CRB-701 (SYS6002) A Next Generation Nectin-4 Targeting Antibody Drug Conjugate Demonstrates Encouraging Safety and Efficacy in Patients with Nectin-4 Positive Tumors in First-In-Human Study Presented at ASCO-GU 2024 - Seite 2

Efficacy

• Dose level 5 (2.7 mg/kg) and above represents the predicted therapeutically relevant doses based on allometric scaling.
• A mixed tumor population (n=7) receiving doses of 2.7 mg/kg or 3.6 mg/kg demonstrated an ORR of 43% (3 partial responses -2 unconfirmed and one non-responding participant with no-nectin-4 expression) and a disease control rate of 71%.
• The longest observed response to date is 11 cycles (~10 months) and ongoing.
• All nectin-4 positive mUC and cervical patients at doses ≥ 2.7 mg/kg that were assessable at the time of the December 2023 data-cut off demonstrated levels of disease control and represent the CRB-701 (SYS6002) responsive population to date.

Dr. Yuval Cohen Chief Executive Office of Corbus commented, “CRB-701 with its novel antibody and next generation linker technology, appears to have a differentiated PK profile compared to EV, with a current safety profile devoid of peripheral neuropathy and skin rash, both dose limiting toxicities for EV. This could translate into meaningful benefits for mUC patients and other nectin-4 positive solid tumors such as cervical cancer.”

In reviewing the emerging profile of CRB-701 with one of the preeminent experts in GU cancers, Dr Daniel P. Petrylak M.D., Professor of Medicine and Urology at Yale School of Medicine, Dr. Petrylak shared that “the clinical responses in nectin-4 positive mUC and cervical cancer patients are encouraging and the early clinical safety provides the first evidence that CRB-701 has clinical activity in multiple nectin-4 expressing tumors. This justifies further investigation into the safety and efficacy of this promising compound.”

Dr. Cohen concluded, “as the current clinical study continues to progress in China with our partner CSPC, we at Corbus are looking forward to commencing our clinical study in the US in Q1 2024 under an already open IND. We are grateful to CSPC for the work that has gone into conducting this ongoing study and to the clinicians and study participants."

Dose escalation and expansion are ongoing and additional data presentations are planned for later 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. 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.