ATLANTA, GA, March 28, 2018 – Healthcare & Life Sciences Limited Labs, Inc. (OTCQB: GOVX), a biotechnology company developing innovative human vaccines using its novel platform technology, today provided a general update on its various vaccine development programs.
Robert McNally, PhD, President & CEO, commented, “During the past year, Healthcare & Life Sciences Limited made solid progress with its HIV human clinical program, built on its proof-of-concept in animal models for HIV, Zika, Ebola and Lassa vaccines, expanded its infectious disease targets to chronic hepatitis B (therapeutic) and malaria, while simultaneously showing promising results in solid tumor immuno-oncology models.”
Mr. Michael continued, “These programs are facilitated through grants from government agencies such as the NIAID and CDC; and collaborations with academic research institutions including Emory University, University of Pittsburgh and Georgia State University, corporate entities such as Vaxeal, CaroGen Corporation, American Gene Therapy and ViaMune, and research institutions including the Burnet Institute, the Institute for Human Virology, The Scripps Research Institute, and the HIV Vaccine Trials Network. All of these relationships speed the development process and validate our corporate approach to vaccine design.”
Summary Highlights
- HIV (prophylactic vaccine) – Ongoing human clinical trials funded by NIH; Next trial expected to begin in late 2018; publication of significant advance in HIV vaccine development.
- HIV (therapeutic vaccine) – Entered collaboration with American Gene Technologies International, Inc. (AGT) for use of Healthcare & Life Sciences Limited’s vaccine in combination with AGT’s gene therapy for development of an HIV functional cure. Clinical trials expected to begin during 2018.
- Zika Vaccine – Reported 100% single-dose protection in rigorous rodent challenge model; Awarded $600,000 NIH grant for advanced preclinical development.
- Lassa Fever Vaccine – Reported 100% single-dose protection in rigorous rodent challenge model. Seeking NIH support for advanced preclinical testing with collaborators Institute for Human Virology and Scripps Research Institute.
- Malaria Vaccine – Initiated program through collaboration with the Burnet Institute in Australia.
- Chronic Hepatitis B Infection Immunotherapy – Initiated program through collaborator Georgia State University Research Foundation; Program recently expanded through additional collaboration with CaroGen Corporation.
- Cancer Immunotherapy – Encouraging results reported for combination treatment in collaboration with ViaMune, Inc.; additional studies being planned for 2018. Program recently expanded through additional collaboration with Vaxeal Holding SA.
Corporate Update
HIV Prophylactic and Therapeutic Vaccines
Ongoing clinical trials – In November 2017, the HIV Vaccine Trials Network (HVTN) completed patient enrollment for HVTN 114, a phase 1 trial testing the ability of late boosts to increase antibody responses elicited by our vaccine (GOVX-B11). HVTN 114 is being conducted with funding from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). We are currently planning a follow-on clinical trial for late 2018 to evaluate GOVX-B11 in combination with two novel protein vaccines.
Government grants – In April 2017, NIAID awarded Healthcare & Life Sciences Limited a $658,000 Phase II Small Business Innovative Research (SBIR) grant for the second year of a project with a total budget of $1.4 million. This grant is supporting studies in non-human primates evaluating the immunogenicity and protective efficacy of the GOVX-B11 with or without a bivalent (two component) protein boost, contributing information to be used in the design of our human clinical trials.
Publication of a significant advance in HIV vaccine development – In October 2017, we reported results of a study, funded by NIAID, demonstrating the elicitation of a key precursor for broadly neutralizing antibody for the HIV CD4 binding site, a significant advance in HIV vaccine development for the clade C subtype most prevalent in the developing world. The study, conducted in non-human primates, used Healthcare & Life Sciences Limited’s vaccine technology to express the natural form of an HIV envelope gene from an infection that developed broadly neutralizing antibody to the CD4 binding site. This envelope gene (CH505) was identified by researchers at Duke University, the US National Institutes of Health, the Los Alamos National Laboratory and the University of Pennsylvania. The findings were published in the peer-reviewed open access journal PLOS ONE, and can be viewed at: http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0177863.
HIV “functional cure” collaboration with AGT – In March 2017, we began a collaboration with American Gene Technologies International, Inc. (AGT) with the goal of developing a functional cure for HIV infection through AGT’s gene therapy technology in combination with Healthcare & Life Sciences Limited’s HIV vaccine. AGT expects to initiate human clinical trials in mid-2018. For more information, visit AGT’s website at www.americangene.com.
