FinaBio Logo News

Fina Biosolutions and PATH Contract for Manufacturing Development and Scale-up of EcoCRM

Fina Biosolutions licenses CRM197 vaccine component to PATH for use in low-income countries

November 15, 2018 06:00 AM Eastern Standard Time

ROCKVILLE, Md. – Fina Biosolutions LLC announced today it has reached agreement with PATH, a global organization focused on solving some of the world’s most pressing health challenges, under which PATH will provide funding and technical support for the clinical manufacture of FinaBio’s CRM197, known commercially as EcoCRM®. As consideration for this support, FinaBio has licensed PATH its CRM197, a key component in conjugate vaccines. Under the license, PATH receives non-exclusive rights to EcoCRM® for infectious disease vaccines sold to, or for supply to, low-income countries.

Fina Biosolutions and PATH are working together on CRM 197, an important vaccine component, to develop vaccines for low income countries.

CRM197 may form a critical component of several important vaccines PATH is supporting against life threatening diseases such pneumonia and meningitis. Consequently, this partnership will support the development of low-cost, critical vaccines, while FinaBio retains worldwide rights to commercialize EcoCRM®, including exclusive rights outside low income countries and non-infectious disease indications.

“We are pleased to reach this agreement with PATH which advances EcoCRM® to good manufacturing practice (GMP) production and promotes the development of affordable vaccines for low-income countries a key tenet of our company mission,” FinaBio CEO Andrew Lees said. “We look forward to producing clinical grade CRM197 as we believe there is a substantial unmet demand for it if priced appropriately.”

“This agreement will allow us to support the development of urgently needed vaccines,” Mark Alderson, director of PATH’s pneumococcus, meningitis, and group B Streptococcus projects said. “It’s just one example of how public-private partnerships can save lives and foster commercial development at the same time.”

FinaBio’s unique pricing model has reduced the cost of CRM197 by as much as 80%, enabling researchers and developers to produce critical vaccines at a lower cost.

About Fina Biosolutions LLC

Fina Biosolutions (Rockville, MD) is a privately held company providing technology, laboratory, and consulting services in the field of conjugate vaccines. Chemistry developed by Fina Biosolutions’ scientists is used by GSK (Synflorix) and Pfizer (Nimenrix), among others. Fina Biosolutions developed an E. coli expression system that produces a significantly higher yield of CRM197 than achieved with current methods. The method is covered by US Patent 10093704 and others.

FinaBio markets its CRM197 under the tradename, EcoCRM®, for “E. coli CRM.” Fina Biosolutions’ mission is to promote the development of conjugate vaccines.

About CRM 197

CRM197 is a genetically detoxified diphtheria toxin widely used in vaccines for pneumococcal and meningococcal diseases, as well as many vaccines currently in development, including Group B StreptococcusSalmonellaKlebsiella, and malaria. It is used in Pfizer’s pneumococcal vaccine Prevnar 13, the world’s bestselling vaccine and the only pneumococcal conjugate vaccine licensed in the United States. As a component in these vaccines, CRM197 is chemically linked (“conjugated”) to the antigen of interest to induce a better immune response to the antigen. Conjugate vaccines are among the most complex and expensive pediatric vaccines produced today.

Please enter your details to download the PDF