Corbus Pharmaceuticals Announces Dosing of First Patient in its First-In-Human Study of CRB-601 to Treat Patients with Advanced Solid Tumors

Rhea-AI Summary

Corbus Pharmaceuticals (NASDAQ: CRBP) has initiated the Phase 1 clinical trial of CRB-601, dosing its first patient for the treatment of advanced solid tumors. CRB-601 is a monoclonal antibody targeting latent TGFβ activation by blocking the integrin αVβ8.

Pre-clinical data has shown that CRB-601 successfully overcomes tumor immune exclusion and enhances the effectiveness of immune checkpoint inhibitors in vivo. The study (NCT06603844) represents a significant step in evaluating CRB-601's potential in immunotherapy and its ability to modulate TGFβ signaling.

Positive

• Advancement to Phase 1 clinical trials with first patient dosed
• Positive pre-clinical data showing enhanced immune checkpoint inhibitor activity

Negative

• None.

Insights

Medical Research Analyst

The initiation of Phase 1 clinical trials for CRB-601 represents a significant development in Corbus's oncology pipeline. The drug's mechanism of targeting αvβ8 to block TGFβ activation is particularly noteworthy, as TGFβ is a key immunosuppressive factor in the tumor microenvironment. Pre-clinical data showing enhanced immune checkpoint inhibitor activity suggests potential for combination therapy approaches. However, early-stage clinical trials carry substantial risks and it will take considerable time to establish safety and efficacy. Phase 1 studies typically focus on safety and dosing, with efficacy being a secondary consideration. While this milestone indicates progress in development, investors should maintain measured expectations as many candidates fail to progress beyond early clinical stages.

Oncology Doctor

CRB-601's approach to targeting the TGFβ pathway through αvβ8 inhibition represents an innovative strategy in immuno-oncology. The focus on preventing TGFβ activation rather than direct inhibition could potentially offer better specificity and reduced side effects compared to traditional TGFβ inhibitors. The involvement of Duke Cancer Institute adds credibility to the trial. The initial focus on advanced solid tumors provides a broad platform to assess efficacy across multiple cancer types. However, this is just the beginning of clinical development and meaningful efficacy data won't be available for some time. Success in pre-clinical models, while promising, doesn't always translate to human patients.

CRB-601 is an anti-αvβ8 monoclonal antibody designed to block activation of latent TGFβ in the tumor micro-environment

NORWOOD, Mass., Dec. 09, 2024 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), an oncology and obesity company with a diversified portfolio, today announced the dosing of the first patient in the  Phase 1 portion of the clinical study of CRB-601 for the treatment of patients with advanced solid tumors (NCT06603844). CRB-601 is a monoclonal antibody targeting latent TGFβ activation-by blocking the integrin αVβ8. Pre-clinical data has demonstrated that CRB-601 overcomes tumor immune exclusion and enhances the activity of immune checkpoint inhibitors in vivo.

“CRB-601 offers an intriguing upstream approach to modulating TGFβ signaling and this dose escalation study could yield valuable insights along with the potential to see the immune system being mobilized and the prospect of tumors responding.” said Dr. Dominic Smethurst, MA, MRCP, Chief Medical Officer of Corbus.”

“Dosing CRB-601 in a clinical trial marks an important milestone, bringing us closer to understanding its potential in the clinic and paving the way for advancements in an exciting corner of immunotherapy," said Dr. Jeffrey M. Clarke, MD., Associate Professor of Medicine, Associate Director of Thoracic Oncology Clinical Research Program, Duke Cancer Institute, Raleigh, NC. and a principal investigator in the CRB-601 study.

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 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 restructuring, 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.

INVESTOR CONTACT:

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

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

FAQ

What is the status of Corbus Pharmaceuticals' CRB-601 clinical trial?

Corbus Pharmaceuticals has begun Phase 1 clinical trials of CRB-601, with the first patient being dosed for the treatment of advanced solid tumors.

What are the pre-clinical results of CRB-601 (CRBP)?

Pre-clinical data shows that CRB-601 overcomes tumor immune exclusion and enhances the activity of immune checkpoint inhibitors in vivo.

What is the mechanism of action for Corbus Pharmaceuticals' CRB-601?

CRB-601 is a monoclonal antibody that targets latent TGFβ activation by blocking the integrin αVβ8 in the tumor micro-environment.