Innovent Biologics and Roche to advance antibody drug conjugate candidate in advanced small cell lung cancer

Innovent Biologics has announced a collaboration and exclusive license agreement with Roche to advance the development of IBI3009, a novel delta-like ligand 3 (DLL3)-targeted antibody drug conjugate (ADC) candidate. IBI3009 has already obtained investigational new drug (IND) approvals in Australia, China, and the U.S., with the first patient for the Phase 1 study dosed in December 2024. This collaboration aims to bring innovative treatment options to patients with advanced small cell lung cancer.

IBI3009 targets DLL3, an antigen with low expression in normal tissues but significantly overexpressed in certain cancers, particularly small-cell lung cancer and other neuroendocrine tumors. Developed leveraging Innovent’s proprietary novel topoisomerase 1 inhibitor (TOPO1i) platform, IBI3009 is one of the leading and potentially best-in-class DLL3-targeting ADCs. IBI3009 has shown encouraging anti-tumor activity in multiple tumor-bearing mouse models, particularly in chemo-resistant tumor types, and has demonstrated a favorable safety profile.

Dr. Samuel Zhang, Chief Business Officer of Innovent, said: “We are delighted to once again enter a strategic collaboration with Roche, a global leader in oncology, to advance our potentially best-in-class DLL3 ADC candidate. By combining Roche’s scientific expertise and global development capabilities with our innovative approach, we are taking a significant step forward in our mission—to empower patients worldwide with affordable, high-quality biopharmaceuticals.”

“We are excited to enter this partnership with the Innovent team to further develop this promising investigational treatment for patients with small cell lung cancer. This partnership builds on Roche’s long history of innovation in the area of ADCs, to address the unmet needs of patients with solid tumors with transformational medicines,” said Boris L. Zaïtra, Head of Corporate Business Development at Roche.

Under the agreement, Innovent has granted Roche exclusive global rights to develop, manufacture and commercialize IBI3009. The two parties will jointly focus on the early-stage development of this ADC candidate, after which Roche will take over full development. Innovent will receive an upfront payment of US$80 million and is eligible to receive up to US$1 billion in development and commercial milestone payments, along with tiered royalties on net sales.

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