Givastomig in combination with nivolumab plus chemotherapy will be evaluated for advanced gastric and oesophageal cancers. Credit: crystal light / Shutterstock.

I-Mab has announced a collaboration and supply agreement with Bristol Myers Squibb (BMS) to assess givastomig in combination with nivolumab plus chemotherapy for advanced gastric and oesophageal cancers.

Givastomig is an investigational Claudin (CLDN) 18.2 x 4-1BB bispecific antibody developed by I-Mab along with ABL Bio. Nivolumab is an immune checkpoint inhibitor of BMS.

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The companies will assess the combination regimen in a multi-national Phase I clinical trial to establish a potential first-line treatment for patients with Claudin 18.2-positive cancers.

I-Mab will carry out the study with BMS supplying nivolumab required for the trial.

Nivolumab works by hindering the programmed death-1 ligand 1 (PD-L1) protein on cancer cells from attaching to PD-1, enhancing T-cell function and anti-tumour responses.

Givastomig is designed to target CLDN18.2 on tumour cells and activate T-cells at the tumour site through 4-1BB.

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The antibody has shown tumour-binding and anti-tumour activity while potentially reducing liver toxicity and systemic immunotoxicity.

Givastomig is under investigation in a Phase I trial in the US and China.

The US Food and Drug Administration (FDA) awarded orphan drug designation to givastomig to treat gastric cancer, including gastroesophageal junction cancer, in March 2022.

I-Mab CEO Raj Kannan stated: “We are pleased to enter into this clinical collaboration agreement with Bristol Myers Squibb as we embark on the next stage of givastomig’s development to explore the significant promise of this bispecific antibody in a triple-therapy regimen.

“The study builds on the encouraging single-agent activity and safety we have observed with givastomig as presented at ESMO 2023. We remain optimistic that givastomig in combination with nivolumab and chemotherapy will drive potent anti-tumour activity in specific tumours, and we look forward to accelerating progress in the clinic.”

In May 2024 the European Commission approved BMS’s Opdivo (nivolumab) combination with gemcitabine and cisplatin as a first-line treatment for adults with unresectable or metastatic urothelial carcinoma.