Datopotamab Deruxtecan

Tempus AI (NASDAQ: TEM) and Daiichi Sankyo have entered a strategic collaboration to apply artificial intelligence and real-world data analytics to the clinical development of an undisclosed antibody drug conjugate in oncology. Chicago-based Tempus will deploy its proprietary AI platform, including the PRISM2 foundation model, to support biomarker discovery and patient stratification for the ADC program. Tokyo-based Daiichi Sankyo, which maintains one of the industry’s largest ADC portfolios, will contribute clinical trial and preclinical research data. Financial terms of the collaboration were not disclosed. The collaboration centers on Tempus’s multimodal data and AI capabilities rather than a transfer of drug rights. Tempus operates one of the largest libraries of clinical and molecular data in healthcare, integrating electronic health records, genomic sequencing, and pathology imaging into a unified analytics platform. The company was founded in 2015 and provides AI-enabled precision medicine tools to both clinicians and pharmaceutical partners. Under the agreement, the two companies will develop proof-of-concept AI models designed to optimize patient selection for the ADC. Tempus’s PRISM2 model combines pathology images with clinical data to generate diagnostic and predictive outputs. These models will be deployed across Tempus’s oncology database to produce response maps intended to support patient stratification and benchmarking of potential control arms for future clinical trials. The specific ADC program was not identified. Daiichi Sankyo’s ADC portfolio includes trastuzumab deruxtecan, marketed as Enhertu in partnership with AstraZeneca, and datopotamab deruxtecan, which targets TROP2. The company has additional ADC candidates in clinical development across multiple tumor types. The press release refers to “a novel ADC” without disclosing the biological target, development stage, or indication. For Daiichi Sankyo, the collaboration reflects a broader industry trend of applying AI-driven analytics to ADC clinical development in oncology, where patient selection and biomarker-guided trial design are increasingly viewed as levers to improve probability of technical success. ADCs as a class face complex pharmacology involving antibody targeting, linker stability, and payload potency, making precise patient stratification a priority in late-stage development. Tempus has signed similar AI-driven collaborations with pharmaceutical companies including AstraZeneca, Takeda, and Merck, focused on applying real-world data and machine learning to drug development. Your email address will not be published. Required fields are marked * Comment * Name * Email * Website

Whitehawk Therapeutics is recruiting patients into a Phase I first-in-human clinical trial (NCT07470853) of HWK-016, a MUC16-directed antibody-drug conjugate (ADC), in adults with advanced solid tumors. The HWK-016 clinical trial focuses initially on platinum-resistant ovarian cancer and endometrial cancer, two indications where response rates to existing therapies remain low. HWK-016 enters the clinic following the discontinuation of Genentech/Roche’s sofituzumab vedotin program, which targeted a different epitope of MUC16 and showed limited clinical activity. Whitehawk says HWK-016 is the first, and currently only known, ADC in clinical development targeting the membrane-bound, non-shed portion of MUC16. The study, designated HWK-016-101, is a multicenter, open-label, dose-escalation and dose-expansion trial enrolling an estimated 265 participants across 12 US sites, including Memorial Sloan Kettering Cancer Center, Ohio State University Wexner Medical Center, and Karmanos Cancer Center. Part A will evaluate HWK-016 as monotherapy in ovarian and endometrial cancers, while Part B will test HWK-016 in combination with bevacizumab in ovarian cancer only. Primary endpoints are determination of maximum and recommended doses, while secondary endpoints include overall response rate and progression-free survival. Primary completion is projected for Q1 2028. HWK-016 targets the membrane-bound, non-shed portion of MUC16, a transmembrane glycoprotein also known as CA-125 that is overexpressed in ovarian and endometrial cancers. This epitope selection distinguishes HWK-016 from sofituzumab vedotin, which bound the shed ectodomain of MUC16 and was neutralized by circulating CA-125 acting as an antigen sink. Whitehawk’s ADC uses the CPT113 linker-payload platform, licensed from Hangzhou DAC Biotech, which carries a topoisomerase I inhibitor payload. Upon binding MUC16-expressing tumor cells, HWK-016 is internalized, and the payload is released intracellularly to induce DNA damage and apoptosis. The linker has been described as 10 to 100 times more stable than those used in typical ADCs, with a reported payload release ratio of approximately 0.01% on a molar basis. The combination with bevacizumab in Part B is rationalized by bevacizumab’s established role in ovarian cancer and the hypothesis that VEGF inhibition may normalize tumor vasculature and improve ADC delivery. The ovarian cancer antibody-drug conjugate space has expanded since the 2022 accelerated US FDA approval of mirvetuximab soravtansine (Elahere, ImmunoGen/AbbVie), which was converted to full approval in 2024. Several other antibody-drug conjugates are in clinical testing for ovarian cancer, including raludotatug deruxtecan (Daiichi Sankyo/AstraZeneca, CDH6-directed), datopotamab deruxtecan (Daiichi Sankyo/AstraZeneca, TROP2-directed), and sacituzumab govitecan (Gilead, TROP2-directed), each in ongoing Phase 2 development in this setting. Within the MUC16 target space, Regeneron’s cell therapy candidate 27T51 is being evaluated in a Phase 1 trial in recurrent or treatment-resistant ovarian cancer (NCT06469281), while oregovomab (OncoQuest) is in a Phase 3 trial combining an anti-CA-125 immunomodulatory antibody with chemotherapy (NCT04498117). HWK-016 is differentiated as a MUC16-targeted antibody-drug conjugate directed against the non-shed epitope and incorporating a topoisomerase I inhibitor payload, a combination that has not previously been evaluated in human clinical studies. Your email address will not be published. Required fields are marked * Comment * Name * Email * Website