Instil Bio and ImmuneOnco Reveal Global Strategy for PD-L1xVEGF Antibody in NSCLC and TNBC

DALLAS, TX, USA and SHANGHAI, China I September 16, 2024 I

Instil Bio, Inc. and ImmuneOnco Biopharmaceuticals (Shanghai) Inc. have revealed their global registration strategy for the PD-L1xVEGF bispecific antibody SYN-2510/IMM2510, combined with chemotherapy, targeting front-line treatments for non-small cell lung cancer (NSCLC) and triple-negative breast cancer (TNBC).

In China, ImmuneOnco plans to expedite the development of IMM2510/SYN-2510 for front-line NSCLC. They aim to initiate a Phase 1b/2 study combining the antibody with chemotherapy by late 2024. This study will focus on patients with non-squamous and squamous NSCLC that do not have driver gene mutations. Additionally, ImmuneOnco is fast-tracking the development of IMM2510/SYN-2510 for front-line TNBC, with Phase 1b/2 studies expected to commence in early 2025.

In the United States, Instil Bio is emphasizing the development of SYN-2510/IMM2510 for NSCLC and TNBC. They plan to submit an Investigational New Drug (IND) application by late 2024, starting with a Phase 2 trial of the antibody as a monotherapy for second-line treatment in non-squamous and squamous NSCLC.

Should the initial data prove promising, both companies are prepared to launch joint global Phase 3 trials. These trials will test the chemotherapy combination in first-line treatments for both non-squamous and squamous NSCLC, as well as TNBC.

Dr. Wenzhi Tian, CEO and CSO of ImmuneOnco, stated, "There are significant unmet medical needs in NSCLC and TNBC cancer patients which may be addressed by IMM2510. 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."

Bronson Crouch, CEO of Instil Bio, expressed optimism about SYN-2510, saying, "SYN-2510 may have the opportunity to meaningfully improve on the current standard of care in NSCLC and TNBC. 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."

SYN-2510/IMM2510 is a PD-L1xVEGF bispecific antibody designed to treat multiple solid tumor cancers. It distinguishes itself from other PD-(L)1xVEGF bispecific antibodies through its VEGF trap, which binds to multiple VEGF receptor ligands beyond VEGF-A, and its bispecific structure that uses PD-L1 as an anchor in the tumor microenvironment. Additionally, it enhances antibody-dependent cellular cytotoxicity (ADCC) for the direct killing of PD-L1-positive tumor cells.

Instil Bio is a clinical-stage biopharmaceutical company dedicated to developing novel therapies. Its leading asset, SYN-2510, is a unique PD-L1xVEGF bispecific antibody intended for treating various solid tumors.

ImmuneOnco is a clinical-stage biotech firm focused on discovering and developing biologics to treat cancers and other diseases. All of its assets, currently more than ten, are developed in-house, with the most advanced one in phase III trials. ImmuneOnco is committed to pioneering innovative therapies to enhance patient health.