On May 15, 2019 Rakuten Medical, a clinical-stage biotechnology company developing precision-targeted cancer therapies based on its proprietary photoimmunotherapy (PIT) platform, reported that it 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 (Free ASCO Whitepaper) annual meeting, May 31 – June 4, 2019 in Chicago (Press release, Rakuten Medical, MAY 15, 2019, View Source;june-4-2019-in-chicago-300851238.html [SID1234536363]).
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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 (Free ASCO Whitepaper) 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, Philadelphia
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
Location:
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 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
Location:
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 needed.
Exhibit Hall
•
Medical Affairs Booth, Rakuten Medical
Location:
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.