Renew Biopharma today announced that the United States Patent and Trademark Office (USPTO) has granted powerful patent claims on the landmark patent application (WO2019183152) relating to the rational-based engineering of a key enzyme that is most efficient for large-scale microbial cannabinoid biosynthesis (i.e. NphB). This key enzyme produces CBGA and CBG, the precursors to most cannabinoids (including THC and CBD).
Renew is a pre-clinical startup drug company developing new, proprietary small molecules using its proprietary drug discovery platform to improve human health — focused particularly on neurotherapeutics.
While some biosynthesis companies have employed different (prenyltransferase) enzymes derived from the Cannabis plant, these plant-derived enzymes are suboptimal for microbial production.
Renew, meanwhile, has engineered NphB to outperform the plant enzymes by orders of magnitude.
The newly granted patent claims provide exclusive rights to employ the best-known, non-natural amino acid substitutions to NphB. Specifically, for example, amino acid substitutions at site 161 (which are now recognized to be powerful for unlocking the remarkable potential of NphB) are included in the granted claims. Overall, these engineered enzymes will have a significant impact on the efficiency, scale-up and profitability of commercial manufacturing of cannabinoids by fermentation.
While several biosynthesis competitors have also converged on similar engineered variants of NphB in their own recent patent applications, Renew’s claims to amino acid substitutions in NphB are the first to be granted by the USPTO for this critical enzyme, thus setting an intellectual property milestone and precedent for cannabinoid biosynthesis commercialization.
Renew’s own research and development program utilizes these same powerful enzymes to create a pipeline of novel cannabinoid molecules that cross the blood-brain barrier and engage specific receptors (not CB1/CB2) in the brain to decrease neuroinflammation that is common to numerous neurological diseases.
Renew’s licensed partners will utilize these enzymes for high-efficiency production of CBGA and other natural molecules to give them a significant market advantage for microbial biosynthesis. Accordingly, Renew has established non-exclusive licensing agreements with two external companies (their identities to be announced at a later date) for biosynthesis of natural molecules including CBGA. This secures the benefit of freedom to operate with best-in-class enzymes to accelerate a path to full-scale commercialization of microbial cannabinoids by biosynthesis. Renew sees potential for additional licensing opportunities for biosynthesis, specifically in yeast.
“In this young field of cannabinoid biosynthesis, few patents have been granted while many companies have invested significant time and money to engineer this key enzyme,” said Michael Mendez, Renew CEO. “It is remarkable that these companies have arrived at similar conclusions on the importance of this particular enzyme. The allowance of the Renew patent with powerful patent claims, establishes our company as a leader in this intellectual property space and provides a clear path to licensing our technology.”
About Renew Biopharma
Renew Biopharma (www.RenewBiopharma.com), a startup biotech company based in San Diego, is focused on creating therapeutics for neuroinflammatory diseases. Renew has built a drug discovery platform using synthetic biology and advanced enzyme engineering to create a pipeline of novel molecules that are alkylresorcinol derivatives (similar to CBGA). These small molecule derivatives naturally cross the blood-brain barrier, are non-psychotropic and engage specific drug target receptors with high efficacy. The company’s intellectual property includes broad claims for libraries of engineered enzymes that enable the creation and large-scale production of novel therapeutic molecules.