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Wednesday, Jun 12, 2024
Mugglehead Magazine
Alternative investment news based in Vancouver, B.C.

Medical and Pharmaceutical

Context Therapeutics and Menarini Group put together clinical trial for breast cancer drug

Breast cancer is the second most common cancer among women.

Photo by Angiola Harry on Unsplash

Context Therapeutics (NASDAQ:CNTX) and the Menarini Group are teaming up on a clinical trial and supply agreement for elacestrant, Menarini’s oral estrogen receptor degrader.

The agreement is in support of the company’s upcoming Phase 1b/2 ELONA clinical proof-of-concept trial to evaluate onapristone extended release (ONA-XR), which is an oral progesterone receptor antagonist. This will come in combination with elacestrant in estrogen receptor positive metastatic breast cancer (mBC) patients who had received previous treatment with a CDK4/6 inhibitor. Context will sponsor the clinical trial and Menarini will supply elacestrant for free.

“We are grateful to Menarini for their collaboration as we explore the therapeutic potential of adding ONA-XR, our oral PR antagonist, to elacestrant. We hope that this combination will further improve the clinical outcome in patients with ER+, PR+, HER2- mBC,” said Tarek Sahmoud, Context’s chief medical officer.

The details on Context Therapeutics is that it’s a women’s oncology company involved in the development of small molecule and immunotherapy treatments to improve care for breast and gynecological cancers. The company clinical program for onapristone extended release (ONA-XR) comprises three Phase 2 clinical trials and one Phase 1b/2 clinical trial in hormone-driven breast, ovarian and endometrial cancer.

In contrast, the Menarini Group is a pharmaceutical and diagnostics company offering a turnover of more than $4 billion and over 17,000 employees. Its worked on therapeutic areas with unmet needs with products dealing with cancer, heart issues, pneumology, gastroenterology, as well as infectious diseases, diabetology, inflammation and analgesia.

The specifics for onapristone is that it is an anti-progestin drug and progesterone receptor (PR) antagonist originally made as a contraceptive and to help treat benign gynecological disorders like uterine leiomyomas (better known as fibroids). The drug was noted as having substantial interaction with advanced breast cancer, and it is suspected that ONA binds to the progesterone receptor, preventing the PR from binding to DNA and inhibiting or eliminating PR-induced DNA transcription.

Breast cancer is the second most common cancer among women, according to the American Cancer Society. It effects 1 in 8 women (13 per cent) over the course of a woman’s lifetime, with 280,000 new cases of invasive breast cancer, and 51,400 cases of non-invasive breast cancer expected in 2022.

Elacestrant is the first oral offering to demonstrate a statistically significant and clinically meaningful improvement in progression-free survival against standard-of-care endocrine therapy in a Phase 3 trial, with a result being a 30 per cent reduction in the risk of death or progression. Data displayed 22 per cent of patients were alive and progression-free within a year after elacestrant treatment initiation versus nine per cent in the overall population.

“ONA-XR’s ability to restore hormone sensitivity and its tolerability profile positions it well for combination with elacestrant,” said Nassir Habboubi, M.D., Menarini’s global head of research and development.

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