ITI and CoImmune Enter into Partnership to Manufacture A Novel Experimental Cell Therapy for GBM

ROCKVILLE, Md. & DURHAM, N.C.–(BUSINESS WIRE)–Immunomic Therapeutics, Inc., (“ITI”), a privately-held clinical-stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms, and CoImmune, Inc. (“CoImmune”), a privately held clinical-stage immuno-oncology company developing cell-based therapeutics to treat unmet medical needs in blood-borne and solid tumor indications, announced today that the companies have entered into a license agreement for ITI to use CoImmune’s proprietary dendritic cell process for certain ITI cell therapy vaccine programs. The partnership highlights the oncology pipeline of ITI and CoImmune’s expertise and technology in the development and manufacture of cell-based therapeutics.

Under the terms of the license agreement that supports this partnership, ITI will employ CoImmune’s process for manufacturing and cGMP work for the advancement of ITI-1020, ITI’s autologous dendritic cell (DC) investigational vaccine loading with mRNA encoding LAMP: pp65 for the treatment of newly diagnosed glioblastoma (GBM). CoImmune is eligible to receive milestone payments from ITI upon the successful achievement of certain agreed-upon programmatic goals, including initiation of clinical studies and regulatory submissions. In addition, CoImmune will be eligible to receive royalty payments based upon net sales of ITI-1020, if the product were to be approved in the future.

“We are excited to work with CoImmune, an emerging leader in the development and manufacture of cell-based immunotherapies,” said Dr. Tim Coleman, Senior Vice President of Operations at Immunomic Therapeutics. “This agreement supports our immediate and long-term goals for developing and commercializing cancer immunotherapies designed from our investigational UNITE nucleic acid platform. We look forward to collaborating with CoImmune and harnessing their expertise in cell therapies to bring our innovative products to patients in need.”

“Our industry is experiencing an increase in the emergence of cell-based therapeutics based on encouraging clinical results to date. Our team at CoImmune has a great deal of expertise in developing and manufacturing these products to efficiently stimulate the immune system against cancer and we are excited to partner with ITI,” said Charles Nicolette, CEO of CoImmune. “By combining our team’s know-how with the unique approach to immune system stimulation by UNITE™, we believe ITI is well positioned to move into advanced clinical development, initially targeting GBM.”

About UNITE

ITI’s investigational UNITE platform, or UNiversal Intracellular Targeted Expression, works by fusing target antigens with the Lysosomal Associated Membrane Protein, an endogenous protein in humans, for immune processing. In this way, ITI’s vaccines (DNA or RNA) have the potential to utilize the body’s natural biochemistry to develop a broad immune response including antibody production, cytokine release and critical immunological memory. This approach could put UNITE technology at the crossroads of immunotherapies in a number of illnesses, including cancer, allergy and infectious diseases. UNITE is currently being employed in Phase II clinical trials as a cancer immunotherapy. ITI is also collaborating with academic centers and biotechnology companies to study the use of UNITE in cancer types of high mortality, including cases where there are limited treatment options like glioblastoma and acute myeloid leukemia. ITI believes that these early clinical studies may provide a proof of concept for UNITE therapy in cancer, and if successful, set the stage for future studies, including combinations in these tumor types and others. Preclinical data is currently being developed to explore whether LAMP nucleic acid constructs may amplify and activate the immune response in highly immunogenic tumor types and be used to create immune responses to 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 investigational proprietary technology platform, UNiversal Intracellular Targeted Expression (UNITE), which is designed to utilize the body’s natural biochemistry to develop vaccines that have the potential to generate broad immune responses. The UNITE platform 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 targeting viral antigens, cancer antigens, neoantigens and producing antigen-derived antibodies as biologics. In early 2020, an investment of over $60M by HLB Co., LTD, a global pharmaceutical company, enabled ITI to accelerate application of its immuno-oncology platform, in particular to glioblastoma multiforme, and rapidly advance other key candidates in the pipeline, including the most recent initiative into infectious diseases with development of its vaccine candidate for COVID-19. The Company has built a large pipeline from UNITE with eight oncology programs, multiple animal health programs and a SARS-CoV-2 program to prevent and treat COVID-19. ITI has entered into a significant allergy partnership with Astellas Pharma and has formed several academic collaborations with leading Immuno-oncology researchers at Duke University and the University of Florida. ITI maintains its headquarters in Rockville, Maryland. For more information, please visit www.immunomix.com.

About CoImmune, Inc.

CoImmune specializes in the development of immuno-oncology therapies based on its two proprietary platform technologies. The autologous RNA-loaded dendritic cell technology for solid tumors specifically targets each patient’s unique tumor antigens. The allogeneic CAR-CIK technology is a variation on CAR-T therapy with greatly reduced toxicity while retaining strong efficacy based on an on-going clinical trial in pediatric and adult acute lymphoblastic leukemia patients. For more information, please visit www.coimmune.com

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