The Food and Drug Administration (FDA) yesterday approved Adimmune Corp’s (國光生技) application to conduct phase I clinical trials of its COVID-19 candidate vaccine, making it the first in the nation to get the green light, the company said in a filing with the Taiwan Stock Exchange yesterday.
The FDA on Monday granted Adimmune conditional approval for its clinical trial application, asking it to submit additional technical data.
After complying with the request, the company received full approval yesterday, it said in a press release.
Adimmune plans to start human tests by the end of this month, after finalizing details with its trial partner, National Taiwan University Hospital (NTUH), in a few days, spokesperson Pan Fei (潘飛) told the Taipei Times by telephone.
The company’s “AdimrSC-2f vaccine” is designed to cause the body to produce antibodies against the novel coronavirus’ spike protein, which the virus uses to bind to and enter human cells.
Adimmune plans to enroll 60 to 70 healthy adult participants, who would be divided into three groups that would receive low, medium and high doses of the drug, Pan said.
Like its peer Moderna Inc, whose mRNA vaccine has entered into phase III trials, Adimmune would monitor participants to see if they show severe side effects after injection and would accordingly select two dose levels that are safer to continue testing in the later phase of testing, he said.
Adimmune would monitor the patients for four months, with plans to conduct an interim analysis in late October or early November, he added.
The trial would be conducted by NTUH’s Infectious Disease Division professor Chang Shan-chwen (張上淳), who is also the Central Epidemic Command Center’s (CECC) specialist advisory panel convener, as the government is highly concerned about the trial’s results, he said.
To speed up development of the vaccine, Adimmune intends to combine the phase II and phase III trials into a phase II/III design and run the final phase in November, subject to FDA approval, he said.
In related news, EirGenix Inc (台康生技), Panion & BF Biotech Inc (寶齡富錦) and AnTaimmu BioMed Co (安?生醫) yesterday applied to the FDA for approval of their rapid antigen tests for COVID-19, they said in stock exchange filings.
The three companies’ new test kits use antibodies to detect viruses and they can deliver results in a few minutes, compared with other types of test kits that require screening equipment and take hours to deliver results, they said.
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