IDEAYA Biosciences, Inc. (IDYA), a precision medicine oncology company, announced that it has entered into exclusive license agreement with Jiangsu Hengrui Pharmaceuticals Co., Ltd. for SHR-4849, a novel DLL3-targeting Topo-I-payload ADC program.
Under deal terms, IDEAYA will develop and commercialize SHR-4849 worldwide outside of Greater China.
The company stated that Hengrui Pharma will receive upfront and milestone payments totaling $1.045 billion, including a $75 million upfront fee, up to $200 million in development and regulatory milestone payments, plus commercial success-based milestones.
Hengrui is also eligible to receive mid-single to low-double digit royalties on net sales outside of Greater China.
The upfront and projected research and development costs, including potential milestone payments, does not change the earlier provided IDEAYA guided cash out runway of at least 2028, the company noted.
SHR-4849 has shown promising antitumor activity in preclinical studies, and is currently being evaluated in a Phase 1 clinical trial for advanced solid tumors in China (NCT06443489). As of the data cut-off date, treatment related adverse events (TRAEs) were predominantly Grade 1 or 2, and the Phase 1 dose escalation is ongoing with no reported drug-related discontinuations, and the maximum tolerated dose has not yet been reached.
IDEAYA is targeting to file a US IND for SHR-4849 in the first half of 2025.
"There is significant unmet medical need in DLL3-expressing solid tumors, and we are excited by the opportunity to develop SHR-4849, which has monotherapy potential in Small Cell Lung Cancer (SCLC) and Neuroendocrine Tumors (NETs)," said Yujiro S. Hata, Chief Executive Officer and Founder, IDEAYA Biosciences.
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