Rakuten Medical Highlights Upcoming Presentations and Activities During the ASCO Annual Meeting, May 31 - June 4, 2019 in Chicago

SAN MATEO, Calif., May 15, 2019 /PRNewswire/ -- Rakuten Medical, a clinical-stage biotechnology company developing precision-targeted cancer therapies based on its proprietary photoimmunotherapy (PIT) platform, will be presenting data from its Phase 2a clinical trial focused on RM-1929 PIT in patients with locoregional, recurrent head and neck squamous cell carcinoma (rHNSCC) during the ASCO annual meeting, May 31 - June 4, 2019 in Chicago.

In addition, study criteria and details on Rakuten Medical's Phase 3 clinical trial of ASP-1929 PIT therapy versus physician's choice standard-of-care for the treatment of patients with locoregional rHNSCC will also be highlighted during a poster presentation.

Details about Rakuten Medical activities throughout ASCO are listed below:

               Poster Discussion Session


        --     Results of a Phase 2a,
               multicenter, open-label,
               study of RM-1929
               photoimmunotherapy (PIT)
               in patients with
               locoregional, recurrent
               head and neck squamous
               cell carcinoma (rHNSCC)
               (Abstract 6014)

                         Presenter:               David M. Cognetti, MD, FACS, Jefferson
                                                   Center for Head and Neck Surgery at the
                                                   Thomas Jefferson University Hospital,

                         Date/time:               1:15 p.m. - 4:15 p.m. CST, with
                                                   discussion from 4:30 p.m. - 6 p.m. CST,
                                                   Saturday, June 1, 2019

        Hall A

              Overview:                In this study, results are reported of a
                                                   Phase 2a trial of PIT with a targeted
                                                   drug, RM-1929, consisting of the EGFR-
                                                   directed antibody, Cetuximab. It is
                                                   conjugated to a photoactivatable dye
                                                   (IRDye(R) 700DX). Binding of the
                                                   antibody-dye conjugate to cancer
                                                   cells, followed by a photoactivation
                                                   with non-thermal red light, induces
                                                   selective and rapid necrosis of cancer
                                                   cells with minimal damage to
                                                   surrounding tissue.

               Poster Presentation


        --     A global Phase 3
               multicenter, randomized,
               double-arm, open-label
               trial of ASP-1929
               photoimmunotherapy vs.
               physician's choice standard
               of care for the treatment
               of patients with
               locoregional, recurrent
               head and neck squamous cell
               carcinoma (rHNSCC)
               (Abstract TPS6094)

                         Presenter:               Jeannie Hou, MD, VP of Clinical
                                                   Development for Rakuten Medical

                         Date/time:               1:15 p.m. - 4:15 p.m. CST, Saturday,
                                                   June 1, 2019

        Hall A

              Overview:                The objective of this Phase 3 study is
                                                   to evaluate the efficacy and safety of
                                                   ASP-1929 (EGFR-directed antibody
                                                   Cetuximab-IR700 conjugate) PIT
                                                   treatment as a monotherapy in patients
                                                   with locoregional rHNSCC. Patients with
                                                   rHNSCC have few curative treatment
                                                   options available and low response
                                                   rates; therefore, new modalities that
                                                   can be targeted, minimally invasive,
                                                   and provide improved tumor response and
                                                   control with limited side effects are

               Exhibit Hall


        --     Medical Affairs Booth,
               Rakuten Medical

        Booth #16024

                         Date/time:               9 a.m. - 5 p.m. CST, Saturday - Monday,
                                                   June 1-3, 2019.

About Photoimmunotherapy
Photoimmunotherapy (PIT) is an investigational, anti-cancer treatment platform that is comprised of a drug and device combination that utilizes monoclonal antibodies conjugated to a dye (IRDye(®) 700DX). Transient excitation of IRDye 700Dx with non-thermal red light (690 nm) is believed to result in anti-cancer activity, which is mediated by biophysical processes that may compromise the membrane integrity of cells. The requirement of targeted binding of antibody-IR700 conjugate to a specific antigen on the cell surface and subsequent illumination is believed to result in rapid and selective cell killing and tumor necrosis with minimal effects on surrounding normal tissue. PIT may also lead to the systemic induction of innate and adaptive immunity.

About Rakuten Medical
Rakuten Medical is a privately funded, clinical-stage biotechnology company with offices in the U.S., Japan, Taiwan, Germany and Netherlands. Rakuten Medical aims to become a leader in precision-targeted medicines through its proprietary photoimmunotherapy platform, which is being studied in ongoing clinical trials, evaluating its safety and effectiveness as a cancer-treatment option that can be administered independently, or in combination with other drugs. Rakuten Medical's lead product, ASP-1929, has achieved Fast Track designation from both the FDA and the Japanese Ministry of Health, Labour, and Welfare; and is in Phase 3 clinical trials for recurrent head and neck squamous cell carcinoma. Additional Phase 2 studies for ASP-1929 PIT are also underway to evaluate the safety in patients with other cancer types. For more information, visit www.rakuten-med.com.

Media Contact
Melissa M. Conger
Global Corporate Communications and Investor Relations, Rakuten Medical
+1 858 761 6953

Forward Looking Statement
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the (United States) Private Securities Litigation Reform Act of 1995 that involve risks, uncertainties, and assumptions that could cause Rakuten Medical's actual results and experience to differ materially from anticipated results and expectations expressed in these forward-looking statements. These forward-looking statements include information concerning the commercialization of services related to Rakuten Medical products such as ASP-1929 and other initiatives toward regulatory approval to be sold and marketed. These products may not successfully be granted regulatory approval to be sold and marketed, or may not be commercially successful. Forward-looking statements suggest potential profitability, efficacy and safety, and the status of the application for approval. Rakuten Medical has in some cases identified forward-looking statements by using words such as "anticipates," "believes," "hopes," "estimates," "looks," "expects," "intends," "potential," "may," "suggest," "plans," "strategizes," "likely", "will", and similar expressions. Such forward-looking statements are based upon Rakuten Medical's current beliefs. Moreover, this press release states an opinion related to clinical research data, hence the use of expressions such as "important," "notable" and "abnormal." Ongoing clinical studies involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including uncertainty of success in regulatory approval or commercialization of ASP-1929 which may be impacted by, among other things, problems with the manufacturing process for ASP-1929, the occurrence of adverse safety events, failure to demonstrate therapeutic benefit, and the other risks and uncertainties, both reasonable and unreasonable. Rakuten Medical undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect new information obtained, events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation. In the event of one or more revisions to Rakuten Medical's forward-looking statement, it should not be inferred that such revisions or other forward-looking statements will be further revised.

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SOURCE Rakuten Medical, Inc.