MALVERN, Pa. and HONG KONG, China, Dec. 1, 2010 /PRNewswire/ -- Ascenta Therapeutics, Inc. (Ascenta), a private, US-based oncology drug development company, and Ascentage Pharma Group Corporation (APGC), a company focused on bringing novel anticancer therapeutics to the Chinese market and establishing partnerships in other markets, today announced the formation of a strategic collaboration to co-develop Ascenta's clinical stage, apoptosis-triggering small molecules, AT-101 and AT-406, in China. The agreements leverage the complementary strengths of the companies in chemistry, manufacturing, preclinical and clinical development in an effort to cost-effectively accelerate progress in these programs in both the United States and China.
"For a small biopharmaceutical company, Ascenta has been ahead of the curve in conducting R&D in China and we have had a presence there since 2005," said Mel Sorensen, M.D., President and CEO of Ascenta Therapeutics. "This collaboration with Ascentage will further increase global oncology drug development efficiencies for our apoptosis programs."
Under the terms of the agreements, APGC will be responsible for all development and regulatory approval efforts for both programs in China and will provide components of manufacturing for global development. Ascenta will receive drug supply, upfront and product development and commercialization milestone payments, and royalties on net sales. APGC will license both programs for China (including Taiwan, Hong Kong and Macau). In addition, APGC will license AT-101 for all regions outside the USA, Canada and Europe. Ascenta will retain all rights to AT-406 outside China and all rights to AT-101 for the USA, Canada and Europe (including Russia). Financial terms of the agreements were not disclosed.
"Collaborating with Ascenta has the potential to bring highly innovative new chemical entities to cancer patients in China much earlier than in the past," said Dajun Yang, M.D., Ph.D., President and CEO of Ascentage Pharma. "Early research indicates that apoptosis-triggering small molecules could play an important role in the next generation of targeted cancer therapeutics."AT-101 and AT-406 are both oral small molecules that trigger apoptosis (programmed cell death) at different points in the apoptosis pathways. AT-101 is a pan-Bcl-2 inhibitor in Phase II development for several cancers. Regulatory approval for clinical development of AT-101 has already been granted by the Chinese SFDA and Phase II clinical trials are expected to begin there in the near future. AT-406 is a multi-IAP inhibitor (including XIAP, cIAP1, cIAP2, ML-IAP). Phase I development of AT-406 began in the US in early 2010 and several phase 2 trials are anticipated to begin in 2011. An "IND" for AT-406 was recently submitted in China, was designated by the SFDA as a class 1.1 for new chemical compounds, and will receive the "Special Review Procedure" designed for innovative agents by the SFDA in January 2009. Ascentage Pharma has already passed the on-site audit for AT-406, conducted by the Shanghai SFDA. About Ascentage Pharma Ascentage Pharma Group Corporation, located in both Hong Kong and Shanghai, China, was founded in 2009 by a team with extensive experience in global drug development. The company is dedicated to the discovery and development of novel therapies with a focus on targeted anti-cancer, small molecule drugs. The Ascentage Pharma R&D team is trained according to US standards and has a proven track record in lead optimization, clinical candidate selection and IND package preparation for filing with both the FDA and SFDA. Ascentage Pharma formed a strategic alliance with 3SBio Inc. (Nasdaq: SSRX) in February 2010. About Ascenta Therapeutics Ascenta Therapeutics is a privately-held, clinical stage biopharmaceutical company located in the Greater Philadelphia area. The company is dedicated to efficient oncology drug development and has a portfolio of apoptosis-triggering small molecules that target protein-protein interactions, including two clinical compounds AT-101 and AT-406. In June 2010, Ascenta announced a $398 million global collaboration and licensing agreement with sanofi-aventis for its third program, targeting the p53-HDM2 (Human Double Minute 2) protein-protein interaction. For additional information on Ascenta Therapeutics, please visit the company's website at www.ascenta.com. SOURCE Ascenta Therapeutics, Inc.