Ho Wah Genting Berhad (Bursa stock code:9601), through its wholly-owned subsidiary HWGB Biotech Sdn Bhd signed a joint venture agreement with US-based E-MO Biology Inc. (“EBI”) for the research and development of vaccines, immunological treatment, and diagnostic product development in relation to the COVID-19 virus, followed by the Memorandum of Agreement signed on 06 August 2020.
Under the JVA, EBI is responsible to undertake phase IV clinical trials for a new indication which proposes the use of existing poliomyelitis virus vaccines (“Polio Virus Vaccines”) for prevention of the infectious disease, including vaccines, immunological treatment, diagnostic product development, and any similar treatment against the Severe Acute Respiratory Syndrome Coronavirus 2 (“SARS-co-V2”) pandemic and other relevant diseases.
Why repurpose polio vaccine?
Both the poliovirus and coronavirus are positive-strand RNA viruses, which means
it is likely that they will induce and be affected by common innate immunity mechanisms. Furthermore, crystal structure analysis has demonstrated structural similarities of RdRp between Poliovirus and SARS (refer to figure). Over one billion doses of oral polio virus vaccine are produced and used annually in more than 140 countries. There are multiple advantages to using OPV: a strong safety record, the existence of more than one serotype that could be used sequentially to prolong protection, low cost, ease of administration and availability.
EBI has obtained approval from the United States Food and Drug Administration (“FDA”) on 28 October 2020 to conduct phase IV clinical trial for a new indication which proposes the use of existing Polio Virus Vaccine for the prevention of the infectious disease, including vaccines, immunological treatment, diagnostic product development and any similar treatment against the Severe Acute Respiratory Syndrome Coronavirus 2 (“SARS-co-V2”) pandemic and other relevant diseases.
HWGB Biotech’s commitment in Phase IV clinical trial upon FDA approval
HWGB Biotech to invest US$1 million in its joint venture partner, EBI to start Phase IV clinical trial leading to the development of a COVID-19 vaccine following approval being obtained from the United States Food and Drug Administration (FDA).
What is Phase IV clinical trial?
Phase IV clinical trial (also known as a post-marketing study) is conducted upon FDA approval. The objective is to collect additional information about side-effects and safety, long-term risks and potential benefits, and/or how well the vaccine works when used widely on several thousand people.
Phase IV can be used to fast-track a vaccine for emergency use. This is also termed as repurposing vaccines which is very common because many effective vaccines are rediscovered from existing approved vaccines.
With the FDA approval in hand, EBI will engage the services of Roderick A. Comunale II MD Inc to conduct a clinical research study entitled “Inactivated Polio Vaccine in prevention of COVID-19 in high risk population in a Phase IV study", and collaborate with America Diagnostic & Genescan Diagnostics Inc to conduct a series of immunology assays in supporting the potential clinic research entitled "Inactivated Polio Vaccine in prevention of COVID-19 in Patients with general population in a Phase IV Research and Development.