Crescent Biopharma Advances Dual Oncology Programs After IND Clearances in US and China

MevTears · 2026-01-12T18:49:02+00:00

Crescent Biopharma Inc. has received regulatory approvals for CR-001 and CR-003, paving the way for accelerated clinical development in cancer treatment. These therapies tackle resistance through dual mechanisms and promising delivery systems, with trials expected to launch in 2026-2027.

MevTears

2026-01-12 18:49:02

Abstract generation in progress

Crescent Biopharma Inc. (CBIO) has secured a significant milestone with regulatory green lights for two promising cancer candidates, positioning the company for accelerated clinical development across multiple markets. The IND (Investigational New Drug) approval from the U.S. FDA clears the way for CR-001, a bispecific antibody targeting both PD-1 and VEGF pathways, while China’s NMPA authorized partner Kelun-Biotech to begin studies with CR-003 (SKB105), an antibody-drug conjugate designed to attack tumors through ITGB6 targeting.

Tackling Resistance in Solid Tumors Through Dual Mechanisms

The oncology landscape presents persistent challenges: many patients develop resistance to single-pathway therapies, whether checkpoint inhibitors or anti-angiogenic treatments. Crescent’s approach diverges from this limitation. CR-001 simultaneously addresses two resistance mechanisms—blocking immune evasion via PD-1 while disrupting tumor blood supply through VEGF inhibition. This dual-hit strategy aims to improve durability of response in both treatment-naive and previously treated patients.

CR-003 represents a distinct mechanism: the ADC platform delivers cytotoxic payloads directly to tumor cells expressing ITGB6, potentially minimizing systemic toxicity while maximizing therapeutic impact on solid tumors.

Clinical Timeline Accelerating Through 2026-2027

The ASCEND Phase 1/2 global trial is expected to launch in Q1 2026, enrolling patients across both first-line and relapsed settings. Early proof-of-concept readouts for CR-001 are targeted for Q1 2027. Simultaneously, CR-003 clinical studies will initiate in China during 2026, leveraging the differentiated regulatory pathway in that market. By year-end 2026, four Crescent-sponsored trials are anticipated to be underway across the pipeline.

Stock Performance and Near-Term Outlook

CBIO shares have fluctuated between $9.81 and $37 over the past twelve months. The stock currently trades at $11.10, up marginally at 0.18%. With multiple IND clearances now in hand and clinical programs ramping through 2026, the company enters a data-generation phase that could reshape its valuation trajectory over the next 18-24 months.

This page may contain third-party content, which is provided for information purposes only (not representations/warranties) and should not be considered as an endorsement of its views by Gate, nor as financial or professional advice. See Disclaimer for details.