HDT Bio and its partner SENAI CIMATEC have received authorisation from Brazil’s National Health Surveillance Agency (Anvisa) to conduct Phase I clinical trials of the former’s ribonucleic acid (RNA) Covid-19 vaccine, HDT-301.
The companies have collaborated to jointly develop the vaccine, which leverages HDT Bio’s LION RNA-delivery technology, in the country.
SENAI CIMATEC agreed to carry out these trials as ‘Vaccine RNA MCTI-CIMATEC-HDT’.
Under the collaboration, the company has obtained a non-exclusive licence to HDT Bio’s technology to research, produce and market HDT-301 in Brazil.
HDT Bio will offer the vaccine required to conduct Phase I, II and III trials.
The company noted that the technology transfer deal permits the complete manufacturing of the vaccine in Brazil, including the API, on concluding the trials.
These initiatives will aid in boosting jobs and vaccine availability for Brazilians, HDT Bio added.
HDT Bio CEO Steve Reed said: “This agreement with SENAI CIMATEC will help build Brazil’s own vaccine and drug manufacturing capabilities and provide the country’s population with greater access to advanced medicines.
“Our company’s unique mission is to initiate value-creating partnerships with drug manufacturers and developers in historically underserved countries as part of our sustainable global health and business strategy.”
Apart from developing therapies for Covid-19, SENAI CIMATEC will use HDT Bio’s technology for other technological and scientific developments in the country.
HDT Bio entered similar agreements to develop HDT-301 in India with Gennova Biopharmaceuticals, as well as Quratis in South Korea, and another undisclosed company in China.
Gennova concluded the Phase I trial of the Covid-19 vaccine (HGCO19) and India’s regulatory authority, Central Drugs Standard Control Organization, granted approval to commence the pivotal Phase II/III trials.
Last month, India’s Department of Biotechnology, Ministry of Science & Technology said that the Phase I data showed that the vaccine candidate was safe, tolerable and immunogenic.
Gennova noted that the company will start scaling up production capacity to meet covid-19 vaccine needs in India.
In July 2021, the US Food and Drug Administration issued a notice to HDT Bio to carry out a Phase I trial of HDT-301 in the country.
The trials of the vaccine candidate are anticipated to commence in the US and Brazil this year.