Gigamune, Inc.

Engineered TCR-T Cell Therapies Targeting Shared Tumor Associated Antigens - Project Summary Project Title: Engineered TCR-T Cell Therapies Targeting Shared Tumor Associated Antigens Organization: Gigamune Inc. Pi: Matthew J Spindler, PH.D. Adoptive Cell Therapies (ACTS) Including Car-t, TCR-T, and Til Therapies Have Shown Strong Clinical Responses for the Treatment of Cancer Patients for Hematological Cancers and Solid Tumors. However, Only ANTI-CD19 Car- T Cell Therapies Have Been Fda Approved and Commercialized for the Treatment of Hematological Cancers. Numerous TCR-T Cell Clinical Trials Are Ongoing for the Treatment of Solid Tumors, But These Trials Target Only a Handful of Tumor Associated Antigens (TAAS) With the Majority Restricted to HLA-A0201. Thus, There Is a Need to Develop Novel Anti-cancer TCR-T Cell Therapies for the Treatment of a Broader Patient Population. Taas Including Cancer/testis and Differentiation Antigens Are Ideal TCR-T Cell Targets as They Are Shared Across Patients and Solid Tumor Types and Can Induce T Cell Responses Across Numerous Hla Alleles. Importantly, a Recent Clinical Trial Demonstrated That Autologous Anti-taa T Cells Can Provide Strong Anti-tumor Efficacy in High- Risk Solid Tumor Patients. However, These Autologous Anti-taa T Cells Require Intensive Ex Vivo Expansion and Can Result in Variable Anti-tumor Reactivity. This Suggests That TCR-T Cell Therapies Targeting Common Taas Would Provide an Effective Treatment for Solid Tumor Patients and Improve Manufacturing Consistency and Efficacy. the Specific Aim of This Phase I Sbir Project Is to Develop a Catalog of Natural Human TCRS That Target Shared Tumor Associated Antigens for Use in Autologous or Allogeneic TCR-T Cells Therapies. Gigamune's Unique Technology Uses Microfluidics, Genomics, and Mammalian Display to Generate Millions-diverse, Natively Paired Tcrab Repertoire Libraries. the Tcrab Libraries Are Immortal, Enabling Repeated Experimentation With a Panel of Antigens. This Will Expedite Discovery of Rare Anti-taa TCRS. the Project Is Led by DR. Matthew J. Spindler, an Expert in Immunogenomics and Inventor of the Gigamune Technology and Supported by Serial Entrepreneur and Co-founder David Johnson (gigagen). After Completing This Phase I Sbir Project, Gigamune Will Further Develop Promising TCRS as TCR-T Cell Therapies, Through in Vivo Efficacy Studies, in Vitro Safety Studies, and Manufacturing Development.