IDEAYA and Hengrui Join Forces for Precision Oncology

IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a leader in precision oncology, has entered an exclusive licensing agreement with Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Hengrui Pharma) for SHR-4849, a novel antibody-drug conjugate (ADC) targeting DLL3. This collaboration allows IDEAYA to develop and commercialize SHR-4849 outside Greater China.

Addressing Unmet Medical Needs in DLL3-Expressing Tumors

SHR-4849 leverages a Topo-I payload and demonstrates significant potential in DLL3-expressing tumors, particularly small cell lung cancer (SCLC) and neuroendocrine tumors (NETs). DLL3 is an attractive therapeutic target due to its expression in several solid tumor types, such as SCLC (85%) and NETs (20-40%), while being minimally expressed in normal tissues.

"We see SHR-4849 as a potential first-in-class therapy in the DLL3 Topo-I ADC field," said Yujiro S. Hata, CEO of IDEAYA. "This program aligns with our strategy to combine topo-payload ADCs with our PARG inhibitor, IDE161, to enhance therapeutic efficacy."

Clinical Progress and Promising Results

SHR-4849 is currently being tested in a Phase 1 trial in China for advanced solid tumors. Early data has shown robust anti-tumor activity:

• Among 11 evaluable SCLC patients treated at therapeutic dose levels, 73% achieved partial responses (RECIST 1.1).
• Treatment-related adverse events (TRAEs) were mostly mild (Grade 1 or 2), with no drug-related discontinuations reported.
• The trial continues to explore optimal dosing, as the maximum tolerated dose has not yet been reached.

Strategic Collaboration to Advance Innovation

Frank Jiang, Chief Strategy Officer at Hengrui Pharma, highlighted SHR-4849's potential:
“This ADC has shown encouraging clinical signals in SCLC with a manageable safety profile. We’re excited to partner with IDEAYA to develop this innovative therapy for patients globally.”

IDEAYA aims to file an Investigational New Drug (IND) application with the U.S. FDA for SHR-4849 in the first half of 2025.

Financial and Commercial Terms

Under the agreement, Hengrui Pharma will receive:

• A $75 million upfront payment.
• Up to $200 million in development and regulatory milestone payments.
• Commercial success-based milestones, bringing the total potential payments to $1.045 billion.
• Mid-single to low-double-digit royalties on net sales outside Greater China.

Despite the financial commitments, IDEAYA maintains its cash runway guidance through at least 2028, underscoring its financial stability.

Expanding Access to Targeted Oncology Treatments

This partnership underscores IDEAYA’s dedication to addressing unmet medical needs in oncology. With SHR-4849’s early promise, IDEAYA and Hengrui aim to offer new hope for patients with DLL3-expressing solid tumors, furthering advancements in the field of precision medicine.