On June 30, 2023 Rakuten Medical, Inc., a global biotechnology company developing and commercializing precision, cell targeting therapies based on its proprietary Alluminox platform, reported that new interim evaluation data from the ASP-1929-103 study has been presented at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2023 Annual Meeting held from June 24 to 27 (Press release, Rakuten Medical, JUN 30, 2023, View Source [SID1234633016]). ASP-1929-103 is a Phase 2, open-label, single-arm, window of opportunity study* of Alluminox treatment (photoimmunotherapy: PIT) using an antibody-dye conjugate ASP-1929 with fluorescence imaging (ClinicalTrials.gov Identifier: NCT05182866) in patients with operable primary or recurrent head and neck squamous cell carcinoma (HNSCC) or cutaneous squamous cell carcinoma (cuSCC).

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The oral presentation was given by Liza Lindenberg, M.D., of the National Cancer Institute (NCI), which has a Cooperative Research and Development Agreement to conduct ASP-1929-103 study. ASP-1929-103 is the very first clinical trial of Alluminox treatment in operable cancer. As part of this trial, early time point (1 day) 18F-FDG PET/CT imaging was investigated as a potential response indicator of Alluminox treatment.

The preliminary, descriptive imaging analysis based on interim evaluation of 6 patients in ASP-1929-103 study presented during the meeting showed that 18F-FDG PET/CT imaging demonstrates a therapeutic response 1 day after Alluminox treatment using ASP-1929. PET/CT is an imaging modality for combined acquisition of positron emission tomography (PET) and computed tomography (CT) pictures. 18F-fluorodeoxyglucose (18F-FDG) is the radiotracer used for this PET study. Like glucose (sugar), 18F-FDG is taken up by cells, particularly rapidly dividing cells such as cancer cells. Following uptake, 18F-FDG accumulates in the cytoplasm rather than undergoing further metabolism which results in signal amplification from labeled cells.

Key findings presented at SNMMI 2023
"Early 18F-FDG Response after Near-Infrared Photoimmunotherapy for Head and Neck and Cutaneous Squamous Cell Carcinoma" (Abstract: P50) presented by Liza Lindenberg, M.D., Molecular Imaging Branch, NCI, NIH

– 18F FDG PET/CT demonstrates a therapeutic response 1 day after a single ASP-1929 PIT treatment
– Delayed 18F-FDG PET/CT imaging may decrease confounding inflammatory uptake on scans
– Pathologic tumor response may add complementary information to 18F-FDG PET/CT in PIT

Disclaimer: These early findings may change upon trial completion and final data analysis.

ASP-1929-103 study overview
ASP-1929-103 is a Phase 2, open-label, single-arm, window of opportunity study* of Alluminox treatment (PIT) using an anti-EGFR antibody-dye conjugate, ASP-1929 with fluorescence imaging in patients with operable primary or recurrent HNSCC or cuSCC. The study, sponsored by Rakuten Medical in collaboration with NCI and Shimadzu Corporation (Shimadzu), will enroll 22 patients in the US to evaluate the efficacy and safety of a single Alluminox treatment using ASP-1929 administered prior to standard of care surgical tumor resection. The feasibility of the Shimadzu fluorescence imaging system for real-time monitoring and recording of the fluorescence of the IRDye 700DX portion of ASP-1929 will also be assessed.

* Window of opportunity study takes place in the period between a cancer diagnosis and the subsequent initiation of standard treatment, during which, the patient receives a non-standard drug or treatment of interest over a short period of time 1.2.
1. Aroldi F, Lord SR. Window of opportunity clinical trial designs to study cancer metabolism. Br J Cancer. 2020;122(1):45-51. doi:10.1038/s41416-019-0621-4.
2. Schmitz S, Duhoux F, Machiels JP. Window of opportunity studies: Do they fulfil our expectations? Cancer Treat Rev. 2016 Feb;43:50-7. doi: 10.1016/j.ctrv.2015.12.005. Epub 2015 Dec 31. PMID: 26827692.