Fina Biosolutions’ Licensee Successfully Completes a Phase 3 Study and Enters World Health Organization (WHO) Registration for Pneumosil®

March 26, 2019 Off By BusinessWire

Serum Institute of India completes a Phase 3 clinical trial with
chemistry developed by Fina Biosolutions

ROCKVILLE, Md.–(BUSINESS WIRE)–lt;a href=”https://twitter.com/hashtag/pneumococcal?src=hash” target=”_blank”gt;#pneumococcallt;/agt;–Fina Biosolutions is pleased to announce that the Serum Institute of
India Private Limited (SIIPL), has completed a Phase 3 study for
Pneumosil® a 10-valent pneumococcal conjugate vaccine, in which the
Serum Institute indicates all primary and secondary objectives were met.
Pneumosil covers over 70% of invasive pneumococcal-disease causing
serotypes and employs conjugation chemistry licensed from Fina
Biosolutions under a 2007 technology agreement.

Under the agreement with the Serum Institute, Fina Biosolutions has
received milestone payments and will receive royalties based on
world-wide sales of pneumococcal conjugate vaccines incorporating
FinaBio conjugation technology. The successful Phase 3 study and World
Health Organization (WHO) registration of Pneumosil® represents an
opportunity for Fina Biosolutions to begin to see returns from vaccine
sales.

The Serum Institute has received an export license for Pneumosil from
the Drug Controller General of India (DCGI) and has initiated the
process of World Health Organization (WHO) prequalification for
Pneumosil®, which is used by the UN and other procurement agencies to
make purchasing decisions regarding vaccines. The commercial market for
Pneumosil includes the Indian Universal Immunization Program as well as
Asian, African and other low and middle-income countries under the Gavi
Advanced Market Commitment (AMC).

“Fina Biosolutions was founded to help make conjugate vaccines more
affordable for low-income countries,” noted CEO and Scientific Director
Andrew Lees. “The cost of pneumococcal conjugate vaccines constitutes a
significant percentage of the cost of WHO-recommended childhood
vaccines. We are pleased to have provided an efficient chemistry that
contributed to reducing the cost of these complex vaccines.”

The Serum Institute has also exclusively licensed an additional
conjugation chemistry from Fina Biosolutions that is being used in a
thermostable Pentavalent Meningococcal Conjugate Vaccine (A, C, Y, W135,
X). This product will soon be starting a Phase 3 clinical trial and also
targets developing countries.

About Conjugate Vaccines

An immune response to polysaccharides (sugar polymers) on the surface of
bacteria can protect against the bacteria. However, these
polysaccharides are poorly immunogenic in infants. Chemically linking a
protein to the polysaccharide (“conjugation”) converts the sugar polymer
into form that is immunogenic. Conjugate vaccines against Haemophilus
influenzae b, Streptococcus pneumoniae and Neisseria meningiditis have
been enormously successful. Fina Biosolutions’ CEO and Scientific
Director Andrew Lees developed conjugation chemistry used by
GlaxoSmithKline for their S. pneumoniae and meningococcal conjugate
vaccines, Synflorix® and Nimenrix®, respectively. Fina Biosolutions has
licensed its conjugation technology to the Serum Institute of India, the
Chengdu Institute of Biological Products and others.

About Fina Biosolutions

Fina Biosolutions LLC is a privately held research and development
company in Rockville, Maryland providing laboratory and consulting
services in the field of conjugate vaccines. Fina Biosolutions’
principal focus is on affordable conjugate vaccines. Its scientists work
with emerging market vaccine companies to develop technology, train
scientists and assist in implementing the processes. FinaBio performs
contract conjugation for companies worldwide and has worked on projects
as disparate as vaccines for S. pneumoniae, for malaria, for drugs of
abuse and for animal health. In addition, Fina Biosolutions has
developed a patented expression system for the widely used conjugate
vaccine carrier protein, CRM197, which it markets as EcoCRM®. EcoCRM®
has been licensed to PATH for use in low-income countries.