Immunomic Therapeutics Announces First Patient Dosed in Phase I Clinical Trial of ITI-3000 pDNA Vaccine for the Treatment of Merkel Cell Carcinoma

ROCKVILLE, Md.--(BUSINESS WIRE)--Immunomic Therapeutics, Inc., (“ITI”), a privately-held clinical-stage biotechnology company pioneering the study of LAMP (Lysosome Associated Membrane Protein)-mediated nucleic acid-based immunotherapy, today announced dosing of the first patient in the company’s Phase 1 study 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). The single-center study is being conducted at the University of Washington School of Medicine and the Fred Hutchinson Cancer Center in Seattle, Washington and is being led by Drs. Paul Nghiem, Song Park and David M. Koelle.

The eight-patient, open label, first-in-humans (FIH) study is designed to evaluate the safety, tolerability, and immunogenicity of 4 mg of ITI-3000 in patients with MCC who have undergone surgery. The study’s primary endpoints include the number of participants experiencing dose limiting toxicities (DLTs), the number of occurrences of adverse events/serious adverse reactions, (AEs/SARs), as well as other standard clinical assessments and safety laboratory parameters.

ITI-3000 leverages the company’s investigational UNiversal Intracellular Targeted Expression (UNITE®) platform, powered by LAMP, 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 balanced immune response, including, of note, ITI-3000 activated antigen-specific CD4+ T cells in vivo.

“Despite recent advances in cancer immunotherapy, there remains a need for therapies to treat this rather rare, but aggressive form of skin cancer, and we believe that our proprietary approach, utilizing nucleic acid vaccines with the power to leverage the body’s natural biochemistry to develop a broad immune response, holds tremendous potential in this indication,” said Dr. William Hearl, Chief Executive Officer of Immunomic Therapeutics. “We look forward to reporting top-line results from the Phase 1 trial in the second quarter of next year.”

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

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, UNiversal Intracellular Targeted Expression (UNITE®), which is designed to utilize the body’s natural biochemistry to develop vaccines that generate broad immune responses. UNITE® has a robust history of applications in various therapeutic areas, including infectious diseases, oncology, allergy, and autoimmune diseases. ITI is primarily focused on applying the UNITE® platform to oncology, where it could potentially have broad applications, including antigen-derived antibodies as biologics. 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.

Contacts ITI Company Contact: Melissa Kemp mkemp@immunomix.com 301-968-3501

ITI Media Contact: Melody Carey mcarey@rxir.com 917-322-2571