Innovent Enters into Exclusive Global License Agreement with Roche for Novel DLL3 Antibody Drug Conjugate

Rhea-AI Summary

Innovent Biologics has entered into an exclusive global license agreement with Roche for IBI3009, a novel DLL3-targeted antibody drug conjugate (ADC) candidate for treating advanced small cell lung cancer. IBI3009 has received IND approvals in Australia, China, and the U.S., with Phase 1 study initiation in December 2024.

IBI3009 targets DLL3, an antigen overexpressed in small-cell lung cancer and neuroendocrine tumors but with low expression in normal tissues. Developed using Innovent's proprietary topoisomerase 1 inhibitor platform, the drug has demonstrated promising anti-tumor activity in mouse models, particularly in chemo-resistant tumors.

Under the agreement, Roche gains exclusive global rights for development, manufacturing, and commercialization. Innovent will receive an $80 million upfront payment and is eligible for up to $1 billion in milestone payments plus tiered royalties on net sales.

Positive

• Secured $80 million upfront payment from Roche
• Potential to receive up to $1 billion in milestone payments plus royalties
• IBI3009 has obtained IND approvals in three major markets (US, China, Australia)
• Partnership with global pharmaceutical leader Roche enhances development capabilities

Negative

• Early-stage development status (Phase 1) indicates long pathway to commercialization
• Development and commercialization control transferred to Roche

SAN FRANCISCO and SUZHOU, China, Jan. 1, 2025 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, today announced a collaboration and exclusive license agreement with Roche (SIX: RO, ROG; OTCQX: RHHBY) to advance the development of IBI3009, a novel DLL3-targeted antibody drug conjugate (ADC) candidate. IBI3009 has already obtained 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: A potentially best-in-class DLL3 ADC Candidate
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, stated: "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.

About Innovent
Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 13 products in the market. It has 4 new drug applications under regulatory review, 3 assets in Phase III or pivotal clinical trials and 17 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, Adimab, LG Chem and MD Anderson Cancer Center.

Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit www.innoventbio.com, or follow Innovent on Facebook and LinkedIn.

Innovent's Forward-Looking Statements
This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly.

These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions.

 

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SOURCE Innovent Biologics

FAQ

What are the financial terms of Innovent's DLL3 ADC agreement with Roche?

Innovent will receive an $80 million upfront payment and is eligible for up to $1 billion in development and commercial milestone payments, plus tiered royalties on net sales.

What is the current development stage of IBI3009?

IBI3009 has received IND approvals in Australia, China, and the U.S., with Phase 1 clinical trials beginning in December 2024.

What type of cancer does IBI3009 target?

IBI3009 targets advanced small cell lung cancer and other neuroendocrine tumors that express the DLL3 antigen.

What rights does Roche receive under the agreement?

Roche receives exclusive global rights to develop, manufacture, and commercialize IBI3009.

What technology platform is IBI3009 based on?

IBI3009 is developed using Innovent's proprietary novel topoisomerase 1 inhibitor (TOPO1i) platform.