IDEAYA Biosciences Licenses SHR-4849 from Hengrui Pharma for Global Development
Monday, December 30, 2024
IDEAYA Biosciences has secured an exclusive licence for SHR-4849, a novel DLL3-targeting Topo-I-payload antibody-drug conjugate (ADC).
The agreement with Jiangsu Hengrui Pharmaceuticals enables IDEAYA to develop and commercialise SHR-4849 globally, excluding Greater China.
SHR-4849, currently in Phase 1 clinical trials in China for advanced solid tumours (NCT06443489), has demonstrated early promise. Preclinical studies have shown tumour regression as a monotherapy in multiple models.
Interim Phase 1 data, as of December 2024, indicated a ~73% overall response rate in small-cell lung cancer (SCLC) patients treated at therapeutic dose levels.
The safety profile appears manageable, with common treatment-related adverse events including reduced white blood cell count, anaemia, and nausea, primarily Grade 1 or 2. The trial is ongoing, with the maximum tolerated dose yet to be determined.
The therapeutic target, DLL3, is expressed in several solid tumours, including approximately 85% of SCLC cases and 20-40% of neuroendocrine tumours, based on data from the Human Protein Atlas.
Its minimal extracellular presence in normal tissues enhances its potential as a targeted treatment for these conditions, which currently face significant unmet medical needs.
IDEAYA plans to submit an Investigational New Drug (IND) application for SHR-4849 in the United States during the first half of 2025.
The programme aligns with the company’s strategy to explore combination therapies, particularly with its PARG inhibitor IDE161, which has shown promising preclinical efficacy when combined with topo-payload-based ADCs.
The financial terms of the agreement include a $75 million upfront payment to Hengrui Pharma, with additional milestone payments potentially totalling $1.045 billion. Royalties on net sales outside Greater China will range from mid-single to low-double digits.
These commitments are not expected to affect IDEAYA’s financial guidance, which projects cash reserves lasting through at least 2028.
This partnership expands IDEAYA’s oncology portfolio while accelerating the development of innovative treatments for difficult-to-treat cancers.
Source: ideayabio.com
