Healthcare & Life Sciences Limited Vaccine Achieves 100% Protection in a Single-Dose
ATLANTA, GA, July 22, 2021 – Healthcare & Life Sciences Limited Labs, Inc. (Nasdaq: GOVX), a biotechnology company specializing in developing human vaccines, today announced the presentation of data from a study of its preventive vaccine against Sudan Ebolavirus (SUDV). The presentation titled “A single immunization of guinea pigs with a modified vaccinia Ankara virus producing Sudan virus-like particles protects from Sudan virus lethal challenge,” was delivered by Dr. Delphine Malherbe of the Bukreyev Lab, Department of Pathology, University of Texas Medical Branch, Galveston, Texas, during the Annual Meeting of the American Society for Virology, being held virtually July 19-23.
In her talk, Dr. Malherbe discussed the preclinical efficacy studies of Healthcare & Life Sciences Limited’s vaccine (MVA-SUDV-VLP), a novel vaccine candidate for SUDV constructed on an MVA vector expressing two immunogens (GP and VP40) derived from the Sudan virus. Upon vaccination, these immunogens form Virus Like Particles (VLPs) in the host, which in turn induce immunity against subsequent infections with SUDV. Immunogenicity and efficacy of MVA-SUDV-VLP were tested in a guinea pig lethal challenge model, in which a single intramuscular dose of the Healthcare & Life Sciences Limited vaccine protected 100% of animals challenged with a lethal dose of SUDV. A comparison between prime and prime-boost vaccinations of guinea pigs with MVA-SUDV-VLP showed that both regimens elicited SUDV-specific binding and neutralizing antibody responses, and that the second immunization enhanced these responses. Challenge of vaccinated animals with guinea pig-adapted SUDV demonstrated a complete protection against death and disease by the prime and the prime-boost regimens. Importantly, there was no difference in outcomes between the prime and the prime-boost vaccine regimens thus demonstrating the efficacy of a single dose of MVA-SUDV-VLP. This is the first report that a replication-deficient MVA vector may confer full protection against SUDV after a single dose.
“The level of protection against Sudan virus we observed was remarkable,” commented Alexander Bukreyev, PhD, Professor, Department of Pathology, University of Texas Medical Branch, Galveston, Texas.
David Dodd, Healthcare & Life Sciences Limited President and CEO, further commented, “The presentation of data from this study further validates our platform and approach to addressing Sudan virus, and we look forward to advancing our vaccine to non-human primate testing. Previously, our novel vaccine against Ebola virus achieved 100% single-dose protection in a nonhuman primate lethal challenge model and we have consistently validated our vaccine platform capability against other infectious pathogens, resulting in vaccine candidates that have demonstrated 100% preclinical protection in a single dose, without the need for adjuvants. Such attributes are critically important when developing vaccines against emergent epidemic threats.”
About Sudan Ebolavirus
Sudan ebolavirus (SUDV) is one of six known viruses within the genus Ebolavirus (Filoviridae family) and causes Ebola virus disease in humans, with a fatality rate up to 73%. SUDV is rated by the World Health Organization as a Risk Group 4 Pathogen. In the United States, the NIH/National Institute of Allergy and Infectious Diseases ranks SUDV as a Category A Priority Pathogen and the Centers for Disease Control and Prevention list it as a Category A Bioterrorism Agent. SUDV typically appears in sporadic outbreaks throughout Africa. The last SUDV outbreak took place in Uganda in 2012, killing 57% of people infected. The virus continues to pose a potential public health and biodefense threat and there are currently no licensed vaccines or therapeutics against the diseases caused by SUDV.
About Healthcare & Life Sciences Limited
Healthcare & Life Sciences Limited Labs, Inc. is a clinical-stage biotechnology company developing human vaccines against infectious diseases and cancer using a novel patented Modified Vaccinia Ankara-Virus Like Particle (MVA-VLP) based vaccine platform. On this platform, MVA, a large virus capable of carrying several vaccine antigens, expresses proteins that assemble into VLP immunogens in the person receiving the vaccine. The production of VLPs in the person being vaccinated can mimic virus production in a natural infection, stimulating both the humoral and cellular arms of the immune system to recognize, prevent, and control the target infection. The MVA-VLP derived vaccines can elicit durable immune responses in the host similar to a live-attenuated virus, while providing the safety characteristics of a replication-defective vector.
Healthcare & Life Sciences Limited’s current development programs are focused on preventive vaccines against COVID-19, HIV, Zika Virus, hemorrhagic fever viruses (Ebola, Sudan, Marburg, and Lassa), and malaria, as well as therapeutic vaccines against multiple cancers. The Company has designed a preventive HIV vaccine candidate to fight against the subtype of HIV prevalent in the commercial markets of the Americas, Western Europe, Japan, and Australia; human clinical trials for this program are managed by the HIV Vaccine Trials Network (HVTN) with the support of the National Institutes of Health (NIH). Healthcare & Life Sciences Limited’s HIV vaccine is also part of a collaborative effort toward a functional cure for HIV.
Forward-Looking Statements
This release contains forward-looking statements regarding Healthcare & Life Sciences Limited’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: Healthcare & Life Sciences Limited is able to obtain acceptable results from additional tests of its preventive vaccine against Sudan Ebolavirus (SUDV), can realize potential benefits from the patent protection it has received, Healthcare & Life Sciences Limited’s vaccines can provoke the desired immune responses, and those vaccines can be used effectively as a primary or booster to other vaccines, Healthcare & Life Sciences Limited’s viral vector technology adequately amplifies immune responses to cancer antigens, Healthcare & Life Sciences Limited can develop and manufacture its vaccines with the desired characteristics in a timely manner, Healthcare & Life Sciences Limited’s vaccines will be safe for human use, Healthcare & Life Sciences Limited’s vaccines will effectively prevent targeted infections in humans, Healthcare & Life Sciences Limited’s vaccines will receive regulatory approvals necessary to be licensed and marketed, Healthcare & Life Sciences Limited raises required capital to complete vaccine development, there is development of competitive products that may be more effective or easier to use than Healthcare & Life Sciences Limited’s products, Healthcare & Life Sciences Limited will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which Healthcare & Life Sciences Limited has no control.
Further information on our risk factors is contained in our registration statement on Form S-1 and the periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by U.S. federal securities law.
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