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Corbus Announces Enrollment Completion of Dose Escalation Stage of Phase 1 Clinical Trial of Its Next Generation Nectin-4 Targeting ADC (CRB-701)

Key Takeaway: Corbus Pharmaceuticals has completed enrollment for the dose escalation part of its Phase 1 clinical trial for CRB-701, a novel antibody-drug conjugate targeting Nectin-4. The open-label trial, conducted in the US and UK, seeks to evaluate CRB-701's safety and efficacy in patients with advanced solid tumors. The first data from this study is anticipated in Q1 2025, and subsequent phases will optimize and expand dosing strategies. The study represents an important step in the development of CRB-701 as a potential treatment option in oncology.

Market Sentiment Analysis

POSITIVE FACTORS

  • Enrollment for the dose escalation stage of the Phase 1 trial has been completed.
  • CRB-701 targets Nectin-4, a validated tumor-associated antigen for advanced solid tumors.
  • The trial is expected to provide data on safety, pharmacokinetics, and preliminary efficacy.

Full Press Release Details

NORWOOD, Mass., Oct. 16, 2024 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), an oncology and obesity company with a diversified portfolio, announced today that it has completed enrollment of the dose escalation part of its bridging Phase 1 clinical trial of CRB-701 (SYS6002). The dose escalation part of this open label study (NCT06265727) is being conducted in the US and the UK. The three-part Phase 1 trial 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 Phase 1 study is evaluating four predetermined doses (1.8 mg/kg, 2.7 mg/kg, 3.6 mg/kg and 4.5 mg/kg) and will be followed by Part B (dose optimization) and Part C (dose expansion) that will determine recommended/optimized doses and seek preliminary efficacy signals.
The company expects to share the first data from dose escalation in Q1 2025.
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.
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 Facebook, LinkedIn and X.
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.
Chief Financial Officer
Corbus Pharmaceuticals
LifeSci Advisors, LLC

Frequently Asked Questions

What is CRB-701?

CRB-701 is a next-generation antibody-drug conjugate targeting Nectin-4 in cancer cells.

What is the current status of CRB-701 clinical trials?

Corbus has completed enrollment for the dose escalation part of its Phase 1 trial.

When will data from CRB-701 trials be released?

The first data from the dose escalation is expected in Q1 2025.

Where are the CRB-701 trials being conducted?

The trials are being conducted in the US and the UK.

What types of tumors does CRB-701 target?

CRB-701 targets advanced solid tumors with high Nectin-4 expression.

Last updated: Oct 16, 2024