Corbus Pharmaceuticals Announces First Patient Dosed with its Nectin-4 Targeting ADC CRB-701 in Combination with Pembrolizumab

Rhea-AI Summary

Corbus Pharmaceuticals (NASDAQ: CRBP) has initiated the PD-1 combination arm of its Phase 1 study for CRB-701, dosing its first participant. The combination therapy involves CRB-701 with Keytruda® (pembrolizumab) at doses of 2.7 mg/kg and 3.6 mg/kg.

The three-part Phase 1 study (NCT06265727) focuses on advanced solid tumors with high Nectin-4 expression, with over 100 participants dosed in the monotherapy cohort. The study prioritizes Head and Neck Squamous Cell Carcinoma (HNSCC) and cervical cancer. The company plans to provide a data update and establish the recommended Phase 2 dose in Q4 2025.

Positive

• Over 100 participants successfully dosed in monotherapy cohort
• CRB-701 shows differentiated safety, tolerability and efficacy profiles in HNSCC, cervical and mUC tumors
• Study progressing well with encouraging enrollment rate

Negative

• None.

• Combination cohort initiated following successful review of monotherapy cohort
• Over 100 participants dosed to-date in monotherapy cohort
• Priority are Head and Neck Squamous Cell Carcinoma (HNSCC) and cervical cancer
• Data update on schedule for later this year  

NORWOOD, Mass., June 25, 2025 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), a clinical-stage company focused on oncology and obesity, today announced the dosing of the first participant in the PD-1 combination arm of its Phase 1 study investigating CRB-701 in solid tumors (the Phase 1 Western study). Participants in this arm of the study are being randomized to the 2.7 mg/kg and 3.6 mg/kg cohorts in combination with Keytruda^® (pembrolizumab).

“We are very pleased to reach this important milestone and with such an encouraging rate of enrollment in our CRB-701 program,” said Dr. Dominic Smethurst, MA MRCP, Chief Medical Officer of Corbus. “CRB-701 data demonstrates differentiated safety, tolerability and efficacy profiles in HNSCC, cervical and mUC tumors.”

The three-part Phase 1 study (NCT06265727) is evaluating the safety, pharmacokinetics and efficacy of CRB-701 in participants with advanced solid tumors associated with high Nectin-4 expression. The Part A dose escalation of the study evaluated four predetermined doses (1.8 mg/kg, 2.7 mg/kg, 3.6 mg/kg and 4.5 mg/kg Q3W) and is followed by Part B (dose optimization) and Part C (dose expansion). The Company expects to provide a data update and establish the recommended Phase 2 dose (RP2D) in the fourth quarter of this year.

About CRB-701
CRB-701 (SYS6002) is a next-generation antibody-drug-conjugate (ADC) targeting Nectin-4, that contains a site-specific, cleavable linker and a homogenous drug antibody ratio of 2, using MMAE as the payload. Nectin-4 is a clinically validated, tumor-associated antigen in urothelial cancer.

About Corbus
Corbus Pharmaceuticals Holdings, Inc. is a clinical-stage company focused on oncology and obesity and is committed to helping people defeat serious illness by bringing innovative scientific approaches to well-understood biological pathways. Corbus’ pipeline includes CRB-701, a next-generation antibody drug conjugate that targets the expression of Nectin-4 on cancer cells to release a cytotoxic payload, CRB-601, an anti-integrin monoclonal antibody that blocks the activation of TGFβ expressed on cancer cells, and CRB-913, a highly peripherally restricted CB1 receptor inverse agonist for the treatment of obesity. Corbus is headquartered in Norwood, Massachusetts. For more information on Corbus, visit corbuspharma.com. Connect with us on X, LinkedIn and Facebook.

Forward-Looking Statements
This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company’s trial results, product development, clinical and regulatory timelines, including timing for completion of trials and presentation of data, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statement that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management’s current beliefs and assumptions.

These statements may be identified by the use of forward-looking expressions, including, but not limited to, “expect,” “anticipate,” “intend,” “plan,” “believe,” “estimate,” “potential,” “predict,” “project,” “should,” “would” and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors on our operations, clinical development plans and timelines, which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company’s filings with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

All product names, logos, brands, and company names are trademarks or registered trademarks of their respective owners. Their use does not imply affiliation or endorsement by these companies.

INVESTOR CONTACT:

Sean Moran
Chief Financial Officer
Corbus Pharmaceuticals
smoran@corbuspharma.com

Dan Ferry
Managing Director
LifeSci Advisors, LLC
daniel@lifesciadvisors.com

FAQ

What is the latest development in Corbus Pharmaceuticals' (NASDAQ: CRBP) CRB-701 clinical trial?

Corbus has dosed the first participant in the PD-1 combination arm of its Phase 1 study, combining CRB-701 with Keytruda® at doses of 2.7 mg/kg and 3.6 mg/kg.

How many participants have been dosed in the CRB-701 monotherapy trial?

Over 100 participants have been dosed in the monotherapy cohort of the Phase 1 study.

What types of cancer is Corbus' CRB-701 targeting?

CRB-701 is primarily targeting Head and Neck Squamous Cell Carcinoma (HNSCC) and cervical cancer, focusing on advanced solid tumors with high Nectin-4 expression.

When will Corbus Pharmaceuticals release the next data update for CRB-701?

Corbus expects to provide a data update and establish the recommended Phase 2 dose (RP2D) in the fourth quarter of 2025.

What are the different parts of the CRB-701 Phase 1 study?

The study consists of three parts: Part A (dose escalation with four predetermined doses), Part B (dose optimization), and Part C (dose expansion).