Bharat Serums and Vaccines has initiated a research project to co-develop an equine polyclonal antibody, alongwith NIV, against COVID-19. The company is planning to get sufficient clinical data for regulatory submission of the equine antibody in the first half of 2021. Dr Jaby Jacob, Head-R&D, Bharat Serums and Vaccines talks about this research project and the company’s other ongoing research activities with Usha Sharma

Tell us about the ongoing research activities of Bharat Serums and Vaccines (BSV).

BSV is engaged in research projects that span multiple modalities such as recombinant proteins including monoclonal antibodies, urine-based proteins, complex drug delivery systems such as liposomal products and microspheres, and equine serum-based products.

When did you initiate the research project of developing an equine antibody and how many equines have been enrolled for the research?

Initial feasibility assessment of this research project was done in March of this year and BSV had initiated communications with the ICMR and other regulatory agencies in India to explore the possibility of co-development, fast-tracking some of the approvals that are required for initiating R&D activities, review and approval processes for pre-clinical and clinical development, etc. Development activities for the project, including procurement of antigens required for immunisation of horses, were initiated in June. Nine equines were initially enrolled for this project and additional equines will be dedicated to this project as required based on process scale-up requirements.

Has anybody initiated a similar project in India or globally?

In India, the ICMR had invited companies for co-development of this project along with NIV, Pune in May and we have expressed interest in this co-development project. Globally, similar projects have been initiated in Argentina and Brazil and in both cases, the equine polyclonal antibodies that have been developed have shown significantly higher potency in in-vitro studies of SARS-CoV-2 virus neutralisation.

What is the technology you have adopted for this equine serum-based antibody research and how promising are the results of the study?

Identifying and developing multiple therapeutic options to treat COVID-19 is required for overcoming this pandemic. While vaccines are expected to be available by late 2020 or early 2021, availability of sufficient doses for covering the masses will likely be a challenge over the next few years. The safety and tolerability of equine polyclonal antibodies as a therapeutic has been established in several cases such as anti-rabies immunoglobulins, anti-snake venom for several decades. BSV has several decades of experience in the production of these products and has successfully developed technologies for the rapid development of these products. Effective immunisation of equines to produce high antibody titers, and processing techniques to produce highly purified injectable forms of the final product have been developed by BSV.

How promising are polyclonal antibodies against monoclonal antibodies for the treatment of COVID-19?

Clinical studies of monoclonal antibody products have shown efficacy in the treatment of COVID-19 while data from clinical studies on polyclonal antibodies are not yet available. Monoclonal antibodies are designed to bind to very specific regions within the target molecule and current technologies enable the production of monoclonal antibodies that have very high binding affinities. Polyclonal antibodies are capable of binding to multiple regions within the target molecule and consequently, it is possible that they have a higher chance of interfering with pathways that allow entry of the virus into cells necessary for viral replication.

Do you have published research reports of equine polyclonal antibodies and their impact/efficacy on infectious diseases?

There are research publications from BSV and also by independent authors on equine polyclonal antibodies.

How do you plan to take this research project to the next level? By when will you be seeking the regulatory approval?

The clinical development plans are being finalised currently. We are also planning to have discussions with regulatory agencies to obtain guidance on accelerating the approval pathways for initiation of clinical studies and eventual regulatory approval. Based on our current plans, we expect to obtain sufficient clinical data for regulatory submission in the first half of 2021.

Tell us about the research candidates in BSVL’s pipeline and their stages of development?

If the question is specific to COVID-19, we do not have any other products in the pipeline. As far as equine R&D is concerned, we have a pipeline of three or four products that are in various stages of development.

Several Indian pharma companies are working to find a COVID-19 vaccine. Is BSV also involved in research collaborations to expedite the process of COVID -19 vaccines?

In addition to the research project on equine polyclonal antibody for the treatment of COVID-19, BSV is conducting a clinical study for the treatment of ARDS in COVID- 19 patients with one of our existing products U-TRYP. We are also considering a global collaboration for this product. We do not have any current collaborations on a vaccine development project.