Aspyrian announces the presentation of clinical data of its investigational therapy RM-1929 demonstrating anti-cancer response in recurrent Head and Neck Cancer patients who have failed all existing treatment options

The data presented are from a multicenter trial of PIT with RM-1929 for patients with recurrent head and neck squamous cell carcinoma that cannot be satisfactorily treated with surgery, radiation or platinum chemotherapy. The data are from seven patients enrolled at Thomas Jefferson University, Philadelphia, PA. The Principal Investigator, Dr. David Cognetti, and his team described the clinical outcomes in patients treated with repeated cycles of PIT with RM-1929. Each treatment consisted of a single drug infusion of RM-1929, followed by light activation of the drug at the tumor at 24-hour post infusion. If persistent disease was present at 4 weeks, the patient could progress into a subsequent treatment cycle.

The investigators noted, "Targeted photoimmunotherapy using a conjugate of cetuximab and IR700 dye is safe and well tolerated and led to evidence of tumor necrosis at the treatment site in 7/7 (100%) patients. No skin photosensitivity or normal tissue toxicity noted. Four out of 7 (57%) patients had durable clinical response to the treatment without progression of disease."

"It is extraordinary how dramatic and rapid the tumor response to RM-1929 Photoimmunotherapy has been on cancers that have been recurrent and resistant to all therapies, while also being well tolerated by the patients.  None of the patients have had any light sensitivities or other systemic side effects, which is a major limitation of other traditional cancer treatment modalities." said Dr. David Cognetti, M.D., Associate Professor, Co-Director, Jefferson Center for Head and Neck Surgery, Sidney Kimmel Cancer Center at Thomas Jefferson University, Philadelphia, PA.

"This is a remarkable outcome for head and neck cancer patients who have failed all previous standard of care therapies and have no viable therapeutic options available to them."   said Dr. Merrill Biel, M.D. Ph.D., Chief Medical Officer of Aspyrian. "These first in human clinical data support the potential for RM-1929 Photoimmunotherapy to uniquely provide a viable option to control this disease while preserving normal healthy tissues in the head and neck area that are so critical to maintaining the patient's quality of life and we look forward to the ongoing clinical trial results."

"In less than two years after initiating clinical studies of RM-1929, we have rapidly gained a good understanding of the safety and anticancer potential of Photoimmunotherapy with RM-1929. Given the significant results so far, we are fully committed to drive this therapy to the market as fast as possible and we intend to initiate the first registration trials in early 2018." said Miguel Garcia-Guzman, Ph.D., President and CEO at Aspyrian. "We intend to develop Photoimmunotherapy with RM-1929 as a single agent and as a combination treatment to provide the best possible outcomes for recurrent head and neck cancer patients, both in the first-line and-second line settings. In addition, we expect to initiate further phase 2 proof-of-concept studies in other EGFR expressing cancer types sometime in the second half of 2018. I congratulate our outstanding team at Aspyrian and our excellent clinical collaborators, particularly Dr. Cognetti, for their exceptional work and commitment to provide cancer patients with better options to conquer their disease".

About RM-1929

RM-1929, a conjugate of Cetuximab and IRDye 700DX^®, targets epidermal growth factor receptor (EGFR), a cancer antigen expressed in multiple types of solid tumors, including head and neck squamous cell carcinomas, esophagus, lung, colon, and pancreas. This first-in-class therapy uses an antibody conjugate to precisely target cancer cells after which it is locally activated with red light to elicit rapid anti-cancer responses. The dual specificity resulting from local 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.

RM-1929 is an investigational compound that is not approved for any use in any country.

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

About Aspyrian Therapeutics Inc.
Aspyrian Therapeutics, Inc., is a privately funded clinical stage biotechnology company developing a new class of precision targeted oncologic drugs for the treatment of solid tumors based on the PIT platform licensed from the National Cancer Institute (NCI).

Aspyrian has secured the exclusive license to use IRDye 700DX^® from LI-COR (Lincoln, Nebraska) for development of PIT 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. 

Aspyrian Therapeutics Inc. Forward Looking Statements

This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 that involve risks, uncertainties and assumptions that could cause Aspyrian Therapeutics Inc. actual results, plans and experience to differ materially from anticipated results and expectations expressed in these forward-looking statements. These “forward-looking” statements include statements relating to, among other things, the commercialization efforts and other regulatory or marketing approval efforts pertaining to Aspyrian Therapeutics’ products such as RM-1929. Such approvals or success may not be obtained or achieved on a timely basis or at all. Forward-looking statements include statements relating to the potential benefits, safety and efficacy of RM-1929, and the status of current regulatory filings. These statements may be identified by words such as “anticipates,” “believes,” “hopes,” “estimates,” “looks,” “expects,” “intends,” “potential,” “may,” “suggest, “plan,” “strategy,” “should,” “will” and similar expressions, and are based on our current beliefs and expectations. In addition, this press release include qualifying terms such as  “significant,”, “remarkable,” “extraordinary,” etc. that describe opinions on clinical data. 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 RM-1929 which may be impacted by, among other things, problems with the manufacturing process for RM-1929, the occurrence of adverse safety events, failure to demonstrate therapeutic benefit, and the other risks and uncertainties. We undertake no obligation to publicly update any forward-looking statement, whether because of new information, future developments or otherwise.

SOURCE Aspyrian Therapeutics Inc.