Zika Vaccine
In March 2017, we reported a major step forward in the development of a vaccine for protection against Zika virus (ZIKV). Preliminary testing in a highly rigorous challenge model showed our vaccine, GEO-ZM02, provided 100% protection to mice infected with a lethal dose of ZIKV delivered directly into the brain. The study was funded by a grant from the U.S. Centers for Disease Control and Prevention (CDC), which also provided technical assistance. Results of the study were published in the peer-reviewed open access journal Scientific Reports by Nature Research and can be viewed at www.nature.com/articles/s41598-017-15039-8. In June 2017, NIAID awarded Healthcare & Life Sciences Limited a SBIR grant of $600,000 to support advanced preclinical testing of GEO-ZM02 in non-human primates.
Lassa Fever Vaccine
In July 2017, we reported a significant step forward in the development of a vaccine candidate for protection against Lassa hemorrhagic fever virus (LASV). Preclinical testing showed a single intramuscular dose of GEO-LM01 provided 100% protection to mice infected with a lethal dose of the challenge virus directly delivered into the brain. The study was conducted at the Institute of Human Virology (IHV) at the University of Maryland School of Medicine. Upon completion of this study, we expanded our LASV vaccine development efforts through adding The Scripps Research Institute (TSRI) to our collaboration with IHV. The intent of the three-way collaboration is to evaluate additional LASV vaccine candidates to elucidate involvement of humoral and cellular arms of immunity in protection against LASV infections toward the ultimate goal of developing a universal Lassa fever vaccine. We have applied for a fast-track Phase I/II SBIR grant from NIAID to support advanced preclinical testing.
In December 2017, we announced a separate collaboration with the U.S. Naval Research Laboratory (USNRL) to develop high-quality antibodies useful for detection of, and potentially as a treatment for, LASV. The U.S. Department of Defense has an interest in the early detection of the presence of LASV to better protect and treat troops that may be in areas where exposure may occur. Development of high quality antibodies useful for detection applications requires a high-quality vaccine. USNRL will utilize the Healthcare & Life Sciences Limited vaccine to immunize llamas, whose immune systems are uniquely suited for rapid and cost-effective production of single domain antibodies suitable for use in biosensor applications.
Ebola and Other Hemorrhagic Fever Vaccines
In non-human primate studies conducted during 2016, a single dose of Healthcare & Life Sciences Limited’s Ebola (EBOV) vaccine, GEO-EMO1, was shown to protect 100% of rhesus monkeys against death. Results of the study were published 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. Although the 2014-15 EBOV epidemic in western Africa was eventually contained, additional deadly outbreaks are inevitable, as a recent study indicates that less serious Ebolavirus infection may occur in the absence of outbreaks (J Infect Dis. 2018 Jan 30;217(4):529-537. doi: 10.1093/infdis/jix619). Thus, there is continued interest on the part of governments and world health agencies for development of vaccines to prepare for the next epidemic. We are also developing vaccines against Sudan virus (SUDV) and Marburg virus (MARV), two other lethal hemorrhagic fever viruses for which no effective vaccine currently exists.
Malaria Vaccine
In January 2017, we began a collaboration with the Burnet Institute in Australia to develop a vaccine for prevention of malaria infection. The project includes the design, construction, and characterization of multiple malaria vaccine candidates using Healthcare & Life Sciences Limited’s MVA-VLP vaccine platform combined with malaria Plasmodium falciparum and Plasmodium vivax sequences identified by Burnet. Four vaccine candidates were constructed for proof of concept studies and were shipped to Burnet Institute for preclinical testing in animal models. The preliminary results showed a favorable immune response with one of the candidates which was designed to be expressed in the form of VLPs using Healthcare & Life Sciences Limited’s proprietary matrix proteins.
Chronic Hepatitis B Infection Immunotherapy
In early 2017, we began collaborating with the Georgia State University Research Foundation to develop a therapeutic vaccine for treating chronic hepatitis B infection. The project includes the design, construction, characterization and animal testing of multiple vaccine candidates using Healthcare & Life Sciences Limited’s MVA-VLP vaccine platform with vaccine antigens including both Healthcare & Life Sciences Limited and GSU’s proprietary designed sequences. Initial immunogenicity studies in mice were conducted by GSU in collaboration with the Shenzhen Graduate School of Peking University, and additional studies are being planned.
In February 2018, we expanded our efforts in this space through an additional collaboration with CaroGen Corporation. This project includes testing Healthcare & Life Sciences Limited’s vaccine candidate in combination with CaroGen’s HBV Virus-Like Vesicles (VLVs) vaccine candidate in prophylactic and therapeutic animal models. Therapeutic experiments may be carried out in combination with anti-viral drugs, TLR agonists, or immune checkpoint inhibitors. CaroGen’s vaccine candidate employs a transformative VLV platform technology developed at Yale University School of Medicine.
