Crescent Biopharma (CBIO) Jefferies London Healthcare Conference 2025 summary

Strategic focus and pipeline development

• Emphasis on building a leading biotech and oncology company through a dual strategy: CR001 (PD-1 VEGF bispecific) and an undisclosed ADC pipeline.

• CR001 is designed to be a best-in-class bispecific, with preclinical data supporting its stability and efficacy; clinical dosing to begin in early Q1.

• CR002, the first ADC, is expected to enter the clinic mid-next year, supporting a transition to a clinical-stage company.

• The portfolio enables both monotherapy and synergistic combination approaches, targeting a broad range of oncology indications.

• The company is leveraging learnings from industry data and competitor studies to inform trial design and strategic direction.

Clinical development and trial design

• Phase I global trial for CR001 will start in the US, focusing on dose escalation, safety, PK, and efficacy, with plans for rapid expansion into phase II/III.

• The trial design incorporates lessons from previous PD-1/VEGF bispecifics, aiming for robust, registration-enabling data.

• The company is prioritizing geographic diversity in clinical data to ensure global regulatory acceptance and avoid reliance on single-region datasets.

• Key readouts, including dose and indication data, are expected in the back half of 2026, with a major proof-of-concept (POC) readout anticipated late 2026 or early 2027.

• Capital is secured through 2027, with flexibility to fund later-stage studies via partnerships or equity.

Industry insights and combination strategies

• The PD-1 VEGF approach is validated by recent HARMONi-6 data, showing robust PFS and safety, especially in populations with low PD-L1 expression.

• CR001 is intentionally designed to mimic the pharmacology of ivonescimab, aiming for best-in-class status and rapid development of synergistic combinations.

• The company is open to both internal development and external partnerships, including with mid-cap oncology players, to maximize combination opportunities.

• ADC development focuses on best-in-class assets, with decisions to build or partner based on synergy with CR001.

• Targeted therapeutic areas for ADCs include thoracic, GI, and reproductive cancers, with a nimble approach to clinical development and partnerships.