Therapy Areas: Devices
US FDA accepts Rakuten Medical's Investigational New Drug application to start clinical studies of RM-1995 photoimmunotherapy
16 December 2021 -

Rakuten Medical Inc, a US-based global clinical stage biotechnology company, announced on Wednesday that the United States Food and Drug Administration (FDA) has accepted the firm's Investigational New Drug (IND) application to start 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, an investigational drug-device combination, is a conjugate of a photoactivatable dye (IRDye 700DX [IR700]) and a monoclonal antibody specific for cell-surface interleukin 2 (IL-2) receptor alpha-chain (CD25). The device part of the treatment is a laser device system (PIT690 Laser System) utilised to activate IR700 by illumination with 690nm nonthermal red light. Tumour-resident regulatory T cells (Tregs), that inhibit antitumor immune responses to promote tumour growth, can be specifically targeted with anti-CD25 antibodies.

Mickey Mikitani, Rakuten Medical Inc., chief executive officer said, 'We are very excited to have achieved this regulatory milestone and delighted to be moving RM-1995 into the clinic.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 tumour. We are developing drugs using various antibodies in our drug discovery program based on Rakuten Medical's IlluminoxTM 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.'

Login
Username:

Password: