Context Therapeutics and The Menarini Group Announce Clinical Trial Collaboration and Supply Agreement to Evaluate the Combination of ONA-XR and Elacestrant

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Preclinical Data Supports the Potential of ONA-XR Plus Estrogen Receptor Degraders in Endocrine Resistant Disease Models

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Context to start phase 1b/2 clinical trial in Q4 2022

PHILADELPHIA and Florence, Italy, Aug 2, 2022 /PRNewswire/ — Context Therapeutics Inc. (“Context” or the “Company”) (Nasdaq: CNTX), a women’s oncology company developing small molecule and immunotherapy treatments for breast and gynecological cancers, and The Menarini Group (“Menarini”) today announced a collaboration and supply agreement for clinical trials for Menarini’s oral selective estrogen receptor degrader (SERD), elatran.

This agreement supports the coming phase 1b/2 ELONA clinical proof-of-concept study evaluating onapristone extended-release (ONA-XR), an oral progesterone receptor (PR) antagonist, in combination with elatran in estrogen receptor positive (ER+), PR+ HER2-metastatic breast cancer (mBC) patients previously treated with a CDK4/6 inhibitor. Context will sponsor the clinical trial and Menarini will provide free elatran.

According to the American Cancer Society, breast cancer is the second most common cancer in women, occurring in 1 in 8 women (13%) 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. Elacestran is the first oral SRD 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 study in patients with ER+, HER2-mBC, with a 30% reduction in risk of progression or death in all patients. Data also showed that 22% of patients were alive and progressing 12 months after initiation of elatran treatment, versus 9% with SOC in the overall population. Therefore, elatran could potentially become the new endocrine spine therapy for ER+, HER2-mBC.

Preliminary data from preclinical studies suggest that dual ER and PR blockade may be associated with improved tumor control. ELONA’s clinical trial will evaluate this important hypothesis.

“We are grateful to Menarini for their collaboration in exploring the therapeutic potential of adding ONA-XR, our oral PR antagonist, to elarest,” said Tarek Sahmoud, MBBCh, Ph.D., Chief Medical Officer of Context. “We hope that this combination will further improve the clinical outcome in patients with ER+, PR+, HER2-mBC.”

“Ona-XR’s ability to restore hormone sensitivity and its tolerability profile positions it well for combination with elamestrant,” said Nassir Habboubi, MD, Menarini’s Global Head of R&D.

Context anticipates the initiation of the phase 1b/2 clinical trial in the fourth quarter of 2022. The two companies will form a joint committee to review the results.

About Menarini Group

The Menarini Group is a leading international pharmaceutical and diagnostics company, with sales of more than $4 billion and more than 17,000 employees. Menarini targets therapeutic areas with high unmet needs with products for oncology, cardiology, pneumology, gastroenterology, infectious diseases, diabetology, inflammation and analgesia. With 18 production sites and 9 research and development centers, Menarini’s products are available in 140 countries around the world. For more information, visit www.menarini.com.

About ONA-XR
ONA-XR (onapristone extended release) is a potent and specific progesterone receptor (PR) antagonist that is administered orally. Currently, there are no approved therapies that selectively target PR+ cancers. Preliminary preclinical and clinical data suggest that ONA-XR has anticancer activity by inhibiting progesterone receptor binding to chromatin, downregulating cancer stem cell mobilization and blocking immune evasion. ONA-XR is currently being evaluated in three Phase 2 clinical trials and one Phase 1b/2 clinical trial in PR+ breast, ovarian and endometrial cancer. ONA-XR is an investigational drug that has not been approved for marketing by any regulatory agency.

About context therapy® Context Therapeutics Inc. (Nasdaq: CNTX), is a women’s oncology company developing small molecule and immunotherapy treatments to transform the care of breast and gynecologic cancers. The company’s robust clinical program for lead candidate extended-release onapristone (ONA-XR) includes three phase 2 clinical studies and one phase 1b/2 clinical trial in hormone-controlled breast, ovarian and endometrial cancer. ONA-XR is a novel, first-class small molecule under development as a potent and specific antagonist of the progesterone receptor, an important uncontrolled mechanism in hormone-mediated female cancer. Context is located in Philadelphia, PA. For more information visit www.contexttherapeutics.com.

Forward-Looking Statements
This press release contains “forward-looking statements” that involve significant risks and uncertainties for the purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, contained in this press release regarding strategy, future operations, prospects, plans and objectives of management, including words such as “may”, “will”, “expect”, “anticipate”, “plan”, “intend” and similar expressions (as well as other words or expressions referring to future events, circumstances or circumstances) are forward-looking statements. These include, without limitation, statements regarding (i) the timing of initiating, enrolling and obtaining initial data for our clinical trials, (ii) the results of our clinical trials, (iii) the potential benefits of the product candidates, (iv) the probability data will support future development, and (v) the likelihood of obtaining regulatory approval from the product candidates. Forward-looking statements in this press release involve significant risks and uncertainties that could cause actual results to differ materially from those expressed or implied by the forward-looking statements, and we therefore make no representation that our plans, intentions, expectations or strategies will reached or be reached. Other factors that could cause actual results to differ from those expressed or implied by the forward-looking statements in this press release are discussed in our filings with the U.S. Securities and Exchange Commission, including the included section entitled “Risk Factors”. Unless otherwise required by law, we disclaim any intent or obligation to update or revise any forward-looking statements, which speak only as of the date they are made, whether as a result of new information, future events or circumstances or otherwise.

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