Corbus Pharmaceuticals initiates combination cohort of CRB-701 study for solid tumors, focusing on HNSCC and cervical cancer. Data update expected this year.
Quiver AI Summary
Corbus Pharmaceuticals Holdings, Inc. announced the initiation of the PD-1 combination cohort in its Phase 1 study for the cancer treatment CRB-701 after successfully reviewing the monotherapy cohort, in which over 100 participants have been dosed. This Phase 1 study, focusing on Head and Neck Squamous Cell Carcinoma and cervical cancer, aims to evaluate CRB-701's safety and efficacy in combination with Keytruda®, with participants randomized to two dosage groups. The company is pleased with the enrollment rate and expects to provide a data update and recommended Phase 2 dose by the end of the year. CRB-701 targets Nectin-4 and is designed as a next-generation antibody-drug conjugate.
Potential Positives
- Initiation of the combination cohort following a successful review of the monotherapy cohort indicates progress in the clinical trial process.
- Over 100 participants dosed to date in the monotherapy cohort highlights strong enrollment and interest in the study.
- The focus on Head and Neck Squamous Cell Carcinoma (HNSCC) and cervical cancer addresses significant healthcare needs for effective cancer treatments.
- Upcoming data update expected later this year signifies potential for important insights into the efficacy and safety of CRB-701.
Potential Negatives
- Risks associated with clinical trials are highlighted, including potential delays or setbacks in the development of CRB-701 and other pipeline products, which could negatively impact investor confidence.
- The press release includes forward-looking statements that may not materialize, creating a risk of investor disappointment should projected timelines and outcomes not be met.
- No definitive data or results from the ongoing studies are presented, which could lead to skepticism about the efficacy and safety of the product in the competitive oncology market.
FAQ
What is the CRB-701 study about?
The CRB-701 study investigates the safety and efficacy of CRB-701 in advanced solid tumors with high Nectin-4 expression.
Which cancers are prioritized in the CRB-701 study?
The study prioritizes Head and Neck Squamous Cell Carcinoma (HNSCC) and cervical cancer among others.
What are the cohorts involved in the CRB-701 study?
The study has a three-part design including dose escalation, optimization, and expansion cohorts for CRB-701.
When will there be a data update on CRB-701?
A data update is scheduled for the fourth quarter of this year, detailing the recommended Phase 2 dose.
What is the mechanism of action for CRB-701?
CRB-701 is an antibody-drug conjugate that targets Nectin-4 on cancer cells to deliver a cytotoxic payload.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
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- YUVAL COHEN (Chief Executive Officer) sold 7,134 shares for an estimated $62,464
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Full Release
- 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
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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.
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INVESTOR CONTACT:
Sean Moran
Chief Financial Officer
Corbus Pharmaceuticals
[email protected]
Dan Ferry
Managing Director
LifeSci Advisors, LLC
[email protected]
