FM DECEMBER 2018 ISSUE - digital edition

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“We hope to start manufacturing
bNAb combos early next year”
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, antibodybased
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 coldchain
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 visa-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.
dollar for a day's pills pack. Significantly, the majority of people
suffering from the HIV disease are located in the regions of the
world where affordability and accessibility are abysmally low.
Hence, the success of the therapy hinges on how promptly it
can be made available across the globe, particularly in places
where HIV infection rates remain unacceptably high.
In October, International AIDS Vaccine Initiative (IAVI)
announced collaboration with SII to develop large-scale, lowcost
manufacturing of antibody-based HIV products. Currently,
the world’s largest vaccine producer, SII supplies vaccines to
over 160 countries in the world.
The goal is to enable the most promising antibodies to be
developed in the most promising combinations to maximize
chances of success, according to IAVI. The collaboration
between IAVI and SII brings together partners with
complementary expertise to expedite the introduction of the
drugs to regions with the highest disease burden.
The efficacy of antibody prophylaxis in blocking HIV
infection, however, is yet to be ascertained. The bNAb
researchers believe that these antibodies have the potential
to not only treat HIV but also prevent the infection. Presently,
pre-emptive antiretroviral medication is available for high-risk
groups. Compliance is a big issue with this kind of prophylaxis,
which requires daily dosing. Long-acting HIV bNAbs could
22 / FUTURE MEDICINE / DECEMBER 2018