Innovent Biologics and Roche have announced a partnership and exclusive license agreement focused on the development of IBI3009, an antibody-drug conjugate (ADC) targeting delta-like ligand 3 (DLL3), for the treatment of advanced small cell lung cancer (SCLC). This collaboration aims to accelerate the development of a promising therapy for a cancer with significant unmet medical needs.
Partnership Terms and Development Strategy
Under the agreement, Roche will gain exclusive worldwide rights to develop, manufacture, and commercialize IBI3009. The initial focus will be on early-stage development, after which Roche will assume full responsibility for the ADC's continued development. Innovent will receive an upfront payment of $80 million and is eligible for up to $1 billion in development and commercial milestones, as well as tiered royalties on net product sales.
Rationale for DLL3 Targeting
DLL3 is an antigen overexpressed in certain cancers, including SCLC, while maintaining low expression in normal tissues. IBI3009 is designed to specifically target DLL3, delivering a topoisomerase 1 inhibitor payload directly to cancer cells. Preclinical studies have demonstrated encouraging anti-tumor activity and a favorable safety profile for the therapy.
Clinical Development and Regulatory Status
IBI3009 has already received investigational new drug (IND) approvals in the US, China, and Australia. A Phase I study, evaluating the safety and efficacy of IBI3009, commenced in December 2024 with the first subject dosed. This ongoing trial will provide critical data on the ADC's potential in treating SCLC.
Expert Commentary
Roche's corporate business development head, Boris Zaïtra, expressed enthusiasm for the partnership, stating, "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 tumours with transformational medicines."
Innovent Biologics' chief business officer, Dr. Samuel Zhang, highlighted the significance of the collaboration: "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."
