IDEAYA Biosciences has entered into a license agreement with Hengrui Pharma for SHR-4849

IDEAYA Biosciences has announced that it has entered into a licensing agreement with Jiangsu Hengrui Pharmaceuticals for SHR-4849, a novel DLL3-targeting Topo-I-payload ADC program.

SHR-4849, an antibody-drug conjugate (ADC) developed by IDEAYA Biosciences, has demonstrated significant antitumor activity in preclinical studies, showing tumor regression as a standalone treatment across various models. Currently, it is being evaluated in a Phase 1 clinical trial in China (NCT06443489) for advanced solid tumors.

“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,” said Yujiro S. Hata, Chief Executive Officer and Founder, IDEAYA Biosciences.

As of the data cut-off on December 10, 2024, the ongoing dose escalation study has reached therapeutic levels, revealing multiple partial responses. Specifically, among 11 evaluable patients with small cell lung cancer (SCLC) treated at these therapeutic doses, 8 achieved partial responses according to RECIST 1.1 criteria, resulting in an impressive overall response rate of approximately 73%. This includes both confirmed and unconfirmed responses, with the latter pending further evaluation.

The safety profile of SHR-4849 appears manageable, with treatment-related adverse events (TRAEs) primarily classified as Grade 1 or 2. The trial continues without any drug-related discontinuations reported, and the maximum tolerated dose has yet to be established.

“In addition, SHR-4849 accelerates IDEAYA’s strategic objective to develop rational clinical combinations of topo-payload based ADCs with our PARG inhibitor IDE161, where we observe enhanced preclinical combination efficacy versus evaluated topo-payload ADCs alone,” said Daniel A. Simon, Chief Business Officer, IDEAYA Biosciences.

The most frequently observed TRAEs included decreased white blood cell count, anemia, decreased neutrophil count, nausea, and decreased platelet count.IDEAYA plans to file an Investigational New Drug (IND) application for SHR-4849 in the United States during the first half of 2025. The drug targets DLL3, a protein expressed in about 85% of SCLC cases and 20-40% of neuroendocrine tumors (NETs), making it a promising candidate for treating these malignancies where there is a significant unmet medical need.

Frank Jiang, Chief Strategy Officer and Board Director, Hengrui Pharma, said:

“SHR-4849 is a novel DLL3 targeting ADC showing encouraging early clinical signals in small-cell lung cancer with a manageable safety profile. We are delighted to partner with IDEAYA to support the development of this ADC globally, which furthers our goal of delivering innovative medicines for the benefit of patients around the world.”

Under the licensing agreement with Hengrui Pharma, IDEAYA will pay an upfront fee of $75 million along with potential milestone payments that could total up to $1.045 billion. This includes payments linked to development and regulatory achievements as well as royalties on net sales outside of Greater China. Despite these financial commitments, IDEAYA’s cash runway is projected to extend through at least 2028.

About IDEAYA Biosciences

IDEAYA is a precision medicine oncology company committed to the discovery and development of targeted therapeutics for patient populations selected using molecular diagnostics. IDEAYA’s approach integrates capabilities in identifying and validating translational biomarkers with drug discovery to select patient populations most likely to benefit from its targeted therapies. IDEAYA is applying its early research and drug discovery capabilities to synthetic lethality – which represents an emerging class of precision medicine targets.

About Hengrui Pharma

Jiangsu Hengrui Pharmaceuticals (Hengrui Pharma) is a global pharmaceutical company focused on unmet clinical needs, with a strong track record of scientific and technological innovation. Since its first innovative drug approval in 2011, Hengrui Pharma has invested more than $5.4 billion in R&D and set up 14 R&D centers in Lianyungang, Shanghai, the U.S., and Europe. It has 9 major manufacturing sites and a global R&D team of more than 5,000 professionals.

Hengrui Pharma has established a number of leading technology platforms such as its ADC platform, proteolysis targeting chimera (PROTAC), molecular gels, bi/multi-specific antibodies, and AI molecular design, which provide a strong foundation for innovative R&D. Hengrui strives for continued innovation and collaboration with global partners to serve a healthy China and benefit patients around the world.