Crescent receives FDA clearance for CR-002 trial

• Crescent Biopharma received FDA clearance for its CR-002 Investigational New Drug application for advanced solid tumors.
• The company plans to begin the Phase 1/2 APOLLO global trial in the fourth quarter of 2026.
• Crescent expects initial safety and activity data from the study in the second half of 2027.

Crescent Biopharma (NASDAQ:CBIO) received FDA clearance for its Investigational New Drug application for CR-002, an antibody-drug conjugate being developed for advanced solid tumors.

CR-002 is designed to target PD-L1 and deliver a topoisomerase inhibitor, combining an antibody with a cancer-killing drug payload to target tumor cells.

Crescent Biopharma said the FDA clearance allows the company to begin clinical testing of CR-002 through its Phase 1/2 APOLLO global trial.

The APOLLO trial is expected to begin in the fourth quarter of 2026 and will enroll patients across the United States, Europe and Asia Pacific, including those with non-small cell lung cancer, head and neck squamous cell carcinoma, and gastrointestinal and gynecological tumors.

Crescent expects to enroll approximately 200 participants across dose-escalation and tumor-specific backfill cohorts, with additional patients potentially included in expansion cohorts.

Following the announcement, Crescent Biopharma's share price was unchanged at $2.42 in premarket trading.

The study will evaluate CR-002’s safety profile, pharmacokinetics and preliminary antitumor activity across multiple tumor types, with initial clinical data expected in the second half of 2027.

Crescent is developing CR-002 as part of its oncology pipeline focused on antibody-drug conjugate therapies, a class of medicines designed to deliver targeted drug payloads to cancer cells.