Orgenesis Mobile Processing Units and Labs (OMPULs) to be Used for Point-of-Care Production and Commercialization of Cell and...
March 08 2021 - 7:30AM
Orgenesis Inc. (NASDAQ: ORGS)
(“Orgenesis” or the “Company”), a global biotech company working to
unlock the full potential of cell and gene therapies (CGTs),
Dong-a University Hospital in South Korea, and Cure Therapeutics,
Inc. (“Cure Therapeutics”), a developer of immuno-oncology and cell
and gene therapies to target cancer and infectious diseases, today
announced the signing of a collaboration agreement. The teams will
align to utilize Orgenesis Mobile Processing Units and Labs
(“OMPULs”) for point-of-care development of cell and gene therapies
and immunotherapies that meet regulatory and governmental approval
standards to scale through to commercialization.
OMPULs are multi-purpose mobile autonomous good
manufacturing practice (GMP) facilities intended to develop,
optimize, and manufacture cell and gene therapies at the point of
use. Process development and validation for the therapies will be
completed at the Dong-a University leveraging the technologies in
the Orgenesis POCare Platform to automate the processes for quality
and reproducibility.
This latest collaboration follows a recent joint
venture agreement between Orgenesis and Cure Therapeutics, whereby
the parties agreed to collaborate in developing and commercializing
Cure Therapeutics’ pipeline on a global basis, as well as
developing, commercializing, and supplying Orgenesis’ therapeutic
pipeline in South Korea and Japan.
“We are excited to expand our collaboration with
Orgenesis by utilizing their OMPULs onsite via a partnership with
Dong-A University. The OMPULs will be placed onsite with the goal
of accelerating development and commercialization of our
immunotherapies targeting cancers and infectious disease, while
ensuring the highest quality control standards and reducing overall
manufacturing costs,” said David Kim, CEO of Cure Therapeutics.
“We are pleased to partner with Cure
Therapeutics and Dong-a University Hospital to accelerate the
development and market launch of breakthrough cell and gene
therapies utilizing our proprietary OMPUL system,” said Vered
Caplan, CEO of Orgenesis. “This latest agreement is another step in
our efforts to rollout OMPULs throughout our network of leading
healthcare facilities and partner companies across the U.S.,
Europe, Asia, and the Middle East.”
About OrgenesisOrgenesis is a
global biotech company working to unlock the full potential of
cell and gene therapies (CGTs) in an affordable and accessible
format. The Orgenesis Point of Care Platform is comprised of three
enabling components: a pipeline of licensed POCare
Therapeutics that are processed and produced in
closed, automated POCare
Technology systems across a
collaborative POCare Network.
Orgenesis identifies promising new therapies and leverages its
POCare Platform to provide a rapid, globally harmonized pathway for
these therapies to reach and treat large numbers of patients at
lowered costs through efficient, scalable, and decentralized
production. The POCare Network brings together patients, doctors,
industry partners, research institutes and hospitals worldwide to
achieve harmonized, regulated clinical development and production
of the therapies. Learn more about the work Orgenesis is doing
at www.orgenesis.com.
About Cure TherapeuticsCure
Therapeutics is a Korea-based cell and gene and immune-oncology
therapy developer to meet unmet medical needs leveraging a data and
evidence driven drug development. The therapy portfolio features
owned and in-licensed novel platform technology based therapies to
provide cure for hard to treat hematological and solid cancers,
life-threatening genetic disorders, and chronic liver diseases
threatening quality of life. Deep scientific, technological,
technical, and regulatory knowledge are melted into a decentralized
structure to best deliver cutting edge new therapies to the urgent
medical need diseases.
Notice Regarding Forward-Looking
Statements This press release contains forward-looking
statements which are made pursuant to the safe harbor provisions of
Section 27A of the Securities Act of 1933, as amended, and Section
21E of the Securities and Exchange Act of 1934, as amended. These
forward-looking statements involve substantial uncertainties and
risks and are based upon our current expectations, estimates and
projections and reflect our beliefs and assumptions based upon
information available to us at the date of this press release. We
caution readers that forward-looking statements are predictions
based on our current expectations about future events. These
forward-looking statements are not guarantees of future performance
and are subject to risks, uncertainties and assumptions that are
difficult to predict. Our actual results, performance or
achievements could differ materially from those expressed or
implied by the forward-looking statements as a result of a number
of factors, including, but not limited to, our ability to further
develop ranpirnase; our reliance on, and our ability to grow, our
point-of-care cell therapy platform; our ability to develop
cell-based and antiviral technologies; our ability to effectively
use the net proceeds from the sale of Masthercell; our ability to
achieve and maintain overall profitability; the development of our
POCare strategy; the sufficiency of working capital to realize our
business plans; our partners’ ability to develop therapies based on
our point-of-care cell therapy platform; technology not functioning
as expected; our ability to retain key employees; our ability to
satisfy the rigorous regulatory requirements for new procedures and
therapies; our competitors developing better or cheaper
alternatives; the impact of COVID-19 on our operations and the
risks and uncertainties discussed under the heading "RISK FACTORS"
in Item 1A of our Annual Report on Form 10-K for the fiscal year
ended December 31, 2019, and in our other filings with the
Securities and Exchange Commission. We undertake no obligation to
revise or update any forward-looking statement for any reason.
IR contact for Orgenesis:Crescendo
Communications, LLCTel: 212-671-1021Orgs@crescendo-ir.com
Communications ontact for
OrgenesisImage Box CommunicationsNeil Hunter / Michelle
BoxallTel +44 (0)20 8943
4685neil@ibcomms.agency / michelle@ibcomms.agency
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