IDEAYA Biosciences, Inc. (IDYA), a leader in precision medicine oncology, has announced a strategic agreement with Jiangsu Hengrui Pharmaceuticals Co., Ltd. This exclusive license pertains to SHR-4849, an innovative Topo-I-payload ADC program specifically targeting DLL3.
According to the agreement, IDEAYA will have the responsibility for the global development and commercialization of SHR-4849, with the exception of Greater China.
The financial aspects of the deal are substantial. Hengrui Pharma is set to receive up to $1.045 billion, which includes an immediate payment of $75 million. Additionally, there are provisions for up to $200 million in developmental and regulatory milestone payments, along with further commercial success-driven milestones.
Furthermore, Hengrui is entitled to royalties ranging from mid-single to low-double digits on net sales outside Greater China.
Despite these significant financial commitments, IDEAYA has reaffirmed its earlier projection that it will maintain a cash runway through at least 2028. This figure accounts for both upfront and anticipated R&D costs, including potential milestone payments.
Preclinical studies of SHR-4849 have indicated strong antitumor activities, and it is currently undergoing a Phase 1 clinical trial in China (NCT06443489), focusing on advanced solid tumors. To date, observed treatment-related adverse events have primarily been Grade 1 or 2, with ongoing dose escalation trials not having reached the maximum tolerated dose and no drug-related discontinuations reported.
IDEAYA aims to submit an Investigational New Drug (IND) application in the US for SHR-4849 by the first half of 2025.
Yujiro S. Hata, CEO and Founder of IDEAYA Biosciences, expressed enthusiasm for the potential of SHR-4849, noting its promise as a monotherapy for Small Cell Lung Cancer (SCLC) and Neuroendocrine Tumors (NETs), both of which represent significant unmet medical needs.