RANCHO CORDOVA, Calif.,
Oct. 22, 2019 /PRNewswire/ -- Cesca
Therapeutics Inc. (Nasdaq: KOOL), a market leader in automated
cell processing and autologous cell therapies for regenerative
medicine, and ThermoGenesis, its wholly owned device subsidiary,
today announced that the company has entered into a definitive
joint venture agreement with HealthBanks Biotech (USA) Inc., one of the world's leading stem
cell bank networks, to commercialize its proprietary cell
processing platform, CAR-TXpress™, for use in immune cell banking
as well as for cell-based contract development and
manufacturing services (CMO/CDMO). The joint venture will be named
ImmuneCyte Life Sciences Inc. ("ImmuneCyte") and is expected to
officially launch during the fourth quarter of 2019.
Under terms of the agreement, ImmuneCyte will initially be owned
80% by HealthBanks Biotech and 20% by Cesca. Cesca will contribute
to ImmuneCyte exclusive rights to use ThermoGenesis' proprietary
cell processing technology for the immune cell banking business and
non-exclusive rights for other cell-based contract development and
manufacturing services. Cesca will also contribute its clinical
development assets to the joint venture, as the company has decided
to discontinue these activities in order to focus exclusively on
the device business.
Once operational, ImmuneCyte will be among the first immune cell
banks in the U.S. to provide clients with the opportunity to bank
their own healthy immune cells for future use as a resource for
cell-based immunotherapies, such as dendritic cell and chimeric
antigen receptor (CAR) T-cell therapies. ImmuneCyte will utilize
ThermoGenesis' proprietary CAR-TXpress platform which allows for
the isolation of different components from 200 ml of blood in cGMP
compliant, closed system. Given that the CAR-TXpress platform can
increase cell processing efficiency by up to 16-fold as compared
with the traditional, labor-intensive ficoll gradient
centrifugation-based cell processing method, ImmuneCyte is expected
to offer customers an unparalleled competitive advantage, including
an ability to store their own immune cells at a tangibly lower
cost.
"The ImmuneCyte joint venture will be paramount to the execution
of our strategy to become a preferred cell processing and
manufacturing solution provider in the cell and gene therapy
field," said Dr. Chris Xu, Chairman
and Chief Executive Officer of Cesca Therapeutics. "CAR-T
therapeutic research is advancing rapidly. Partnering with
HealthBanks Biotech, one of the foremost stem cell bank networks,
with an experienced team and an established global infrastructure,
will offer customers the ability to preserve younger, healthier and
uncontaminated immune cells for potential future use. By applying
our proprietary CAR-TXpress technology to immune cell banking and
other CDMO cellular manufacturing services, we will allow for the
manufacture and production of more effective and less costly
immunotherapies."
In 2017, the U.S. Food and Drug Administration (FDA) approved
two CAR-T cell therapies, under breakthrough designation, for the
treatment of advanced B cell leukemia and lymphomas. Both use
autologous (a patient's own) immune T cells to fight cancer and
have reported an over 80% response rate in the "no-option" patient
group, for those who have failed both chemo- and radiation
therapies. This has helped to spur massive global interest for the
development of additional CAR-T immunotherapies1. By the
end of September 2019, there were
over 800 CAR-T cell clinical trials registered on the
www.clinicaltrials.gov website, targeting a wide variety of blood
cancers and solid tumors.
Although highly effective, several recent studies on the
eligibility of patients to enroll in CAR-T clinical trials showed
that as many as 30-50% of cancer patients may not be eligible to
enroll or to get sufficient CAR-T cells manufactured for the
therapy. Reasons may include: (1) the function of the immune system
declines with age and can be negatively affected by other medical
conditions, (2) most standard cancer therapies, such as
chemotherapy and radiation, destroy the immune system, and (3) in
many cases of advanced cancer, cancer cells will enter circulation,
invade and interfere with the body's natural production of immune
cells. According to a recently reported JULIE trial, a CAR-T
clinical trial in relapsed or refractory diffuse large B-cell
lymphoma (DLBCL), one-third of the 238 screened patients failed to
be enrolled, and more than half of the 238 failed to receive the
intended CAR-T therapy2,3. ImmuneCyte will offer
customers the ability to preserve younger, healthier and
uncontaminated immune cells, for potential future use in advanced
cancer immunotherapy.
About HealthBanks Biotech (USA) Inc.
HealthBanks Biotech,
headquartered in Irvine, CA, is
one of the leading stem cell bank networks in the world and offers
services globally through its sister companies located in
the United States and other
regions and nations. HealthBanks Biotech is accredited by the FDA,
AABB, and CAP. The HealthBanks Biotech group was originally founded
in 2001 with a vision that stem cells and cell and gene therapies
could transform modern medicine. HealthBanks Biotech is a
subsidiary of Boyalife Group, Inc. (USA), an affiliate of Boyalife (Hong Kong) Limited, the largest stockholder of
Cesca. For more information about HealthBanks Biotech (USA) Inc.,
please visit: www.healthbanks.us.
About ImmuneCyte Life Sciences Inc.
ImmuneCyte will
provide clients with the opportunity to bank their own immune cells
when the cells are "healthy and unaffected" as a future resource
for cellular immunotherapies, such as CAR-T. ImmuneCyte utilizes a
proprietary CAR-TXpress™ platform, a GMP compliant close-system
capable of automated separating and cryopreserving different
components from blood. For more information about ImmuneCyte
Life Sciences Inc.,
please visit: www.immunecyte.com.
About Cesca Therapeutics Inc.
Cesca
Therapeutics develops, commercializes and markets a range of
automated technologies for CAR-T and other cell-based therapies.
Its device division, ThermoGenesis develops, commercializes and
markets a full suite of solutions for automated clinical
biobanking, point-of-care applications, and automation for
immuno-oncology. The Company has developed a semi- automated,
functionally closed CAR-TXpress™ platform to streamline the
manufacturing process for the emerging CAR-T immunotherapy market.
For more information about Cesca and ThermoGenesis,
please visit: www.cescatherapeutics.com.
Company Contact:
Wendy
Samford
916-858-5191
ir@thermogenesis.com
Investor Contact:
Paula Schwartz, Rx
Communications
917-322-2216
pschwartz@rxir.com
References:
1. Facts About Chimeric Antigen Receptor (CAR) T-Cell Therapy,
Leukemia and Lymphoma Society (2018). https://www.lls.org
2. Updated Analysis of JULIET Trial: Tisagenlecleucel in
Relapsed or Refractory DLBCL (2018).
3. Eligibility Criteria for CAR-T Trials and Survival Rates in
Chemorefractory DLBCL. Journal of Clinical Pathways (2018).
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SOURCE Cesca Therapeutics Inc.