Immunomic Therapeutics Reports Positive Results from Its Phase 1 Clinical Trial of ITI-3000 in Patients Diagnosed with Merkel Cell Carcinoma

ITI-3000 Demonstrated a Favorable Safety and Tolerability Profile

Patients showed encouraging immunological responses, which will be further confirmed with a Phase II trial

ROCKVILLE, Md.–(BUSINESS WIRE)–#MCC–Immunomic Therapeutics, Inc. (ITI), a privately-held clinical-stage biotechnology company pioneering the development of LAMP-mediated nucleic acid-based immunotherapy, today announced safety and tolerability results from its phase 1 clinical trial evaluating ITI-3000, a plasmid DNA (pDNA) vaccine, targeting patients with Merkel cell carcinoma (MCC), a rare but aggressive form of skin cancer that is typically caused by the Merkel cell polyomavirus (MCPyV). ITI-3000 was granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) in November 2022.

“The reporting of results from our phase 1 trial of ITI-3000 in patients with MCC, marks the achievement of a significant milestone in our mission to create a therapeutic solution for this rare, yet highly aggressive skin cancer,” stated D.G. Kim, Chief Executive Officer of ITI. “As we expected, ITI-3000 proved to be safe and well tolerated in the study, with no dose-limiting toxicities, no reported treatment-related adverse events or serious adverse reactions. As we are encouraged by the immunological responses in patients, we look forward to continuing the development of ITI-3000. The advancement of this program is paving the way for the expansion of our pipeline via our UNITE® platform.”

The phase 1 clinical trial was a six-patient, single center, open label, first-in-human (FIH) study, investigating the safety, tolerability and immunogenicity of ITI-3000 in patients with polyomavirus-positive Merkel cell carcinoma (MCC). Participants received 4 doses of ITI-3000 vaccine, one 4 mg dose every month for four months. Participants in the study were those who are both diagnosed and had completed standard of care (SOC) surgical and/or radiation therapy at least one year prior to enrollment in the study, and who had no evidence of active disease (NEAD). Participants who were previously diagnosed with MCC and had recurrence but exhibited no evidence of active disease (NEAD) for more than two years prior to enrollment, were also included in the study.

Additional information regarding the phase 1 trial may be found at clinicaltrials.gov, using identifier: NCT05422781.

About ITI-3000

ITI-3000 leverages the company’s investigational UNiversal Intracellular Targeted Expression (UNITE®) platform, powered by LAMP (Lysosome Associated Membrane Protein), which fuses sequences from the mutated form of the large T antigen (LT) of the MCPyV into the sequence of the LAMP-1 gene. This lysosomal targeting technology has been shown to result in enhanced antigen presentation and a potent immune response.

About Immunomic Therapeutics, Inc.

Immunomic Therapeutics, Inc. (ITI) is a privately-held, clinical-stage biotechnology company pioneering the development of vaccines through its proprietary technology platform UNITE®, which is designed to utilize the body’s natural biochemistry to develop vaccines that generate broad immune responses. ITI is primarily focused on applying the UNITE platform to oncology indications, where it could potentially have broad applications, including development of antigen-derived antibodies as biologics in a number of cancers. The company has built a pipeline leveraging UNITE with programs in oncology, animal health, infectious disease, and allergy. ITI maintains its headquarters in Rockville, Maryland. For more information, please visit www.immunomix.com.

Forward-Looking Statements

This press release includes statements relating to the current progress of the ITI-3000 program for Merkel cell carcinoma and ITI’s technology platform and development efforts. These statements and other statements regarding our future plans and goals constitute “forward-looking statements” and are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that are often difficult to predict, are beyond our control and which may cause results to differ materially from expectations, including, without limitation, whether we are able to capitalize on the Fast Track Designation for the ITI-3000 program, receive additional accelerated review from the FDA, achieve positive results in our clinical trials to develop an immunotherapy that is successful in treating MCC, and be able to advance the utilization of our UNITE® platform. You are cautioned not to place undue reliance on these forward-looking statements, which are based on our expectations as of the date of this press release and speak only as of the origination date of this press release. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

Contacts

Melissa Kemp

[email protected]
301-968-3501