13 March 2020 - - China-based small molecule drug discovery and development Tyligand Bioscience, Ltd., a leader in small molecule drug discovery and development, and US-based clinical stage biopharmaceutical company Context Therapeutics LLC have signed collaboration agreements for the development, manufacturing, registration and future commercialisation of onapristone extended release, the companies said.

Onapristone ER is currently being evaluated in patients with progesterone receptor positive 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 endometrial cancers are planned for mid-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 commercialisation of onapristone ER in China, Hong Kong and Macau, 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 commercialise 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 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 endometrial cancers will be initiated in 2020.

Onapristone ER is an investigational drug that has not been approved for marketing by any regulatory authority.

Context Therapeutics LLC is a clinical-stage biopharmaceutical company advancing medicines to treat hormone driven cancers.

Context's lead programme is onapristone ER, an investigational Phase 2 drug that is being developed for progesterone receptor positive breast, ovarian and endometrial cancers.

Tyligand Bioscience is a Shanghai based biotechnology company focusing on the discovery and development of novel small molecule therapeutics to help patients with cancer and autoimmune diseases.

Tyligand focuses on the discovery and development of small molecule agents for cancer and immunological diseases through the precision modulation of phosphorylation status of signaling biomolecules.