FDA Accepts Rakuten Medical’s IND Application for Oncology Candidate

The U.S. Food and Drug Administration ( FDA ) has accepted Rakuten Medical Inc’s Investigational New Drug ( IND ) application to begin clinical studies of RM-1995 photoimmunotherapy in patients with advanced cutaneous squamous Cell carcinoma or with head and neck squamous cell carcinoma.

RM-1995 photoimmunotherapy treatment is an investigational drug-device combination being developed by Rakuten Medical Inc. The drug portion of the treatment, RM-1995, is a conjugate of a photoactivatable dye (IRDye 700DX [IR700]) and a monoclonal Antibody specific for cell-surface interleukin 2 (IL-2) Receptor α-chain (CD25). The device portion of the treatment is a laser device system (PIT690 Laser System) used to activate IR700 by illumination with 690nm nonthermal red light. Tumor-resident regulatory T cells (Tregs), that inhibit antitumor immune responses to promote tumor growth, can be specifically targeted with anti-CD25 antibodies1. Rakuten Medical, Inc is investigating RM-1995 as a potential new treatment to provide targeted, direct reduction of Tregs specifically within light-treated tumor lesions to induce systemic anticancer immune responses.
"We are very excited to have achieved this regulatory milestone and delighted to be moving RM-1995 into the clinic," said Mickey Mikitani, CEO of Rakuten Medical Inc. "RM-1995 has the potential to attack the cancer in a novel way, targeting Tregs. Based on data from Preclinical studies , RM-1995 photoimmunotherapy treatment is expected to result in acute killing of Tregs within the tumor.”

“We are developing drugs using various antibodies in our Drug Discovery program based on Rakuten Medical's Illuminox platform, and RM-1995 is the second pipeline drug developed on this platform. We will continue to advance our business with a sense of speed so that we can deliver these important treatments to as many patients as possible."