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

Rhea-AI Summary

Crescent Biopharma (Nasdaq: CBIO) announced dosing of the first patient in the global ASCEND Phase 1/2 trial of CR-001, a PD-1 x VEGF bispecific antibody, for advanced solid tumors on Feb 18, 2026.

ASCEND may enroll up to 290 patients across the US, Europe and Asia Pacific; the company expects proof-of-concept data in Q1 2027 and said ASCEND is the first of four portfolio trials planned to start in 2026.

Positive

• First patient dosed in ASCEND Phase 1/2 (milestone advancement)
• Planned enrollment up to 290 patients across multiple regions
• Proof-of-concept timing targeted for Q1 2027, offering a defined near-term data milestone
• Program scale: ASCEND is first of four trials expected to initiate in 2026

Negative

• Primary objective is safety/tolerability, meaning no immediate efficacy guarantees
• Readout timeline risk: proof-of-concept not expected until Q1 2027, a ~1-year data wait

Key Figures

Planned enrollment: up to 290 patients Proof-of-concept timing: first quarter of 2027

2 metrics

Planned enrollment up to 290 patients ASCEND Phase 1/2 trial for CR-001

Proof-of-concept timing first quarter of 2027 Expected ASCEND proof-of-concept data readout

Market Reality Check

Price: $9.33 Vol: Volume 78,476 with relati...

low vol

$9.33 Last Close

Volume Volume 78,476 with relative volume of 0.34x is below the 20-day average of 232,807 ahead of this milestone update. low

Technical Shares at $9.33 are trading below the 200-day MA of $10.79 and sit at the 52-week low, 56.4% below the $21.40 52-week high.

Peers on Argus

Sector move flag is false, with only one momentum peer (TRDA) up and a mixed tap...

1 Up

Sector move flag is false, with only one momentum peer (TRDA) up and a mixed tape across key biotech peers (moves ranging from about -9% to +4%). This points more to company-specific factors than a broad biotech rotation.

Historical Context

5 past events · Latest: Feb 05 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Feb 05	Conference appearance	Positive	-3.1%	Announcement of management fireside chat at Guggenheim biotech summit.
Jan 30	Inducement grants	Neutral	+2.4%	Equity option awards to five non-executive employees under inducement plan.
Jan 05	IND clearances	Positive	+0.3%	Regulatory clearance of INDs for CR-001 and CR-003 in solid tumors.
Dec 18	Inducement grants	Neutral	-3.0%	Inducement option awards to three non-executive employees with 10-year terms.
Dec 04	Partnership & financing	Positive	-4.2%	Kelun-Biotech partnership and $185M private placement to fund global pipeline.

Pattern Detected

Recent history shows mixed to negative price reactions around generally constructive corporate and pipeline news, including a partnership and regulatory milestones.

Recent Company History

Over the past few months, Crescent Biopharma has progressed its oncology pipeline and strengthened its capital base. A $185 million private placement and Kelun-Biotech partnership in December 2025 outlined plans for multiple Phase 1/2 trials in 2026. Subsequent inducement award grants and conference participation maintained visibility. IND clearances for CR-001 and CR-003 on Jan 5, 2026 set up the ASCEND trial now dosing its first patient, consistent with earlier guidance for a global Phase 1/2 program and proof-of-concept data in Q1 2027.

Market Pulse Summary

This announcement confirms Crescent has moved from planning to execution by dosing the first patient...

Analysis

This announcement confirms Crescent has moved from planning to execution by dosing the first patient in ASCEND, a global Phase 1/2 trial of CR-001 in advanced solid tumors, with enrollment up to 290 patients and proof-of-concept data expected in Q1 2027. It follows prior IND clearances and partnership financing that outlined this path. Investors may focus on trial design, breadth of tumor types, and upcoming safety and pharmacokinetic data as key markers of future development risk.

Key Terms

pd-1, vegf, bispecific antibody, nsclc, +4 more

8 terms

pd-1 medical

"CR-001, a PD-1 x VEGF bispecific antibody, for the treatment of advanced solid tumors."

PD-1 is a protein found on certain immune cells that acts like a brake, signaling the immune system to slow down and avoid damaging healthy tissue. Drugs that block PD-1 release that brake so immune cells can better attack cancer cells; because such therapies can produce large clinical benefits, regulatory approvals, trial outcomes, pricing and market uptake for PD-1 drugs can materially affect a drugmaker’s prospects and investor returns.

vegf medical

"CR-001, a PD-1 x VEGF bispecific antibody, for the treatment of advanced solid tumors."

