• CRB-601 is a potent and selective anti-αvβ8 integrin monoclonal antibody designed to block the activation of latent TGFβ selectively within the tumor microenvironment
• CRB-601 significantly inhibits tumor growth as a single agent and enhances the efficacy of anti-PD-1 immunotherapy in checkpoint inhibitor (CPI) sensitive and CPI-resistant tumor models
• Data indicate that anti-tumor activity of CRB-601 as a monotherapy correlates with protein expression of αvβ8
• CRB-601 is on schedule for IND submission in mid-2023 in solid tumor cancers

NORWOOD, Mass., Nov. 10, 2022 /PRNewswire/ -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) ("Corbus" or the "Company"), an oncology company, is presenting new preclinical data for CRB-601 today in a poster presentation at the Society for Immunotherapy of Cancer (SITC) Annual Meeting in Boston.

The latest preclinical data demonstrate significant tumor growth inhibition by CRB-601 as a single agent and in combination with anti-PD-1 treatment in the syngeneic murine tumor models MC38 and EMT6. In addition, treatment with CRB-601 appears to restore sensitivity to checkpoint inhibitors in the Pan02 and 4T1 syngeneic tumor models, regarded as "desert" tumors that are non-responsive to current CPIs. CRB-601 is the only anti-αvβ8 targeting agent known to demonstrate such an effect in these models to date.

The anti-tumor effects in the immune excluded EMT6 model correlated with changes in the immune cell populations in the tumor microenvironment. There were increases in proliferating CD4+ and CD8+ T-cells and Natural Killer cells, and a shift in macrophage polarization to the inflammatory M1 phenotype. Collectively these data suggest that treatment with CRB-601 could address tumors with an immune excluded phenotype, as represented by this model, and facilitate sensitization to anti-PD-1 therapy.  

Additionally, tumor protection is associated with a durable T-cell memory response. Tumor-bearing mice initially rendered tumor-free by treatment with the combination of CRB-601 + anti-PD-1 were subsequently reinoculated with the same tumor cells (MC38) and monitored for tumor establishment and growth. After 30 days no tumors had formed in this cohort of animals, whereas implantation and eventual death occurred in 100% of the treatment naïve control animals. T-cell depletion studies indicated that protection against MC38 tumor growth in these rechallenged animals was dependent upon CD8+ T-cells.

"CRB-601 demonstrates robust pre-clinical anti-tumor activity alone and in combination with anti-PD-1 therapy in tumors exhibiting a range of sensitivities to anti-PD-1 therapy. The ability of CRB-601 to significantly reduce the growth of tumors that are non-responsive to CPIs and to sensitize these tumors to CPI therapy continues to support our hypothesis that effective blockade of latent TGFβ activation should lead to enhanced immune cell invasion in the tumor microenvironment and augment the effects of anti-PD-1 therapy. The increased activity of CRB-601 in tumors expressing αvβ8 provides a promising biomarker for patient selection and stratification," commented Rachael Brake, Ph.D., Chief Scientific Officer of Corbus.  

Corbus is currently developing CRB-601 as a potential treatment for solid tumor cancers, and the program is on schedule for an IND submission in mid-2023. 

Dr. Daqing Wang, PhD will be presenting the new data today in Poster #815 in Hall C from 11:40 am – 1:10 pm and again from 7:30 pm – 9 pm. The SITC poster is available on the company website at: https://www.corbuspharma.com/SITC-37-presentation

Corbus is an oncology company committed to connecting innovation to our purpose of improving lives by developing new medicines that target the nexus between the immune system and cancer. Corbus' current pipeline includes anti-integrin monoclonal antibodies that block activation of TGFβ and small molecules that activate or inhibit the endocannabinoid system. Corbus is headquartered in Norwood, Massachusetts. For more information on Corbus, visit corbuspharma.com. Connect with us on Twitter, LinkedIn and Facebook.

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, including the potential impact of the recent COVID-19 pandemic and the potential impact of sustained social distancing efforts, 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 CONTACTS:

Sean Moran
Chief Financial Officer
smoran@corbuspharma.com

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

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SOURCE Corbus Pharmaceuticals