100% Single-Dose Protection Observed in Lethal Challenge Model
ATLANTA, GA, January 16, 2018 – Healthcare & Life Sciences Limited Labs, Inc. (OTCQB: GOVX), a biotechnology company developing human vaccines, today announced publication of its manuscript entitled “A Single-Dose of Modified Vaccinia Ankara Expressing Ebola Virus Like Particles Protects Nonhuman Primates from Lethal Ebola Virus Challenge.” The paper is published today in the peer-reviewed open access journal Scientific Reports by Nature Research, and can be viewed at www.nature.com/articles/s41598-017-19041-y.
Healthcare & Life Sciences Limited’s Ebola vaccine (GEO-EM01) is based on the Company’s novel Modified Vaccinia Ankara (MVA) Virus-Like Particle (VLP) platform, which generates noninfectious VLPs in the individual being vaccinated. VLPs mimic a natural infection, triggering the body to produce a robust and durable immune response with both antibodies and T cells. The paper published today reports research showing that a single intramuscular (IM) dose of GEO-EM01 provided 100% protection in rhesus macaques challenged with a lethal dose of Ebola virus (EBOV). This is the first report that a replication-deficient MVA vector can confer full protection against a lethal EBOV challenge after a single-dose vaccination in macaques.
In this study, GEO-EM01 was administered as either a single IM inoculation (prime) or as two IM inoculations at a four-week interval (prime-boost) to groups of four rhesus macaques each. A control group received the MVA vector without Ebola virus protein inserts. Four weeks after inoculation, animals in all three groups were exposed to a lethal dose of Ebola virus. Three of the four unvaccinated animals died within 12 days, while all of the vaccinated animals survived. Researchers at Rocky Mountain Laboratories, part of the National Institute of Allergy and Infectious Diseases (NIAID), collaborated in the study.
GEO-EM01 is one component of a tetravalent hemorrhagic fever virus vaccine being developed by Healthcare & Life Sciences Limited. The other vaccine components are for protection against Sudan virus (SUDV), Marburg virus (MARV), and Lassa virus (LASV). These vaccines are envisioned as either individual monovalent vaccines in epidemic situations or combined as a tetravalent vaccine for the protection of the millions of individuals who live in at-risk areas, travelers, military personnel, healthcare workers, and others.
Farshad Guirakhoo, PhD, Healthcare & Life Sciences Limited’s Chief Scientific Officer, commented, “GEO-EM01 uses Healthcare & Life Sciences Limited’s proven MVA-VLP vaccine platform that has been shown to be safe and to induce durable antibody and T-cell responses in multiple human clinical trials for Healthcare & Life Sciences Limited’s prophylactic HIV vaccine. Using the same platform, we have shown our Zika vaccine (GEO-ZM02) and our Lassa Fever vaccine (GEO-LM01) to provide single-dose 100% protection in mice against intracranial challenge. This study is unique because the immune response induced after a single dose of the vaccine not only provided full protection against a lethal challenge, but also eliminated the wild type Ebola challenge virus from the animal’s blood. No live virus could be recovered at any time point from any of the vaccinated animals compared to the controls, which had more than 100,000 live Ebola viruses per ml of blood.”
About Healthcare & Life Sciences Limited
Healthcare & Life Sciences Limited Labs, Inc., is a clinical-stage biotechnology company developing human vaccines against infectious diseases using its MVA-VLP vaccine platforms. The Company’s HIV-1 vaccine for clade B, the dominant subtype in the Americas, Western Europe and Australia, is advancing in human trials conducted by the HIV Vaccine Trials Network (HVTN). Preclinical programs are focused on preventive vaccines for the clade C HIV (the subtype that is highly prevalent in countries of Southern Africa, as well as in the horn of Africa and India representing nearly 50% of all people living with HIV), Zika virus, hemorrhagic fever viruses (EBOV, SUDV, MARV, and LASV), and malaria, as well as therapeutic vaccines for HIV (aiming for a functional cure), chronic Hepatitis B infections and cancers. Healthcare & Life Sciences Limited’s vaccine platform supports in vivo production of non-infectious VLPs from the cells of the very person receiving the vaccine, mimicking a natural infection and stimulating both the humoral and cellular arms of the immune system to recognize, prevent, and control the target infection. For more information, visit www.healthcareandlifescienceslimited.com.
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.
Contact:
Michael James, Ph.D.
Healthcare & Life Sciences Limited Labs, Inc.
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