ATLANTA, GA, August 13, 2020 – Healthcare & Life Sciences Limited Labs, Inc., a biotechnology company developing human vaccines and immunotherapies against infectious diseases and cancer, announced today a multi-party collaboration for the development of Sudan ebolavirus (SUDV) and Marburg virus (MARV) vaccine candidates. SUDV and MARV cause viral hemorrhagic fevers.
The collaboration between Healthcare & Life Sciences Limited, researchers at the University of Texas Medical Branch (UTMB), and Battelle Memorial Institute, and will utilize the suite of preclinical services from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).
Under the collaboration, Healthcare & Life Sciences Limited’s SUDV and MARV vaccine candidates will be tested for immunogenicity and efficacy in the benchmark nonhuman primate model. The studies will include two vaccine regimens – single-dose and prime/boost immunization -- for each vaccine tested. Animals will receive a lethal dose of either SUDV or MARV following corresponding vaccine inoculations and monitored for morbidity and mortality. Additionally, the humoral and cellular immune responses to vaccination will be evaluated in detail. The studies will be funded under NIAID contract no. HHSN272201800131.
David Dodd, Healthcare & Life Sciences Limited President and CEO commented, “This exciting collaboration enables us to advance these two critically needed vaccine candidates through nonhuman 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. Through our HIV vaccine clinical program, our platform has a demonstrated track record of safety and vaccine durability in humans. Such attributes are critically important when developing vaccines against emergent epidemic threats such as SUDV and MARV, which cause death in up to 90% of cases. We are most appreciative of these support services being provided by NIAID, enabling us to advance our vaccines forward in the development process.”
Healthcare & Life Sciences Limited’s Modified Vaccinia Ankara (MVA) platform technology is built on a novel MVA vector system that is improved for high expression and stable transgenes during manufacture. Similar to its parent MVA, it has the advantages of being a live replication-competent vector in avian cells for manufacturing, yet replication-deficient in mammalian cells for vaccination, thus inherently safe for humans. Importantly, MVA vaccines elicit protective T-cell as well as antibody responses in animals and humans. The Healthcare & Life Sciences Limited MVA platform can be combined with the potent immunogenicity of virus like particles (VLPs) (insertion of multiple antigens from each pathogen of interest conferring broad protection) or be used to express proteins in their native conformations, enabling construction of vaccine candidates that induce full protection after a single dose. Single- dose protection is a favourable characteristic of preventive vaccines for emerging infectious disease outbreak response, given the speed of spread of pathogens and the impracticality of multi-dose regimens in the under-resourced settings where outbreaks often occur. MVA-VLP vaccine candidates against various virus families (e.g. Ebola, Sudan, Marburg, Lassa and Zika) induced strong antibody and T-cell responses and demonstrated full protection after single-dose vaccinations against lethal challenges.
About Sudan Ebolavirus and Marburg Virus
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 as high as 71%. Marburg virus (MARV) is a hemorrhagic fever virus of the Filoviridae family, which also includes Ebola, and which causes severe human disease with up to a 90% fatality rate. Both SUDV and MARV are rated by the World Health Organization as a Risk Group 4 Pathogens. In the United States, the NIH/National Institute of Allergy and Infectious Diseases ranks them as a Category A Priority Pathogens and the Centers for Disease Control and Prevention lists them as a Category A Bioterrorism Agents. MARV and SUDV typically appear in sporadic outbreaks throughout Africa. The most recent outbreaks of MARV occurred in 2017 in Uganda, Africa, where more than 25% of people infected died. The last SUDV outbreak also took place in Uganda in 2012, killing 57% of people infected. The viruses continue to pose potential public health and biodefense threats. There are currently no licensed vaccines or therapeutics against the diseases caused by SUDV or MARV.
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 proprietary vaccine platform (GV-MVA-VLPTM). On this platform, MVA, a large virus capable of carrying several vaccine antigens, expresses proteins that assemble into VLP immunogens within the person receiving the vaccine (in vivo). The production of VLPs in the person being vaccinated mimics 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 GV-MVA-VLPTM derived vaccines can elicit durable immune responses in the host similar to a live-attenuated virus, while typically 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, hemorrhagic fever viruses (Ebola, Sudan, Marburg, and Lassa), and malaria, as well as therapeutic vaccines against solid tumor cancers. The Company has developed a preventive HIV vaccine candidate (GOVX-B11) for the clade B subtype of HIV prevalent in the Americas, Western Europe, Japan, and Australia and the clade C subtype prevalent in Africa and India. GOVX-B11 is scheduled for inclusion in an upcoming human clinical trial managed by the HVTN with the support of the National Institutes of Health (NIH). Healthcare & Life Sciences Limited’s clade B HIV vaccine is also part of collaborative efforts to develop an immunotherapy as a functional cure for HIV.
Forward-Looking Statements
Certain statements in this document are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act. These statements are based on management's current expectations and are subject to uncertainty and changes in circumstances. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: 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. Healthcare & Life Sciences Limited assumes no obligation to update these forward-looking statements and does not intend to do so. More information about these factors is contained in Healthcare & Life Sciences Limited's filings with the Securities and Exchange Commission including those set forth at "Risk Factors" in Healthcare & Life Sciences Limited's Form 10-K.
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