Corbus Announces Dosing of First Patient in U.S. Phase 1 Clinical Trial of Its Next Generation Nectin-4 Targeting ADC

2024-04-02

临床1期上市批准抗体药物偶联物加速审批

Study enrolling patients with metastatic urothelial cancer (mUC) and other Nectin-4 enriched tumors Nectin-4 enriched tumors

Emerging clinical profile from CSPC’s Phase 1 China study indicates differentiation from PADCEV

NORWOOD, Mass., April 02, 2024 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), a precision oncology company with a diversified portfolio, announced today the first patient in the U.S. has been dosed in the Phase 1 clinical trial of CRB-701 (SYS6002), a next-generation antibody-drug-conjugate (ADC) targeting Nectin-4.

The Phase 1 portion of the open label study design (NCT06265727), being conducted in the U.S. and Europe, will evaluate the safety, efficacy and pharmacokinetics (PK) of CRB-701 in participants with advanced solid tumors associated with high Nectin-4 expression. The Phase 1 trial initiates with dose escalation followed by dose optimization and concludes with dose expansion to determine the recommended Phase 2 dose.

“The initiation of our clinical trial is a significant milestone for Corbus and builds on the encouraging CRB-701 data presented by our development partner CSPC Pharmaceutical Group at ASCO-GU 2024 from the phase 1 study in China,” said Yuval Cohen, PhD. Chief Executive Office of Corbus. “Those data suggest CRB-701 has a differentiated PK and safety profile compared to PADCEV® (enfortumab vedotin-ejfv) which could translate into meaningful clinical benefits for patients with mUC and other Nectin-4 positive solid tumors Nectin-4 positive solid tumors.”

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. The Nectin-4 ADC PADCEV® (enfortumab vedotin-ejfv) is approved for use in late metastatic urothelial cancer and recently received an expanded label under an accelerated approval from the Food and Drug Administration for use in combination with KEYTRUDA® for patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-containing chemotherapy.

About Corbus

Corbus Pharmaceuticals Holdings, Inc. is a precision oncology 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 Twitter, LinkedIn and Facebook.

Forward-Looking Statements

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INVESTOR CONTACT:

Sean Moran

Chief Financial Officer

Corbus Pharmaceuticals

smoran@corbuspharma.com

Bruce Mackle

Managing Director

LifeSci Advisors, LLC

bmackle@lifesciadvisors.com