IDEAYA Biosciences Enters $1.045B Licensing Deal

By Bobby Samwell • Monday, December 30 10:22 • Permanent Link

Ideaya Biosciences, Inc. has recently announced an exclusive license agreement for SHR-4849, a novel DLL3-targeting Topo-I-payload antibody drug conjugate (ADC), with Jiangsu Hengrui Pharmaceuticals Co., Ltd. Under this agreement, Ideaya will develop and commercialize SHR-4849 worldwide outside of Greater China.

SHR-4849, a phase 1 DLL3-targeting Topo-I-payload ADC, has shown promising antitumor activity in preclinical studies, including tumor regression as a monotherapy in multiple models. In the ongoing phase 1 clinical trial for advanced solid tumors in China, SHR-4849 has demonstrated encouraging early clinical signals in small-cell lung cancer (SCLC) with a manageable safety profile. It has reached therapeutic dose levels, resulting in an overall response rate of approximately 73% among evaluable SCLC subjects.

Furthermore, the agreement outlines that Hengrui Pharma is eligible to 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. Additionally, Hengrui is set to receive mid-single to low-double digit royalties on net sales outside of Greater China.

Moreover, Ideaya is targeting to file a US Investigational New Drug (IND) for SHR-4849 in the first half of 2025. DLL3 has been reported to be expressed in multiple solid tumor types, including in SCLC and neuroendocrine tumors at approximately 85% and 20-40%, respectively, based on the Human Protein Atlas database.

Ideaya's CEO and founder, Yujiro S. Hata, expressed excitement about the opportunity to develop SHR-4849, highlighting its potential in SCLC and NETs. The company aims to develop rational clinical combinations of Topo-payload-based ADCs with their PARG inhibitor IDE161.

Hengrui Pharma's Chief Strategy Officer and Board Director, Frank Jiang, expressed delight in partnering with Ideaya to support the global development of SHR-4849, emphasizing the drug's encouraging early clinical signals in small-cell lung cancer.

Today the company's shares have moved -2.5% to a price of $24.52. Check out the company's full 8-K submission here.

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