Vaccine maker Adimmune Corp (國光生技) plans to conduct phase I clinical trials of its COVID-19 candidate vaccine next month to assess its safety, the firm said yesterday.
Adimmune expects to receive approval from the Food and Drug Administration (FDA) later this month to start trials, as the review has been going smoothly so far, Adimmune spokesman Pan Fei (潘飛) told the Taipei Times by telephone.
The vaccine provider would cooperate with National Taiwan University Hospital (NTUH) for the trials, Pan said.
The company plans to enroll 60 to 80 healthy adult participants, who would be divided into several groups and receive vaccines at different doses, to see if the experimental vaccine is safe, Pan said.
“We will monitor if there are any severe side effects to the participants and if they produce coronavirus antibodies. Based on the results of phase I trials, we will select two dose levels that show the most promise to continue with phase II clinical trials,” Pan said.
Although Minister of Health and Welfare Chen Shih-chung (陳時中) last week said that the government would allow biotechnology firms to skip phase III clinical trials of their vaccine candidates to accelerate vaccine development, Adimmune would not eschew the final phase of human trials, Pan said.
“We are considering combining phase II and phase III trials into a phase II/III design to save time and reduce the total number of test participants,” he said.
The firm still needs to discuss with the regulator the protocol for a phase II/III trial, including clinical endpoints and the number of enrolled participants, he added.
Adimmune, the nation’s largest flu vaccine provider, is a frontrunner in the local race to develop a COVID-19 vaccine, as it was the first to apply to the FDA to conduct human trials.
Its vaccine candidate, developed using the novel coronavirus’ genetic sequence and the firm’s recombinant protein technology, in an animal test in April caused laboratory mice to produce antibodies that could inhibit the growth of the coronavirus, company data showed.
The firm’s achievements have been rewarded by investors, with its stock price rising from NT$36.35 on May 6 — when it announced the results of its animal test — to NT$75.6 at the close of Taipei trading yesterday.
However, the company did not take advantage of its high stock price to raise capital, as it did not issue new common shares, but took out a NT$4.2 billion (US$142 million) syndicated loan from nine local banks to fuel research, new factories and international development.
“Taking the syndicated loan did not increase our financial burden thanks to lower interest rates while we did not want to expand the number of shares in the short term due to concerns over stock dilution,” Pan said.
Last week, Medigen Vaccine Biologics Corp (高端疫苗) applied to the FDA to run phase I human trials for its spike protein-based vaccine candidate, becoming second in the local race to produce a COVID-19 vaccine, company data showed.
Separately yesterday, Golden Biotechnology Corp (GBC, 國鼎生物科技) announced that it has gained approval from the US Food and Drug Administration to conduct phase II human trials for its small molecule drug, Antroquinonol (Hocena), as COVID-19 treatment, it said in a filing with the Taipei Exchange.
The drug, originally developed to treat pancreatic cancer, has proven safe in its phase I human trial in the US, the firm said.
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