidly integrate DM in both adult and pediatric patients into the Company’s clinical development plan for IFNα-Kinoid. Because of the recognized orphan status of DM, Neovacs estimates that clinical development of active immunotherapy in this indication could be considerably shortened (phase III trials may not be necessary), with the potential to bring a treatment to market in a few years.

 

Final Review of TNF-Kinoid Phase IIb results in Rheumatoid Arthritis (RA)

 

The final outcome of the February Neovacs’ SAB meeting was the analysis of the Company’s TNF-Kinoid development plan that led to the December 2014 Phase IIb results in RA. Findings included:

 

-          Preclinical results of TNF-Kinoid in a mouse model of arthritis showed significant binding and neutralizing antibody responses, and clinical efficacy nearly identical to the comparator (infliximab), justifying fully the start of clinical development (Delavallée et al., 2009 Arthritis Research & Therapy)

 

-          The results of the Phase IIa RA trial in 40 patients demonstrated a good tolerance of the product, as well as a significant increase of binding anti-TNF antibodies, with indication of an association between antibodies and clinical response (Durez et al, 2014 PlosOne). The protocol and design of Phase IIb trial with TNF Kinoid in RA were informed based on these Preclinical and Phase IIa results.

 

-          The results of the phase IIb trial in RA confirmed both the good tolerance  and the immunogenicity of TFN-Kinoid. However, trial participants’ immune response proved insufficient, with no generation of neutralizing antibodies. The lack of neutralizing antibodies appears to be the most likely explanation for the lack of clinical improvement versus placebo.

 

Neovacs has conducted preliminary analyses following the Phase II trial results in RA and has identified two hypotheses to explain these outcomes:

 

-          The cytokine TNF could be formed in a way that makes it impossible to date to obtain in human a sufficient neutralization with self-antibodies. The lack of success observed by two other companies also working on an active immunotherapy, using different technologies, would support this assumption.

 

-          The strong level of inactivation of the very toxic cytokine TNF, necessary in the production of TNF-Kinoid may have modified the structure of the cytokine, thereby affecting its immunogenicity and inhibiting the production of neutralizing antibodies.

 

Jacques Banchereau, Chairman of Neovacs’ SAB and Director concluded, “Our February session was extremely productive and offers an interesting perspective on Neovacs’ IFNα-Kinoid development program and planned pipeline extension. We also conducted a deep review of the TNF-Kinoid data, and  these conclusions will inform the Company’s ongoing research and development initiatives. It remains very clear for us that results obtained with that Kinoid product are specific to TNF, its target cytokine, and do not preclude in any way the further development of kinoids with other cytokines.”



[1]  Abstract FRI0378 Eular Congress 2014 Paris. Abstract available at https://b-com.mci-group.com/AbstractList/EULAR2014.aspx

Financial Results for 2014

Paris,  February 27, 2015 – NEOVACS (Alternext Paris : ALNEV), a leader in active immunotherapies for the treatment of autoimmune diseases, today announced its full-year 2014 financial results, as approved by its Board of Directors on February 26, 2015.

 

Full Year 2014 Results

 

Summary financial information 

In K€             2014                     2013    
Revenues 161 44
Operating costs 9,815 7,941
    of which, R&D 7,753 6,194
Operating profit / loss -9,654 -7,898
Pretax profit / loss -9,812 -8,028
Exceptional items -7 -10
Research Tax Credit -2,306 -1,148
Net profit / loss -7,513 -6,870

 

Revenues for the year ended December 31, 2014 were €161,046, mainly comprised of the reimbursement of salary and other expenses related to two employees who performed work for another company during 2014 . As Neovacs is still a development stage enterprise, it does not generate sales revenue.

 

Operating costs increased by 22% year-over-year to €9.8 million in 2014, an increase that was primarily the result of the continuation of the Phase IIb clinical study in Rheumatoid Arthritis that the Company initiated in 2013. R&D expenses were 79% of the Company’s total operating costs for 2014, while general and administrative expenditures remained under tight control.

 

Consequently, full-year operating losses were €9.7, an increase compared to 2013 (€7.9 million). After taking into account €2.3 million in Research Tax Credit, the net loss for the year ended 31 December 2014 was €7.5 million. This compares to a net loss of €6.9 million for the same period in 2013.

 

Significant strengthening of financial resources

 

In order to address its long term financing needs, Neovacs secured a flexible, multiyear equity financing with Kepler Cheuvreux in November 2014. The equity line, through which Neovacs can access up to €20 million is arranged in three tranches of optional equity financing, one of €7 million and two of €6.5 million each. Less than half of the first tranche of financing has been utilized to date.

