IDEAYA Biosciences secures exclusive license with Hengrui Pharma for SHR-4849, a novel Phase I DLL3 Topo-I-Payload ADC targeting solid tumors SCLC and NET

• Exclusive global license out Greater China For SHR-4849, a Topo-I-payload DLL3 phase I antibody drug conjugate (ADC)
• DLL3 is highly expressed in the parenchyma Lung cancer (SCLC) and neuroendocrine tumors (NETs), respectively 85% and 20-40%
• sane (LON:) Combination opportunities with IDEAYA's DNA damage repair ( Disarmament, demobilization and reintegration (NYSE:)) clinical pipeline, including phase I of the PARG inhibitor IDE161
• The US IND filing for SHR-4849 is targeting the first half of 2025

South San Francisco, California. and Shanghai, December 29, 2024 /PRNewswire/ — Ideaya Biosciences (NASDAQ:), Inc. (NASDAQ: IDYA), a precision oncology company committed to the discovery and development of targeted therapies, announced that it has entered into an exclusive licensing agreement for SHR-4849, a novel Topo-I-payload ADC that targets DLL3 with… Jiangsu Hengrui Pharmaceutical Co., Ltd (Hengrui Pharma, SHA: 600276), an innovative global pharmaceutical company headquartered in China Focused on unmet clinical needs. Under the terms of the agreement, IDEAYA will develop and market SHR-4849 worldwide outside of Greater China.

“There is a significant unmet medical need in DLL3-expressing solid tumors, and we are excited about the opportunity to develop SHR-4849, which has potential for monotherapy in SCLC and NETs. SHR-4849 is competitively well positioned with first-in-class potential,” said Yujiro S. Hata, MD, president and CEO of SHR-4849. Executive and Founder, Ideaia Biosciences. “In addition, SHR-4849 accelerates IDEAYA's strategic goal to develop rational clinical combinations of top-load-based ADCs with our PARG inhibitor IDE161, as we observe improved preclinical efficacy of the combination versus estimated top-load ADCs alone,” Daniel said. A. Simon, Chief Business Officer, Ideaia Biosciences.

Frank Jiang“SHR-4849 is a novel DLL3 targeting ADC that shows encouraging clinical signals in NSCLC with a manageable safety profile. We are pleased to partner with IDEAYA to support the development of this ADC globally,” Hengrui Pharma Chief Strategy Officer and Board Director said. “This reinforces our goal of providing innovative medicines to benefit patients around the world.”

SHR-4849 has shown promising antitumor activity in preclinical studies, including tumor regression as monotherapy in multiple models. This drug is currently being evaluated in phase I clinical trials for advanced solid tumors China (NCT06443489). In ongoing Phase 1 dose escalation, SHR-4849 has reached therapeutic dose levels where multiple partial responses have been observed as of the data cutoff date December 10, 2024. Among 11 SCLC patients treated at therapeutic dose levels, 8 partial responses were observed by RECIST 1.1, resulting in an overall response rate of ~73% (including confirmed and unconfirmed responses, all of which were Unconfirmed responses await further evaluation). As of the data cut-off date, treatment-related adverse events (TRAEs) were predominantly grade 1 or 2, phase 1 dose escalation continues with no drug-related discontinuations reported, and the maximum tolerated dose has not yet been reached. The most common TRAEs were low white blood cell counts, anemia, low neutrophil counts, nausea, and low platelet counts.

IDEAYA aims to file a US IND for SHR-4849 in the first half of 2025.

Expression of DLL3 in multiple types of solid tumors, including SCLC and neuroendocrine tumors, has been reported to be approximately 85% and 20–40%, respectively, based on the Human Protein Atlas (NYSE:) database. DLL3 has limited extracellular expression in normal tissues, making it a promising therapeutic target in these tumor types, for which there remains a significant unmet medical need.

Under the terms of the agreement, Hengrui Pharma is eligible to receive the total advance and milestone payments $1.045 billionincluding A $75m Introduction fee of up to 200 million dollars In development and regulatory payments, as well as milestones based on commercial success. Hengrui is also eligible for mid- to low-double-digit returns on net off-sales Greater China. Initial and expected R&D costs, including potential milestone payments, do not alter IDEAYA's previously provided directed cash exit path for at least 2028.

on Ideaia Biosciences

IDEAYA is a precision oncology company committed to discovering and developing targeted therapies for selected patient groups 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 artificial killing, which represents an emerging class of precision medicine targets.

About Hengrui Pharma

Jiangsu Hengrui Pharmaceutical Co., Ltd Hengrui Pharma is an innovative global pharmaceutical company focused on unmet clinical needs, with a proven 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, Shanghaithe weand Europe. It has 9 major manufacturing sites and a global R&D team of more than 5,000 professionals. Hengrui Pharma has independently established a number of leading technology platforms such as its own ADC platform, proteolysis targeting chimera (PROTAC), molecular gels, bi/polyspecific antibodies, and AI-based molecular design, which provide a solid foundation for R&D Innovator. Hengrui strives to continue innovation and cooperation with global partners to serve a healthy environment China Patients around the world benefit from it.

Forward-looking statements
This press release contains forward-looking statements, including, without limitation, statements regarding (1) the timing of a potential IND filing, (2) potential development strategies, (3) the estimated potential addressable market and (4) the benefits Therapeutic potential of IDEAYA treatments. Such forward-looking statements involve significant risks and uncertainties that may cause IDEAYA's preclinical and clinical development programs, future results, performance or achievements to differ materially from those expressed or implied by the forward-looking statements. These risks and uncertainties include, among others, the uncertainties inherent in the drug development process, including the early phase of development of IDEAYA programs, the process of designing and conducting preclinical and clinical trials, regulatory approval processes, the timing of regulatory filings, challenges associated with manufacturing drug products, and the ability to IDEAYA to successfully establish, protect and defend its intellectual property, and other matters that could affect the adequacy of its current cash to fund operations. IDEAYA undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks related to IDEAYA's business generally, see IDEAYA's Annual Report on Form 10-K dated February 20, 2024 and any current and periodic reports filed I have US Securities and Exchange Commission.

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Ideaia BiosciencesAndres Ruiz BricenoSenior Vice President, Head of Finance and Investor Relations
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