For Immediate Release: Fina Biosolutions’ Licensee Successfully Completes a Phase 3 Study and Enters World Health Organization (WHO) Registration for Pneumosil®
Serum Institute of India completes a Phase 3 clinical trial with chemistry developed by Fina Biosolutions.
Rockville, Maryland, March 26, 2019 — 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 Biosolution 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 Biosolution 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.
Andrew Lees, Fina Biosolutions
Phone: 301 633-0464