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.
READ: Context Therapeutics ends 1Q with $45.7M as it gears up for 'pivotal' 2022
“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.
Edison analysts upbeat
In a note commenting on the company's plans to collaborate with the Menarini Group, analysts at research firm Edison said: "This is a key development as elacestrant is the first oral SERD to demonstrate higher efficacy than fulvestrant (standard of care) in Phase III studies. Fulvestrant is an injectable SERD and we believe an oral formulation within this drug class would improve patient adherence."
They added: "Greater efficacies are often observed in combinational oncology therapies, so we believe the upcoming ONA-XR/elacestrant trial is an encouraging clinical advancement. ONA-XR has previously shown promising preclinical data in combination with anti-estrogen therapy."
The Edison analysts said they value an incremental contribution of $1.1 per share for Context from this program.
In Tuesday morning trading in New York, Context shares were up over 14.5% at $2.16.
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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