Rakuten Medical and LOTTE Biologics sign manufacturing agreement to support global oncology program

Rakuten Medical and LOTTE Biologics announced a contract manufacturing agreement at the J.P. Morgan Healthcare Conference for LOTTE to produce monoclonal antibody intermediates and conjugates to support Rakuten Medical's Alluminox photoimmunotherapy program.

Rakuten Medical and LOTTE Biologics announced a contract manufacturing agreement during the J.P. Morgan Healthcare Conference in San Francisco. LOTTE Biologics will provide advanced manufacturing services for monoclonal antibody intermediates and their conjugates to support Rakuten Medical's Alluminox photoimmunotherapy program. The Alluminox therapy is approved in Japan for recurrent head and neck cancer and is investigational outside Japan. Rakuten Medical is continuing global clinical work, including a Phase 3 trial and planned Phase 1 activity in Japan. What we know: - The agreement was announced at the J.P. Morgan Healthcare Conference and covers manufacturing of monoclonal antibody intermediates and conjugates. - LOTTE Biologics will support production through its ADC-capable facility at the Syracuse Bio Campus in New York. - Rakuten Medical's Alluminox platform combines cell-targeting moieties with light-activatable agents; the therapy is approved in Japan for recurrent head and neck cancer and investigational elsewhere. - A global Phase 3 clinical trial is underway in the United States, Taiwan and Japan, with plans to start treatment in Ukraine and Poland; Rakuten Medical also plans a Phase 1 trial in Japan for other solid tumors this year. - LOTTE Biologics reports its Syracuse campus has a reported 40,000 L production capacity and is investing in ADC conjugation capabilities while building additional large-scale plants in Songdo, South Korea. Summary: The agreement aims to strengthen Rakuten Medical's manufacturing capacity for Alluminox photoimmunotherapy as clinical and commercial activity expands. LOTTE Biologics will provide ADC and bioconjugation manufacturing at its Syracuse facility and is expanding overall capacity with new plants under construction. Ongoing trials and planned studies will continue while supply arrangements are implemented.