Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”), an innovative
biopharmaceutical company focused on acquiring and advancing assets
to enhance long-term value for shareholders through product
revenue, equity holdings and dividend and royalty revenue, and its
majority-owned subsidiary, Helocyte, Inc. (“Helocyte”), today
announced that the first patient was dosed in a multi-center,
placebo-controlled, randomized Phase 2 study of Triplex, a vaccine
for control of cytomegalovirus (“CMV”), in patients undergoing
liver transplantation. The trial is funded by a grant from the
National Institutes of Health’s National Institute of Allergy and
Infectious Diseases (“NIH/NIAID”) to University of Washington
Seattle. This grant has provided $9.0 million to date with an
estimated additional $12 million over the next four years in
support of the Phase 2 clinical trial. The trial will be conducted
in up to 20 nationally recognized transplant centers in the United
States. Triplex was initially developed by City of Hope, a
world-renowned cancer treatment and research organization, and
exclusively licensed to Helocyte.
Ajit Limaye, M.D., Professor of Medicine and
Director of the Solid Organ Transplant Infectious Disease Program
at the University of Washington and Principal Investigator of the
“CMV vaccine in Orthotopic Liver Transplant” (“COLT”, see
NCT06075745) trial, said, “The first dosing in this multi-center
Phase 2 clinical trial is a major milestone and the culmination of
years of effort to advance Triplex. There remains a significant
unmet medical need to develop new therapies that can reduce the
frequency and severity of CMV events in the organ transplant
setting, where CMV continues to present life-threatening
complications that directly impact patient outcomes and
survival.”
COLT is a multi-center, randomized,
placebo-controlled, double-blinded clinical trial in up to 416 CMV
seronegative prospective liver transplant recipients to determine
the safety and efficacy of two doses of Triplex, a Modified
Vaccinia Ankara-vectored CMV vaccine, administered to participants
anticipated to receive transplant within one to twelve months after
study enrollment. The primary objective of the trial is to assess
the effect of pre-transplant Triplex vaccination on the duration of
CMV antiviral therapy within the first 100 days post-transplant in
CMV seronegative liver transplant recipients whose liver donor is
CMV seropositive. Secondary endpoints relate to the development of
CMV disease by six months post-transplant as well as time to
onset.
Lindsay A. Rosenwald, M.D., Chairman, President,
and Chief Executive Officer of Fortress, said, “We are very pleased
with the advancement of Triplex in this Phase 2 clinical trial
evaluating CMV control in liver transplantation. If successful,
this trial could demonstrate the potential of Triplex to
significantly improve the outcomes, morbidity, and mortality of
liver transplant recipients. Our Triplex vaccine is currently the
subject of multiple ongoing and planned clinical trials for the
prevention and treatment of CMV in several transplant indications,
as well as in HIV. We look forward to providing updates as these
trials progress.”
About TriplexTriplex is a
universal (non-HLA-restricted) recombinant Modified Vaccinia Ankara
viral vector vaccine engineered to induce a robust and durable
virus-specific T cell response to three immuno-dominant proteins
[UL83 (pp65), UL123 (IE1), UL122 (IE2)] linked to CMV complications
in the post-transplant setting. In completed Phase 1 (see
NCT01941056) and Phase 2 (see NCT02506933, NCT03383055) studies,
Triplex was found to be safe, well-tolerated and highly
immunogenic. Triplex is currently the subject of multiple ongoing
clinical trials, including: a Phase 2 evaluation for CMV control in
recipients of liver transplant (see NCT06075745); a Phase 1/2 trial
for CMV control in pediatric recipients of HCT (see NCT03354728); a
Phase 2 trial for safety and immunogenicity in adults living with
HIV and CMV (see NCT05099965); a Phase 2 trial for CMV control in
recipients of stem cell transplant in which the stem cell donor is
vaccinated with Triplex (see NCT06059391) and a Phase 1 trial of
Triplex in combination with a bi-specific CMV/CD19 Chimeric Antigen
Receptor (CAR) T cell for the treatment of non-Hodgkin lymphoma
(see NCT05432635). Triplex is also the subject of several planned
studies, including a Phase 2 trial for CMV control in recipients of
kidney transplant. In 2023, Helocyte additionally entered into an
option agreement with City of Hope for exclusive worldwide rights
to a novel bispecific CMV/HIV CAR T cell therapy (optionally for
use in combination with Triplex), which is currently the subject of
a Phase 1 trial in adults living with HIV-1 (see NCT06252402).
About HelocyteHelocyte is a
clinical-stage company developing novel immunotherapies for the
prevention and treatment of cancer and infectious diseases,
including cytomegalovirus (“CMV”) and human immunodeficiency virus
(“HIV”). The Centers for Disease Control estimate that 50 to 80
percent of Americans are living 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 or
uneducated immune systems. Patients undergoing allogeneic stem cell
and solid organ transplantation are at particularly high risk of
experiencing complications associated with CMV. According to the
Center for International Blood and Marrow Transplant Research,
there were over 9,300 allogeneic (unrelated and related) bone
marrow and cord blood transplants performed in the United States in
2021. According to preliminary data from the Organ Procurement and
Transplantation Network, there were over 46,000 organ transplants
performed in the United States in 2023, comprised primarily of
kidney and liver transplant procedures. Helocyte’s Triplex vaccine
is engineered to induce a robust and durable virus-specific T cell
response to control CMV in transplant recipients. 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 may also educate the
body’s innate 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 and advancing assets to enhance
long-term value for shareholders through product revenue, equity
holdings and dividend and royalty revenue. The company has seven
marketed prescription pharmaceutical products and over 20 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 focused
on leveraging its significant biopharmaceutical industry expertise
and network 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, City of Hope, Fred
Hutchinson Cancer Center, Nationwide Children’s Hospital and
Sentynl. For more information, visit www.fortressbiotech.com.
Forward-Looking
StatementsStatements in this press release that are not
descriptions of historical facts are “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. The
words “anticipates,” “believes,” “can,” “continue,” “could,”
“estimates,” “expects,” “intends,” “may,” “might,” “plans,”
“potential,” “predicts,” “should,” or “will” or the negative of
these terms or other comparable terminology are generally intended
to identify forward-looking statements. These 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, financing and strategic agreements and relationships; our
need for substantial additional funds and uncertainties relating to
financings; our ability to identify, acquire, close and integrate
product candidates successfully and on a timely basis; our ability
to attract, integrate and retain key personnel; the early stage of
products under development; the results of research and development
activities; uncertainties relating to preclinical and clinical
testing; our ability to obtain regulatory approval for products
under development; our ability to successfully commercialize
products for which we receive regulatory approval; our ability to
secure and maintain third-party manufacturing, marketing and
distribution of our and our partner companies’ products and product
candidates; 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. The information contained herein is
intended to be reviewed in its totality, and any stipulations,
conditions or provisos that apply to a given piece of information
in one part of this press release should be read as applying
mutatis mutandis to every other instance of such information
appearing herein.
Company Contact:Jaclyn Jaffe Fortress Biotech,
Inc.(781) 652-4500ir@fortressbiotech.com
Media Relations Contact:Tony Plohoros6
Degrees(908) 591-2839tplohoros@6degreespr.com
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