Crescent Biopharma (CBIO) 3rd Annual Guggenheim Healthcare Innovation Conference summary

Portfolio strategy

• CR-001 is positioned as a next-generation PD-1 x VEGF IO backbone, with chemo, ADC and other combinations selected indication by indication across 40–50+ solid tumor indications.

• The matrix strategy spans wholly owned ADCs and Kelun-Biotech’s portfolio, enabling monotherapy and combination development with access to partner-generated data.

• Management cited a $100B+ market opportunity and a potential $2B–$10B opportunity for the foundational phase III strategy.

Clinical progress and 2027 catalysts

• Three programs are in clinical development: CR-001, CR-002, which began dosing this quarter, and Kelun-Biotech’s CR-003 Phase I/II study in China.

• Q1 2027 ASCEND data will cover CR-001 safety, tolerability, PK and pharmacodynamics across more than 125 dosed patients; first-line NSCLC antitumor activity is also planned.

• For Q1 2027 first-line NSCLC activity, management cited ~50% ORR from ivonescimab monotherapy in HARMONi-2 as a benchmark; safety, tolerability and PK/PD will be compared with ivonescimab’s phase I profile.

• Mid-2027 updates are planned for CR-001 chemo-combination expansion cohorts, including first-line lung, biliary, endometrial and colorectal, plus Kelun-Biotech’s sac-TMT + CR-001 combination.

• CR-003 ITGB6 topo ADC monotherapy data are expected in Q1 2027; CR-002 PD-L1 topo ADC monotherapy data are expected in H2 2027.

Development plans

• Management expects more than 2,000 patients to be dosed across the portfolio by mid-2027, generating a broad data set to guide development.

• Initial phase III studies are targeted to start in early 2028, informed by emerging clinical data and indication-specific prioritization.

• Decisions on chemo-combination indications will weigh clinical results, competitive dynamics, potential partnerships and how broadly phase III development can proceed.