Fortress Biotech Subsidiary Helocyte Announces Grant that Could Provide Over $20 Million from National Institute of Allergy and Infectious Diseases for Phase 2 Study of Triplex for Control of Cytomegalovirus in Patients Undergoing Liver Transplantation
August 11 2022 - 8:00AM
Fortress Biotech, Inc. (NASDAQ: FBIO) (“Fortress”), an innovative
biopharmaceutical company focused on efficiently acquiring,
developing and commercializing or monetizing promising therapeutic
products and product candidates, today announced that Triplex, a
cytomegalovirus (“CMV”) vaccine being developed by its subsidiary
Helocyte, Inc. (“Helocyte”), received a grant from the National
Institute of Allergy and Infectious Diseases of the National
Institutes of Health (“NIAID/NIH”) that could provide over $20
million in non-dilutive funding. This competitive award will fund a
multi-center, placebo-controlled, randomized Phase 2 study of
Triplex for control of CMV in patients undergoing liver
transplantation. The study will be conducted across up to 15
nationally recognized transplant centers in the United States.
Triplex was developed by City of Hope, one of the largest cancer
research and treatment organizations in the United States. Helocyte
secured an exclusive worldwide license to Triplex from City of Hope
in 2015.
Dr. Ajit Limaye, M.D., Professor of Medicine and
Director of the Solid-Organ Transplant Infectious Disease Program
at the University of Washington, and the principal investigator of
the CMV vaccine in Orthotopic
Liver Transplant
(“COLT”) trial, said, “If successful, the
COLT trial could demonstrate the potential of
Triplex to significantly improve the outcomes of liver transplant
recipients.”
Lindsay A. Rosenwald, M.D., Fortress’ Chairman
and Chief Executive Officer, said, “We are very excited that
Triplex, being progressed by our subsidiary Helocyte, is the
subject of this substantial grant from the NIAID/NIH, as it will
allow us to investigate its potential to control CMV in patients
undergoing liver transplant. CMV is a common opportunistic
infection in transplantation, directly impacting post-transplant
outcomes and patient mortality.i The COLT trial
will build upon the growing patient database of Triplex, which has
already been dosed safely in over 100 subjects and is the subject
of multiple other ongoing and planned studies.”
Research reported in this publication was
supported by the NIAID of the NIH under Award Number U01AI163090.
The content is solely the responsibility of the authors and does
not necessarily represent the official views of the NIH. Helocyte
will provide clinical materials to support the trial.
About TriplexTriplex is a
universal (non-HLA-restricted) recombinant Modified Vaccinia Ankara
viral vector vaccine engineered to induce a robust and durable
CMV-specific T cell response to three immuno-dominant proteins
[UL83 (pp65), UL123 (IE1), UL122 (IE2)] linked to CMV events in
those infected with the virus. In previous Phase 1 and Phase 2
studies, Triplex was found to be safe, well-tolerated and
immunogenic.
About HelocyteHelocyte is a
clinical-stage company developing novel immunotherapies for the
prevention and treatment of cancer and infectious disease (and in
particular, cytomegalovirus or “CMV”). The Centers for Disease
Control estimate that 50 to 80 percent of Americans are infected
with CMV by the age of 40. While the virus is asymptomatic in
healthy individuals, it can cause severe and life-threatening
disease in those with weakened immune systems. Patients undergoing
allogeneic stem cell and solid organ transplantation are at
particularly high risk of CMV-related complications. Helocyte’s
Triplex vaccine is engineered to induce a robust and durable
virus-specific T cell response to control CMV. Helocyte’s ConVax
vaccine is designed to induce a neutralizing antibody response to
prevent the transmission of CMV, particularly from mother to fetus,
the most common congenital infection. There is no approved therapy
for the prevention or treatment of congenital CMV. While current
antiviral therapies have reduced the rate of CMV disease-related
mortality in transplant recipients, such treatments have been
linked to increased toxicity, delayed immune reconstitution and
late onset of CMV. The Helocyte vaccines can educate the body’s
adaptive immune system to fight CMV. For more information, please
visit www.helocyte.com.
About Fortress Biotech Fortress
Biotech, Inc. (“Fortress”) is an innovative biopharmaceutical
company focused on acquiring, developing and commercializing
high-potential marketed and development-stage drugs and drug
candidates. The company has nine marketed prescription
pharmaceutical products and over 30 programs in development at
Fortress, at its majority-owned and majority-controlled partners
and subsidiaries and at partners and subsidiaries it founded and in
which it holds significant minority ownership positions. Such
product candidates span six large-market areas, including oncology,
rare diseases and gene therapy, which allow it to create value for
shareholders. Fortress advances its diversified pipeline through a
streamlined operating structure that fosters efficient drug
development. The Fortress model is driven by a world-class business
development team that is focused on leveraging its significant
biopharmaceutical industry expertise to further expand the
company’s portfolio of product opportunities. Fortress has
established partnerships with some of the world’s leading academic
research institutions and biopharmaceutical companies to maximize
each opportunity to its full potential, including AstraZeneca plc,
City of Hope, Fred Hutchinson Cancer Research Center, St. Jude
Children’s Research Hospital, Nationwide Children’s Hospital and
Sentynl Therapeutics, Inc. For more information, visit
www.fortressbiotech.com.
Forward-Looking StatementsThis
press release may contain “forward-looking statements” within the
meaning of Section 27A of the Securities Act of 1933 and Section
21E of the Securities Exchange Act of 1934, as amended. As used
below and throughout this press release, the words “we”, “us” and
“our” may refer to Fortress individually or together with one or
more partner companies, as dictated by context. Such statements
include, but are not limited to, any statements relating to our
growth strategy and product development programs, ability to
generate shareholder value, ability of our products to receive
necessary approvals, including FDA, ability of our products and
therapies to help patients and any other statements that are not
historical facts. Forward-looking statements are based on
management’s current expectations and are subject to risks and
uncertainties that could negatively affect our business, operating
results, financial condition and stock price. Factors that could
cause actual results to differ materially from those currently
anticipated include: risks relating to our growth strategy; our
ability to obtain, perform under and maintain financing and
strategic agreements and relationships; risks relating to the
results of research and development activities; uncertainties
relating to preclinical and clinical testing; risks relating to the
timing of starting and completing clinical trials, including
disruptions that may result from hostilities in Europe; our
dependence on third-party suppliers; risks relating to the COVID-19
outbreak and its potential impact on our employees’ and
consultants’ ability to complete work in a timely manner and on our
ability to obtain additional financing on favorable terms or at
all; our ability to attract, integrate and retain key personnel;
the early stage of products under development; our need for
substantial additional funds; government regulation; patent and
intellectual property matters; competition; as well as other risks
described in our SEC filings. We expressly disclaim any obligation
or undertaking to release publicly any updates or revisions to any
forward-looking statements contained herein to reflect any change
in our expectations or any changes in events, conditions or
circumstances on which any such statement is based, except as may
be required by law, and we claim the protection of the safe harbor
for forward-looking statements contained in the Private Securities
Litigation Reform Act of 1995.
Company Contacts:Jaclyn Jaffe and Bill
BegienFortress Biotech, Inc.(781)
652-4500ir@fortressbiotech.com
Media Relations Contact:Tony Plohoros6
Degrees(908) 591-2839tplohoros@6degreespr.com
——————————————
i Lizaola-Mayo BC, Rodriguez EA. Cytomegalovirus infection after
liver transplantation. World J Transplant. 2020 Jul
29;10(7):183-190. doi: 10.5500/wjt.v10.i7.183. PMID: 32844094;
PMCID: PMC7416364.
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