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 .

Forward-Looking Statements

Certain statements in this press release, other than purely historical information, may constitute "forward-looking statements" within the meaning of the federal securities laws, including for purposes of the "safe harbor" provisions under the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements relating to Crescent’s expectations, hopes, beliefs, intentions or strategies regarding the future of its pipeline and business including, without limitation, the potential for CR-001 to be a best-in-class therapy and immuno-oncology backbone, the potential for ASCEND 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 the Company’s development strategy across multiple indications, the anticipated enrollment, timing of reporting proof-of-concept clinical data and, success of the ASCEND trial, the potential for CR-001 to be developed in additional combinations, including with other proprietary ADC pipeline assets, and the timing and success of the first Phase 1/2 ADC combination trial with CR-001. The words "opportunity," "potential," "milestones," "pipeline," "can," "goal," "strategy," "target," "anticipate," "achieve," "believe," "contemplate," "continue," "could," "estimate," "expect," "intends," "may," "plan," "possible," "project," "should," "will," "would" and similar expressions (including the negatives of these terms or variations of them) may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements are based on current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting Crescent will be those that have been anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond Crescent’s control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, that the expected benefits of, and opportunities related to, CR-001 may change, that CR-001 may not receive regulatory approval and, if approved, may not be commercially successful, that Crescent has no clinical data regarding cancer patients that have been treated with CR-001, either as a monotherapy or in combination with ADCs, and there can be no assurance that Crescent’s clinical trials will be completed successfully and/or produce results necessary to support regulatory approval for commercialization, that Crescent may not reach the anticipated milestones at the times outlined in this release or at all, Crescent’s limited operating history, including with respect to clinical trials, risks associated with clinical development and regulatory approval, Crescent’s reliance on third parties, including to help develop its product candidates and run its clinical trials, as well as to manufacture its product candidates, as well as those factors more fully described in Crescent’s most recent filings with the Securities and Exchange Commission (including its Quarterly Report on Form 10-Q), and Crescent’s other filings with the Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should any of Crescent’s assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements in this press release, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. Crescent does not undertake or accept any duty to release publicly any updates or revisions to any forward-looking statements. This press release does not purport to summarize all of the conditions, risks and other attributes of an investment in Crescent.

Contact:

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