A Phase 2 trial evaluates Triplex vaccine's effectiveness in reducing CMV reactivation for HSCT recipients from vaccinated donors.
Quiver AI Summary
Fortress Biotech, Inc. and its subsidiary Helocyte, Inc. have initiated a Phase 2 clinical trial to assess the efficacy of the Triplex vaccine, designed to prevent cytomegalovirus (CMV) reactivation in recipients of hematopoietic stem cell transplants (HSCT) from vaccinated donors. This groundbreaking study is the first randomized, controlled trial focused on the vaccine's effectiveness in this context. Encouraging results from earlier pilot studies suggest that vaccinating stem cell donors with Triplex may convey protective CMV-specific T cell immunity to transplant recipients, potentially minimizing the incidence of CMV-related complications, which are common and severe among these patients. The trial is funded by a grant from the National Cancer Institute and is being conducted at multiple renowned transplant centers across the U.S. The research aims to establish whether Triplex can safely and effectively reduce CMV events in HSCT recipients, potentially reducing reliance on antiviral medications that can impede immune recovery.
Potential Positives
- The initiation of a multicenter, placebo-controlled Phase 2 clinical trial for Triplex represents a significant advancement in exploring a novel treatment approach to reduce CMV events in HSCT recipients.
- The trial is funded by a grant from the National Cancer Institute, highlighting institutional support and validation of the study's importance.
- Promising pilot study results suggest that vaccinating donors with Triplex may improve outcomes for HSCT patients by promoting early and robust CMV-specific immunity.
- This innovative vaccination strategy could potentially reduce the reliance on antiviral medications, optimizing patient recovery and long-term health outcomes.
Potential Negatives
- The press release relies heavily on future-oriented language, indicating that the results and effectiveness of the Triplex vaccine are still uncertain and contingent on ongoing trials, which may affect investor confidence.
- The involvement of a paid consultant with potential financial interest may raise conflicts of interest concerns regarding the trial's integrity and transparency.
- The press release highlights numerous ongoing trials, which may signal that Triplex is still in a developmental stage and not yet commercially viable, raising questions about the company’s immediate financial prospects.
FAQ
What is the focus of the Triplex clinical trial?
The trial evaluates the effectiveness of the Triplex CMV vaccine administered to stem cell donors in reducing CMV events in HSCT recipients.
Who funded the Phase 2 clinical trial for Triplex?
The trial is funded by a grant from the National Cancer Institute (NCI).
What is cytomegalovirus (CMV) and its relevance to HSCT?
CMV is a common virus that poses significant risks to recovery in patients undergoing hematopoietic stem cell transplantation (HSCT).
How does Triplex work in relation to stem cell transplant recipients?
Triplex induces CMV-specific immunity in donors, which is then transferred to recipients, potentially reducing CMV infection risks.
What prior studies have been conducted on Triplex?
Triplex has undergone Phase 1 trials showing safety and immunological response, with results presented at the 2023 Tandem Meetings.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
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Full Release
Study is the first randomized, controlled trial examining a vaccine’s effectiveness in controlling CMV in recipients of HSCT from vaccinated donors
Encouraging pilot study results demonstrated the benefit of vaccinating donors with Triplex to convey protective CMV-specific T cell immunity to allogeneic HSCT recipients at risk for CMV reactivation
MIAMI, Jan. 27, 2025 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”), and its majority-owned subsidiary, Helocyte, Inc. (“Helocyte”), today announced that the first patient was dosed in a multicenter, placebo-controlled and randomized Phase 2 clinical trial to evaluate Triplex, a cytomegalovirus (“CMV”) vaccine, when administered to human leukocyte antigen (“HLA”) matched related stem cell donors to reduce CMV events in patients undergoing hematopoietic stem cell transplantation (“HSCT”).
The
Phase 2 clinical trial
is funded by a grant from the National Cancer Institute (“NCI”). Triplex is anticipated to induce a CMV-specific immune response in the donor’s body who then conveys that virus-specific immunity to the intended recipient of the stem cell transplant through the concept of adoptive immunity. Vaccination of donors with Triplex prior to stem cell harvest and transplant is believed to introduce virus-specific immunity sooner, and in turn, reduce CMV events in patients undergoing stem cell transplantation. The objective of the trial is to determine whether Triplex is safe and effective in reducing CMV events in recipients of HSCT from vaccinated donors.
CMV reactivation is one of the most common and life-threatening complications following allogeneic HSCT. The virus reactivates in an estimated 60-70% of CMV-seropositive recipients of HSCT with primary CMV infection occurring in 20-30% of CMV-seronegative recipients of HSCT from CMV-seropositive donors.
“CMV frequently affects patients undergoing transplants, posing significant risks to their recovery and survival. In this Phase 2 clinical trial, we are testing a new treatment approach, offering promise for better CMV management in HSCT recipients. This approach transfers CMV immunity from donors to transplant recipients, thereby potentially reducing the need for antiviral medications that can delay reconstitution of virus-specific immunity,” said Don J. Diamond, Ph.D., Professor, Hematology & Hematopoietic Cell Transplantation, City of Hope’s Los Angeles campus and the grants’ principal investigator. Dr. Diamond and his team developed Triplex in cooperation with the NCI “NExT” program. Dr. Diamond also serves as a paid consultant to Helocyte and holds equity in the company.
The initial Phase 2 clinical trial (
NCT03560752
) builds upon Phase 1 pilot trial data that evaluated the potential safety and immunological response of Triplex
presented
at the 2023 Tandem Meetings: Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR and
published
in the
American Journal of Hematology
. The study is being conducted across three nationally recognized transplant centers in the United States (City of Hope in Duarte, California; Brigham & Women’s Hospital and the Dana-Farber Cancer Institute in Boston; and Northside Medical Center in suburban Atlanta). A second trial, also funded by the NCI award, will formally test the same concept and will include higher risk transplant recipients, who are only partially HLA-matched to their donors. A preliminary study of that transplant population was also recently completed (
NCT04060277
)
.
Lindsay A. Rosenwald, M.D., Fortress’ Chairman and Chief Executive Officer and Executive Chairman of Helocyte, Inc., said, “This new vaccination paradigm carries the advantage of potentially conveying earlier and more robust CMV immunity to a stem cell transplant recipient, versus vaccinating a HSCT recipient after engraftment has occurred around four weeks following transplant. We are very pleased that this trial is underway and believe that this novel treatment approach could play a significant role in the prevention and treatment of CMV in the future. Triplex is the subject of multiple ongoing, planned clinical trials in the transplant setting and for HIV-1.”
Triplex was originally developed by City of Hope, one of the largest and most advanced cancer research and treatment organizations in the United States, and exclusively licensed to Helocyte.
About Triplex
Triplex 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 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 HSCT (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 transplants. 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 Helocyte
Helocyte 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 approximately 9,000 allogeneic (unrelated and related) bone marrow and cord blood transplants performed in the United States in 2023. 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 Statements
Statements 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 or receive royalties or other distributions from third parties; 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) 652-4500
ir@fortressbiotech.com
Media Relations Contact:
Tony Plohoros
6 Degrees
(908) 591-2839
tplohoros@6degreespr.com
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