Andrew J. Storaska, a Patent Agent and Scientific Advisor at Rothwell Figg, is experienced in a wide variety of patent law matters, including patent prosecution in the chemical, pharmaceutical, and biotechnology arts. In his current role, he handles various aspects of patent prosecution, conducts prior art searches, and performs patent landscape analysis.
During his postdoctoral research at the Cornell Medical College (New York, NY) and New York University School of Medicine (New York, NY), Dr. Storaska focused on neuroscience, investigating the molecular connections between oncogenic signaling pathways and stem cell transcriptional networks in brain tumor stem cells. Part of this work included the evaluation of FDA-approved small molecule drugs for anti-glioma effects on the stem cell phenotypes of brain tumor stem cells. Dr. Storaska also gained experience working on a human stem cell-derived cerebral organoid model of the human brain for use in cancer research.
Over the course of his doctoral work, Dr. Storaska managed several small molecule screening projects focused on identifying and developing inhibitors of protein-protein interactions. He collaborated with medicinal chemists on chemical optimization steps using a broad range of biochemical and biophysical approaches to characterize protein-small molecule interactions.
The author of many published articles, Dr. Storaska also served as a research assistant in biochemistry and biophysics at the University of Maryland (College Park), and as a chemical toxicology intern at Leadscope, Inc. and the U.S. Food and Drug Administration.
Dr. Storaska is a registered patent agent with the USPTO.
In Part I of this three-part series, we focused on three market players: BioNTech, Moderna and CureVac. In this second post, we will focus on Translate BIO, Arcturus Therapeutics, and eTheRNA and discuss certain issues relating to lipid nanoparticle (LNP) delivery technology. Translate Bio, Inc. (NASDAQ: TBIO) is headquartered in Lexington, MA, and as of April 2021, has a market capitalization of over $1.3 billion. According to its website, Translate BIO’s mRNA product pipeline is directed to several indications including cystic fibrosis, primary ciliary dyskinesia, pulmonary arterial hypertension, COVID-19, influenza, viral pathogens, and bacterial pathogens. The company does not presently have any products on the market. However, it has one cystic fibrosis candidate and one COVID-19 vaccine candidate (with Sanofi) that are both in Phase 1/2 clinical trials. Translate BIO also appears to have one infectious disease candidate in the “IND-enabling” Phase (with Sanofi), and three lung candidates, one liver candidate, and two infectious disease candidates (with Sanofi) in the discovery phase.
Shortly after we posted about Moderna, Inc.’s October 2020 pledge not to enforce its COVID-19-related patents during the pandemic, the United States Food & Drug Administration (FDA) granted emergency regulatory approval for two COVID-19 vaccines produced by Moderna and BioNTech (with Pfizer), making these groups the first to ever enter the commercial market with mRNA-based therapies. This little-known and never-before-approved mRNA technology has since been widely administered and represents a primary weapon being used to defeat the pandemic. While this effort carries on, market players are confident that COVID-19 is but one of many indications that the mRNA technology platform might be utilized for, and that approval of the mRNA vaccines could open the door for the approval of other mRNA-based medicines, creating a wide range of new markets. With the anticipated increase in market activity and competition, we will provide an overview of the mRNA IP and competitive landscape in a series of three posts in the context of certain key players’ patent positions, drug pipelines, strategic relationships, and other attributes. These posts are based on publicly available information, are non-exhaustive, and do not identify all market players or potential market players in this space.