Orgenesis Enters Second Phase of Collaboration with Hospital Infantil Universitario Niño Jesús in Madrid with Exclusive Lic...
March 11 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, today
announces that it has entered the planned second phase of a
collaboration with Hospital Infantil Universitario Niño Jesús in
Madrid, Spain. The collaboration is focused on an exclusive license
agreement to further develop and commercialize the hospital’s
proprietary Celyvir therapy for the treatment of solid tumors.
The agreement follows an initial collaboration
between FIB Hospital Infantil Universitario Niño Jesús and
Orgenesis to establish a point-of-care center leveraging the
Orgenesis POCare Platform, announced in May 2020. The POCare
Platform has been designed by Orgenesis to enable hospitals and
healthcare facilities globally to develop, optimize and manufacture
cell and gene therapies throughout a POC Network of global
healthcare facilities.
“The Phase 1 trial data from children and adults
with solid tumors indicates that Celyvir has a favorable safety
profile and promotes disease stabilization,” said Dr. Manuel
Ramírez MD, PhD, Head of the Pediatric Advanced Therapies Unit at
the Hospital. “We have partnered with Orgenesis to rapidly develop
Celyvir to its full potential. Both of our teams are dedicated to
bringing groundbreaking cell and gene therapies, potentially
starting with Celyvir, to patients worldwide through the Orgenesis
POCare Network.”
The Celyvir therapy takes a new approach to the
treatment of solid metastatic tumors. An oncolytic virotherapy is
administered using autologous Mesenchymal Stem Cells (MSCs)
obtained from bone marrow to improve the oncolytic virus potency.
Oncolytic viruses are genetically modified viruses that induce
targeted cancer-killing mechanisms. Traditionally, the intravenous
administration of an unshielded oncolytic virus elicits an
antiviral response. This leads to virus clearance without the
desired oncolytic action. The bone marrow derived Celyvir therapy
shields the virus using MSCs with reduced capacity to inhibit viral
replication and viral load. These proprietary MSCs carry an
oncolytic adenovirus (ICOVIR-5) that is designed to enhance
oncolytic virus potency, to boost the acquired immune response and
intensify the overall anti-tumor effect. This program represents a
novel approach for the treatment of solid metastatic tumors, either
as a monotherapy or in a combination with additional
immunotherapies.
“Orgenesis has seen the potential of the Celyvir
therapy to transform the treatment of solid metastatic tumors. This
offers patients a lower toxicity profile and simpler treatment
protocol. Aiding hospitals such as the Hospital Infantil
Universitario Niño Jesús with developing these kind of therapies
themselves is the exact reason why Orgenesis developed its POCare
Platform,” said Vered Caplan, CEO of Orgenesis. “Now that the
POCare Platform has demonstrated direct value to the Hospital
Infantil Universitario Niño Jesús, we have decided to enter the
second phase of the collaboration, and carry forward a long-term
commitment to commercializing other promising immune-oncology
therapies developed by the hospital.”
About Hospital Infantil Universitario
Niño JesúsNiño Jesús University Children's Hospital,
birthplace of pediatrics in Spain, has been a national benchmark in
pediatric healthcare since it was founded in 1877. It is leading
the field of ATMPs for childhood and adolescent diseases in Spain,
including cancer, transplantation, neuropediatrics and orthopedics,
through an ambitious program of research, development, and
manufacturing. It has the only authorized GMP facility for both
gene and cell therapies in a medical center in Spain.
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
effectively use the net proceeds from the sale of Masthercell, our
ability to achieve and maintain overall profitability, the
sufficiency of working capital to realize our business plans, the
development of our POCare strategy, our transdifferentiation
technology as therapeutic treatment for diabetes which could, if
successful, be a cure for Type 1 Diabetes, the technology behind
our in-licensed ATMPs not functioning as expected, 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, 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.
Contact for Orgenesis:Crescendo
Communications, LLCTel: 212-671-1021Orgs@crescendo-ir.com
Orgenesis (NASDAQ:ORGS)
Historical Stock Chart
From Aug 2024 to Sep 2024
Orgenesis (NASDAQ:ORGS)
Historical Stock Chart
From Sep 2023 to Sep 2024