IDEAYA Biosciences, Inc. (IDYA), a precision medicine oncology company, Sunday announced that it has entered into an exclusive global license agreement for antibody drug conjugate SHR-4849 with China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd.
Under the agreement, the company will develop and commercialise SHR-4849 outside Greater China. IDEAYA aims to file a US IND for SHR-4849 in the first half of 2025.
In the deal, Hengrui Pharma can earn up to $1.045 billion through upfront and milestone payments, including a $75 million upfront fee, up to $200 million for development and regulatory milestones, and additional payments based on commercial success.
Hengrui will also receive royalties ranging from mid-single to low-double digits on sales outside Greater China. These payments and research costs do not affect IDEAYA's previously announced cash runway, which is projected to last until at least 2028.
SHR-4849 is a novel DLL3-targeting Topo-I-payload antibody drug conjugate or ADC program in Small Cell Lung Cancer or SCLC, and Neuroendocrine Tumors or NETs.
SHR-4849 has shown promising antitumor activity in preclinical studies, including tumour regression as a monotherapy in multiple models. It is currently being evaluated in Phase 1 clinical trial for advanced solid tumours in China (NCT06443489).
According to the Human Protein Atlas database, DLL3 is found in several solid tumour types, including about 85 percent of Small Cell Lung Cancer cases and 20-40 percent of Neuroendocrine Tumors. Since DLL3 has limited extracellular expression in normal tissues, it is considered a promising treatment target for these tumors, which currently lack effective treatment options.
Yujiro Hata, Chief Executive Officer and Founder, IDEAYA, said, "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 SCLC and NETs. SHR-4849 is competitively well positioned with first-in-class potential in the DLL3 topo-I-payload ADC field, a therapeutic area that has demonstrated preliminary monotherapy clinical validation in SCLC."
IDEAYA said SHR-4849 supports its strategic goal of creating effective clinical combinations of topo-payload based ADCs with their PARG inhibitor IDE161.
Friday, IDYA had closed 2.71% less at $25.16 on the Nasdaq.
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