American firm Ascenta Therapeutics and Chinese company Ascentage Pharma (APGC) have teamed up to co-develop two of the former’s small molecule anticancer agents, AT-101 and AT-406, in China. APGC gains licenses for both programs in China including Taiwan, Hong Kong, and Macau and licenses for AT-101 in all regions outside the U.S., Canada, and Europe.
AT-101 and AT-406 both trigger apoptosis at different points in the apoptosis pathways, Ascenta explains. AT-101 is a pan-Bcl-2 inhibitor in Phase II trials for several cancers in the U.S. including B-cell, brain, esophageal, lung, and prostate cancers. Regulatory approval for its clinical development in China has been granted, and Phase II studies are expected to begin in the near future, APGC notes.
AT-406 is a multi-IAP inhibitor (including XIAP, cIAP1, cIAP2, and ML-IAP). U.S. Phase I development in solid tumors, lymphoma, and leukemia began in early 2010 and several Phase II trials are anticipated to begin in 2011, according to Ascenta. An IND for the compound was recently submitted in China.
APGC says that it has already passed the on-site audit for AT-406, conducted by the Shanghai SFDA.
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, up-front, and development and commercialization milestone payments. It is also entitled to royalties on net sales.
APGC, founded in 2009, has offices in both Hong Kong and Shanghai. The company is dedicated to the discovery and development of novel therapies with a focus on targeted anticancer, small molecule drugs.
Ascenta Therapeutics is located in the Greater Philadelphia area and dedicated to oncology drug development. Besides AT-101 and AT-406, it has a third clinical-stage program, which targets p53-HDM2 protein-protein interactions. In June sanofi-aventis obtained an exclusive, worldwide license for two molecules from this p53-HDM2 program. The deal is valued at $398 million and covers MI-773 and MI-519-64.