“We hope to start manufacturing bNAb combos early next year”

January 14, 2019 0 By S Harachand

Adar Poonawalla is the chief executive officer of Serum Institute of India (SII). Headquartered in Pune, western India, SII is currently the world’s largest vaccine manufacturer by the number of doses produced. In October, the International AIDS Vaccine Initiative (IAVI) and SII announced a partnership to develop and manufacture affordable and accessible monoclonal antibody products for HIV. Mr Poonawalla shared his views on the collaboration with FM. Excerpts:

Serum Institute has joined hands with IAVI to produce bNAbs against HIV. Can you elaborate on the nature and scope of the agreement?
Through this partnership, SIL and IAVI are committed to the development of accessible, low-cost, antibody-based therapeutics for HIV and other global health challenges (e.g., snake bite and anti-microbial resistance) and to enable global access to the same. Leveraging the joint ability of discovery, development and manufacturing with IAVI and SIL through their individual or joint investments and complementary roles and responsibilities will ensure appropriate selection, development and low-cost manufacturing, while delivering a formulation that meets end-user needs via Serum Institute’s established cold-chain mechanisms that currently deliver vaccines to over 160 countries, including LMICs.

In what way are bNAbs going to help in bringing down the HIV numbers vis-a-vis ART? Have SII and IAVI identified any potential bNAbs for development?
bNAbs have demonstrated a significant potential in neutralizing several strains of HIV. They are currently being evaluated as potent tools for disease prevention and vaccine design. Due to their ability to suppress and prevent viral rebound, studies are ongoing to evaluate their use as a passive immunotherapeutic agent. They are also being evaluated for treatment when administered alone or concomitantly with ART.
Researchers at IAVI have identified a few bNAbs that are both potent and broadly neutralizing against a majority of the HIV strains circulating globally. Through these antibodies of IAVI and others, that we as partners will identify, we shall be looking at creating an innovative combination that would have the most potent response against HIV. It is our hope to initiate the manufacturing of these combinations of antibodies through a platform approach by early next year.

The production of monoclonals is highly resource-intensive. And the prevalence rate of HIV infection is rather high in the regions of the world where the accessibility and affordability are poor. How will the agreement IAVI help to address this?
In addition to investments in discovery, development and production technologies, SIL and IAVI shall implement an integrated business approach mapped to regional needs and preferences, through this agreement. We shall engage with other relevant agencies in the country and globally for facilitating policy, financial, and implementation support to promote the effort of making the product widely available and affordable for HIV disease management.

What other programmes/initiatives does SII have to deal with HIV?
SIIPL is in advanced clinical development of r-BCG, which will play a key role in [controlling] TB in HIV-exposed population.