Orgenesis Selects Therapeutics, Inc. as CRO to Support Development and Planned Phase 2 Clinical Study of Ranpirnase for the T...
August 20 2020 - 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), has entered into
a Services Agreement with Therapeutics, Inc., a premier U.S.
Clinical Research Organization (CRO) dedicated to dermatology
product development. Under the agreement, the parties will
collaborate for the development of Orgenesis’ Ranpirnase topical
drug formulation for the treatment of external genital warts (EGW)
caused by human papilloma virus (HPV) in advance of an
investigational new drug (IND) submission. Once those studies are
underway, the teams will investigate enhanced intracellular
targeting of Ranpirnase using Orgenesis’ Bioxomes™ technology.
Ranpirnase is a member of the pancreatic ribonuclease
(RNase A) enzyme family and has demonstrated a broad spectrum of
antiviral applications. The parties plan to seek FDA guidance for a
Phase 2 clinical study of topical Ranpirnase for EGW in early 2021.
The study will build on existing safety and efficacy data from a
placebo-controlled phase 1/2 clinical study with 75 subjects with
EGW. In that study, topical Ranpirnase applied twice daily for 8
weeks showed a significant reduction in the lesion area compared to
placebo and was shown to be generally safe and well-tolerated
without any additional adverse effects versus placebo.
“EGW is one of the most common sexually transmitted diseases
with approximately 400,000 new cases annually in the US alone. In a
phase 1/2 clinical study, topical Ranpirnase was well tolerated and
demonstrated signals of efficacy against HPV via a unique mechanism
of action (MOA) that appears to eradicate the virus and modulate
the immune system. With this work underway, we look forward to
commencing our Phase 2 study, as well as exploring other
indications for Ranpirnase across our Point of Care (POCare)
Platform. Ranpirnase has already demonstrated preclinical activity
against a variety of viruses such as cytomegalovirus (CMV),
influenza, HIV, and SARS,” said Vered Caplan, CEO at Orgenesis.
“We are excited to partner with Orgenesis for this important
work on the EGW application of Ranpirnase, and conduct further
exploratory work using Bioxomes for enhanced payload delivery into
cells,” commented Daniel J. Piacquadio, MD, President & CEO of
Therapeutics, Inc. “As a CRO, our business is built on supporting
customer goals with thoughtfully integrated solutions that help to
bring viable drug candidates through each development phase and
into commercialization.”
Bioxomes are synthetic exosomes/extracellular vesicles that have
demonstrated the ability to fuse with cell membranes and deliver an
intracellular cargo in a similar manner to natural exosomes without
the risks and difficulties of administering entire cells to
patients. Orgenesis has developed a breakthrough manufacturing
process for Bioxomes with distinct advantages over natural
exosomes, which is designed to optimize scale up and reduce costs,
while generating consistent and repeatable results, including
uniform particles sizes.
About TherapeuticsTherapeutics, Inc. The
Dermatology CRO, designs, creates, and executes turn-key
development programs for regulatory registration of topical, oral
and injectable dermatology drugs, biologics and devices. The
company distinguishes itself as a full service provider from
concept to commercialization; providing program management,
non-clinical, clinical, regulatory affairs and CMC capabilities and
support for its clients. Therapeutics’ full service perspective
provides their clients a “development advantage” independent of the
engagement; be it a focused Phase 1-4 clinical trial program or a
full service engagement starting with an API. Therapeutics, Inc. is
committed to moving products from concept to bench top to
proof-of-concept followed by all aspects of development to achieve
regulatory review and approval. Additional information is available
at: http://www.therapeuticsinc.com/
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 (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 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
development of our POCare strategy, the sufficiency of working
capital to realize our business plans; our ability to retain key
employees; our ability to satisfy the rigorous regulatory
requirements for new procedures; 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
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