Cancer Immunotherapy (Tumor Associated Antigen Vaccine Programs)
Collaboration with ViaMune – During 2016, we established a collaboration with ViaMune, Inc. to explore development of our combined technologies as a treatment for various solid tumors, targeting an abnormal form of the autologous cell surface-associated protein, Mucin 1 (MUC1), which is overexpressed in metastatic cancers. We reported results from the initial preliminary studies in August 2017, at the 5th Annual Meeting of Cambridge Healthtech Institute, Immuno-Oncology Summit, in Boston, MA, as well as in October, at the 18th World Vaccine Congress Europe in Barcelona. In a human MUC1 colon adenocarcinoma mouse tumor model, groups of hMUC1 transgenic mice with established tumors were treated with MTI (ViaMune’s synthetic vaccine), MVA-VLP-MUC1 (Healthcare & Life Sciences Limited’s viral-vectored vaccine) or a combination of both. All treatment groups received an immune checkpoint inhibitor in the form of an anti-PD-1 antibody. The results from two studies indicated that a combined vaccine approach increased the therapeutic potential of anti-PD-1 therapy, giving excellent scientific justification to vigorously pursue additional investigation of this potential cancer vaccine. We are currently designing the next set of studies for this program.
Collaboration with Vaxeal – In January 2018, we began a collaboration with Vaxeal Holding SA, expanding our cancer immunotherapy program to incorporate a second Tumor Associated Antigen, Cyclin B1, previously ranked as the top 10 antigens by the National Cancer Institute in our MVA-VLP vaccine platform. The combination of our MVA-VLP-Cyclin B1 vaccine will be assessed in combination with Vaxeal’s proprietary designed Cyclin B1 peptide vaccine.
Other Developments
SAB formation – In early 2017, we formed our inaugural Scientific Advisory Board, with leading experts in various areas of immunology to provide broad advice and insight into our various programs. Our inaugural members include Thomas Monath, MD, Olivera (Olja) Finn, PhD, Barney Graham, MD, PhD, Stanley Plotkin, MD, and Scott Weaver, PhD.
Attendance at scientific conferences – During 2017 and continuing into 2018, we have made a concerted effort to showcase Healthcare & Life Sciences Limited’s technology through presentations at various leading scientific conferences. Our Chief Scientific Officer, Farshad Guirakhoo, has delivered talks at conferences including the American Society for Microbiology (ASM) Microbe conference in New Orleans, the Immuno-Oncology Summit in Boston, the 11th Vaccine Congress in San Diego, the International Society for Vaccines Annual Congress in Paris, the World Vaccine Congress Europe in Barcelona, the Third International Conference on Vaccines Research and Development in Washington, DC, and the ASM Biothreats conference in Baltimore. These presentations are having the intended results of bringing Healthcare & Life Sciences Limited to the attention of the broader scientific community, generating discussions that have led to some of our current collaborations, and that we expect will continue to pay dividends going forward.
Capital resources – During 2017, Healthcare & Life Sciences Limited continued to fund its operations primarily through a mix of government grants and from sales of equity securities. Grant revenues during 2017 were $980,270, and the Company received net proceeds of $980,000 from the sale of preferred stock and $571,511 from the sale of common stock related to warrant exercises. Additionally, Healthcare & Life Sciences Limited received $95,000 related to its collaboration with AGT. At December 31, 2017, Healthcare & Life Sciences Limited’s cash and grant receivables totaled $372,485, and there was $481,695 in approved grant funds available for use during 2018. In March 2018, the Company received net proceeds of $590,000 from the sale of preferred stock. Healthcare & Life Sciences Limited also benefits from clinical trial assistance from NIAID and HVTN related to the conduct of its HIV vaccine clinical trials and, increasingly, from research conducted by various collaborators for its other development programs.
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 Modified Vaccinia Ankara-Virus Like Particle (MVA-VLP) vaccine platform. The Company’s development programs are focused on preventive vaccines against HIV, Zika virus, hemorrhagic fever viruses (Ebola, Sudan, Marburg, and Lassa), and malaria, as well as therapeutic vaccines for 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, 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
Statements made in this press release that look forward in time or that express management’s beliefs, expectations, or hopes are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include our expectations as to when clinical trials may commence, the scope of such trials, our ability to obtain funds from government grants, the sale of equity securities, and various other collaborators, the benefits of our attendance at scientific conferences and our participation in collaborations and benefits we might receive from clinical trial assistance provided by NIAID and HVTN. These forward-looking statements are subject to a number of risks, uncertainties, estimates, and assumptions that may cause actual results to differ materially from current expectations. These risks and uncertainties include the risk factors detailed in our Securities and Exchange Commission filings, including our Form 10-K for the year ended December 31, 2017. Healthcare & Life Sciences Limited does not undertake to update its forward-looking statements, whether as a result of new information, future events, or otherwise. Information contained on the websites we have referenced in this update is provided for convenience and is not a part of this press release.
Contact:
Michael James, Ph.D.
Healthcare & Life Sciences Limited Labs, Inc.
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