On November 6, 2023 Rakuten Medical, Inc., a global biotechnology company developing and commercializing precision, cell-targeted therapies based on its proprietary Alluminox platform reported the presentation of two posters of AI-based analyses at the 38th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), held November 3-5, 2023, in San Diego, CA (SITC 2023) (Press release, Rakuten Medical, NOV 6, 2023, View Source [SID1234637072]). The posters present data that may be relevant to improved clinical outcomes with treatment based on Rakuten Medical’s Alluminox platform (photoimmunotherapy).
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The samples analyzed for these posters are from patients enrolled in an open-label Phase 1b/2 clinical trial (ASP-1929-181 study/ClinicalTrials.gov Identifier: NCT04305795) of ASP-1929 photoimmunotherapy in combination with anti-PD-1 for recurrent or metastatic head and neck squamous cell cancer or advanced or metastatic cutaneous squamous cell carcinoma. Promising early evaluation data from the ASP-1929-181 study* was presented at the American Head and Neck Society (AHNS) in July 2023 (Abstract #: S252). The studies presented at SITC (Free SITC Whitepaper) 2023 utilized AI technology developed by Rakuten Institute of Technology Bengaluru, a part of Rakuten India Enterprise Private Limited and a branch of the global R&D organization of Rakuten Group, Inc., to further interpret the response data presented at AHNS. Rakuten Medical and Rakuten Institute of Technology Bengaluru have collaborated on AI-based analyses of patient samples since 2020.
* These preliminary findings may change upon completion of follow up and final data analysis.
Key findings presented at SITC (Free SITC Whitepaper) 2023
Title: Development of an image-based tumor microenvironment analysis coupled with peripheral flow cytometry reveals a distinct immune cell phenotype in responder patients in the Phase 1b/2 study ASP-1929-181
Abstract #: 83
The first poster addresses immune characteristics between responders and non-responders who received ASP-1929 photoimmunotherapy. Potentially predictive immune biomarkers were identified using a combination of multiplex immunofluorescent imaging methods with AI-based quantification and flow cytometry analyses of peripheral blood. The study results suggest that lower frequencies of CD8+ T cells in the blood at screening correlate with treatment response. Interestingly, of CD8+ T cells in the blood, an increased frequency of PD-1 co-expression also correlates with treatment outcome. At the tumor, an increase in cytotoxic CD8+ T cells in all 22 analyzed patients was observed over the course of treatment, suggesting the induction of the immune response following photoimmunotherapy.
Title: Development of a novel, cellular-level drug uptake quantification pipeline for accurate quantification of fluorescence-conjugated therapeutics: Data from the Phase 1b/2 open-label study ASP-1929-181
Abstract #: 1307
The second poster describes the quantification of drug binding to target cells for ASP-1929 photoimmunotherapy. The preliminary data suggested that a modified drug quantification method using AI-based tumor detection and cell segmentation has the potential to accurately measure drug uptake in tumors at the cellular level. Using this method, high drug uptake (>50-100%) in tumors prior to light treatment was observed for the first time in the clinical samples. Understanding drug uptake levels could help support dose response analyses in future preclinical studies and clinical trials.