CSIR’s Institute Plans to Seek Emergency Approval by Dec for Horse-based Antibody Therapy to Rein In Covid

The Hyderabad-based Centre for Cellular and Molecular Biology (CCMB) is planning to seek emergency-use approval for its horse-based antibody therapy for Covid treatment within the next two months, its chief told News18.com. The CCMB, a fundamental life science research institute, works under the aegis of the Council of Scientific and Industrial Research (CSIR) — an autonomous body established by the Government of India.

Known as fragment-based therapeutic antibody treatment, these antibodies are raised in horses using inactivated coronavirus, which are fractionated and purified to produce antibody fragments for neutralising the virus in the patients for recovery.

The therapy — on which CCMB is working in collaboration with VINS Bioproducts, which manufactures equine-based immunoglobulins — is in the advanced stages of phase I/II trials.

‘Data looks promising’

“While the cases of Covid-19 have been going down and it’s difficult to complete the trials within a stipulated time frame, we expect to submit the data of phase II trials before the drug controller general of India (DCGI) in the next one or two months and may seek emergency-usage approvals,” Dr Rakesh Mishra, director, CCMB, told News18.com. “It will depend on experts at regulatory authorities including DCGI to take a call on whether the therapy can be given emergency approval while phase III can continue alongside. Also, a lot may depend on the Covid-19 situation at that time.”

Mishra said that “till now, the data looks promising and we are hopeful that it will continue to show good results.”

Therapeutic antibody treatment more promising than plasma

According to experts, therapeutic antibody treatment could prove more effective and feasible than plasma therapy.

While plasma therapy has now been proven ineffective against the treatment of Covid-19, therapies using horses or other animals to generate antibodies against the SARS-CoV-2 viral antigens are expected to show efficacy.

Covid mRNA vaccine in development

The CCMB, this year, had set up an exclusive ‘RNA platform’, a facility to develop mRNA (messenger RNA) technology to be used in Covid vaccines — the same platform used in Pfizer-BioNTech and Moderna’s vaccine.

The research institute is in advanced stages of developing an mRNA vaccine against Covid-19.

“While the current effort is for use against Covid-19, in future it can be tweaked against other diseases. One of the advantages of mRNA-based vaccines or therapeutics is that once established, it can be tweaked for other purposes in a matter of a few weeks,” said Mishra.

Price factor

The objective, the CCMB chief says, is to manufacture cheaper priced mRNA technology that can help reduce vaccine inequality across the globe.

The Pfizer-BioNTech coronavirus vaccine, for instance, was priced $19.5 (Rs 1,423) per dose in the United States, and around $21 (Rs 1,532) a dose in the United Kingdom.

“This is relatively new technology and for several reasons more expensive. Our effort is to make it affordable and, thereby, be a viable option for the population,” Mishra said.

The CCMB chief explained that there are three main stages in the making of mRNA vaccines — designing vaccines, synthesis/purification of stabilised mRNA and, finally, the formulations like lipid nanoparticles (LNP).

“We are in the advanced at the second stage and once completed, which we expect in the next 3 to 6 months, the product is likely to enter animal testing stage for its safety and toxicity estimation,” he said.

While the institute was in talks with Moderna to manufacture the American biotechnology firm’s vaccine in India, the discussions haven’t progressed yet.

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