Orgenesis Enters into Collaboration Agreement with MIDA to Deploy OMPULs for Point-of-Care Research and Development of Promis...
March 18 2021 - 7:00AM
Orgenesis Inc. (NASDAQ: ORGS)
(“Orgenesis” or the “Company”), a global biotech company working to
unlock the full potential of cell and gene therapies,
announces that it has entered a collaboration with MIDA Biotech
B.V. (MIDA). Together, the companies will work to establish
point-of-care centers at hospitals and other medical institutions
across western Europe.
Orgenesis and MIDA plan to deploy Orgenesis
Mobile Processing Units and Labs (“OMPULs”) at leading hospitals
for the onsite development of promising cell and gene therapies and
immunotherapies from MIDA. The OMPULs are multi-purpose, mobile,
autonomous good manufacturing practice (GMP) facilities used to
develop, optimize, and manufacture cell and gene therapies at the
point of care. Via the collaboration, the teams will align with
various hospitals with projects focused on scaling the therapies
through to commercialization with regulatory compliance and
governmental approval standards as guiding principles.
In connection with the Agreement, Orgenesis and
MIDA entered into agreements to establish point-of-care centers and
deploy OMPULs within leading hospitals in Italy, Germany, Spain and
Benelux, as well as other activities including joint research,
development and validation activities related to the development of
cell and gene therapies.
“These agreements mark a major milestone towards
the commercial launch of our OMPULs across Europe, and we believe
provide further validation of our platform, as each of the
respective hospitals conducted extensive due diligence and
verification around our technology and capabilities prior to
signing the agreements,” stated Vered Caplan, CEO of Orgenesis. “We
see MIDA as an ideal partner based on their established
relationships with the leading medical centers across western
Europe and their promising science. Our teams are aligned in the
desire to help lower costs and eliminate the logistical nightmares
of building a centralized production facility or cleanrooms in the
hospitals, which can stand in the way of getting a therapy to
market effectively.”
The additional sites will significantly expand
the Orgenesis POCare Network capacity, which already includes
active development centers in the United States, Belgium, Israel,
and South Korea, as well as a growing number of joint venture
agreements with regional partners and ongoing therapeutic
development programs.
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 at the point of care. The Orgenesis
POCare 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.
Notice Regarding Forward-Looking
StatementsThis 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 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 reliance on, and our ability to
grow, our point-of-care cell therapy platform, our ability to
achieve and maintain overall profitability, our ability to manage
our research and development programs that are based on novel
technologies, our ability to control key elements relating to the
development and commercialization of therapeutic product candidates
with third parties, the timing of completion of clinical trials and
studies, the availability of additional data, outcomes of clinical
trials of our product candidates, the potential uses and benefits
of our product candidates, our ability to manage potential
disruptions as a result of the coronavirus outbreak, the
sufficiency of working capital to realize our business plans, the
development of our POCare strategy, our trans differentiation
technology as therapeutic treatment for diabetes, the technology
behind our in-licensed ATMPs not functioning as expected, our
ability to further our CGT development projects, either directly or
through our JV partner agreements, and to fulfill our obligations
under such agreements, our license agreements with other
institutions, our ability to retain key employees, our competitors
developing better or cheaper alternatives to our products 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, 2020, 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.
Contact for Orgenesis:Crescendo
Communications, LLCTel: 212-671-1021Orgs@crescendo-ir.com
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