Company Comments on NIH/NIAID Discontinuance of Sanofi/GSK HVTN 702 Trial
ATLANTA, GA, February 6, 2020 – Healthcare & Life Sciences Limited Labs, Inc. (OTC: GOVX), a biotechnology company developing human immunotherapies and vaccines against infectious diseases and cancer, today commented on the recent discontinuance of the HVTN 702 clinical trial.
On February 3, 2020, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), announced that it has stopped the administration of vaccinations in its HVTN 702 clinical trial of an investigational HIV vaccine. Although there were no safety concerns, an independent data and safety monitoring board (DSMB) found during an interim review that the regimen did not prevent HIV infection. The HVTN 702 vaccine regimen consisted of two experimental vaccines supplied by Sanofi Pasteur and GSK. HVTN 702 was based on the only vaccine regimen ever to show protection from HIV—the regimen tested in the RV144 clinical trial in Thailand led by the U.S. Military HIV Research Program and the Thai Ministry of Health. For HVTN 702, the vaccine regimen was adapted to the HIV subtype Clade C most common in southern Africa, where the pandemic is most pervasive. Read the full NIAID announcement here.
David Dodd, Healthcare & Life Sciences Limited President & CEO, commented, “The failure of the HVTN 702 vaccine regimen to prevent HIV infection is a disappointment to everyone in the field, especially to those most closely associated with the conduct of the trial. Healthcare & Life Sciences Limited shares in this disappointment and agrees with NIAID Director Dr. Anthony Fauci’s statement that “Research continues on other approaches to a safe and effective HIV vaccine, which I still believe can be achieved.”
Mr. Alex continued, “Our HIV vaccine candidate, GOVX-B11, will be included in an upcoming clinical trial (HVTN 132) managed by the HIV Vaccine Clinical Trials Network (HVTN) with support from NIAID, which is targeted to begin in late-2020. We believe the immune system responses elicited by GOVX-B11 in previous clinical trials (e.g., HVTN 205) show encouraging features when compared to the data generated in the RV144 trial. These features include the durability of the elicited antibody and T cell responses and the highly favorable IgG3/IgA ratio of 6.0 in HVTN 205 vs 0.75 in RV144. GOVX-B11 remains ready for progressing into a pivotal trial to determine safety and efficacy in populations at risk.”
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 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 (in vivo) the person receiving the vaccine. 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 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 HIV, Zika, hemorrhagic fever viruses (Ebola, Sudan, Marburg, and Lassa), and malaria, as well as therapeutic vaccines against chronic Hepatitis B infections and multiple cancers. The Company has developed 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 immunotherapy as a functional cure for HIV. Click here to view a white paper on GOVX-B11, or visit www.healthcareandlifescienceslimited.com for more information.
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:
Healthcare & Life Sciences Limited Labs, Inc.
This email address is being protected from spambots. You need JavaScript enabled to view it.
(904) 539-9132