On September 27, 2022 Context Therapeutics Inc. ("Context" or the "Company") (Nasdaq: CNTX), a women’s oncology company developing novel treatments for breast and gynecological cancers, reported updated cash guidance to extend its runway into Q1 2024 (Press release, Context Therapeutics, SEP 27, 2022, View Source [SID1234621503]).

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The company plans to defer noncritical R&D activities, reduce future overhead and infrastructure expenditures, and prioritize its onapristone extended release (ONA-XR) ELONA Phase 1b/2 clinical trial and Claudin 6 (CLDN6) program.

"Context has been fortunate to collaborate with two tremendous organizations – The Menarini Group and Integral Molecular. We believe these collaborations have broadened the therapeutic potential for ONA-XR through the ELONA trial and accelerated the development of a new treatment modality to address CLDN6 positive tumors," said Martin Lehr, CEO of Context Therapeutics. "In light of the challenging current investment climate for biotechnology, we are streamlining the organization’s resources with the intent to take the Company through the execution of the Phase 1b portion of the ELONA trial and the advancement of our CLDN6xCD3 bispecific antibody program to an Investigational New Drug Application (IND)."

The ELONA Phase 1b/2 clinical trial is evaluating ONA-XR, an oral progesterone receptor (PR) antagonist, in combination with Menarini’s elacestrant in estrogen receptor positive (ER+), PR+, HER2- metastatic breast cancer (mBCa) patients who have previously been treated with a CDK4/6 inhibitor. An IND amendment filed specifically for this trial was submitted to the U.S. Food and Drug Administration in September 2022. The Company remains on track to initiate the ELONA clinical trial in Q4 2022 and to report Phase 1b data in Q4 2023. Context retains worldwide rights for ONA-XR, other than the rights it out-licensed for Greater China.

Context anticipates the nomination of a CLDN6xCD3 bispecific monoclonal antibody (BsMAb) development candidate from the organization’s research collaboration with Integral Molecular in Q4 2022. An IND submission is planned in Q1 2024. Context retains worldwide rights to certain CLDN6 antibody patents in the field of bispecific antibodies.

In addition, Context will continue to provide access to ONA-XR through the Company’s ongoing Investigator-Sponsored Trials (ISTs) and anticipates sharing preliminary data from its Phase 2 clinical trials in granulosa cell tumors and endometrial cancer in November 2022, and from its Phase 2 clinical trial in breast cancer in December 2022.

"We’re fortunate to have ISTs that can continue to explore the potential of ONA-XR while we focus on derisking and moving our near-term priority programs forward," said Lehr. "We’re thinking long-term; Context is committed to improving the lives of women with cancer and we believe that these thoughtful and future-focused changes best position us to be nimble during the current market challenges. We continue to concentrate on fully realizing the value of our collaborations and pipeline."