Source: CNA News by Han Ting-ting and Ko Lin
Taiwan-based biotech firm OBI Pharma Inc.announced Tuesday that the COVID-19 vaccine it developed called BCVax will enter phase 1 & 2 clinical trials in the second half of this year.
According to the company, the results of animal experiments have shown that BCVax can produce high levels of antibody titers and has neutralizing effects against different variants of the SARS-CoV-2 virus.
OBI Pharma Chairman Michael Chang (張念慈) said while the company focuses primarily on cancer drugs it has also been following closely the COVID-19 vaccines currently available.
Although the COVID-19 vaccine market seems to have turned into a "red ocean," meaning cutthroat competition, OBI Pharma still decided to go ahead with its research and development into a COVID-19 vaccine in July last year, Chang said.
The company chief said it has already filed a provisional patent application with the United States Patent and Trademark Office for its vaccine, and expects to submit applications for clinical trials with Taiwan's Center for Drug Evaluation in July or August.
According to Chang, a phase 1 clinical trial will take place in Taiwan in the second half of this year, while the plan is to conduct phase 2 trials outside the country.
OBI Pharma will also seek partnerships to carry out phase 3 clinical trials overseas consisting of more than 20,000 volunteers, Chang added.
The biotech firm said it had originally intended to announce the unveiling of BCVax in January, but due to the Omicron variant which has swept the world since November 2021, further animal experiments focused on that variant have been conducted as part of an effort to ensure the greater efficacy of its COVID-19 vaccine.
Chief Scientific Officer Lai Ming-tain (賴明添) said BCVax is a recombinant protein-based vaccine, and that OBI Pharma has been working on a vaccine that boasts minimal side effects with effective adjuvants that can induce stronger T-cell responses.
Yang Ming-chen (楊明臻), who is a project manager at the company, said the coronavirus vaccine works against different COVID-19 variants, including Omicron, given the immune-stimulating complex (ISCOM) technology that it developed for BCVax.
ISCOM is a particle that contains several copies of an antigen, with a built-in adjuvant. It is designed to provide a physically optimal presentation of antigen to the immune system.