IDEAYA Biosciences Partners with Hengrui Pharma to Develop Novel SHR-4849 for Cancer Treatment
IDEAYA Biosciences, Inc., a cutting-edge oncology company focused on precision medicine, has recently announced a significant strategic partnership with Jiangsu Hengrui Pharmaceuticals Co., Ltd. This exclusive licensing agreement grants IDEAYA worldwide rights (outside of Greater China) to develop and commercialize SHR-4849, a novel antibody-drug conjugate (ADC) specifically targeting DLL3, a protein linked to small cell lung cancer (SCLC) and neuroendocrine tumors (NETs).
SHR-4849 is a DLL3-targeting Topo-I payload ADC, which shows great promise in treating solid tumors where DLL3 is expressed at notable levels. Research indicates that DLL3 is found in about 85% of SCLC cases and between 20-40% of NETs, presenting a remarkable opportunity for targeted cancer therapies. This ADC has demonstrated encouraging preclinical results, showing significant anti-tumor activity in various models of cancer.
Currently, SHR-4849 is undergoing Phase 1 clinical trials in China, evaluating advanced solid tumors, with a focus on SCLC. Preliminary findings have shown a favorable response rate, with an approximate 73% overall response rate among evaluable subjects. As of December 2024, treatment-related adverse events have mostly been mild, categorized as Grade 1 or 2, allowing further investigation into its therapeutic potential without significant safety concerns. This phased trial showcases the promise that SHR-4849 may hold for the future of oncology treatments, especially in areas with high unmet medical needs.
IDEAYA's strategic approach to combine SHR-4849 with its PARG inhibitor, IDE161, is noteworthy. This strategy aims to enhance the therapeutic efficacy of both agents in treating DLL3-expressing cancers, leveraging the company's advanced pipeline in DNA Damage Repair (DDR) therapies. With expected Investigational New Drug (IND) filing for SHR-4849 in the United States slated for the first half of 2025, IDEAYA is on track to expedite this treatment to market.
The partnership with Hengrui comes with significant financial implications, including upfront payments and milestone milestones, which could total $1.045 billion. Hengrui Pharma will receive an initial fee of $75 million, along with potential development and regulatory milestones that could contribute up to $200 million. Additionally, Hengrui is eligible for royalty payments based on net sales outside of Greater China, generating a lucrative financial environment for ongoing development.
Yujiro S. Hata, CEO and Founder of IDEAYA, expressed enthusiasm about the collaboration, noting the vast unmet medical need in treating DLL3-expressing tumors. Hata emphasized SHR-4849's potential as a first-in-class therapeutic option and the strategic benefit of this partnership in IDEAYA’s overarching goal of advancing innovative cancer treatments.
Frank Jiang, Chief Strategy Officer and Board Director at Hengrui Pharma, echoed these sentiments, highlighting the promising clinical signals observed in early studies and the partnership’s alignment with Hengrui’s commitment to addressing significant clinical needs worldwide.
The collaboration between IDEAYA Biosciences and Hengrui Pharma marks a pivotal development in targeted cancer therapies. With the promising results from SHR-4849 and an actively engaged clinical trial process, this partnership is set to play a critical role in addressing the substantial medical needs present in SCLC and NETs. The community’s anticipation towards the US IND filing adds to the excitement surrounding this innovative approach to cancer treatment, highlighting the potential for transformative medical advancements in oncology. As both companies continue their work in this field, the healthcare community watches closely, hoping for breakthroughs that could benefit countless patients globally.
Background of SHR-4849
SHR-4849 is a DLL3-targeting Topo-I payload ADC, which shows great promise in treating solid tumors where DLL3 is expressed at notable levels. Research indicates that DLL3 is found in about 85% of SCLC cases and between 20-40% of NETs, presenting a remarkable opportunity for targeted cancer therapies. This ADC has demonstrated encouraging preclinical results, showing significant anti-tumor activity in various models of cancer.
Progress and Future Plans
Currently, SHR-4849 is undergoing Phase 1 clinical trials in China, evaluating advanced solid tumors, with a focus on SCLC. Preliminary findings have shown a favorable response rate, with an approximate 73% overall response rate among evaluable subjects. As of December 2024, treatment-related adverse events have mostly been mild, categorized as Grade 1 or 2, allowing further investigation into its therapeutic potential without significant safety concerns. This phased trial showcases the promise that SHR-4849 may hold for the future of oncology treatments, especially in areas with high unmet medical needs.
IDEAYA's strategic approach to combine SHR-4849 with its PARG inhibitor, IDE161, is noteworthy. This strategy aims to enhance the therapeutic efficacy of both agents in treating DLL3-expressing cancers, leveraging the company's advanced pipeline in DNA Damage Repair (DDR) therapies. With expected Investigational New Drug (IND) filing for SHR-4849 in the United States slated for the first half of 2025, IDEAYA is on track to expedite this treatment to market.
Financial Implications of the Partnership
The partnership with Hengrui comes with significant financial implications, including upfront payments and milestone milestones, which could total $1.045 billion. Hengrui Pharma will receive an initial fee of $75 million, along with potential development and regulatory milestones that could contribute up to $200 million. Additionally, Hengrui is eligible for royalty payments based on net sales outside of Greater China, generating a lucrative financial environment for ongoing development.
Statements from Leadership
Yujiro S. Hata, CEO and Founder of IDEAYA, expressed enthusiasm about the collaboration, noting the vast unmet medical need in treating DLL3-expressing tumors. Hata emphasized SHR-4849's potential as a first-in-class therapeutic option and the strategic benefit of this partnership in IDEAYA’s overarching goal of advancing innovative cancer treatments.
Frank Jiang, Chief Strategy Officer and Board Director at Hengrui Pharma, echoed these sentiments, highlighting the promising clinical signals observed in early studies and the partnership’s alignment with Hengrui’s commitment to addressing significant clinical needs worldwide.
Conclusion
The collaboration between IDEAYA Biosciences and Hengrui Pharma marks a pivotal development in targeted cancer therapies. With the promising results from SHR-4849 and an actively engaged clinical trial process, this partnership is set to play a critical role in addressing the substantial medical needs present in SCLC and NETs. The community’s anticipation towards the US IND filing adds to the excitement surrounding this innovative approach to cancer treatment, highlighting the potential for transformative medical advancements in oncology. As both companies continue their work in this field, the healthcare community watches closely, hoping for breakthroughs that could benefit countless patients globally.
Topics Health）
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