Aspyrian Therapeutics Inc. Announces FDA Acceptance of an Investigational New Drug Application for RM-1929, a First-in-Class, Precision-Targeted Therapy for Cancer

Aspyrian Therapeutics Inc. Announces FDA Acceptance of an Investigational New Drug Application for RM-1929, a First-in-Class, Precision-Targeted Therapy for Cancer

April 30, 2015, San Diego, CA: Aspyrian Therapeutics Inc., a drug development company creating precision-targeted therapies to treat cancer based on its proprietary Photoimmunotherapy platform, today announced the U.S. Food & Drug Administration (FDA) has accepted the Company’s first Investigational New Drug (IND) application to begin clinical studies of RM-1929 for the treatment of patients with recurrent head and neck cancer. This first-in-class therapy uses an antibody conjugate to precisely target cancer cells after which it is locally activated to elicit rapid anticancer responses. The dual specificity resulting from in-tumor activation of a tumor-selective conjugate promises to deliver oncologists the ability to achieve locoregional tumor control with minimal damage to surrounding healthy tissues and structures.

"This clinical trial is the first of its kind to evaluate a novel therapy with a two-step targeting approach designed to deliver unparalleled tumor specificity" said Dr. Merrill Biel, M.D. Ph.D., Chief Medical Officer of Aspyrian. "Recurrent head and neck cancer patients who have failed standard treatments of surgery, radiation, and chemotherapy currently have no further treatment options available. RM-1929 offers hope to these difficult-to-treat patients and has the added advantage that it targets their cancer while sparing damage to adjacent normal tissues that are critical to their quality of life, such as those required for normal speech and swallowing".

RM-1929 was developed in collaboration with Dr. Hisataka Kobayashi and Dr. Peter Choyke at the National Cancer Institute (USA), the inventors of the Photoimmunotherapy platform. "Activation of RM-1929 at the tumor triggers very rapid tumor destruction with exquisite specificity" said Miguel Garcia-Guzman, Ph.D., President and Chief Scientific Officer at Aspyrian "RM-1929 provides oncologists a new, precision-targeted approach for the effective locoregional management of cancer either alone or in combination with other anticancer therapies".

RM-1929 targets a specific cancer antigen that is highly expressed in carcinomas allowing treatment of a number of different cancer types, including cancers of the head and neck, esophagus, lung, colon, and pancreas. "The initiation of this clinical study marks a key milestone for Aspyrian, as we continue to develop a pipeline of precision-targeted therapies for the treatment of solid tumors. The broad therapeutic potential of our lead product candidate gives us the opportunity to expand the clinical program for RM-1929 into a range of cancer indications during 2016 " said Scott Salka, Chief Executive Officer of Aspyrian.

About Aspyrian Therapeutics Inc.

Aspyrian is developing a new class of precision-targeted oncologic drugs for the treatment of solid tumors based on the Photoimmunotherapy platform licensed exclusively from the National Cancer Institute (USA). Photoimmunotherapy utilizes cancer-selective antibodies conjugated to the molecule IRDye® 700DX that is activated with a laser at the tumor site to induce rapid cancer cell destruction. Importantly, laser activation can be accomplished on an outpatient basis by either external illumination or by needle placement of an optical fiber to illuminate a deep-seated tumor from within. Aspyrian has secured the exclusive license to use IRDye 700DX from LI-COR (Lincoln, Nebraska) for development of Photoimmunotherapy products. The Company is currently working with a number of monoclonal antibodies with the potential to treat various types of cancers, including head and neck, esophageal, lung, brain, pancreatic, colorectal, breast and ovarian.

For more information on the clinical trial, please follow this link to the study record on ClincalTrials.gov: Study of RM-1929 and Photoimmunotherapy in Patients With Recurrent Head and Neck Cancer



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