Context Therapeutics, Inc. is a clinical-stage biopharmaceutical company, which is dedicated to improving the lives of women living with cancer. It engages in developing advanced small molecule and immunotherapy treatments to transform care for hormone-driven breast and gynecological cancers. The firm's robust clinical program for candidate 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, as well as two Phase 0 biomarker pharmacodynamic trials in breast cancer. Its ONA-XR is a novel, first-in-class small molecule under development as a complete antagonist of the progesterone receptor, a key unchecked mechanism in hormone-driven women?s cancers. The company was founded by Martin Lehr and Felix Kim in April 2015 and is headquartered in Philadelphia, PA.
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- Context Therapeutics received FDA Fast Track Designation for CTIM-76, a CLDN6 x CD3 T cell engaging bispecific antibody, for treating platinum-resistant ovarian cancer in patients who have exhausted standard therapies. - The company is currently conducting a Phase 1 clinical trial evaluating CTIM-76's safety and efficacy in patients with CLDN6-positive advanced or metastatic ovarian, endometrial and testicular cancers. - Interim data from the ongoing Phase 1a trial is expected to be released in June 2026, marking a key milestone for the drug's development. - CTIM-76 targets CLDN6, a protein enriched in various solid tumors including ovarian, endometrial, lung, gastric and testicular cancers.
- Context Therapeutics is advancing three T-cell engaging bispecific antibodies for solid tumors, with CTIM-76 showing preliminary anti-tumor activity and no dose-limiting toxicity in Phase 1 trials. - The company expects to report Phase 1a interim data for CTIM-76 in June 2026 and CT-95 in September 2026, with first patient dosing for CT-202 planned for Q3 2026. - Context maintains a strong financial position with $66.0 million in cash expected to fund operations into mid-2027, supporting multiple clinical milestones throughout 2026.
- BioAtla's Board of Directors has launched a formal process to explore strategic options including asset sales, licensing deals, and partnerships to maximize shareholder value. - The company is implementing a significant restructuring plan with approximately 70% workforce reduction and expanded cost-containment measures to reduce operating expenses. - BioAtla will continue its Phase 1 clinical study of BA3182 T-cell engager while maintaining a robust pipeline including Phase 3 ozuriftamab vedotin for OPSCC treatment. - The biotechnology company has engaged Tungsten Advisors as exclusive strategic financial advisor, though no assurance exists that the process will result in transactions.
- Context Therapeutics presented data on CT-95 and CT-202 bispecific T cell engagers at SITC 2025, targeting mesothelin and Nectin-4 respectively for solid tumor treatment. - CT-95 Phase 1 trial has enrolled 6 patients with no cytokine release syndrome greater than Grade 2 and no dose-limiting toxicity observed to date. - CT-202 demonstrates best-in-class potential in preclinical studies with a favorable safety profile, expected to enter first-in-human trials in Q2 2026. - Both candidates utilize innovative design features to overcome traditional challenges in targeted cancer therapy, including shed antigen interference and off-target toxicity.
- Context Therapeutics has dosed the first patient in a Phase 1 trial of CTIM-76, a bispecific antibody targeting CLDN6-positive gynecologic and testicular cancers. - The open-label, dose-escalation study will evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of CTIM-76 in up to 70 patients. - Initial data from the CTIM-76 Phase 1 trial are anticipated to be shared in the first half of 2026, marking a key milestone for the company. - Preclinical data suggest CTIM-76 offers convenient dosing, low immunogenicity risk, and scalable manufacturing, potentially benefiting a significant patient population.
- Context Therapeutics has acquired the exclusive worldwide license to BioAtla's BA3362, a Nectin-4 x CD3 T-cell engager (TCE), for up to $133 million, including upfront and milestone payments. - BA3362 leverages BioAtla's Conditionally Active Biologics (CAB) platform, designed to enhance anti-tumor potency while minimizing off-target toxicities by targeting Nectin-4. - BioAtla will receive up to $133 million, including $15 million upfront and in near-term milestones, plus potential clinical, development, and commercial milestones, and tiered royalties on net sales. - The acquisition aligns with Context Therapeutics' strategy to expand its pipeline of TCE assets, with first-in-human studies for BA3362 expected to begin in approximately 18 months.