Vascular endothelial growth factor (VEGF) is a naturally occurring protein that signals the body to grow new blood vessels, like a fertilizer prompts plants to sprout. It matters to investors because drugs that block or mimic VEGF can dramatically change outcomes for cancers and eye diseases, making them major drivers of clinical trial results, regulatory approvals, market value and future revenue potential for biopharma companies.

bispecific antibody medical

"CR-001, a PD-1 x VEGF bispecific antibody, for the treatment of advanced solid tumors."

A bispecific antibody is a specially designed protein that can attach to two different targets at the same time. Think of it as a custom-made connector that brings two things together—such as a disease cell and an immune system component—helping the body fight illnesses more effectively. For investors, understanding bispecific antibodies is important because they represent innovative therapies that could lead to new treatments and potentially lucrative market opportunities.

nsclc medical

"including non-small cell lung cancer (NSCLC) and various gastrointestinal and gynecological cancers"

NSCLC stands for non-small cell lung cancer, which is the most common type of lung cancer. It develops in the lungs and can spread to other parts of the body, making it serious but often treatable if caught early. Understanding NSCLC helps people recognize the importance of lung health and early detection.

pharmacokinetic medical

"Secondary objectives include assessment of pharmacokinetic and pharmacodynamic profiles"

Pharmacokinetic describes how a drug moves through and leaves the body — how it is absorbed, spread to tissues, broken down and excreted — like tracking a package from pickup to delivery and disposal. For investors, these properties determine effective dose, safety risks, how often a medicine must be taken, and how reliably it works, which in turn influence clinical trial success, regulatory approval chances, production complexity and a drug’s commercial value.

pharmacodynamic medical

"Secondary objectives include assessment of pharmacokinetic and pharmacodynamic profiles"

Pharmacodynamic describes how a drug acts on the body — the biological effects it produces, how strong those effects are, and how long they last. For investors, pharmacodynamic data show whether a treatment actually works and at what dose, shaping expectations about a drug’s safety, effectiveness, regulatory success and market potential; think of it like testing how well a key turns a lock and whether it reliably opens the door.

overall response rate medical

"including overall response rate (ORR), duration of response (DoR), progression-free survival (PFS)"

Overall response rate is the percentage of patients in a clinical study whose measurable disease shrinks or disappears after receiving a treatment. Investors watch it like a product’s “hit rate” because higher response rates can signal a drug’s effectiveness, boost chances of regulatory approval and market demand, and affect a company’s future revenue prospects, similar to how a higher batting average suggests a more reliable player.

progression-free survival medical

"duration of response (DoR), progression-free survival (PFS) and overall survival (OS)."

Progression-free survival is the length of time during and after a treatment that a patient's disease does not get worse, measured from the start of treatment until the disease shows measurable signs of progression or the patient dies. Investors care because longer progression-free survival in clinical trials often signals that a drug is effective, improving chances of regulatory approval, market adoption, and revenue potential—think of it as a stopwatch showing how long a therapy can keep the illness at bay.

AI-generated analysis. Not financial advice.

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
amy.reilly@crescentbiopharma.com
617-465-0586

FAQ

What is ASCEND and what does Crescent Biopharma (CBIO) aim to evaluate in 2026?

ASCEND is a global Phase 1/2 study of CR-001 aiming to assess safety and dose in advanced solid tumors. According to Crescent Biopharma, the trial includes dose-escalation, backfill and dose-optimization cohorts across multiple regions and tumor types.

How many patients will the ASCEND trial for CR-001 (CBIO) enroll and where?

The trial is expected to enroll up to 290 patients across the United States, Europe and Asia Pacific. According to Crescent Biopharma, cohorts will include treatment-naïve and previously treated patients across several tumor types.

When does Crescent Biopharma (CBIO) expect to report proof-of-concept data from ASCEND?

Crescent Biopharma expects initial proof-of-concept data in Q1 2027, covering safety and preliminary antitumor activity. According to Crescent Biopharma, data will include safety, PK/PD and early efficacy from escalation and backfill cohorts.

What tumor types is CR-001 being tested in under the ASCEND trial (CBIO)?

CR-001 will be evaluated in multiple solid tumors including non-small cell lung cancer and gastrointestinal and gynecological cancers. According to Crescent Biopharma, the study includes both first-line and previously treated patient populations.

What are the primary and secondary objectives of the ASCEND trial for CR-001 (CBIO)?

The primary objectives are to evaluate safety and tolerability; secondary objectives include PK/PD, recommended Phase 2 dose and preliminary antitumor activity. According to Crescent Biopharma, efficacy measures include ORR, DoR, PFS and OS.

Why is the first-patient-dosed milestone important for Crescent Biopharma (CBIO)?

First patient dosing signals transition from setup to active clinical evaluation and program progress. According to Crescent Biopharma, it enables data generation toward a planned proof-of-concept readout and supports broader development across multiple indications.