March 12, 2018
Keio University Hospital
RIKEN
Ambicion, Inc.
On March 12, 2018, Professor Kenzo Soejima of the Clinical and Translational Research Center at Keio University Hospital, Professor Ryuji Tanosaki of the Center for Transfusion Medicine and Cell Therapy at the same hospital, and their colleagues initiated a Phase I investigator-initiated clinical trial to evaluate the safety and efficacy of an NKT cell-targeted cancer therapy using a newly developed regenerative medicine product. This therapy applies the mechanism of immune cell activation by natural killer T (hereinafter "NKT") cells, discovered by Director Masaru Taniguchi of the Laboratory for Immune Regulation Strategy at the RIKEN Center for Integrative Medical Sciences (hereinafter "RIKEN") and his team. This clinical trial will be conducted on patients with advanced or recurrent solid tumors for whom standard treatments have been ineffective or for which no standard treatment has been established.
This investigational product activates NKT cells, a type of lymphocyte. The activation of NKT cells triggers a chain reaction, activating various immune cells in the body that attack cancer cells, thereby treating the cancer. Animal experiments using mice have confirmed that a single administration of this product can create long-term cancer immune memory lasting for about one year. It is expected to have a sustained effect in attacking cancer and suppressing its progression, recurrence, and metastasis.
Furthermore, since this investigational product is manufactured using immune cells isolated from the patient's own blood, it is expected to be a highly safe therapeutic product with a lower risk of allergic reactions, such as anaphylactic shock, compared to cell products made from other individuals.
NKT cells are the only immune cells that are common to all humans. Moreover, because this is a treatment that activates the patient's own cancer immunity rather than directly attacking the cancer, it is a new concept in cancer immunotherapy that is expected to be effective for all cancer types and in all individuals. This clinical trial marks the first time this investigational product will be administered to humans. It is hoped that this will lead to the establishment of a new cancer treatment method.
This investigational product was developed through joint research between RIKEN, Ambicion, Inc. (hereinafter "Ambicion"), and the Keio University School of Medicine, with support from the Clinical and Translational Research Center at Keio University Hospital. It is manufactured and supplied by Ambicion. This clinical trial, supported by the Clinical and Translational Research Center at Keio University Hospital, will be conducted at Keio University Hospital, with plans to expand to other institutions.
For the full press release, please see below.