In the early days of the Covid-19 global pandemic, scientists scrambled to understand its nature, transmissibility, identify and create defense mechanisms including therapies and vaccines.
Leaning on Drug Innovation Ventures at Emory’s (DRIVE’s) focus and years of research and development of broad-spectrum, early stage drug candidates intended to combat viral diseases of global concerns, British regulators approved the use of molnupiravir, the first antiviral pill approved for the treatment of SARS-CoV-2.
A relay race to the finish, the first leg of the race to develop an oral therapy for Covid-19 was actually more of a marathon.
The first major challenge was funding the discovery and development effort. “The commercial biotech industry won’t spend resources to develop therapies for a disease and a market that doesn’t exist,” DRIVE CIPO David Perryman told us. “We had to find funding for our broad spectrum antiviral research and the U.S. Government came to the rescue.”[Paul, I moved this and added context]
“Over the course of eight years we focused on oral broad-spectrum antivirals for existing as well as yet-to-surface high risk viruses. It took a lot of work to find high potential drugs, but we ultimately focused on molnupirovir – known earlier by the internal identification code EIDD-2801,” Perryman said. “It was a massive undertaking, but against all odds we were able to advance the drug to the verge of clinical testing just as SARS-CoV-2 was emerging.
“The research that lead to the discovery and development of molnupiravir, now a key tool in fighting COVID-19, originated from [DRIVE CEO and Director of the Emory Institute for Drug Development, George Painter III, PhD] and his team’s search to find compounds that interfered with the replication of Venezuelan Equine Encephalitis Viruses, a virus that had been weaponized during the cold war. The compound (EIDD-2801), though, proved to have much broader efficacy, including activity against highly pathogenic coronaviruses such as the original SARS-CoV and its distant relative, Middle East respiratory syndrome (MERS) virus. With an original goal to use EIDD-2801/molnupiravir to treat influenza, Painter and his team were able to quickly redirect their efforts to address COVID-19.
From the Emory University News Center, “In January 2020, [George] Painter met Wendy Holman, CEO and co-founder of the company Ridgeback Biotherapeutics. She and her husband, Wayne Holman, had experience developing an antibody against Ebola and were eager to contribute to the fight against COVID-19. With the extensive data that Emory scientists and DRIVE’s collaborators accumulated on the activity of the drug in animal models with viral diseases, Ridgeback was able to obtain FDA approval for phase 1 testing in humans. DRIVE and Ridgeback announced a collaboration in March 2020 to move EIDD-2801 into clinical trials, with Ridgeback licensing the technology from DRIVE.”
Continuing from Emory News, “In early October , Merck and Ridgeback Biotherapeutics, which developed the drug after licensing it from DRIVE, reported that a Phase 3 study showed that molnupiravir [commercially dubbed ‘Lagevrio’] significantly reduced the risk of hospitalization or death in patients with mild to moderate COVID-19.
“In December, 2021, the FDA issued an emergency use authorization (EUA) for molnupiravir for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19.”
DRIVE was created in 2012 as a non-profit conduit for translating university based research into commercialization opportunities critical to making therapies available to patients worldwide. Less than ten years later, it had an authorized drug helping save lives during the COVID pandemic.
“DRIVE is still a not-for-profit entity, hyper-focused on infectious diseases, and seeking to anticipate pandemics or viral disease outbreaks, be they of natural evolution, lab escape or unleashed humans with bad intentions,” Perryman told us. “Our goal today is the same as it’s been since our inception: to address viruses of global concern and get a series of broad spectrum drugs on the shelf that can anticipate pandemics so that whatever viruses emerge, we have an effective proactive pill to minimize the harm to human life and to world economies.
According to Perryman, Ridgeback sold $3.2 billion in molnupiravir (fueled by advance government contracts) in Q1 2022.
DRIVE Awarded First Southeast Life Sciences Breakthough Award at AdvanSE 2022
At the 2022 edition of AdvanSE, Southeast Life Science’s (SLS) flagship event, DRIVE’s Painter and Perryman were presented with the first SLS Breakthrough Award for the most commercially significant product launched in the past year.
Where is the opportunity for others to learn from DRIVE’s experience. We’ll let Perryman’s words speak for themselves.
“There’s an old lesson that tends to come later in life. What’s critical is to focus on something the world really needs, not what you think it needs, but what doctors and caregivers are telling you they need.
“When demand for your technology is validated, or very nearly validated, form a team among the very best in that technology’s field of opportunity.
“Then, ensure every member of that team is perfectly aligned on the goals and focus, focus, focus. Do not get distracted.
“There will always be a need to spend time on financing, for example, but many high performing scientists, innovators and aspiring leaders can be easily distracted by many other activities that seem to merit their attention, but actually distract from achievement of the primary goal. When that becomes true, successful achievement of the ultimate need and goal diminishes.
“Find and engage the best in finance, legal counsel, science and business development and keep them laser focused on how and why their expertise contributes to a very specific goal.”
The team at Southeast Life Sciences thanks the DRIVE team for their remarkable contributions to global health, the southeastern United States’ life science ecosystem and Mr. Perryman for taking the time to share his insights with us here.
Emory University formed DRIVE to advance the development of early-stage drug candidates to address viral diseases of global concern. DRIVE has a leadership team with deep industry experience and applies an entrepreneurial mindset and the focus of a biotechnology company to address the world’s need for therapies that address pandemics, an area that for-profit companies have historically neglected. By taking advantage of Emory’s renowned research enterprise, DRIVE increases the probability that promising drugs will be developed for the ultimate benefit of humanity.
About Southeast Life Sciences
Southeast Life Sciences is dedicated to the growth of the life sciences industry. It was formed in 2019 through the merger of Southeast BIO and the Southeast Medical Device Association (SEMDA). Our mission is to cultivate, convene, and connect the Southeast entrepreneurial ecosystem to foster life science innovation & investment across the region for the greater good.
We facilitate connections, conversations and capital investments through continuous networking, education and funding opportunities for life-science innovators of all shapes and sizes. We are the proud creator and producer of the AdvanSE Life Sciences Conference, an annual gathering of the most innovative life sciences companies, researchers and discriminating, accomplished investors and corporations that want to do business with them.