FX.co ★ IDEAYA Signs License Agreement For ADC SHR-4849 With Jiangsu Hengrui Pharma

IDEAYA Biosciences, Inc. (IDYA), a company specializing in precision medicine oncology, announced on Sunday the establishment of an exclusive global licensing agreement for the antibody-drug conjugate SHR-4849 with Jiangsu Hengrui Pharmaceuticals Co., Ltd., a firm based in China.

Through this accord, IDEAYA will be responsible for the development and commercialization of SHR-4849 outside of Greater China. The company plans to submit a U.S. Investigational New Drug (IND) application for SHR-4849 in the first half of 2025.

Under the terms of the agreement, Hengrui Pharma has the potential to earn up to $1.045 billion through a combination of upfront and milestone payments. This includes an initial payment of $75 million, up to $200 million tied to development and regulatory milestones, and additional payments contingent upon commercial achievements.

Hengrui will also earn royalties from mid-single to low-double digits on sales generated outside Greater China. It's notable that these financial commitments and research expenses will not impact IDEAYA's previously projected cash runway, which is estimated to last until at least 2028.

SHR-4849 is a groundbreaking antibody-drug conjugate (ADC) program that targets DLL3 using a Topo-I payload, specifically for Small Cell Lung Cancer (SCLC) and Neuroendocrine Tumors (NETs).

Preclinical studies have demonstrated SHR-4849's promising antitumor activity, including tumor regression when used as a monotherapy in various models. The compound is currently under evaluation in a Phase 1 clinical trial for advanced solid tumors in China (NCT06443489).

The Human Protein Atlas database indicates that DLL3 is present in several solid tumor types, appearing in approximately 85% of Small Cell Lung Cancer cases and 20-40% of Neuroendocrine Tumors. Due to DLL3's limited extracellular expression in normal tissues, it is considered a compelling therapeutic target for these tumors, which have few effective treatment options.

Yujiro Hata, CEO and Founder of IDEAYA, expressed, "There is a significant unmet medical need for patients with DLL3-expressing solid tumors. We are enthusiastic about the opportunity to advance SHR-4849, which holds potential as a monotherapy for both SCLC and NETs. It is competitively positioned to be a first-in-class contender within the DLL3 topo-I payload ADC landscape, a sector that has shown early clinical validation as a monotherapy in SCLC."

IDEAYA highlighted that SHR-4849 aligns with its strategic objective of developing effective clinical combinations of topo-payload based ADCs in conjunction with their PARG inhibitor, IDE161.

On Friday, shares of IDYA closed at $25.16 on the Nasdaq, marking a 2.71% decrease.