SAN DIEGO — In a collaboration that could lead to a new class of drugs to replace opioids and help fight the national opioid epidemic, Renew Biopharma today announced it is collaborating with Ken Mackie from the Indiana University (Bloomington) Gill Center for Biomolecular Science to help screen and develop human therapeutics using Renew’s natural and novel cannabinoid molecules in a pre-clinical drug discovery program.

The program will explore – for the first time – the efficacy of numerous molecules for medications across a wide variety of possible indications, from pain management to epilepsy and various neurodegenerative diseases.

Many of the Renew-produced molecules have not been explored before because they occur in very limited quantities in the Cannabis plant. Instead of using Cannabis plants, Renew’s microbial biosynthetic platform can produce these natural and novel cannabinoid molecules in industrial microorganisms, including microalgae, a single-cell plant suspended in liquid.

Before Renew’s platform, achieving molecular purity without contamination from THC that might impart psychoactivity or other unwanted consequences was practically unattainable.

Renew also brings to the collaboration dominating intellectual property and unique expertise. The company has been assigned or has licenses for more than 110 issued patents to produce cannabinoids in microalgae.  Microalgae was earlier cultivated at massive scale in the context of the biofuel industry.  Michael Mendez, Renew’s CEO and co-founder, led the microalgae biofuel effort as co-founder of Sapphire Energy.

At Renew, cannabinoid production follows pharmaceutical industry accepted practices at unprecedented scale, under strict controls without the carbon footprint caused by agriculturally-grown Cannabis plants.

Renew also announced the appointment of Gill Chair Dr. Ken Mackie as a member of Renew’s Scientific Advisory Board, effective immediately.

“Dr. Mackie and the Gill Center are world renowned for their understanding of the endocannabinoid system. They bring a level of sophistication and critical scientific thinking to this space, allowing us to go from cell-based screening to preclinical models, all under one partnership,” said Mendez.

“Together we will bring cannabinoids as API’s (active pharmaceutical ingredients) to the forefront of human therapeutics. We expect this work to ultimately lead to significant improvements in human health, which is our company’s most important goal,” Mendez continued.

“Our synthetic biology platform will be able to produce any of the (at least) 144 known cannabinoids in quantities and purity that Cannabis plants cannot produce.  This represents a bold step in moving these molecules beyond the plants and into human clinical trials. The Gill Center’s ability to test the efficacy of these natural and novel molecules across a wide range of cell-based and preclinical models is truly unprecedented.”

Dr. Mackie said: “I couldn’t be more excited to work with a synthetic biology company like Renew because they can deliver conventional and novel cannabinoid molecules in amounts and purity for potential human therapeutics in a completely new and innovative way. Renew is opening up an entire new pipeline of API’s for drug discovery that can interact with the endocannabinoid system. The cannabinoid space as it relates to big pharma has been plagued for decades by the stigma surrounding marijuana plants and other synthetics, but now, for the first time in a GMP (good manufacturing practices) environment, we can use the natural and novel molecules that Renew will supply to explore the possibilities for an entire new category of medicines that I’m certain will benefit human health.”

“I am honored to not only work with Renew in my capacity as a Gill Chair, but also to join their Scientific Advisory Board, where I hope to bring my particular expertise to this unique company. I am thrilled to work with Dr. Joe Noel, of the Salk Institute for Biological Studies, and Dr. Mike Burkart of University of California San Diego, both co-founders and SAB members of Renew,” Dr. Mackie continued.

About Renew:

Renew Biopharma (www.RenewBiopharma.com) is a Delaware C Corporation based in San Diego, California, focused on creating a pipeline of 100 percent pure, uncontaminated and non-psychoactive cannabinoids in quantities large enough to enable human therapeutic breakthroughs and improve human health globally. As a synthetic biology company, Renew relies on molecular biology and pathway engineering instead of using agriculturally-grown, energy-intensive Cannabis plants. (Plants simply cannot produce many of the most desirable cannabinoids in sufficient quantities, nor can they produce cost-efficient cannabinoids free of undesirable contaminants – from psychoactive THC to pesticides, molds, bacteria and other pathogens.) While Renew’s focus is strictly on human health, the legalization of medical and recreational Cannabis (the original source of cannabinoid molecules) across the United States (and soon in Canada) has caused a seismic shift in interest and acceptance. Renew is poised to unlock a multi-billion-dollar pharmaceutical sector based on a proprietary family of pharmacological chemical compounds — cannabinoids — specifically starting with pure forms of CBG (cannabigerol) and CBD (cannabidiol) and later including many novel cannabinoids that are potential breakthrough molecules that have previously shown promise as human therapeutics. Renew’s intellectual property portfolio is the result of more than a decade of academic and private-sector research for industrial applications.  Renew has exclusive access to novel tools for synthetic biology and genetic engineering of microorganisms for the production of natural and novel cannabinoids at industrial scale. Renew’s dominating IP in this space includes both specific genes in the biosynthesis of cannabinoids and the ability to engineer a synthetic cannabinoid pathway into microorganisms, including microalgae. The cannabinoid pathway has evolved for millions of years in the Cannabis plant, and the best way to express this pathway outside of the Cannabis plant is in another plant, such as microalgae.

About The Gill Center for Biomolecular Science at Indiana University Bloomington and Professor Mackie:

The Gill Center was established to advance the understanding of complex biological processes and to train the next-generation of neuroscientists. It consists of five Gill Chairs and their research labs. A particular focus of Dr. Mackie’s team in the Gill Center are cannabinoid receptors, the cellular receptors responsible for most of the psychoactive and therapeutic actions of Cannabis. His group uses a variety of techniques, including electrophysiological, molecular biology, immunological, and imaging, to better understand how cannabinoid receptors signal and how their signaling interacts with other cellular processes. Much of the current work in his lab centers on how phytocannabinoids interact with cannabinoid receptors, such as the ability of cannabidiol (CBD) to counteract the detrimental neurodevelopmental consequences of THC. His team is deeply involved in pre-clinical and clinical drug discovery as cannabinoids have an effect on processes as diverse as memory, analgesia, anxiety, schizophrenia, and obesity. The few phytocannabinoids that have been studied to date (mainly THC and CBD) have demonstrated developing success in no less than 50 ongoing clinical trials internationally.

Forward-looking Statements:

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