Crescent Biopharma Milestones the First Patient Dose in the ASCEND Phase 1/2 Trial of CR‑001

Crescent Biopharma Inc. (Nasdaq: CBIO), a clinical‑stage biotechnology company headquartered in Rockville, United States, has announced the initiation of its ASCEND program, a global Phase 1/2 study evaluating CR‑001, a PD‑1 × VEGF bispecific antibody, in patients with advanced solid tumors. The first patient was dosed on 18 February 2026, marking a critical step forward in the company’s drug development pipeline.

The ASCEND Study Design

ASCEND (NCT07335497) is an open‑label, dose‑escalation and dose‑optimization trial that will enroll up to 290 participants across the United States, Europe and the Asia‑Pacific region. The study will assess safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity in both treatment‑naïve and previously treated patients with a variety of solid tumors, including non‑small‑cell lung cancer (NSCLC) and gastrointestinal and gynecological malignancies.

The primary objective is to evaluate the safety profile of CR‑001. Secondary endpoints encompass pharmacokinetic and pharmacodynamic parameters, determination of the recommended Phase 2 dose, and early signals of efficacy such as overall response rate (ORR), duration of response (DoR), progression‑free survival (PFS) and overall survival (OS).

What is CR‑001?

CR‑001, also known as SKB118, is a tetravalent bispecific antibody that simultaneously targets two validated mechanisms in oncology: PD‑1 checkpoint inhibition and VEGF blockade. By restoring the ability of T cells to recognize tumor cells and by reducing tumor vascularization, CR‑001 is designed to deliver a dual attack on tumor growth. Preclinical studies have shown cooperative pharmacology, enhanced PD‑1 binding in the presence of VEGF, and robust antitumor activity. The antibody’s anti‑VEGF activity may also normalize tumor vasculature, potentially improving drug delivery and immune cell infiltration.

Development Timeline and Expectations

Crescent anticipates reporting proof‑of‑concept data from ASCEND in the first quarter of 2027, including initial safety, pharmacokinetic and pharmacodynamic findings, as well as preliminary efficacy signals from the dose‑escalation and backfill cohorts. The ASCEND program is the first of four clinical trials across Crescent’s portfolio that are expected to commence in 2026, reflecting the company’s commitment to rapidly advancing its therapeutic candidates.

Strategic Context

Crescent Biopharma’s focus on developing small‑molecule drug compounds for blood cancers and inflammatory conditions positions CR‑001 within a broader strategy to expand the company’s therapeutic portfolio. The announcement comes at a time when the company’s share price sits near the lower end of its 52‑week range, at $9.33 per share on 16 February 2026, following a market cap of approximately $175 million. The announcement underscores the company’s intent to generate robust clinical data that could establish CR‑001 as a best‑in‑class immuno‑oncology therapy.

Key Takeaways

  • First patient dose achieved in the ASCEND Phase 1/2 trial of CR‑001 on 18 February 2026.
  • ASCEND will enroll up to 290 patients across multiple regions, testing CR‑001 in a range of advanced solid tumors.
  • Primary focus: safety and tolerability; secondary focus: pharmacokinetics, pharmacodynamics, and early efficacy signals.
  • Proof‑of‑concept data expected in Q1 2027, potentially setting the stage for future Phase 2 and Phase 3 studies.
  • CR‑001 combines PD‑1 and VEGF blockade in a bispecific format, offering a dual‑mechanism approach to tumor suppression.

Crescent’s progress on ASCEND illustrates a pivotal moment in the company’s pursuit of innovative cancer therapies, with the potential to reshape treatment options for patients with advanced solid tumors.