(Rockville, MD, November 10, 2020) – Fina Biosolutions LLC (“FinaBio”) is pleased to announce that it has received a Certificate of Patent entitled “Expression and Purification of CRM Proteins and Related Proteins, and Protein Domains” from the European Patent Office(EPO). EP Patent No. 3099800 is 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, efficiently, and cost-effectively. FinaBio’s proprietary production method will facilitate the availability of vaccines to protect adults and children in developing countries from pneumonia, meningitis, and more.”
Prior to FinaBio’s new production method, the CRM197 protein was manufactured by Corynebacterium diphtheriae at low yields or commercially available only at a 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 CRM197 expression method, 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.
CRM197 is a critical component of many vaccine formulations utilized by pharmaceutical companies worldwide for pneumococcal, meningococcal, and other conjugate vaccines. Fina Biosolutions markets CRM197 under the tradename EcoCRM® for E. coli CRM197. The company has executed several license agreements to utilize EcoCRM® for vaccines in clinical and preclinical development and ensure access to EcoCRM® for low-income countries. EcoCRM® 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 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).
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 LLC is a privately held research and development stage biotechnology company that discovers, develops, and collaborates to commercialize novel vaccine conjugates for prevention of life-threatening diseases. FinaBio has patented novel techniques to conjugate, purify, and manufacture conjugates using its proprietary chemistry to create complex conjugate vaccines. The technology is currently licensed by leading vaccine manufacturers in both Europe and Asia, including GlaxoSmithKline for marketed vaccines Synflorix™ Menitorix™, Nimenrix™, The Serum Institute of India, Pvt., Ltd. (SIIPL) vaccine Pneumosil®, The Chengdu Institute of Biological Products Co., Ltd (CDIBP) China, and others.
For more information and licensing opportunities, please contact:
Dr. Andrew Lees
Scientific Director, Fina Biosolutions