With 80 patients enrolled in India on a global trial involving Rakuten Medical Inc’s “transformative therapy” targeting head and neck cancer, the US-headquartered biotech company expects to potentially launch in certain countries including India in 2026.

Rakuten’s precision, cell-targeting therapies based on its proprietary Alluminox platform is approved in Japan, and is presently undergoing global phase III trials, involving 275 patients, in the US, Taiwan and India.

This “highly selective treatment using light” has the potential to become the fifth pillar of cancer treatment, after surgery, chemotherapy, radiotherapy and immunotherapy, Abhijit Bhatia, Rakuten Medical’s Chief Operating Officer, told businessline, speaking from San Diego. The company expects to complete its trials next year and launch in 2026, he said.

Six medical institutions are participating in the study, all sites have gone live, and the first patient in India received Alluminox treatment (photoimmunotherapy) using ASP-1929 in August 2023, the company said. The patients on theASP-1929-301 trial include a mix of those getting the innovative therapy and those getting the standard of care.

Novel platform

The Alluminox platform is an investigational technology platform based on a cancer therapy called photoimmunotherapy, developed by Dr Hisataka Kobayashi and team from the US National Cancer Institute, the company said. Rakuten Medical’s Alluminox platform comprises a drug, device, and other related components, the company explained. It has a tie-up with Hikma Plc, giving the latter an exclusive license to commercialise products in Rakuten Medical’s pipeline using its photoimmunotherapy technology platform, Alluminox, in all its MENA (Middle East and North African markets.

India’s unmet need

Bhatia said, “India has an unmet medical need, as it accounts for 25 percent of all new head and neck cancer cases worldwide”. Without commenting on how it intends to price the product, he said that the aim is to make it available in the country as soon as possible. Besides, he said, a majority of patients present with advanced diseases and corresponding poorer outcomes.

Innovative drug

Rakuten Medical’s first drug on this platform is ASP-1929, an antibody-dye conjugate comprising the antibody cetuximab and IRDye 700DX, a light activatable dye. ASP-1929 binds to epidermal growth factor receptor (EGFR), a cancer antigen expressed in multiple types of solid tumors, including head and neck, breast, lung, colorectal, prostate and pancreatic cancers, the company said. After binding to cancer cells, ASP-1929 is locally activated by non-thermal red light (690 nm) illumination emitted by a laser device system, resulting in photochemical reaction. “This is believed to cause damage to the membrane of cancer cells, leading to selective necrosis of cancer cells,” it added. ASP-1929 has received Fast Track designation from the US Food and Drug Administration in January 2018, and is currently undergoing Phase III trials.