Neovacs Strengthens North American Presence with Formation of U.S. Subsidiary
Mar 23 15
NEOVACS announced the establishment of its wholly-owned U.S. subsidiary, Neovacs Inc. 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, IFNa-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.
NEOVACS Announces Executive Changes
Mar 11 15
NEOVACS 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. Dr. Croughs’s 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 IFNa-Kinoid in lupus and dermatomyositis, while and preparing for the launch of the VEGF-Kinoid development program. 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. 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.
NEOVACS Provides Details about Updated Clinical Path Forward, Focusing on IFNa-Kinoid
Mar 4 15
NEOVACS provided details about its updated clinical path forward, focusing on IFNa-Kinoid. The company's decision to focus on IFNa-Kinoid was based on conclusions from its international Scientific Advisory Board (SAB) meeting, which took place in New York on February 12, 2015. Neovacs' SAB reviewed the pre-clinical trials of IFNÎ±-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 IFNÎ±-Kinoid against an anti-IFNÎ± monoclonal antibody under clinical development. In this comparative trial, Neovacs' IFNÎ±-Kinoid achieved strong neutralization of all 13 subtypes of IFNÎ±, 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 IFNÎ±-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 by mid-2015. A second Phase I/IIa trial for SLE using IFNÎ±-Kinoid in the U.S. is planned to commence by early 2016. Extension of IFNÎ±-Kinoid development program to include dermatomyositis. As a result of the positive safety profile and encouraging results from IFNÎ±-Kinoid thus far, the SAB recommended broadening Neovacs' scope of IFNÎ±-Kinoid treatment targets to dermatomyositis, another indication where a positive IFNÎ± 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% 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 IFNÎ±-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 (DelavallÃ©e 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.