Federal grant · project grant (b)
Feasibility Study of a Novel NK and CD8 T Cells Stimulating Agent - Abstract Cell-based Therapies, Whether NK or T Cell-based Therapies, Have Demonstrated Great Efficacy in Treating Hematological Malignancies in the Clinic. to Date, There Are at Least Seven Car-t Based Therapies, Including Four CD19CAR-T and Two Bcma Car-t, Have Been Approved for Treating Hematological Malignancies. These Successes Brough Excitement and Promises to Use Cell-based Therapy Treating Solid Tumors. Currently, There Are Over 300 CD8T-CELL Based Therapy and Over 150 NK Cell-based for Solid Tumors in Clinical Trials, But the Outcomes From Completed Studies Are Disappointing. the Foremost Common Challenges of T and NK Cell-based Therapy for Solid Tumors Is Persistence and Sustained Function of Infused Cells in Solid Tumors. Two Factors Could Contribute to This Problem: 1) Solid Immune Suppressive Tumor Microenvironment; 2) Over-stimulation of NK or CD8 T Cells During Ex Vivo Expansion to Drive Cells to a Terminal Differentiation Status. to Circumvent These Challenges, We Have Discovered a New Complex Molecule Composed of a Soluble Peptide and Its Conformational Binding Agent That Can Be Used as an Additive During NK and Antigen-specific CD8 T Cell Expansion to Enable Their Superior Efficacy in Treating Solid Tumors. We Understood That Complex Programming Can Induce Polyfunctional Heterogenic Subpopulations With Enriched Cell Pool of TCF1+ Stemlike NK and CD8 T Cells, in Addition to Upregulating the Expression of Key Effector Molecules in Respective Effector Cell Subsets. However, the Complex Could Bring Two Potential Challenges for Ind-enabling Studies and Clinical Use: I) the Batch-to-batch Consistency in the Complex Formation; Ii) a Significantly Higher Cost in CMC (chemistry, Manufacturing, and Controls) of Producing Two Gmp-grade Materials Than a Single Cmc-grade Reagent. These Challenges Will Subsequently Bring Difficulty in Technology Commercialization or Pharma Partnership. to Circumvent These Challenges, Cancure Has Designed and Generated a Panel of Fusion Proteins Composed of the Peptide and the Binding Agent. the Goal/milestone of This Sbir Phase I Application Is to Screen This Panel of Fusion Proteins for the Best Candidate to Move Forward or Make a Go VS. No-go Decision With the Fusion Product and Inform Future Plans. the Screening Will Be Based on Biological Activity and Pilot De-risking Biochemical/biophysical Characterizations for the Developability.
Committed
$399,444
Paid out
$226.0K
57%
Committed, not yet paid
$173.5K
43%
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