Helocyte, Inc. (“Helocyte”), a subsidiary company of Fortress
Biotech, Inc. (“Fortress”) (Nasdaq: FBIO), today announced that it
executed an exclusive option agreement with City of Hope for patent
rights to use Triplex, a cytomegalovirus vaccine, in combination
with cytomegalovirus (“CMV”)-specific, Anti-Human Immunodeficiency
Virus (“HIV”) Chimeric Antigen Receptor (“CAR”) (collectively,
CMV/HIV-CAR) T Cells for the treatment of adults living with HIV.
Triplex was initially developed by City of Hope, one of the largest
cancer research and treatment organizations in the United States,
and exclusively licensed to Helocyte in 2015.
Additionally, the California Institute for
Regenerative Medicine (“CIRM”) recently awarded a $11.3 million
grant to City of Hope to fund a Phase 1 clinical trial. The Phase 1
trial is expected to enroll up to 12 healthy individuals living
with HIV-1 on stable anti-retroviral therapy (“ART”) who have
maintained viral suppression for at least 48 weeks. The study will
include three dose-escalating cohorts, along with an expansion
cohort. Other cohorts will include further vaccination of subjects
with Triplex to drive continued proliferation of the CAR. The trial
will initially enroll at City of Hope and University of California
at San Diego.
“City of Hope made a major advancement when our
transplant team helped a patient achieve remission for both HIV and
leukemia,” said John A. Zaia, M.D., the Aaron D. Miller and Edith
Miller Chair for Gene Therapy at City of Hope. “We are hoping to
evaluate a CAR T therapy for HIV in a Phase 1 clinical trial so
that one day more people with HIV might be able to achieve
long-term HIV remission.”
The clinical study will build upon preclinical
data published in Molecular Therapy - Methods & Clinical
Development which demonstrated the potential efficacy of combining
a CMV vaccine and CMV/HIV CAR T cell therapy to eradicate HIV. The
study illustrated the potential long-term durability of the
combination therapy, which induced therapeutic immune cells to take
hold in bone marrow. The objective of this approach is to target
and eradicate latent viral T cell reservoirs in immune cells to
achieve complete HIV clearance.
The current standard of care for the treatment
of HIV relies upon the use of ART, which is a non-curative,
life-long therapy. Optimal use of ART can effectively control HIV
replication; prevent the onset of Acquired Immuno-Deficiency
Syndrome (“AIDS”); prolong survival; and reduce the risk of
transmission to others. However, there are several challenges
associated with the use of ART, including: chronic treatment
adherence; drug resistance, particularly in those who do not fully
adhere to treatment; adverse events; and the persistence of immune
dysfunction during treatment. There remains a significant unmet
medical need to provide a functional cure for HIV and eliminate the
need for ART.
To date, the engineering of T cells to express
HIV-specific CAR T cells has failed to demonstrate meaningful
clinical benefits. This is believed to be due in part to the
effectiveness of highly active ART, which reduces HIV viral load to
a level that prevents the activation of CAR T cells. The use of
Triplex is believed to stimulate CMV/HIV-CAR T cells to proliferate
within patients’ bodies. In the aforementioned preclinical study,
CAR T cells were engineered to target and kill cells tagged with a
particular protein called gp120, which is expressed in all HIV
viruses, frequently with mutations that cause the virus to evade
natural immunity without affecting healthy cells.
Lindsay A. Rosenwald, M.D., Fortress’ Chairman
and Chief Executive Officer and Chairman of Helocyte, Inc., said,
“Our goal is to deliver transformational treatment options to
patients suffering from conditions associated with high unmet
medical need. We are pleased to expand our relationship with City
of Hope and remain encouraged by the potential to combine
Helocyte’s Triplex with a bispecific CMV/HIV-CAR T cell therapy
that can eradicate HIV without safety issues. We look forward to
building upon the data that continue to be generated relating to
the use of Triplex in the treatment of HIV, including an ongoing
Phase 2 clinical trial evaluating the safety and efficacy of
Triplex in eliciting a CMV-specific immune response and reducing
CMV replication in adults co-infected with HIV and CMV. Triplex is
the subject of multiple other ongoing and planned studies.”
The California Institute for Regenerative
Medicine was created in 2004 after 59% of California voters
approved California Proposition 71: the Research and Cures
Initiative, which allocated $3 billion to fund stem cell research
in California. For additional information regarding the
grant, please see
https://www.cirm.ca.gov/our-progress/awards/evaluation-safety-and-feasibility-cytomegalovirus-specific-anti-hiv-chimeric-antigen-receptor-cmv-hiv-car-t-cells-people-hiv/.
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 previous Phase 1 and Phase 2
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 1/2 trial for CMV control in
pediatric recipients of HCT (see NCT03354728); a Phase 2 trial for
reduction in viral load of Human Immunodeficiency Virus (“HIV”) in
adults co-infected with HIV and CMV (see NCT05099965); and a Phase
1 trial of Triplex in combination with a bi-specific CMV/CD-19
Chimeric Antigen Receptor T Cell for the treatment of Non-Hodgkin
Lymphoma (see NCT05432635). Triplex is also the subject of several
planned studies, including: a Phase 2 evaluation for CMV control in
recipients of liver transplant (see NCT06075745); a Phase 2 trial
for CMV control in recipients of kidney transplant; and 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).
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 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
9,000 unrelated and related bone marrow and cord blood transplants
performed in the United States in 2020. According to preliminary
data from the Organ Procurement and Transplantation Network, there
were over 40,000 organ transplants performed in the United States
in 2021, 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 can educate the body’s innate immune system to fight CMV.
For more information, please visit www.helocyte.com.
About Fortress BiotechFortress
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 eight marketed prescription
pharmaceutical products and over 25 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 plc, City of Hope, Fred Hutchinson Cancer
Center, St. Jude Children’s Research Hospital, Nationwide
Children’s Hospital and Sentynl Therapeutics, Inc. For more
information, visit www.fortressbiotech.com.
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Company Contact:Jaclyn JaffeFortress Biotech,
Inc.(781) 652-4500ir@fortressbiotech.com
Media Relations Contact:Tony Plohoros6
Degrees(908) 591-2839tplohoros@6degreespr.com
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