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Rakuten Medical announces good safety profile and clinically significant anti-cancer effect in phase IIa clinical trial of photoimmunotherapy with RM-1929 at the American Society of Clinical Oncology (ASCO)

Rakuten Medical Japan Ltd. Rakuten Medical announces good safety profile and clinically significant anti-cancer effect in phase IIa clinical trial of photoimmunotherapy with RM-1929 at the American Society of Clinical Oncology (ASCO) …………………………………………………………………………………………
● In a phase IIa clinical trial of photoimmunotherapy with RM-1929 for patients with locally recurrent head and neck cancer, the overall response rate is 43% (95% confidence interval: 25.5-62.6), adverse events are limited Yes, it was generally well tolerated.
● A multicenter, randomized, two-group, open-label, phase III clinical trial of photoimmunotherapy with ASP-1929 in approximately 275 locally recurrent head and neck cancer patients in the United States, Europe, and the Asia-Pacific region LUZERA-301 “is underway. Rakuten Medical Co., Ltd. (Head office: San Mateo, California, USA Chairman and Chief Executive Officer: Hiroshi Mikitani) promotes development of cancer treatments with high selectivity for cancer cells under an exclusive license for photoimmunotherapy. Showed good results in a phase IIa clinical trial to evaluate the safety and efficacy of photoimmunotherapy with RM-1929 (complex with anti-EGFR antibody) for patients with locally recurrent head and neck cancer Announced. We also announced the details of the international joint phase III clinical trial. For results in Phase IIa clinical trials, 30 with multiple pre-treatment histories at the Poster Discussion Session of the American Society of Clinical Oncology (ASCO) Annual Meeting held in Chicago, USA on June 1, 2019 (Sat). The clinically significant anti-cancer effects of photoimmunotherapy with RM-1929 have been announced, as demonstrated in patients with locally recurrent head and neck cancer. The main results of the phase IIa clinical trial are as follows. In an independent central assessment, the overall response rate was 43% (95% confidence interval: 25.5-62.6), of which 4 (13%) had a complete response and 9 (30%) had a partial response. Median progression-free survival was 5.2 months (95% confidence interval: 2.1-5.5) and median overall survival was 9.3 months (95% confidence interval: 5.2-16.9). It was generally well tolerated. Of 13 patients (43.3%) who had serious adverse events, 3 were considered to be related to photoimmunotherapy with RM-1929. Rakuten Medical, Inc. Vice President of Clinical Development, Jeannie Hou, said: “We are tackling the unmet need for treatment that cancer patients have. The results of the Phase IIa clinical trial presented this time will support this challenge. Phase IIa Clinical Trial Based on the results of this study, the possibility of treating head and neck cancer with minimal impact on normal tissues by combining local radiation with a drug that utilizes an antibody that selectively targets cancer cells. Based on this result, I would like to expect the next international joint phase III clinical trial. ” The outline of the international joint phase III clinical trial “LUZERA-301” was also presented in a poster presentation at ASCO. A phase III clinical trial is for patients with locally recurrent head and neck cancer who have at least two or more types of treatment history, including one or more systemic chemotherapy (recommended platinum-based treatments recommended). A multicenter, randomized, two-group, open-label, blind comparison of photoimmunotherapy in ASP-1929 (a drug with the same active ingredient as the complex with anti-EGFR antibody and the same active ingredient as RM-1929) and standard therapy selected by physicians. It is a clinical examination. The primary endpoints in this trial are overall survival and progression free survival, and secondary endpoints are objective response rates. Rakuten Medical plans to conduct approximately 275 patients in the United States, Europe, and the Asia-Pacific region in the future. For more information on Phase III clinical trials (NCT 03769506), visit www.clinicaltrials.gov. About Rakuten Medical Rakuten Medical, Inc. (Head office: San Mateo, Calif., USA) is a comprehensive bioinventor that is developing a highly selective treatment for cancer cells based on its proprietary photoimmunotherapy (PIT) platform. It is a technology company. We aim to consistently achieve from the research and development of therapeutics to the delivery of therapeutics to cancer patients all over the world, for the mission of overcoming cancer. Rakuten Medical Japan Ltd. is a Japanese subsidiary of Rakuten Medical. About photoimmunotherapy (PIT; Photoimmunotherapy) Since 2013, Rakuten Medical has developed new cancer treatments using a photoimmunotherapy platform. Photoimmunotherapy is a treatment that uses antibodies to selectively target cancer cells, and a laser to rapidly kill cancer cells. This is an innovative way that combines both biological and physical mechanisms. While accurately and rapidly killing cancer cells, it has only a minor effect on normal tissue. Rakuten Medical will conduct clinical trials of monotherapy and combination therapy with other drugs and aim for commercialization. About ASP-1929 light immunotherapy ASP-1929, a complex of cetuximab and IRDye (R) 700DX, is a cancer antigen expressed in various types of solid cancer such as head and neck cancer, esophageal cancer, lung cancer, colon cancer, and pancreatic cancer, Targets epidermal growth factor receptor (EGFR). After binding to cancer cells, ASP-1929 is locally activated by non-thermal red light emitted by a laser machine with exclusive license and optical fiber. This treatment targets cancer cells, not the surrounding normal tissue. ASP-1929 is an unapproved drug and can not actually be treated. Currently, clinical trials are being conducted in Japan and overseas for patients with “head and neck cancer” and “esophageal cancer”. Forward looking statement (description about future prospects) The statements contained in this press release correspond to the forward-looking statements contained in the 1995 Private Securities Litigation Reform Act of 1995 Safe Harbor clause. Because the statement contains a variety of risks, uncertainties and assumptions, Rakuten Medical’s business plans and results may differ from the results and forecasts expected in this statement. The Forward-Looking Statement contains information on the commercialization of services associated with our products, such as ASP-1929, other regulatory and sales approval efforts. Product approval or commercial success may not be achieved. Forward-looking statements indicate potential benefits, efficacy and safety of ASP-1929, and regulatory status. Such statements include “expect”, “believe”, “hope”, “estimate”, “see through”, “expect”, “intention” Uses expressions such as “possible”, “may”, “propose”, “plan”, “strategize”, “will”, “do”, etc. Is also used based on our current beliefs. In addition, this press release uses the terms “important,” “noticeable,” and “anomalous,” to provide an opinion on clinical trial data. Clinical trial research that is continuous includes various risks and uncertainties, and in particular, rational matters such as problems in the production stage of ASP-1929, occurrence of adverse events related to safety, and situations where therapeutic effects can not be expected. It may be influenced by various risks, including unreasonable ones, and uncertain factors. As a result, actual results may differ from published information, including regulatory approvals and uncertainties in the commercialization of ASP-1929. The Company, excluding the scope required by applicable law, whether or not new information was obtained, and whether any developments or events occurred in the future, Whether there is a change in assumptions, whether there is a change in factors that affect the forward-looking statements, or any other reason, the obligation to formally revise this or any other statement regarding forward-looking statements I do not bear it. If the Company revises one or more forward-looking statements, it should not infer that the revision, or any other forward-looking statement, is further revised. Rakuten Medical Japan Co., Ltd. Public Relations Contact info.jp@rakuten-med.com

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