On September 16, 2024 Instil Bio, Inc. (Nasdaq: TIL, "Instil") and ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (HKEX:1541, "ImmuneOnco") reported the global registrational strategy for the PD-L1xVEGF bispecific antibody SYN-2510/IMM2510 in combination with chemotherapy in front-line non-small cell lung cancer (NSCLC) and in front-line triple-negative breast cancer (TNBC) (Press release, Instil Bio, SEP 16, 2024, View Source [SID1234646655]).
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In China, ImmuneOnco is accelerating the development of IMM2510/SYN-2510 in front-line NSCLC by targeting initiation in late 2024 of a Phase 1b/2 front-line chemo combination study. This study is expected to enroll patients with driver gene mutation-negative non-squamous and squamous NSCLC. ImmuneOnco is also accelerating development of IMM2510/SYN-2510 in front-line TNBC with initial Phase 1b/2 chemotherapy combination studies targeted to begin in early 2025.
In the United States, Instil is prioritizing development of SYN-2510/IMM2510 in NSCLC and TNBC. US IND submission is targeted for late 2024, starting with a Phase 2 trial of SYN-2510/IMM2510 monotherapy in second-line non-squamous and squamous NSCLC.
With potential positive proof-of-concept data, ImmuneOnco and Instil may initiate joint global randomized Phase 3 chemotherapy combination trials in first-line non-squamous and squamous NSCLC and/or first-line TNBC.
"There are significant unmet medical needs in NSCLC and TNBC cancer patients which may be addressed by IMM2510," said Dr. Wenzhi Tian, PhD, CEO and CSO of ImmuneOnco. "This practical and accelerated registrational strategy, which is aligned with Instil, paves a clear pathway to a potential regulatory approval for us in China and for Instil Bio globally."
"SYN-2510 may have the opportunity to meaningfully improve on the current standard of care in NSCLC and TNBC," said Bronson Crouch, CEO of Instil. "Our expectation for the initial US study of SYN-2510 is that it would lay a foundation for the efficient enrollment of potential global Phase 3 studies."
About SYN-2510/IMM2510
SYN-2510/IMM2510 is a PD-L1xVEGF bispecific antibody in development for the treatment of multiple solid tumor cancers. SYN-2510/IMM2510 is differentiated from other PD-(L)1xVEGF bispecific antibodies by its VEGF trap, which binds multiple VEGF receptor ligands beyond VEGF-A, a bispecific structure which leverages PD-L1 as an anchor in the tumor microenvironment (TME), and enhanced antibody-dependent cellular cytotoxicity (ADCC) to direct killing of PD-L1-positive tumor cells.