 

Available cash balances as of December 31, 2014 were €5.6 million, in line with the Company’s projections based on its clinical program. Taking into account the equity financing, Neovacs has the financial resources to cover its expenditures for the next 12 months.

 

The Company has no debt and benefits from a sound balance sheet.

 

 

2014 highlights :

 

Phase IIb clinical trial of TNF-Kinoid in Rheumatoid Arthritis (RA)

 

Neovacs initiated mid-2013 a phase IIb clinical trial of TNF-Kinoid in RA, following positive Phase IIa results obtained in 2012[1]. This international, double blind versus placebo study recruited 140 RA patients naïve to anti-TNF treatments. Its primary endpoint was clinical efficacy as measured by changes in DAS28 and ACR20 scores.

 

The results of the clinical trial were published in December 2014. Although the study confirmed the good safety profile and immunogenicity of the product, it failed to meet its primary endpoint. Several hypotheses are currently being evaluated to determine why TNF-Kinoid did not demonstrate clinical efficacy in RA.

 

Preparation of IFNα-Kinoid studies in Systemic Lupus Erythematosus (SLE or lupus)

 

In 2014, Neovacs continued to monitor patients from the phase I/II clinical trial of IFNα-Kinoid in  SLE who still present Kinoid-induced antibody titers. New data generated from this follow-up analysis allowed the Company to present two posters[2],[3] at the EULAR (European League Against Rheumatism) annual meeting in June 2014 and the American College for Rheumatology (ACR) annual meeting in November 2014. These results further support the superiority of a polyclonal antibody strategy over monoclonal antibodies in the treatment of SLE.

 

Based on these positive results, Neovacs made the strategic decision to initiate two clinical trials with IFNα-Kinoid in SLE:

-          A 160-patient phase IIb clinical trial in Europe,  Asia and Latin America;

-          A 50-patient phase I/II clinical trial in the United States

 

Preliminary preparation for the clinical trials began in Q4 2014. Most notably, Neovacs secured a sourcing agreement to supply IFNα. Neovacs also formed a Clinical Advisory Board dedicated to lupus in November 2014.

 

Preclinical development program of VEGF-Kinoid

 

In February 2014, Neovacs resumed preclinical activity on VEGF-Kinoid, an anti-VEGF immunotherapy developed in Age-Related Macular Degeneration (AMD) and solid tumors. Neovacs presented promising results for VEGF-Kinoid in AMD at the EVER conference in 2009[4]. First results from this preclinical activity are expected in the third quarter of 2015, with the goal of initiating clinical studies in 2016 for the most advanced VEGF-Kinoid program.

 

Outlook for 2015 :

 

New members join Scientific Advisory Board (SAB)

Neovacs formed a scientific committee comprised of leaders in immune therapy, chronic inflammatory and autoimmune diseases in October 2014, with the goal of strengthening the Company’s scientific base. The U.S.-based SAB meets several times a year under the Chairmanship of Prof. Jacques Banchereau, PharmD, Ph.D. Neovacs announced changes in its SAB membership to reflect the shift in the Company’s therapeutic focus in favor of IFNα-Kinoid and VEGF-Kinoid in February 2015.

 

Miguel Sieler, Chief Executive Officer of Neovacs, concluded:“Financial results for 2014 are in line with our expectations and reflect a prudent management of expenditures despite the increase in clinical activity over the year. Thanks to a solid cash balance, strengthened by the equity financing in place with Kepler Cheuvreux, we have the financial resources necessary to pursue our clinical development program in 2015. We are integrating what we have learned in our previous trial as we are now focusing our efforts on IFNα-Kinoid and VEGF-Kinoid, two products with vast clinical potential and encouraging preliminary data”.   



[1] Results published in January 2012. Press release here : http://neovacs.fr/news-and-media/press-releases/?y=2012

[2] “Serum IFN-alpha, but not IFN-beta or IFN omega, correlates with IFN signature in SLE patients” EULAR14-SCIE-3726. Abstract available at https://b-com.mci-group.com/AbstractList/EULAR2014.aspx

[3]Potent, broad, and specific neutralizing capacities of polyclonal anti-interferon alpha antibodies induced by IFN-Kinoid in SLE patient” EULAR14-SCIE-3713. Abstract available at https://b-com.mci-group.com/AbstractList/EULAR2014.aspx

[4] European Association for Vision and Eye Research (EVER) 2009, September 30-October 3, Portoroz, Slovenia. Abstract 4352.

