RANCHO CORDOVA, Calif., September 14, 2021 — ThermoGenesis Holdings, Inc. (Nasdaq: THMO), a market leader in automated cell processing tools and services in the cell and gene therapy field, today announced that the Company was awarded a $250,000 Phase I Small Business Innovation Research (SBIR) grant to develop and test the single-use sterile cell processing disposable, that will be used by the fully automated Quintessence System. These programs allow US-owned life science companies that are creating innovative technologies that align with NIH’s mission to improve health and save lives to engage in federal research and development that has a strong potential for commercialization. This technology is protected by 15 issued patents and 13 pending applications.
Philip Coelho, Chief Technology Officer (CTO) and Principal Investigator for this grant further explained: “Gene-engineered autologous cell (GEAC) therapies for hematologic cancers and inherited disorders are earning growing numbers of FDA approvals, but manufacturing inefficiencies (90+% scrap rates) contribute to long workflows and high costs. Current automation efforts do not offer a solution, because the cell processing techniques they automate are themselves inefficient (in terms of cell recoveries). This Phase 1 SBIR will validate the suitability of significantly more efficient cell handling processes enabled by our functionally closed X-Series® cell processing cartridge and X-BACS® buoyancy-based cell isolation reagents, recently licensed to Corning Life Sciences for global distribution. This enhanced cell processing cartridge will be integrated into a ‘one-pot’ GEAC manufacturing workflow lending itself to full automation in the simple, compact, moderately priced Quintessence instrument (the subject of a follow-on Phase 2 SBIR proposal.”
Existing X-Series cartridges are proven to enrich mononuclear cells from blood with target cell recovery efficiencies of 90-100% (for T cells and hematopoietic stem cells), and to wash or volume-reduce cell solutions with equal recovery efficiency. Similarly, X-BACS reagents used in X-Series cartridges prove up to 50% more efficient than conventional ferrous bead/magnetic field methods at target cell isolation at very high purity. Combined, these innovations can offer at least a 6-fold improvement in cell yield relative to conventional techniques. Target blood cells thus prepared have been shown to be transduced with lentiviral vectors as readily as are conventionally produced target cells.
This Grant’s Specific Aims are: (1) to prototype and manufacture in small quantities an enhanced X-Series cartridge with additional features required to support the subsequent Aim; and (2) to validate and optimize the performance of all the steps of GEAC manufacturing (from blood to transduced, expanded and washed cells comprising a typical therapeutic dose) in a single such cartridge (‘one-pot’ workflow), the milestone for application for a Phase 2 SBIR to design and validate the Quintessence instrument that will fully automate that workflow.
About NIH SBIR Grants
The Small Business Innovation Research (SBIR) program allow US-owned and operated small businesses to engage in federal research and development that has a strong potential for commercialization. NIH’s SBIR program invests into health and life science companies that are creating innovative technologies that align with NIH’s mission to improve health and save lives. A key objective is to translate promising technologies to the private sector and enable life-saving innovations to reach consumer markets.
About ThermoGenesis Holdings, Inc.
ThermoGenesis Holdings, Inc. develops, commercializes, and markets a range of automated technologies for CAR-T and other cell-based therapies. The Company currently markets a full suite of solutions for automated clinical biobanking, point-of-care applications, and automation for immuno-oncology, including its semi-automated, functionally-closed CAR-TXpress™ platform, which streamlines the manufacturing process for the emerging CAR-T immunotherapy market. For more information about ThermoGenesis, please visit: www.thermogenesis.com.
Paula Schwartz, Rx Communications