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Press Release

Data from Phase 1 Trial of Triplex Vaccine for Control of Cytomegalovirus Published in Blood


Posted on: 28 Oct 16

Triplex Demonstrated Favorable Safety and Immunogenicity at Multiple Dose Levels in Healthy Volunteers 

Data Published in Blood Support Ongoing Phase 2 Trial of Triplex in Allogeneic Hematopoietic Stem Cell Transplant Recipients

DUARTE, Calif., and NEW YORK, Oct. 28, 2016 (GLOBE NEWSWIRE) -- City of Hope, a world-renowned independent research and cancer treatment center, and Helocyte, Inc., a majority-owned subsidiary of Fortress Biotech, Inc. (NASDAQ:FBIO), announced today that data from the Phase 1 trial of Helocyte’s Triplex vaccine were published online this month in Blood, the journal of the American Society of Hematology. The vaccine is initially being developed for control of cytomegalovirus (CMV) in allogeneic hematopoietic stem cell transplant (HSCT) and solid organ transplant (SOT) recipients. In the Phase 1 study, Triplex was found to be safe, well-tolerated and highly immunogenic when administered to healthy volunteers at multiple dose levels. These data supported the initiation of an ongoing Phase 2 trial evaluating Triplex in patients undergoing allogeneic HSCT.

In the Phase 1 trial, City of Hope researchers studied the response to the vaccine in 24 healthy volunteers. They found that Triplex generated robust and durable virus-specific immunity in those previously infected with CMV (addressing patients at greatest risk of viral complications following allogeneic HSCT) as well as in those with no prior CMV infection (addressing patients at greatest risk of viral complications following SOT).

CMV can impede the recovery of patients undergoing HSCT for the treatment for certain blood or bone marrow cancers. The virus can be transmitted to seronegative transplant recipients through infected donor grafts, or reactivated in seropositive transplant recipients (particularly those with low baseline immunity) as a result of their immuno-suppressed condition. In either instance, CMV can cause severe and life-threatening complications, including pneumonia, gastroenteritis and retinitis. Triplex has the potential to benefit patients in numerous clinical settings since the immune response generated by most individuals to CMV is far greater than the response associated with any other virus or condition.

“After years of work, it is very gratifying that we are making advancements in helping people worldwide achieve better health outcomes after a transplant procedure,” said Don J. Diamond, Ph.D., Chair of the Department of Experimental Therapeutics at City of Hope who led the team that developed Triplex. “Furthermore, Triplex’s favorable safety and immunogenicity may make the vaccine an ideal therapeutic platform to combat significant complications in many disease areas, like solid organ transplant and glioblastoma,” Diamond said.

“We are pleased to announce the publication of these important data in Blood. CMV is a ubiquitous virus that causes life-threatening disease in those with weakened immune systems,” said Frank Taffy, Co-Founder, President, CEO and Board Member of Helocyte. “We look forward to a continued collaboration with City of Hope as we advance our ongoing Phase 2 in HSCT, and initiate studies of Triplex across multiple other indications,” said Mr. Taffy.

John A. Zaia, M.D., Director of City of Hope’s Center for Gene Therapy and the Aaron D. Miller and Edith Miller Chair in Gene Therapy, served as the Phase 1 trial’s principal investigator.

Research reported in the aforementioned Blood publication was supported by the National Cancer Institute of the National Institutes of Health under grant numbers: R01CA077544, R01CA181045 and P30CA033572. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

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 a Phase 1 study, Triplex was found to be safe, well-tolerated and highly immunogenic when administered to healthy volunteers at multiple dose levels (ClinicalTrials.gov Identifier: NCT01941056).  The vaccine is currently being investigated in a randomized, multicenter, double-blind, placebo-controlled Phase 2 study in seropositive recipients of allogeneic HSCT (ClinicalTrials.gov Identifier:  NCT02506933).

About City of Hope
City of Hope is an independent research and treatment center for cancer, diabetes and other life-threatening diseases. Designated as one of only 47 comprehensive cancer centers, the highest recognition bestowed by the National Cancer Institute, City of Hope is also a founding member of the National Comprehensive Cancer Network, with research and treatment protocols that advance care throughout the world. City of Hope is located in Duarte, California, just northeast of Los Angeles, with community clinics throughout Southern California. It is ranked as one of "America's Best Hospitals" in cancer by U.S. News & World Report. Founded in 1913, City of Hope is a pioneer in the fields of bone marrow transplantation, diabetes and numerous breakthrough cancer drugs based on technology developed at the institution. For more information about City of Hope, follow us on Facebook, Twitter, YouTube or Instagram.

About Helocyte
Helocyte 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. Helocyte’s PepVax and Triplex vaccines are engineered to induce a robust and durable virus-specific T cell response to control CMV in transplant recipients. Helocyte’s Pentamer vaccine is designed to induce a neutralizing antibody response to prevent the transmission of CMV 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 innate immune system to fight CMV. For more information, please visit www.helocyte.com.

About Fortress Biotech
Fortress Biotech, Inc. (“Fortress”) is a biopharmaceutical company dedicated to acquiring, developing and commercializing novel pharmaceutical and biotechnology products. Fortress develops and commercializes products both within Fortress and through subsidiary companies, also known as Fortress Companies. In addition to its internal development programs, Fortress leverages its biopharmaceutical business expertise and drug development capabilities and provides funding and management services to help the Fortress Companies achieve their goals.  Fortress and the Fortress Companies may seek licensing, acquisitions, partnerships, joint ventures and/or public and private financings to accelerate and provide additional funding to support their research and development programs. For more information, visit www.fortressbiotech.com.

Forward-Looking Statements
This 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. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs 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 related to our growth strategy; risks relating to the results of research and development activities; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; uncertainties relating to preclinical and clinical testing; our dependence on third party suppliers; 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.

GlobeNewswire
globenewswire.com

Last updated on: 31/10/2016

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