Crescent Biopharma (CBIO) 12th Annual Cantor Fitzgerald Global Healthcare Conference summary

Key developments and strategic progress

• Advanced three oncology assets into the clinic: CR-001 (bispecific), CR-002 (PD-L1 Topo1i ADC), and CR-003 (integrin beta-6 Topo1i ADC), with CR-003 dosing initiated in China and CR-002 entering the clinic this year.

• Established a significant partnership with Kelun-Biotech, enabling combination studies and access to a broad ADC portfolio, with ongoing and planned combination trials involving CR-001.

• Designed global clinical trials from the outset, focusing on rapid phase III study starts and leveraging lessons from prior China-to-global development efforts to optimize regulatory and operational execution.

• Phase I/II study for CR-001 enrolls eight tumor types, using an innovative design with dose escalation and tumor-specific backfill cohorts to efficiently generate safety, PK, and efficacy data.

• Multiple data readouts are scheduled for 2027, including efficacy and safety from first-line non-small cell lung cancer, standard of care chemo combinations, and ADC combination cohorts.

Clinical and competitive insights

• CR-001 was engineered to match the structure and function of ivonescimab, with improvements in PD-1 binding and manufacturing stability, potentially enabling subcutaneous administration.

• The global development approach differentiates the program from competitors, with only one unpartnered VEGF PD-1 bispecific in global phase I or later development.

• Lessons from the HARMONi trials highlight the importance of synchronized global enrollment and sufficient follow-up in Western populations to achieve statistical significance in survival analyses.

• The company is closely monitoring the evolving ADC and bispecific oncology landscape, with plans to pursue both first-in-class and fast-follower opportunities across multiple indications.

• Ongoing collaborations with Kelun-Biotech may expand to additional ADC targets, supporting a broad combination therapy strategy.

Upcoming milestones and data disclosures

• Comprehensive phase I data for CR-001, including efficacy in first-line non-small cell lung cancer, is expected in Q1 2027, with additional combination data mid-year.

• CR-003 monotherapy data from China is also anticipated in Q1 2027, with potential for global studies and combination trials with CR-001.

• CR-002, the internally developed PD-L1 Topo1i ADC, will enter the clinic this year, with data expected in the second half of 2027.

• An update this fall will detail indications for standard of care chemo combinations, progress on dose escalation, and further plans for the Kelun-Biotech partnership.

• Decision-making on future indications will be data-driven, balancing competitive landscape and foundational revenue opportunities.