HOOKIPA Pharma Announces Oral Presentation of HB-101 CMV Vaccine Phase 1 Data at the American Transplant Congress
New York, US and Vienna, Austria, May 29, 2019 - HOOKIPA Pharma Inc. (NASDAQ: HOOK), a company developing a new class of immunotherapeutics targeting infectious diseases and cancers based on its proprietary arenavirus platform, today announced that it has secured an oral presentation of Phase 1 data from its HB-101 cytomegalovirus (CMV) clinical program including an update on the ongoing Phase 2 trial at the upcoming American Transplant Congress (ATC), taking place June 1-5, 2019 in Boston, MA, USA. The Phase 1 data showed that the vaccine has a good safety profile, was well tolerated, and elicited strong humoral and cellular immune responses.
The data will be presented by Camille Kotton, M.D., Clinical Director, Transplant and Immunocompromised Host Infectious Disease at Massachusetts General Hospital. Further details of the presentation are below:
Title: A CMV Vaccine Based on Non-Replicating Lymphocytic Choriomeningitis Virus Vectors Expressing gB and pp65 is Safe and Immunogenic in Healthy Volunteers and Entering a Phase 2 Trial in Kidney Transplant Recipients
Publication Number: 330
Session Date & Time: Monday, June 3, 2019, 4:30 pm - 6:00 pm EST
Session Location: Ballroom A, John B. Hynes Convention Center
The abstract for the presentation is available on the ATC website here.
HB-101 is a VaxWave®*-based product candidate designed to stimulate the immune system against cytomegalovirus and to protect against future cytomegalovirus infection or reactivation from latency.
In 2018, HOOKIPA commenced a randomized, placebo-controlled, Phase 2 clinical trial for HB-101 in cytomegalovirus-negative patients awaiting kidney transplantation from living cytomegalovirus-positive donors. We expect safety and immunogenicity data from the first cohorts enrolled in this trial in the first half of 2020, and preliminary efficacy data to follow in the second half of 2020.
Cytomegalovirus (CMV) is a virus that is commonly transmitted in childhood and early adulthood. A majority of the U.S. population has been exposed and is latently infected. Worldwide data indicate that while half the people in industrialized countries have been exposed, up to 99% of people in developing countries, including China and India, have been exposed.
Infections result in lifelong latent persistence of the virus with few symptoms, if any. However, in unborn children, when infected in utero, CMV infection can lead to significant morbidity and mortality. In addition, in immunosuppressed patients, such as transplant recipients, primary cytomegalovirus infection or reactivation causes significant morbidity, mortality and graft rejection. There are two scenarios in which cytomegalovirus infections are relevant in the transplant setting. In one case, the recipient could be cytomegalovirus negative, or previously uninfected, and the donor cytomegalovirus positive. In this case, introduction of cytomegalovirus into the immunocompromised recipient can lead to rapid virus spread and development of serious complications. In the other case, the recipient is already cytomegalovirus positive, but the immunosuppressive treatments required as part of the transplant procedure lead to reactivation of latent virus.
HOOKIPA Pharma Inc. (NASDAQ: HOOK) is a clinical stage biopharmaceutical company developing a new class of immunotherapeutics, targeting infectious diseases and cancers based on its proprietary arenavirus platform that is designed to reprogram the body’s immune system.
HOOKIPA’s proprietary arenavirus-based technologies, VaxWave®*, a replication-deficient viral vector, and TheraT®*, a replication-attenuated viral vector, are designed to induce robust antigen specific CD8+ T cells and pathogen-neutralizing antibodies. Both, VaxWave® and TheraT®, are designed to allow for repeat administration while maintaining an immune response. TheraT® has the potential to induce CD8+ T cell response levels previously not achieved by other published immuno-therapy approaches. HOOKIPA’s “off-the-shelf” viral vectors target dendritic cells in vivo to activate the immune system.
HOOKIPA has successfully completed a Phase 1 trial of a VaxWave®-based prophylactic vaccine to protect against cytomegalovirus infection and has started dosing patients in a Phase 2 trial in cytomegalovirus-negative patients awaiting kidney transplantation from cytomegalovirus-positive donors. To expand its infectious disease portfolio, HOOKIPA has entered into a collaboration and licensing agreement with Gilead Sciences, Inc. to jointly research and develop functional cures for HIV and Hepatitis B infections. HOOKIPA is building a proprietary immuno-oncology pipeline by targeting virally mediated cancer antigens, self-antigens and next-generation antigens.
TheraT® and VaxWave® are not approved anywhere globally and their safety and efficacy have not been established.
*Registered in Europe; Pending in the US.
HOOKIPA Forward Looking Statements
Certain statements set forth in this press release constitute “forward-looking” statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements can be identified by terms such as “believes,” “expects,” “plans,” “potential,” “would” or similar expressions and the negative of those terms.. Such forward-looking statements involve substantial risks and uncertainties that could cause HOOKIPA’s research and clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the drug development process, including HOOKIPA’s programs’ early stage of development, the process of designing and conducting preclinical and clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, HOOKIPA’s ability to successfully establish, protect and defend its intellectual property and other matters that could affect the sufficiency of existing cash to fund operations and HOOKIPA’s ability to achieve the milestones under the agreement with Gilead. HOOKIPA undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the company in general, see HOOKIPA’s quarterly report on Form 10-Q for the quarter ended March 31, 2019 which is available on the Security and Exchange Commission’s website at www.sec.gov and Surface Oncology’s website at www.hookipapharma.com.