Crescent Biopharma, Inc. (CBIO) News & EventsCBIOCrescent Biopharma, Inc.

Crescent Biopharma Announces Clinical Pipeline Momentum

Crescent Biopharma announced clinical pipeline momentum, including enrolling patients in cohorts combining CR-001, a PD-1 x VEGF bispecific antibody, plus standard of care chemotherapy regimens in its global Phase 1/2 ASCEND trial, as well as the initiation of additional antibody-drug conjugate, or ADC, combination studies with CR-001. The company is on track to report initial monotherapy data from ASCEND in Q1 2027. Crescent has completed dose escalation in the global Phase 1/2 ASCEND trial of CR-001, its investigational PD-1 x VEGF bispecific, developed in collaboration with Paragon Labs, with patients enrolled across several tumor types at clinical sites in the United States, Europe and South Korea. The Company plans to report initial monotherapy data from ASCEND in the first quarter of 2027, including: preliminary antitumor response as measured by overall response rate from a first-line NSCLC cohort of up to 12 patients. Safety, tolerability, pharmacokinetic and pharmacodynamic data from more than 125 treatment-naive and previously-treated patients across multiple solid tumor types. Crescent plans to report initial data from the chemotherapy combination cohorts in mid-2027.

Crescent Biopharma's CR-002 Receives FDA Approval

Crescent Biopharma announced that the FDA has cleared its investigational new drug, or IND, application for CR-002, a topoisomerase inhibitor antibody drug-conjugate targeting programmed cell death ligand 1, being developed for the treatment of advanced solid tumors. 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, head and neck squamous cell carcinoma, 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.

Crescent CEO: CR-001 Clinical Data to be Released in 2027

"We have continued to demonstrate exceptional execution and are on track for multiple key clinical data readouts across our portfolio in 2027. The positive momentum in our ASCEND trial of CR-001 positions us for robust datasets from hundreds of patients globally in monotherapy and standard of care chemotherapy combinations across several tumor types. CR-001 is the first PD-1 x VEGF bispecific antibody to be evaluated in combination with sac-TMT, and we are proud to be partnering with Kelun-Biotech to realize its full potential as an immuno-oncology backbone. Our ADC pipeline also is advancing, with the CR-003 clinical trial enrolling in China and we are preparing for CR-002 to enter the clinic in a global study during the second half of this year," said Joshua Brumm, chief executive officer of Crescent. "Our recent financing extends our expected cash runway into the second half of 2028, beyond key catalysts, strengthening our balance sheet as we work to deliver transformative therapies for people living with cancer."