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)
David M. Cognetti, MD, FACS, Jefferson Center for Head and Neck Surgery at the Thomas Jefferson University Hospital, Philadelphia
1:15 p.m. – 4:15 p.m. CST, with discussion from 4:30 p.m. – 6 p.m. CST, Saturday, June 1, 2019
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® 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.
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)
Jeannie Hou, MD, VP of Clinical Development for Rakuten Medical
1:15 p.m. – 4:15 p.m. CST, Saturday, June 1, 2019
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 needed.
Medical Affairs Booth, Rakuten Medical
9 a.m. – 5 p.m. CST, Saturday – Monday, June 1-3, 2019.
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.
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.
SOURCE Rakuten Medical, Inc.