IDEAYA Biosciences Licenses SHR-4849 ADC from Hengrui for SCLC and NET Tumors

IDEAYA Biosciences, a precision medicine oncology company, has announced an exclusive global license agreement with Jiangsu Hengrui Pharmaceuticals for SHR-4849, a cutting-edge DLL3-targeting antibody drug conjugate (ADC). This deal grants IDEAYA the rights to develop and commercialize SHR-4849 outside Greater China. SHR-4849 is an innovative drug that targets DLL3, a protein predominantly expressed in small cell lung cancer (SCLC) and neuroendocrine tumors (NETs), at rates of about 85% and 20-40%, respectively.

The growing demand for effective treatments for DLL3-expressing tumors highlights the potential of SHR-4849. IDEAYA's CEO, Yujiro S. Hata, expressed enthusiasm for the monotherapy potential of SHR-4849 in treating SCLC and NETs, emphasizing its promising position as a leading candidate in the DLL3 topo-I-payload ADC sector. The company sees an opportunity to develop strategic clinical combinations between SHR-4849 and IDEAYA's own PARG inhibitor, IDE161. According to Daniel A. Simon, the Chief Business Officer at IDEAYA, preclinical trials have shown enhanced efficacy when combining these treatments compared to using ADCs alone.

Hengrui Pharma's Chief Strategy Officer, Frank Jiang, highlighted the promising early clinical signals of SHR-4849, noting its manageable safety profile in SCLC. He expressed delight in collaborating with IDEAYA to advance the global development of this ADC, furthering Hengrui’s goal of providing innovative therapies for patients worldwide.

SHR-4849 has demonstrated significant antitumor activity in preclinical studies, including tumor regression as a standalone treatment across multiple models. Currently, this drug is under evaluation in a Phase 1 clinical trial for advanced solid tumors in China. The ongoing trial involves dose escalation to identify optimal therapeutic levels. As of December 10, 2024, 11 subjects with SCLC were evaluated, with partial responses observed in eight cases, indicating an overall response rate of approximately 73%. The adverse events reported were primarily mild or moderate, with no discontinuations due to drug-related issues. Common adverse effects included reduced white blood cell count, anemia, decreased neutrophil count, nausea, and lower platelet count.

IDEAYA plans to submit an Investigational New Drug (IND) application for SHR-4849 in the United States by the first half of 2025. Given the high expression of DLL3 in certain solid tumors and its limited expression in normal tissues, SHR-4849 represents a promising therapeutic target, addressing significant unmet medical needs in these tumor types.

The agreement with Hengrui Pharma includes provisions for upfront and milestone payments to Hengrui, totaling up to $1.045 billion. This includes a $75 million upfront fee and up to $200 million in development and regulatory milestone payments. Hengrui is also entitled to royalties from net sales outside of Greater China. Despite these financial commitments, IDEAYA maintains its previous financial guidance, ensuring sufficient funds to sustain operations through at least 2028.

IDEAYA Biosciences is committed to creating tailored cancer treatments by integrating advanced biomarker identification with drug discovery, focusing on precision medicine. Meanwhile, Hengrui Pharma continues to emphasize innovation in addressing unmet medical needs, boasting substantial investment in research and development to support collaborations and serve global health advancements.