Context Therapeutics (NASDAQ:CNTX) Inc and The Menarini Group have announced a clinical trial collaboration and supply agreement for Menarini’s oral selective estrogen receptor degrader (SERD), elacestrant.
The women’s oncology company said the agreement will support the upcoming Phase 1b/2 ELONA clinical proof-of-concept trial evaluating onapristone extended release (ONA-XR), an oral progesterone receptor (PR) antagonist, in combination with elacestrant in estrogen receptor positive (ER+), PR+ HER2- metastatic breast cancer (mBC) patients who have previously been treated with a CDK4/6 inhibitor.
“We are grateful to Menarini for their collaboration as we explore the therapeutic potential of adding ONA-XR, our oral PR antagonist, to elacestrant,” Context Therapeutics chief medical officer Tarek Sahmoud said in a statement.
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“We hope that this combination will further improve the clinical outcome in patients with ER+, PR+, HER2- mBC,” Sahmoud added.
Context noted that elacestrant is the first oral SERD to demonstrate a statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus standard-of-care (SOC) endocrine therapy in a Phase 3 trial in patients with ER+, HER2- mBC, with 30% reduction in the risk of progression or death in all patients.
The company added that data also showed that 22% of patients were alive and progression-free at 12 months after elacestrant treatment initiation compared with 9% with SOC in the overall population.
As well, Context Therapeutics said preliminary data from preclinical studies suggest that a dual ER and PR blockade may be associated with enhanced tumor control, with the ELONA clinical trial set to evaluate this hypothesis.
The Phase 1b/2 clinical trial is expected to begin in the fourth quarter of 2022, and the two companies will form a joint committee to review the results, Context said.
Based in Philadelphia, Context Therapeutics is a women’s oncology company developing small molecule and immunotherapy treatments for breast and gynecological cancers.
Its clinical program for lead candidate onapristone extended release (ONA-XR) consists of three Phase 2 clinical trials and one Phase 1b/2 clinical trial in hormone-driven breast, ovarian, and endometrial cancer.
ONA-XR is a novel, first-in-class small molecule under development as a potent and specific antagonist of the progesterone receptor, a key unchecked mechanism in hormone-driven women's cancers.
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