BIO Europe Spring 2015

Neovacs will be presenting at the BIO Europe Spring 2015 Partnering Conference to be held in Paris, Porte de Versailles, on March 9-11, 2015.

 

Miguel Sieler, CEO of Neovacs, will present on March 10, 2015 at 4:30 pm C.E.T. Neovacs will be attending the three-day conference with a booth.

 

More information on BIO Europe Spring here.

 

Neovacs to present at BIO Europe Spring 2015

Paris,  January 19, 2015 – NEOVACS (Alternext Paris: ALNEV), a leader in active immunotherapies for the treatment of autoimmune diseases, announced today that the Company will be presenting at the BIO Europe Spring 2015 Partnering Conference to be held in Paris, Porte de Versailles, on March 9-11, 2015.

 

The spring  edition of BIO Europe Conference attracts thousands of representatives from the biotechnology and pharmaceutical industries.

 

Miguel Sieler, CEO of Neovacs, will present on March 10, 2015 at 4:30 pm C.E.T. Neovacs will be attending the three-day conference with a booth.

Neovacs realigns scientific board to support shift in therapeutic focus

Paris,  February 3, 2015 – NEOVACS (Alternext Paris : ALNEV), a leader in active immunotherapies for the treatment of autoimmune diseases, today announced that new members have joined the Company’s Scientific Advisory Board (SAB). Current SAB chairman, Prof. Jacques Banchereau, PharmD, Ph.D. will also join Neovacs’ Board of Directors.

 

Neovacs formed a scientific committee comprised of leaders in immune therapy, chronic inflammatory and autoimmune diseases in October 2014 with the goal of strengthening the Company’s scientific base and increasing international visibility of its innovative technology in the treatment of autoimmune diseases.

 

Recent enhancements to Neovacs’ SAB reflect the change in the Company’s pipeline, with a greater emphasis on pathologies targeted by IFNα-Kinoid and VEGFα-Kinoid. Professor Banchereau will remain SAB chairman.

 

“The new members of the Scientific Advisory Board bring high-level experience in onco-immunology, neuro-immunology and ophthalmology to Neovacs. We are grateful for their participation and look forward to their expert analysis and guidance regarding our clinical and preclinical portfolio,” said Miguel Sieler, Chief Executive Officer of Neovacs.  “We are also very proud to announce that Professor Banchereau has agreed to join our Board of Directors. As a Director, Jacques will play an even greater role in the strategic direction of the Company, including the development of Neovacs’ Kinoid technology.”

 

SAB members include:

 

Prof. Jacques Banchereau, PharmD, Ph.D. (Chairman)

Professor and Director of Immunological Sciences

Jackson Laboratory for Genomic Medicine, Farmington, Conn.

 

 

Prof. Betty Diamond, M.D.

Investigator & Head of Center for Autoimmune and Musculoskeletal Diseases, The Feinstein Institute for Medical Research; Professor of Molecular Biology and Medicine, Hofstra North Shore-LIJ School of Medicine, Manhasset, N.Y.

 

Prof. Napoleone Ferrara, M.D.

Professor of Ophthalmology and Pathology

University of California at San Diego – La Jolla, Calif.

 

Prof. Steve A Greenberg, M.D.

Department of Neurology, Brigham and Women’s Hospital and Children’s Hospital Informatics Program, Harvard Medical School and Harvard-MIT Division of Health Sciences and Technology, Boston

 

Prof. Bernard Lauwerys, M.D., Ph.D.

Professor of Rheumatology

Cliniques Universitaires Saint Luc & Université Catholique de Louvain, Brussels, Belgium

 

Prof. Miriam Merad, M.D., Ph.D.

Professor of Oncological Sciences and Medicine

Tisch Cancer Institute at The Mount Sinai Health System, New York, N.Y.

 

Prof. Virginia Pascual, M.D., Ph.D.

Director, Center for Inflammation and Autoimmune Diseases

Baylor Institute for Immunology Research, Dallas, Texas

 

Laurence Zitvogel, M.D.             

Research Director at INSERM U1015, Gustave Roussy Cancer Center, Villejuif, France

 

The first meeting of the new SAB will be held in New York City on Feb. 12, 2015. Members will discuss the results of Neovacs’ phase IIb study of TNF-Kinoid in Rheumatoid Arthritis and a path forward for this research program. Members will also finalize the development plan for Neovacs’ IFNα-Kinoid therapeutic, including the upcoming clinical trials in lupus and potentially other indications.

 The SAB will meet again in mid-2015 to discuss a development plan for VEGF-Kinoid,   Neovacs’ preclinical therapeutic candidate targeting Age-related Macular Degeneration and solid tumors.