Crescent Biopharma Announces First Patient Dosed in ASCEND Phase 1/2 Clinical Trial of CR-001 for the Treatment of Advanced Solid Tumors

ASCEND to evaluate CR-001, a PD-1 x VEGF bispecific antibody, in multiple solid tumor types, including NSCLC and gastrointestinal and gynecological cancers in first-line and previously treated patients

Company anticipates reporting proof-of-concept data in the first quarter of 2027

ASCEND is the first of four clinical trials across the portfolio expected to initiate in 2026

WALTHAM, Mass., Feb. 18, 2026 (GLOBE NEWSWIRE) -- Crescent Biopharma, Inc. (“Crescent” or the “Company”) (Nasdaq: CBIO), a clinical-stage biotechnology company dedicated to rapidly advancing the next wave of therapies for cancer patients, today announced that the first patient has been dosed in its global ASCEND Phase 1/2 clinical trial evaluating CR-001, an investigational PD-1 x VEGF bispecific antibody, for the treatment of advanced solid tumors.

“The initiation of ASCEND is a significant milestone for Crescent and the development of CR-001, which we believe has the potential to be a best-in-class therapy and immuno-oncology backbone,” said Ellie Im, M.D., chief medical officer of Crescent. “We are excited to be working with clinicians across the globe as we strive to improve the standard of care for people living with cancer. ASCEND is designed to comprehensively assess the clinical profile of CR-001, including its potential in both first-line and previously treated patients, and to generate a robust data set to drive our development strategy across multiple indications.”

ASCEND (NCT07335497) is a global, open-label Phase 1/2 clinical trial evaluating CR-001 in multiple solid tumor types, including non-small cell lung cancer (NSCLC) and various gastrointestinal and gynecological cancers, in both treatment-naïve and previously treated patients. The trial is expected to enroll up to 290 patients in dose-escalation, backfill and dose-optimization cohorts at centers across multiple regions, including the United States, Europe and Asia Pacific. The primary objectives of the study are to evaluate the safety and tolerability of CR-001. Secondary objectives include assessment of pharmacokinetic and pharmacodynamic profiles, identification of the recommended Phase 2 dose, and evaluation of preliminary antitumor activity, including overall response rate (ORR), duration of response (DoR), progression-free survival (PFS) and overall survival (OS).

Crescent anticipates reporting proof-of-concept clinical data from the ASCEND trial in the first quarter of 2027, including initial safety, pharmacokinetics, pharmacodynamics and preliminary antitumor activity from dose escalation and backfill cohorts.

About CR-001 (also known as SKB118)

CR-001 (SKB118) is an investigational tetravalent bispecific antibody being developed for the treatment of solid tumors that combines two complementary, validated mechanisms in oncology via a blockade of PD-1 and VEGF. PD-1 checkpoint inhibition is aimed at restoring T cells’ ability to recognize and destroy tumor cells, and blocking VEGF is intended to reduce blood supply to tumor cells and to inhibit tumor growth. In preclinical studies, CR-001 demonstrated cooperative pharmacology with increased binding to PD-1 and signal blockade in the presence of VEGF as well as robust antitumor activity. CR-001 is currently being evaluated as a monotherapy in ASCEND, a global Phase 1/2 trial in patients with advanced solid tumors. CR-001’s anti-VEGF activity may also normalize the vasculature at the tumor site, which has the potential to improve the localization and effectiveness of combination therapies, such as the administration of CR-001 with Crescent’s antibody-drug conjugates (ADCs) in development. The first Phase 1/2 ADC combination trial with CR-001 is expected to initiate in the second half of 2026.

Under its strategic collaboration, Crescent has granted Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., exclusive rights to research, develop, and commercialize CR-001 in Greater China (including mainland China, Hong Kong, Macau and Taiwan).

CR-001 was discovered by Paragon Therapeutics, an antibody discovery engine founded by Fairmount.

About Crescent Biopharma

Crescent Biopharma’s vision is to build a world leading oncology company bringing the next wave of therapies for cancer patients. The Company’s clinical-stage pipeline includes its lead program, a PD-1 x VEGF bispecific antibody, as well as novel antibody-drug conjugates (ADCs). By leveraging multiple modalities and established targets, Crescent aims to rapidly advance potentially transformative therapies either as single agents or as part of combination regimens to treat a range of solid tumors. For more information, visit www.crescentbiopharma.com and follow the Company on LinkedIn and X.

Contact

Amy Reilly Chief Communications Officer [email protected] 617-465-0586