On July 8, 2021 Rakuten Medical, Inc. (Rakuten Medical) reported that data from a phase I, single-center, open-label study of RM-1929 photoimmunotherapy in Japanese patients with recurrent head and neck squamous cell carcinoma (rHNSCC) was accepted for publication in the International Journal of Clinical Oncology and published on June 24, 2021 (Press release, Rakuten Medical, JUL 8, 2021, View Source [SID1234584732]).
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The manuscript describes the design of a Phase I study, where patients were given a single fixed dose (640 mg/m²) of RM-1929, an anti-EGFR antibody cetuximab conjugated with a light-activatable dye (IRDye700DX), and a fixed light treatment dose (50 J/cm² for superficial illumination; 100 J/cm fiber diffuser length for interstitial illumination) in Japan. The study was designed to evaluate the safety, tumor response (modified RECIST v1.1 by central radiology review), pharmacokinetics, and immunogenicity administered in subjects with rHNSCC.
The data concluded that RM-1929 photoimmunotherapy showed a manageable safety profile in rHNSCC – and showed tumor response in the heavily pre-treated patient population was clinically meaningful and warranted further investigation.
RM-1929 is a first-in-class drug developed on the Illuminox platform based on photoimmunotherapy and received conditional marketing approval in Japan from the Ministry of Health, Labour and Welfare in September 2020.
A paper of full text is available at View Source
*RM-1929 and ASP-1929 are analogous. Extensive physiochemical studies show that they have comparable physical and chemical properties.