Aurobindo Pharma hopes to submit Phase 2/3 data of UB-612 COVID-19 vaccine by July 2021

Aurobindo Pharma has said it expects to submit clinical trial data of its COVID-19 vaccine UB-612 by July this year. The drugmaker had entered into an exclusive agreement with US biotech company COVAXX in December last year to develop and manufacture UB-612 for India and UNICEF.

Aurbindo has sought permission from Indian drug regulator CDSCO to conduct Phase-2/3 trial of the vaccine candidate in India, as the animal studies and Phase I clinical trial were conducted in Taiwan.

However, the Subject Expert Committee (SEC) of CDSCO which reviewed Aurbindo's proposal on February 3 recommended that the firm should submit the Phase II/III clinical

trial protocol approved by the regulatory authority of Brazil. It also suggested some revisions to the protocol. It is not known whether Aurobindo has resubmitted its proposal or not.

"We are expecting to submit the data by July. And then we expect approval in the next financial year," said N Govindarajan, Managing Director of Aurobindo Pharma, in a recent earnings call.

Aurobindo said it is investing Rs 250-Rs 275 crore on a new facility to manufacture vaccines that would be ready by April. The company’s upcoming vaccine facility will have the capacity to manufacture 400 - 450 million doses of COVID-19 vaccines.

The company said it is exploring collaboration with potential partners who are getting ready with their products.

"If you're talking about FY '22, definitely, we expect to utilise the facility for COVID vaccine. So when I talk about contract manufacturing, after accounting for whatever our needs, whatever is the available capacity, we'll explore for the future.. and also our own arrangement with COVAXX also allows us to do some contract manufacturing for them," Govindarajan said.

Aurobindo said that it has the capabilities to manufacture most virus vector platforms, including mRNA and DNA technologies; mRNA stands for Messenger RNA.

Aurobindo has announced its own COVID-19 vaccine development programme through its US subsidiary Auro Vaccines. That vaccine, which uses a recombinant vesicular stomatitis virus (RVSV) vector platform, is being developed by Profectus BioSciences, which was acquired by Aurobindo Pharma in November last year. This vaccine is still in the pre-clinical phase.

Aurobindo has also partnered with three CSIR labs – Centre for Cellular and Molecular Biology (CCMB), Hyderabad, Institute of Medical Technology (IMTECH), Chandigarh, and the Indian Institute of Chemical Biology (IICB), Kolkata, for vaccine candidates using three different technology platforms. Aurobindo will undertake the clinical development and commercialisation of these vaccines.