Proprietary method of producing CRM197 will be used to develop affordable vaccines for children and adults in developing nations
Rockville, MD., November 4, 2020– Fina Biosolutions LLC (“FinaBio”) is very pleased to announce that the European Patent Office has granted FinaBio EP Patent No. 3099800, a patent directed to the expression and purification of the conjugate vaccine protein CRM197 in E.coli.
“Our goal is to lower the vaccine cost barrier and grant people in need access to life-saving vaccines”, said Dr. Andrew Lees, Founder and CEO of FinaBio. “We are pleased to announce that we succeeded in creating a needed vaccine protein, CRM197, in an efficient and cost-effective way. Our proprietary method of production will facilitate the availability of vaccines to protect adults and children in developing countries from pneumonia, meningitis and more.”
CRM197 is a key component of many vaccine formulations utilized worldwide. Fina Biosolutions markets CRM197 under the tradename EcoCRM®, for E. coli CRM197. The company has executed several license agreements ensuring access to EcoCRM® for use in low income countries; several vaccines using EcoCRM® are in clinical development. EcoCRM® is available for licensing and has been evaluated extensively in preclinical studies, including vaccines for infectious diseases, cancer, addiction treatment and Alzheimer’s disease. The grant of this European Patent follows the issuance of corresponding Patents in the Australia (AU 2015/210674), China (CN 201580018271.2), New Zealand (NZ 722505), South Africa (ZA 2016/05384), and the United States (US 10,093,704 and US 10,597,664).
Prior to FinaBio’s new method of production, the CRM197 protein was manufactured by Corynebacterium diphtheriae at low yields or was available commercially only at high cost. Limited access to the protein hindered vaccine development and increased vaccine production costs considerably, creating barriers to access for emerging market manufacturers. The recently granted patent is for FinaBio’s revolutionary new method of CRM197 expression, which produces the protein at very high yields without the need for Corynebacterium diphtheriae. The CRM197 manufactured by this method is soluble, properly-folded and expressed in the cytoplasm of E. coli, a bacterium commonly used in biotechnology.
With this invention, low-cost production of a valuable vaccine component is now possible and opens the door to manufacturing conjugate vaccines at lower cost.
Many vaccine components do not induce an immune response unless linked (conjugated) to a protein, such as CRM197, a genetically detoxified diphtheria toxin. CRM197 is a widely used component of conjugate vaccines, including the world’s best-selling vaccine, Prevnar13 (Pfizer’s pneumococcal vaccine). CRM197 is also a component of vaccines for Haemophilus influenzae b, meningococcal and many vaccines in development.
About Fina Biosolutions
Fina Biosolutions is a privately-owned R&D biotechnology company located in Rockville, MD. The company provides laboratory services and technology in the field of conjugate vaccines. Chemistry developed by Fina Biosolutions scientists is used in GlaxoSmithKline’s and the Serum Institute of India’s pneumococcal conjugate vaccines, Pfizer’s meningococcal conjugate vaccine and others. Fina Biosolutions and scientists collectively hold fourteen patents in the field of conjugate vaccines, with several currently used in some of the most important vaccines on the market today.
For more information, contact:
Dr. Andrew Lees