Policy & Regulation
Context Therapeutics signs clinical trial collaboration and supply agreement with The Menarini Group
3 August 2022 -

Context Therapeutics Inc. (Nasdaq: CNTX), a US-based women's oncology company developing small molecule and immunotherapy treatments for breast and gynaecological cancers, announced on Tuesday that it has signed a clinical trial collaboration and supply agreement with Italy-based The Menarini Group for Menarini's oral selective estrogen receptor degrader (SERD), elacestrant.

This agreement is intended to support the upcoming Phase 1b/2 ELONA clinical proof-of-concept trial assessing onapristone extended release (ONA-XR), an oral progesterone receptor (PR) antagonist, along with elacestrant in estrogen receptor positive (ER+), PR+ HER2- metastatic breast cancer (mBC) patients who have earlier been treated with a CDK4/6 inhibitor.

Under the contract, Context is to sponsor the clinical trial, while Menarini is to provide elacestrant at no cost. Context is planning to start the Phase 1b/2 clinical trial in the fourth quarter of 2022. Both firms will establish a joint committee to review results.