Context Therapeutics Inc. (NASDAQ: CNTX) experienced a significant boost in its stock price on Friday. The biopharmaceutical company’s stock rose 3.07% and was at $0.94 in after-hours trading. This increase in value was a result of the announcement of a positive regulatory decision, allowing the company to move forward with its trials.
CNTX got the go ahead for what?
Context Therapeutics (CNTX) last week announced that Stemline Therapeutics, Inc., a wholly owned subsidiary of The Menarini Group (“Menarini”), had received FDA approval for its clinical trial. A FDA approval was granted for ORSERDU (elacestrant) for the treatment of postmenopausal women and men with advanced or metastatic breast cancer that has progressed following at least one line of endocrine therapy that is estrogen receptor-positive (ER+), HER2-negative (HER2-), or a mutation of the Estrogen Receptor 1 gene (ESR1). Efficacy of ORSERDU over fulvestrant, the current standard-of-care (SOC) treatment, has been demonstrated in patients with advanced or metastatic breast cancer that has ER+, HER2-, or ESR1 mutations.
There has been a long-standing industry effort to develop a next-generation endocrine therapy that is pharmacologically superior to single endocrine therapies, such as fulvestrant, for the last 20 years. In the United States, approximately 43% of the estimated 43,500 patients with metastatic hormone-driven breast cancer have ESR1-mutated breast cancer, which can be treated with ORSERDU. With Menarini’s support, CNTX is developing its oral progesterone receptor antagonist onapristone extended release (ONA-XR), which may enhance ORSERDU’s activity in patients with ESR1 mutations and wild-type breast cancers. A combination like this could potentially improve patient outcomes without causing significant side effects.
How is CNTX going ahead?
As part of its collaboration with Menarini, Context Therapeutics (CNTX) began enrolling patients in the ELONA trial in January 2023. In the ELONA study, ONA-XR is combined with ORSERDU to determine its efficacy. CNTX expects Phase 1b data from the trial to be available in Q4 2023.