Context Therapeutics (NASDAQ:CNTX) Inc has announced a plan to streamline its resources and extend its cash runway into 2024 as market pressures put a strain on biotechnology companies.
The women’s oncology company plans to defer noncritical R&D activities, reduce future overhead and infrastructure expenditures and push forward with its onapristone extended release (ONA-XR) ELONA Phase 1b/2 clinical trial and Claudin 6 (CLDN6) program.
“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),” CEO Martin Lehr said in a statement.
READ: Context Therapeutics ends 2Q with strong $42.9M cash runway to advance pipeline programs
The ELONA trial is evaluating ONA-XR, an oral progesterone receptor (PR) antagonist, in combination with Menarini’s drug 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, and Context is on track to initiate the ELONA trial in the fourth quarter. Phase 1b data could then be reported in the first quarter of 2023.
Lehr pointed to a pair of partnerships that have made a significant difference.
“Context has been fortunate to collaborate with two tremendous organizations – The Menarini Group and Integral Molecular,” Lehr said. “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.”
Meanwhile, Context said it expects to nominate a CLDN6xCD3 bispecific monoclonal antibody (BsMAb) development candidate from its research collaboration with Integral Molecular in the fourth quarter, with an IND submission planned for the first quarter of 2024.
Context will also continue to provide access to ONA-XR through ongoing Investigator-Sponsored Trials (ISTs). The company plans to share preliminary data from its Phase 2 clinical trials in granulosa cell tumors and endometrial cancer in November and from its Phase 2 clinical trial in breast cancer in December.
“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,” Lehr said. “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.”
Contact Andrew Kessel at andrew.kessel@proactiveinvestors.com
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