Rakuten Medical, Inc. and Shimadzu Corporation announced enrollment of the first patient in the phase 2 clinical trial of ASP-1929 photoimmunotherapy with fluorescence imaging (Study number: ASP-1929-103) at the National Cancer Institute of the National Institutes of Health in the United States. This is a phase 2, open-label, single-arm, window of opportunity study of an antibody-dye conjugate, ASP-1929 photoimmunotherapy with fluorescence imaging in patients with operable primary or recurrent head and neck squamous cell carcinoma (HNSCC) or cutaneous squamous cell carcinoma (cuSCC) and will enroll 22 patients. This trial, conducted under Cooperative Research and Development Agreements with the National Cancer Institute, will assess the efficacy and safety of a single ASP-1929 photoimmunotherapy treatment administered prior to standard of care surgical tumor resection in patients with operable primary or recurrent HNSCC or cuSCC.

Additionally, the feasibility of the Shimadzu fluorescence imaging system for real-time monitoring and recording of fluorescence of the IRDye® 700DX (IR700) portion of ASP-1929 will also be studied. Other trials being conducted by Rakuten Medical, Inc. with ASP-1929 include a global phase 3 clinical trial for recurrent HNSCC and a U.S. phase 1b/2 clinical trial for recurrent HNSCC and cuSCC using combination therapy with anti-PD1. Moreover, in September 2020, the combined drug and a laser device system received marketing approval in Japan from the Ministry of Health, Labour and Welfare for ASP-1929 photoimmunotherapy to treat unresectable locally advanced or recurrent head and neck cancer.