Immunomic Therapeutics Receives FDA Fast Track Designation for ITI-3000, a pDNA Vaccine, in Development for the Treatment of Merkel Cell Carcinoma

ROCKVILLE, Md.--(BUSINESS WIRE)--#FTD--Immunomic Therapeutics, Inc. (ITI), a privately-held clinical-stage biotechnology company pioneering the development of LAMP-mediated nucleic acid-based immunotherapy, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to the ITI-3000 program for the treatment of patients with Merkel cell carcinoma. The company is currently enrolling a 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 FDA’s decision to grant FTD underscores the potential for the ITI-3000 program to address a serious unmet need and serve as a meaningful therapeutic option for patients with Merkel cell carcinoma,” stated Dr. William Hearl, Chief Executive Officer of ITI. “We are committed to unlocking the full potential of ITI-3000 in patients with this aggressive form of skin cancer. We expect to report top-line data from our ongoing phase 1 trial of ITI-3000 in MCC patients next year and look forward to working closely with the FDA on a potential next phase clinical study design, while simultaneously continuing dialogue with possible partners.”

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 balanced immune response, including, of note, ITI-3000 activated antigen-specific CD4+ T cells in vivo.

About Fast Track Designation
Fast Track Designation is designed to facilitate the development and expedite the FDA review of drugs to treat serious conditions and fulfill unmet medical needs, enabling drugs to reach patients earlier. Clinical programs with Fast Track Designation benefit from early and frequent communication with the FDA throughout the regulatory review process. These clinical programs may also be eligible to apply for accelerated approval and breakthrough designation review by the FDA if relevant criteria are met.

About UNITE®
ITI’s UNITE platform leverages the ability to engineer chimeric proteins, directing antigen presenting cells to present antigens to the immune system through a targeted pathway and driving a robust immune response. UNITE vaccines are distinct in that they combine two components: nucleic acid constructs that encode a specific antigen and an endogenous Lysosomal Associated Membrane Protein (LAMP-1) sequence. The UNITE platform harnesses LAMP-1 as a means of presenting the vaccine target to the immune system, resulting in antibody production, inflammatory cytokine release, and establishing critical immunological memory, something that other vaccine approaches commonly lack. This approach could put UNITE technology at the crossroads of immunotherapies in multiple indications, including cancer, human allergy, animal health, and infectious disease. Preclinical data is currently being developed to explore whether LAMP-1 nucleic acid constructs may amplify and activate the immune response in highly immunogenic tumor types and be used to create immune responses in tumor types that otherwise do not provoke an 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.

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

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