Fortress Biotech Announces First Patient Dosed in Multi-Center Phase 2 Study of Triplex for Control of CMV in Patients Undergoing Liver Transplantation

Helocyte, a majority-owned subsidiary of Fortress Biotech, is developing Triplex for the prevention and treatment of cytomegalovirus in multiple transplant indications, as well as HIV

Clinical trial funded by a NIAIDgrant to a multi-center university consortium

Study is evaluating whether Triplex is safe and effective in improving the outcomes of liver transplant recipients

MIAMI, May 14, 2024 (GLOBE NEWSWIRE) -- 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 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 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 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 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 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; 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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