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Tessa Therapeutics, in Collaboration with Baylor College of Medicine

– Preclinical, ‘proof-of-concept’ results for a novel ‘all-in-one’ immunotherapy for the treatment of Human Epidermal Growth Factor Receptor 2 (HER2)-positive solid tumors

– The preclinical findings support the advancement of this multimodal immunotherapy into a Phase I clinical trial

Tessa Therapeutics, a clinical-stage cell therapy company focused on autologous and allogeneic therapies for a wide range of cancers, today announced ‘proof-of-concept’ data from the preclinical study of TT16, a first-of-its-kind combination immunotherapy that integrates Chimeric Antigen Receptor (CAR) T cell therapy and oncolytic adenovirus expressing immunomodulatory molecules for the treatment of Human Epidermal Growth Factor Receptor 2 (HER2)-positive solid tumors.

The results of the preclinical study, a collaboration between Tessa Therapeutics and Baylor College of Medicine, were presented today at the 2019 American Society of Gene & Cell Therapy (ASGCT) Annual Meeting in Washington, D.C.

“The preclinical data presented today demonstrates the feasibility of combining CAR T cell therapy with other immunotherapy agents to overcome the challenges of the immunosuppressive tumor microenvironment and enhance the T cells’ anti-tumor activity against HER2-positive cancer cells,” said Dr. Ivan D. Horak, M.D., President of Research and Development, Tessa Therapeutics. “These results support our plans to further develop this next-generation product candidate. We look forward to progressing the therapy into a Phase I clinical trial for patients with HER2-positive solid tumors.”

In the preclinical study, HER2-specific CAR T anti-tumor activity was evaluated in HER2-positive human solid tumor animal models. The therapy consists of a two-step process, in which the models were first injected with a binary oncolytic adenovirus (CAd) followed by the infusion of HER2-CAR T cells.

The combination therapy showed durable responses in the various tumor models. Furthermore, CAd secreting PD-L1 blocking antibody and activation cytokine IL-12p70 improved the persistence and activity of the HER2-CAR T cells even in advanced disease models showing metastasis similar to those seen in patients.

The data also demonstrates that local treatment of this ‘all-in-one’ therapy can systemically enhance the responses of HER2-CAR T cells against HER2-positive cancer cells.

The abstract, titled “Combination Local Oncolytic Adenoimmunotherapy and Systemic CAR-T Cell Therapies for Advanced Solid Tumor Treatment” can be found on the ASGCT meeting website at .

About Tessa Therapeutics

Tessa Therapeutics is a clinical-stage cell therapy company focused on the development of autologous and off-the-shelf, allogeneic therapies targeting a wide range of cancers. Tessa’s Virus-Specific T cell (VST) platform harnesses the body’s potent anti-viral immune response and has shown early efficacy and a strong safety profile in the treatment of solid tumors.

Tessa is building a portfolio of innovative, next-generation therapies by combining VSTs with other immuno-oncology approaches. This portfolio includes a rapidly growing pipeline of clinical and pre-clinical autologous programs that target a wide range of cancers, including nasopharyngeal carcinoma, cervical cancer, oropharyngeal cancer, lung cancer, breast cancer, bladder cancer, as well as head and neck cancer. In addition, Tessa is leveraging its platform to develop allogeneic therapies to address Epstein-Barr virus-associated lymphomas and solid tumors.

Tessa has built up robust operational and supply chain capabilities to successfully deliver T cell therapy treatments to a large patient pool worldwide. Together with the Company’s academic, clinical, and commercial research partners, Tessa has created a fully-integrated approach to the treatment of cancer with immunotherapy.

/Public Release.