On September 26th, Oneness Biotech announced that its broad-spectrum nucleic acid drug for COVID-19, SNS812, will soon apply for a grant under the "Project NextGen" program by the U.S. Biomedical Advanced Research and Development Authority (BARDA). The program, with a total grant pool of up to $5 billion, aims to accelerate international collaborations and facilitate the drug’s future market entry.
Oneness Biotech explained that "Project NextGen" is a collaboration between BARDA and the U.S. National Institute of Allergy and Infectious Diseases. It incentivizes public-private partnerships to develop new vaccines, treatments, and technologies aimed at better addressing current SARS-CoV-2 strains and preparing for future viral outbreaks.
Earlier this September, SNS812 successfully completed its Phase II clinical trials, demonstrating the most effective treatment results globally for infections caused by COVID-19 variants. As the only broad-spectrum COVID-19 treatment currently available, SNS812 meets the objectives set by Project NextGen. The trial results showed three major advantages of SNS812 over other COVID-19 drugs:
It alleviates patients' difficulty in breathing.
It restores lost senses of smell and taste.
It significantly reduces the time needed for patients to test negative for the virus.
Following these results, Oneness Biotech plans to pursue international partnerships for SNS812 and apply for financial support from BARDA. The company also intends to seek Emergency Use Authorization (EUA) from governments worldwide.
According to BARDA, three COVID-19 treatment drugs in development have already received Project NextGen funding. These include Regeneron's monoclonal antibody REGN17029, which received $326 million for its Phase I trials; ModeX Therapeutics' multispecific antibody, which secured $168 million for preclinical studies; and Vir Biotechnology's monoclonal antibody VIR-7229, which was granted $40 million.
Oneness Biotech emphasized that while many people believe the threat of COVID-19 is receding, the reality is that new virus variants emerge every three to four months, outpacing the development of current vaccines and treatments. The urgent global need is for broad-spectrum drugs that are not limited by viral mutations. In response, the U.S. Department of Health and Human Services has launched the $5 billion NextGen program to drive the development of treatments and vaccines that can "overcome COVID-19 mutations."
In the Phase II human clinical trial of SNS812 announced by Oneness Biotech in early September, genetic sequencing of all participants' viral strains demonstrated its effectiveness across various globally prevalent strains, including the JN.1, KP1-4, LB.1, BA.2, and XBB families. Notably, 90% of the cases involved highly immune-evasive variants, such as JN.1, KP1-4, and LB.1, confirming SNS812’s broad-spectrum efficacy against COVID-19.
Resource (mandarin): 合一新冠廣效型核酸新藥SNS812將向美國BARDA申請獎勵
