On October 5, 2026 Crescent Biopharma, Inc. ("Crescent" or the "Company") (Nasdaq: CBIO), a clinical-stage biotechnology company dedicated to rapidly advancing the next wave of therapies for cancer patients, reported that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for CR-002, a topoisomerase inhibitor antibody drug-conjugate (ADC) targeting programmed cell death ligand 1 (PD-L1), being developed for the treatment of advanced solid tumors.
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"FDA clearance of the CR-002 IND is an important milestone for Crescent and is the third distinct program in our portfolio to enter the clinic," said Ellie Im, M.D., chief medical officer of Crescent. "The strong scientific rationale and encouraging preclinical profile of CR-002 underscores its promise in addressing a range of solid tumors. We look forward to initiating the APOLLO trial this quarter and working with global investigators to generate important clinical insights and advance our mission of bringing new treatment options to patients living with difficult-to-treat cancers."
The Phase 1/2 APOLLO global clinical trial plans to enroll patients in the United States, Europe and Asia Pacific with advanced solid tumors, including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and various gastrointestinal and gynecological tumors. The study’s dose escalation and tumor-specific backfill cohorts are expected to enroll approximately 200 participants with the opportunity for additional participants in expansion cohorts. Crescent anticipates reporting initial clinical data from the APOLLO trial in the second half of 2027, including safety, pharmacokinetic and preliminary antitumor activity in multiple tumor types.
About CR-002
CR-002, internally developed in collaboration with Paragon Therapeutics, is a topoisomerase inhibitor ADC directed to PD-L1, a validated target known to have high expression in multiple solid tumors and comparatively limited expression in healthy tissue. CR-002 incorporates a PD-L1 antibody selected for high internalization to facilitate payload release in target cells and a linker designed for intracellular cleavage and high stability in circulation, an approach intended to concentrate payload delivery in tumor tissue. APOLLO, a global Phase 1/2 trial of CR-002 in patients with solid tumors, is anticipated to commence in the fourth quarter of 2026. Crescent also plans to evaluate CR-002 in combination with CR-001, its PD-1 x VEGF bispecific antibody, as part of its efforts to evaluate synergistic ADC and immuno-oncology combinations.
(Press release, Crescent Biopharma, OCT 5, 2026, View Source [SID1234673206])