RANCHO CORDOVA, Calif.,
Sept. 14, 2021 /PRNewswire/ --
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
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
SOURCE ThermoGenesis Holdings, Inc.