Roche Forms Partnership Worth Potentially More than $1 Billion with Innovent to Develop Novel ADC for SCLC

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Editor's note: this story was originally published on BioPharmInterntional.com.

Innovent Biologics (Innovent), a China-based biopharmaceutical company specializing in treatments for oncology, cardiovascular and metabolic, autoimmune, ophthalmology, and other major diseases, announced on Jan. 2, 2025 that it has entered into a collaboration and exclusive license agreement with Roche. The companies will advance the development of IBI3009, Innovent’s novel delta-like ligand 3 (DLL3)-targeted antibody drug conjugate (ADC) candidate. The collaboration is aimed at bringing innovative treatment options to patients with advanced small cell lung cancer (SCLC).

Under the agreement, Roche receives exclusive global rights to develop, manufacture, and commercialize IBI3009; however, the two companies will jointly focus on the early stage development of the candidate. After early stage development, Roche will take over full development. Innovent, in turn, will receive an upfront payment of $80 million and is eligible to receive up to $1 billion in development and commercial milestone payments. Innovent is also eligible to receive tiered royalties on net sales.

“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,” said Samuel Zhang, PhD, chief business officer, Innovent, in the press release (1).

DLL3 is an antigen with low expression in normal tissues but is significantly overexpressed in certain cancers, particularly SCLC and other neuroendocrine tumors, making it an attractive target for emerging therapy development (2). IBI3009 has already received investigational new drug (IND) approvals in the United States, China, and Australia and is currently in a Phase I study.

IBI3009 was developed using Innovent’s proprietary novel topoisomerase 1 inhibitor (TOPO1i) platform. It has shown positive anti-tumor activity in multiple tumor-bearing mouse models, particularly chemo-resistant tumor types. The ADC has also demonstrated a favorable safety profile, according to the company press release.

“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, Roche, in the release.

Innovent has four new drug applications under regulatory review, and the company’s pipeline includes three assets in Phase III or pivotal clinical trials with 17 more molecules in early clinical stage. Innovent’s global partners include Eli Lilly and Company, Sanofi, Incyte, Adimab, LG Chem, and MD Anderson Cancer Center.

References

1. Innovent Biologics. Innovent Enters into Exclusive Global License Agreement with Roche for Novel DLL3 Antibody Drug Conjugate. Press Release. Jan. 2, 2025.
2. Rudin, C. M.; Reck, M.; Johnson, M. L.; et al. Emerging Therapies Targeting the Delta-like Ligand 3 (DLL3) in Small Cell Lung Cancer. J. Hematol. Oncol. 2023,16, 66. DOI: 10.1186/s13045-023-01464-y