Paris, May 17, 2010 – Neovacs (Alternext Paris: ALNEV), a biotech company focused on an active immunotherapy
technology platform (KinoidsTM) with applications in the treatment of autoimmune diseases, inflammatory diseases
and cancer, today announced that it has recruited the last two patients into its Phase I/II clinical trial of anti-TNF?
KinoidTM (TNF-K) in Crohn's disease and has administered interferon-alpha KinoidTM (IFN-K) to the first patient in its
Phase I/II trial in lupus.
"These two milestones are consistent with our expectations at the time of our IPO in April; our clinical development
programs are hitting their milestones on schedule. The final results of the Phase I/II trial of TNF-K in Crohn's disease
should be available by the end of this year. We now have three clinical studies underway, with TNF-K in Crohn's
disease (Phase I/II), TNF-K in rheumatoid arthritis (Phase II) and IFN-K in lupus (Phase I/II)", commented Neovacs
CEO Guy-Charles Fanneau de La Horie.
About the Phase I/II trial of TNF-K in Crohn's disease
The trial is an open-label, non-controlled, dose-escalation Phase I/II study with 3 dose levels of TNF-K (60, 180 and
360 mcg) administered at 0, 7 and 28 days or 0, 7, 28 and 168 days in patients with moderate-to-severe Crohn’s
disease. Two patients have received three 60 mcg doses, one has received four 60 mcg doses, seven have received
three 180 mcg doses, two have received four 180 mcg doses, two have received four 360 mcg doses and seven
have received three 360 mcg doses. The last 2 patients recruited will both receive three 360 mcg doses. No
product-related serious adverse events have been reported and none of the patients has withdrawn from the study
for tolerability or safety reasons. The study's primary objective is to assess the KinoidTM's safety and its ability to
induce an immune response to tumor necrosis factor alpha (TNFa). A secondary objective is to look at the
therapeutic effect, as measured by the clinical disease score and markers of disease activity.
"This study is the first to have produced positive immunologic and clinical results with an active, anti-cytokine
immunotherapy in the treatment of a chronic inflammatory disease. The preliminary results are very encouraging
and additional studies are now underway or being planned, in order to confirm and complete these observations",
added Pierre Vandepapelière, Chief Medical Officer at Neovacs.
Neovacs has just published a poster on the latest clinical results for TNF-K in Crohn's disease at the Digestive
Disease Week 2010 convention (DDW 2010) in New Orleans, LA, USA. The work was selected as a "Poster of
Distinction".
About the Phase I/II trial of INF-K in lupus
This double-blind, dose-escalation Phase I/II study will recruit up to 28 patients, with randomization by dose level.
Study subjects must present moderate disease symptoms. The study's primary objective is to gather information on
the treatment's safety and tolerability. Secondary objectives include measurement of the immune response to the
KinoidTM, the disease activity index and disease markers related to interferon-alpha (IFNa). Depending on patient
recruitment, the study's preliminary results (after the blinding codes have been broken) may be available in early
2011. Neovacs has already obtained approval for the trial from the regulatory authorities in France, Belgium and
Bulgaria and clinical trial applications have been filed in other European countries.
"Lupus patients are still facing significant unmet medical needs because there haven't been any new drugs launched
in this indication for several decades now. Our approach could provide major benefits in terms of efficacy, safety
and ease of treatment. This study highlights our commitment to improving the standard of care for these patients",
stated Neovacs CEO Guy-Charles Fanneau de La Horie.
"This first-in-man administration constitutes a key milestone in the clinical development of IFN-K and provides a
further illustration of the medical community's interest in the KinoidTM approach", added Pierre Vandepapelière,
Chief Medical Officer at Neovacs.
About Neovacs
Neovacs is a biotechnology company focused on an active immunotherapy technology platform (KinoidsTM) with applications in
autoimmune diseases and other chronic conditions. It was founded as a spin-off from Pierre & Marie Curie University in Paris by
Professor Daniel Zagury, MD, one of the world’s leading immunologists. Neovacs' current portfolio consists of 3 drug candidates:
TNFa-KinoidTM, IFNa-KinoidTM and VEGF-KinoidTM. The company’s lead immunotherapy program (TNFa-KinoidTM) is targeting
TNF?-mediated chronic inflammatory diseases. For TNFa-KinoidTM, the last two patients have just been recruited into a Phase
I/II clinical trial in Crohn’s disease and a Phase II trial in rheumatoid arthritis (RA) is also underway. The latter clinical study is also
the focus of a collaboration with the diagnostics company BMD, with the goal of developing theranostic tools for personalized
care in RA. At the end of 2008, TNFa-KinoidTM was selected by Thomson Reuters as the most promising drug in Phase II clinical
trials. Patient recruitment has started in a Phase I/II trial of Neovacs’ second product candidate (IFNa KinoidTM, an
immunotherapy targeting interferon alpha) in the treatment of lupus. Neovacs’ R&D has generated a broad patent estate.
For more information, visit the Neovacs web site at www.neovacs.com.
Disclaimer
This press release and the information contained herein do not constitute an offer to sell or subscribe to, or a solicitation of an offer to buy or
subscribe to, shares in Neovacs ("the Company") in any country. This press release contains forward-looking statements that relate to the
Company’s objectives. Such forward-looking statements are based solely on the current expectations and assumptions of the Company’s
management and involve risk and uncertainties. Potential risks and uncertainties include, without limitation, whether the Company will be
successful in implementing its strategies, whether there will be continued growth in the relevant market and demand for the Company’s
products, new products or technological developments introduced by competitors, and risks associated with managing growth. Unfavorable
developments in connection with these and other risks and uncertainties described, in particular, in the Company’s prospectus prepared in
connection with its IPO and on which the French Autorité des marches financiers (“AMF”) granted its visa no. 10-085 on April 8, 2010, could
cause the Company to fail to achieve the objectives expressed by the forward-looking statements above.
