RANCHO CORDOVA, Calif.,
Nov. 13, 2018 /PRNewswire/ -- Cesca
Therapeutics Inc. (NASDAQ: KOOL), a market leader in automated cell
processing and point-of-care, autologous cell-based therapies,
today announced that its device subsidiary, ThermoGenesis® Corp.,
has filed a Device Master File (MAF) with the U.S. Food and Drug
Administration (FDA) for its X-LAB® automated cell processing
device.
The X-LAB device isolates and purifies target cell fractions
from blood, bone marrow or leukapheresis in a "closed system," with
precision and high efficiency. It also serves as an efficient and
ficoll-free platform to isolate human T cells for chimeric antigen
receptor-T (CAR-T) cell therapeutics. This MAF contains all the
relevant information that the FDA will need to allow principal
investigators to include Cesca's systems in their investigational
new drug applications, or INDs, while also protecting Cesca's
intellectual property.
Philip Coelho, ThermoGenesis's
Chief Technology Officer, explained, "An MAF is the device
equivalent of a Drug Master File, or DMF. As such, the filing
represents a key milestone for Cesca, as it will help support the
use of X-LAB in the clinical development of CAR-T therapeutics as
well as for premarket submissions in which reagents and devices are
used in the manufacturing and processing of the final drug. X-LAB's
MAF filing advances ThermoGenesis' commitment to support clinical
development of the ever-growing cell-based therapeutics market,
including the most recent advances in the immuno-oncology
field."
Next steps
Management noted that it intends to add
Thermogenesis' X-WASH™ and X-BACS™ automated cell processing
systems, which share essentially all the proprietary construction
features as the X-LAB, to this MAF in 2019.
- The X-WASH is a semi-automated, functionally-closed system
that washes and reformulates cells of interest by removing
(washing) contaminants, such as cryoprotectants or spent growth
media, in a precise and rapid process, while yielding cell
recovery, viability and purity of more than 90% of the starting
cell population.
- The X-BACS purifies and/or activates cells of interest from
blood, bone marrow or leukapheresis in a semi-automated "closed
system" process with precision and speed.
X-BACS utilizes gas-filled microbubbles linked to antibodies to
bind to specific antigens on target cells, causing them to separate
from non-target cells by "buoyance," allowing them to be harvested
during a simple centrifugation process. This results in cell
recovery, viability and purity of great than 90%.
The X-LAB, X-WASH and X-BACS automated cell processing devices
constitute Cesca's CAR-TXpress™ platform, a proprietary, high
efficiency, low cost, semi-automated manufacturing solution
introduced in 2018 to address the time consuming and cost related
challenges faced by today's CAR-T developers.
About Cesca Therapeutics
Inc.
Cesca
Therapeutics Inc. develops, commercializes and markets a range of
automated technologies for CAR-T and other cell-based therapies.
For more information, please visit: www.cescatherapeutics.com.
Company Contact:
Cesca Therapeutics Inc.
Wendy Samford
916-858-5191
ir@cescatherapeutics.com
Investor Contact:
Rx Communications
Paula Schwartz
917-322-2216
pschwartz@rxir.com
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SOURCE Cesca Therapeutics