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Corbus Pharmaceuticals Announces that Clinical Data for CRB-701 from Western Dose Escalation Study to be Presented at ASCO GU 2025

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Corbus Pharmaceuticals (NASDAQ: CRBP) announced that data from its first-in-human dose escalation clinical study of CRB-701 (SYS6002) will be presented at the 2025 ASCO Genitourinary Cancers Symposium in San Francisco. The study, conducted in the US and UK, focuses on a next-generation Nectin-4 targeting antibody-drug conjugate.

The Phase 1 study (NCT06265727) consists of three parts and evaluates safety, pharmacokinetics, and efficacy in patients with advanced solid tumors showing high Nectin-4 expression. Part A of the study examined four predetermined doses: 1.8 mg/kg, 2.7 mg/kg, 3.6 mg/kg, and 4.5 mg/kg Q3W. The study will continue with Part B (dose optimization) and Part C (dose expansion) to determine recommended doses and assess preliminary efficacy.

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Positive

  • Phase 1 clinical trial successfully completed dose escalation phase with four different dose levels
  • Study data selected for presentation at major industry conference (ASCO GU 2025)

Negative

  • None.

News Market Reaction 1 Alert

-1.27% News Effect

On the day this news was published, CRBP declined 1.27%, reflecting a mild negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

NORWOOD, Mass., Jan. 08, 2025 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), today announced data from its first-in-human dose escalation clinical study conducted in the United States and the United Kingdom (“Western study”) of CRB-701 (SYS6002) will be presented at the 2025 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU), to be held in San Francisco, CA February 13–15, 2025.

The poster is titled Phase 1 Dose-Escalation Study of Next-Generation Nectin-4 Targeting Antibody-Drug Conjugate CRB-701 (SYS6002) in US And UK Patients with Urothelial Cancer and other Solid Tutors (Perez, et al) and will be presented on Friday February 14, 2025 [Poster Session B: Urothelial Carcinoma; Poster BD# G30].

The three-part Phase 1 study (NCT06265727) is evaluating the safety, pharmacokinetics and efficacy of CRB-701 in patients 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) that will determine recommended/optimized doses and seek preliminary efficacy signals.

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 an oncology and obesity company with a diversified portfolio 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 which 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, 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
Sean.moran@corbuspharma.com

Bruce Mackle
Managing Director
LifeSci Advisors, LLC
bmackle@lifesciadvisors.com


FAQ

What are the dose levels being tested in the CRB-701 Phase 1 trial by CRBP?

The Phase 1 trial tested four predetermined doses: 1.8 mg/kg, 2.7 mg/kg, 3.6 mg/kg, and 4.5 mg/kg Q3W in Part A of the study.

When will CRBP present the CRB-701 clinical data at ASCO GU 2025?

Corbus will present the CRB-701 clinical data on February 14, 2025, during Poster Session B: Urothelial Carcinoma.

What type of cancer patients are included in CRBP's CRB-701 clinical trial?

The trial includes patients with advanced solid tumors associated with high Nectin-4 expression, including urothelial cancer.

What are the three parts of CRBP's Phase 1 trial for CRB-701?

The trial consists of Part A (dose escalation), Part B (dose optimization), and Part C (dose expansion) to determine recommended doses and assess preliminary efficacy.

What is CRB-701's mechanism of action in CRBP's clinical trial?

CRB-701 is a next-generation Nectin-4 targeting antibody-drug conjugate being evaluated for safety, pharmacokinetics, and efficacy.
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