On March 12, 2020 Tyligand Bioscience, Ltd., a leader in small molecule drug discovery and development, and Context Therapeutics LLC, a clinical stage biopharmaceutical company focused on hormone driven cancers, reported the signing of collaboration agreements for the manufacturing, registration and future commercialization of onapristone extended release (ER) (Press release, Context Therapeutics, MAR 12, 2020, View Source [SID1234555478]).
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Onapristone ER is currently being evaluated in patients with progesterone receptor positive (PR+) rare ovarian and endometrial cancers in the ongoing Phase 2 ONWARD 220 clinical trial. Initiation of additional Phase 2 clinical trials in ER+, PR+, HER2- breast cancer and PR+ endometrial cancers are planned for 2020.
Under the terms of the agreements, Tyligand will be solely responsible for the design and optimization of a novel manufacturing process for onapristone ER to meet Context’s development and future commercialization needs, and standards for quality, safety and cost. Upon completion of specific performance-based milestones, Tyligand will be granted the exclusive right and will be solely responsible for the development and commercialization of onapristone ER in China, Hong Kong and Macau (the "Territory"), and Context will be eligible to receive royalties on net sales of onapristone ER in the Territory. Context will retain rest of world rights to commercialize onapristone ER.
"We are thrilled to partner with Tyligand as we accelerate onapristone ER’s Phase 2 evaluation and prepare for Phase 3," said Martin Lehr, CEO of Context. "Tyligand is renowned for its expertise in process development and has strong networks with manufacturing and clinical capabilities in China and the U.S. Partnering with Tyligand will enable Context to optimize and efficiently scale our manufacturing and clinical capacity to support the evaluation and future commercialization of onapristone ER, our experimental oral therapy, to address the unmet need in treating patients with PR+ cancers."
"Even with the major advances in cancer therapies in recent years, treatment options for patients with hormone driven cancers remain limited," said Tony Zhang, CEO of Tyligand. "Onapristone ER has the potential to be the first-in-class therapeutic agent specifically targeting progesterone receptors and the best-in-class treatment option for breast, endometrial and ovarian cancers. We are proud to partner with Context to develop onapristone ER and make this innovative medicine ultimately more accessible for patients around the world."
About Onapristone ER
Onapristone ER (extended release) is a potent and specific antagonist of the progesterone receptor that is orally administered. Currently, there are no approved therapies that selectively target progesterone receptor positive (PR+) cancers. Preclinical and clinical data suggest that onapristone ER has anticancer activity by inhibiting progesterone receptor binding to chromatin, downregulating cancer stem cell mobilization and blocking immune evasion. Onapristone ER is currently being evaluated in patients with PR+ rare ovarian and endometrial cancers in the ongoing Phase 2 ONWARD 220 clinical trial. Additional Phase 2 clinical trials in ER+, PR+, HER2- breast cancer and PR+ endometrial cancers will be initiated in 2020. Onapristone ER is an investigational drug that has not been approved for marketing by any regulatory authority.