Corbus Pharmaceuticals to Present CRB-701 Phase 1/2 Data at ESMO 2025

Rhea-AI Summary

Corbus Pharmaceuticals (NASDAQ: CRBP) will present updated Phase 1/2 data for CRB-701 (SYS6002) at ESMO 2025 on October 19, 2025 (Poster #967P) with a poster session from 12:00–12:45 CEST. The poster reports a September 1, 2025 data cut showing 167 enrolled participants, of which 122 were evaluable for efficacy across HNSCC (n=41), cervical (n=37), metastatic urothelial (n=23) and other dose-escalation tumors (n=21).

The abstract also includes safety data from an April 2025 cut on 70 participants. Corbus will host an in-person and virtual HNSCC KOL event in Berlin on October 19 at 10:00 CEST featuring HNSCC experts and a live Q&A.

Positive

• Total enrollment of 167 participants in the Phase 1/2 study
• 122 participants evaluable for efficacy as of Sept 1, 2025
• Cohorts include HNSCC (n=41), cervical (n=37), and urothelial (n=23)

Negative

• Safety dataset cited is limited to 70 participants from the April 2025 cut

Insights

Oncology clinical development expert

Early but tangible clinical progress: expanded dataset for CRB-701 presented at ESMO; safety snapshot and cohort counts disclosed, but no efficacy outcomes reported.

The company, Corbus, will present Phase 1/2 data for CRB-701 at ESMO on October 19, 2025, showing an updated enrollment of 167 participants with 122 evaluable for efficacy and specific cohort sizes (HNSCC n=41, cervical n=37, metastatic urothelial n=23, other dose-escalation n=21). The abstract also notes safety data from an April 2025 cut for 70 participants; the poster will use a September 1, 2025 data cut. These facts indicate trial momentum and broader exposure to the oncology community via a poster and a KOL event.

Key dependencies and risks include the absence of disclosed efficacy or detailed safety outcomes in this announcement; without those results, the commercial or regulatory impact remains unclear. The trial's value hinges on the forthcoming presented metrics (safety signals, objective response rates, duration of response, and pharmacokinetics) and whether subgroup efficacy emerges among the listed cohorts.

Concrete items to watch: the poster presentation on October 19, 2025 (Poster #967P) and any slide/poster data on safety events, objective response rate, and duration of response for the HNSCC and cervical cohorts; the company's KOL discussion the same day may add qualitative context. Expect near-term clarity within days of the presentation and a fuller readout only if the poster provides numeric efficacy and safety tables.

Data to be presented for 167 enrolled participants of which 122 were evaluable for efficacy

                               Company to host HNSCC KOL event to review and discuss data

NORWOOD, Mass., Oct. 14, 2025 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings Inc. (NASDAQ: CRBP), a clinical stage company focused on oncology and obesity, announced today the European Society for Medical Oncology (ESMO) Congress 2025 abstract for its Phase 1/2 clinical study has been released. Updated data will be presented as a poster during ESMO. The abstract describes safety data for 70 participants from an April 2025 data cut. The poster will present updated data from a September 1^st, 2025 data cut on 167 enrolled participants of which 122 participants were evaluable for efficacy with either head and neck squamous cell carcinoma (HNSCC)(n=41), cervical(n=37), metastatic urothelial tumors(n=23),or other tumor types enrolled during dose escalation(n=21).

The poster titled, “Phase 1/2 study of the next-generation Nectin-4-targeting antibody–drug conjugate CRB-701 (SYS6002) in patients with urothelial and non-urothelial solid tumours” by Perez et al, will be presented on Sunday, October 19 from 12:00-12:45 CEST (Poster # 967P).

Corbus will also host an in-person and virtual HNSCC KOL event to review and discuss the data. The event will be held at the Berlin Germany Marriott starting at 10AM CEST on Sunday October 19th. The event will feature insights from leading HNSCC experts:

• Ari Rosenberg, MD – University of Chicago
• Glenn Hanna, MD - Dana-Farber Cancer Institute
• Cesar Augusto Perez Batista, MD - Sarah Cannon Research Institute
  

A live question and answer session will follow the formal presentation. To register for the HNSCC KOL event, click here.

The ongoing CRB-701 Phase 1/2 clinical trial (NCT06265727) is being conducted in the U.S. and Europe is evaluating the safety, pharmacokinetics, and efficacy of CRB-701 in participants with advanced solid tumors known to be associated with high Nectin-4 expression. The study is enrolling primarily participants with either HNSCC or cervical tumors.

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 monomethyl auristatin E (MMAE) as the payload. Nectin-4 is a clinically validated, tumor-associated antigen in urothelial cancer. The FDA has granted two Fast Track designations to CRB-701 in HNSCC and cervical 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 statements 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.

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INVESTOR CONTACTS:

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

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

FAQ

When will Corbus (CRBP) present CRB-701 data at ESMO 2025?

The poster for CRB-701 (Poster #967P) is scheduled for October 19, 2025, 12:00–12:45 CEST.

How many participants were enrolled and evaluable in the CRB-701 Phase 1/2 study (CRBP)?

The Sept 1, 2025 data cut shows 167 enrolled with 122 evaluable for efficacy.

Which tumor types are included in the CRB-701 trial results announced by Corbus (CRBP)?

Reported cohorts include HNSCC (n=41), cervical (n=37), metastatic urothelial (n=23), and other dose-escalation tumors (n=21).

What safety data will Corbus (CRBP) present for CRB-701 at ESMO 2025?

The abstract includes safety data from an April 2025 cut covering 70 participants.

When and where is Corbus hosting the HNSCC KOL event during ESMO 2025?

The HNSCC KOL event is October 19, 2025 at 10:00 CEST at the Berlin Germany Marriott and will be offered virtually.