HIGHLIGHTS
- The New Mexico-based biotech is taking a prodrug approach to water solubility, binding CBD to glucose molecules.
- The production method, which uses genetically modified yeast or plant cell suspension cultures, has only been validated at a small lab scale.
- Trait claims its modified CBD is safer than CBD contained in nanoemulsions, although animal testing is early stage.
No one wants to drink something that looks like salad dressing, tastes like mud and takes hours to kick in. Many cannabinoid beverages, unfortunately, fall into this category – a problem created by the fact that THC and CBD are not water soluble, making infused drinks aesthetically unappealing and slow to absorb into the bloodstream.
Trait Biosciences Inc., a biotech lab in New Mexico backed by Canadian venture capital, is claiming to have solved the problem, at least for CBD. Unlike most other companies making similar claims, Trait’s method does not use nanoemulsion technology, which involves encapsulating cannabinoids within oil-based nano-particles to increase their water solubility. Trait is taking a prodrug approach, altering the CBD molecule itself by attaching it to a more water-soluble glucose molecule. A prodrug is a compound that metabolizes into an active pharmacological drug after it’s administered.
“It’s actually a chemical bond, so it’s a modified CBD,” explained Trait’s chief science officer Richard Sayre, a former Ohio State University professor and former director of the Donald Danforth Plant Science Center’s renewable fuel program. “In the gut flora of the human body, potentially as well as in your body, there are enzymes that will remove the sugar, and do it very efficiently, and then they regenerate the parent compound without the sugar.”
The research, which Trait is presenting this week at a Canaccord Genuity conference in California, is still relatively early stage; production methods have only been validated on a small scale, Dr. Sayre said, and research into the physiological effects of the Glucose-CBD molecule is just getting started in animal trials.
"We've proven the bio-molecular process… now we’re looking at onset time and metabolism,” he said, noting that the company has filed dozens of patents around the production process.
Dr. Sayre says his team has developed a method of binding glucose to CBD using genetically modified yeast cultures as well as a type of non-GMO plant cell suspension culture: "These are undifferentiated plant cells that continuously divide in the growth media, like in a fermentor. What we do is we add the cannabinoids to those clumps of cells, and they process them and make the water soluble form.”
The resulting substance is colourless, odorless, tasteless, and shelf-stable, Dr. Sayre said.
Trait isn’t the only company taking a prodrug approach. Vitality Biopharma Inc. out of Los Angeles, is developing similar glucose-binding approach for CBD, but is using a different production method, according to Dr. Sayre. “We do it in living organisms, they do outside in a non-living organism,” he said.
According to Vitality’s website,“Vitality has filed intellectual property applications and is seeking worldwide patent protection through 2035 with strong composition of matter claims for prodrugs of THC, CBD, and CBDV, as well as for its proprietary prodrug biosynthesis platform utilizing enzymatic glycosylation.”
Although Trait has produced limited data on how CBD prodrugs interact with the human body, it is already pitching it as a safer alternative to nanoemulsion based solutions. This is based on a general, though not necessarily substantiated, concern about using various nanotechnologies in foods.
While nanoemulsions are used in a variety of mainstream drug-delivery systems, Dr. Sayre said he has concerns about the quantity of nanoemulsion particles that would be entering the bloodstream if consumed in a recreational beverage.
“If you’re dying from cancer or you have a serious disease, the risk associated with nanoemulsions and the small amounts that are used, is offset by the benefit of the drug-delivery system. Where our concern is, is the risk-benefit analysis of nanoemulsions at the scale of consumer beverages, which is an order of magnitude larger than drug therapy for a disease, and it’s continuous, it never ends,” Dr. Sayre said.
Trait’s next step is attracting partners and investors to help take its production technology from a small lab scale to a pilot lab scale and on to a commercial scale.
“To go to industrial or commercial scale will require additional investment to make that happen. We’re in discussion with pilot-scale contract research organizations now to do it at say a 500 litre-scale to 1000 litre-scale. We anticipate moving into that space within a month, and from there it’s generally easy to adapt to tens of thousands, if not millions of litres of scale," Dr. Sayre said.
The company has also begun discussions with several Canadian LPs and U.S. hemp companies about potential partnerships or intellectual property licensing agreements, said Trait CEO Peter McDonough, a former Diegeo and Procter & Gamble executive who joined Trait last month.
"We are positioning ourselves for licensing, or potentially as an acquisition target for any organization that really needs to beef up their science capabilities,” said Mr. McDonough. "We do have the ability now within the next six to nine months to partner with people who want to start to develop commercial product propositions for launch.”
Mark Rendell