DGAP-News: Neovacs S.A. / Key word(s): Miscellaneous
NEOVACS SCIENTIFIC ADVISORY BOARD ENDORSES COMPANY'S UPDATED
IFNα-KINOID DEVELOPMENT PLAN
04.03.2015 / 08:00
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PRESS RELEASE
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.*
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."
* Abstract FRI0378 Eular Congress 2014 Paris. Abstract available at
https://b-com.mci-group.com/AbstractList/EULAR2014.as
About Neovacs
Created in 1993, Neovacs is today a leading biotechnology company focused
on an active immunotherapy technology platform (Kinoids) with applications
in autoimmune and/or inflammatory diseases. On the basis of the company's
proprietary technology for inducing a polyclonal immune response (covered
by five patent families that potentially run until 2032) Neovacs is
focusing its clinical development efforts on IFNα-Kinoid, an immunotherapy
being developed for the indication of lupus. Neovacs is also conducting
preclinical development works on other therapeutic vaccines in the fields
of auto-immune diseases, oncology and allergies. The goal of the Kinoid
approach is to enable patients to have access to safe treatments with
efficacy that is sustained in these life-long diseases.
For more information about Neovacs, please visit www.neovacs.fr
Contacts
NEOVACS
Nathalie Trépo
+33 (0)1 53 10 93 00
ntrepo@neovacs.com
Press - Financial Communications- Publicis
Stéphanie Tabouis
+33 (0) 1 44 82 46 35
stéphanie.tabouis@consultants.publicis.fr
Investor Relations - Financial Communications Germany - MC Services
Raimund Gabriel
+49-89-210228-30
raimund.gabriel@mc-services.eu
Press - U.S. Inquiries - The Ruth Group
Melanie Sollid-Penton
1.646.536.7023
msollid@theruthgroup.com
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Language: English
Company: Neovacs S.A.
3-5, Impasse Reille
75014 Paris
France
Phone: +33 (0)1 53 10 93 00
Fax: +33 (0)1 53 10 93 03
E-mail: www.neovacs.fr
Internet: info@neovacs.fr
ISIN: FR0004032746
WKN: A1CVKR
Listed: Regulated Unofficial Market in Stuttgart; Open Market in
Frankfurt
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DGAP-News: NEOVACS SCIENTIFIC ADVISORY BOARD ENDORSES COMPANY'S UPDATED IFNα-KINOID DEVELOPMENT PLAN
| Source: EQS Group AG