rBIO succeeds in biomanufacturing insulin

PHARMA: Partnership with Washington University Adds Key Process

For many Type-1 diabetes patients and the health plans that cover them, the cost of insulin is a burdensome problem. And amidst a global supply chain crisis, access to insulin has only compounded the issue. San Diego-based rBIO looks to solve both problems with a novel approach to manufacturing the drug.

On May 3, the company announced it had attained commercial viability for its synthetic biology manufacturing process for insulin, potentially yielding twice the volume of insulin compared with legacy recombinant manufacturing techniques.

Coding Biology

rBIO CEO Cameron Owen said the company's origin grew from his interest in synthetic biology. “Specifically, to look at biology as a kind of coding language, but instead of ones and zeroes it's the DNA building block proteins of A, T, C, and G,” he said.

Owen applied to a few post-graduate programs to formally study his idea for a Ph.D. But they turned him down, which he said was “the best thing that ever happened” because it inspired him to turn his attention to pursuing the science's potential as a business.

Owen said he and his co-founders wrote pages of biology code into notebooks for several months with the idea of writing “life from scratch.” At a University of Nevada Reno lab, they experimented to see if what was created would be “viable life.” Owen realized the potential for the microbes he was creating to manufacture different compounds and decided on insulin as a target.

After raising seed funding, Owen and his team formed the company and commenced research into “LEGO-piecing” genetic codes into viable plasmids, and then inserting those plasmids into E. Coli-vectored systems to over-express the basic protein framework of the hormone insulin.

In 2020, the team was successfully synthesizing insulin in the lab and published their results.

A Perfect Partnership

Shortly after releasing the results of their lab work, Owen was contacted by a research group out of Washington University in St. Louis, who learned about rBIO's work and saw a synergy with its own work.

The Washington University researchers, led by Dr. Sergej Djuranovic, had discovered coding motifs used to decrease the expression of certain proteins in cancer cells. The researchers also discovered the inverse was true and that their coding could also increase expression, so Dr. Djuranovic reached out to rBIO and offered to partner in studying how rBIO's lab results could be scaled up. The two teams spent all of 2021 in research and

wrapped up testing in mid-January this year.

“The results that we saw were pretty spectacular,” Owen said. “We started with some bugs that we created and then added on the genetic tricks of Wash U and their research, and we got some microbes that can produce pharmaceutical compounds, especially insulin, at really high yields especially compared to what's been out there traditionally.”

Dr. Djuranovic described the traditional production of insulin and other recombinant proteins as “complex, expensive, and time-consuming.” “Being able to show these results opens the possibility to increase production yields and drive down the cost of certain pharmaceutical proteins,” he said. “We've begun research into other molecules of interest that may open the door to other verticals in addition to peptide hormones such as insulin.”

Other Opportunities

Owen said one of the compounds rBIO is looking at is H1N1 hemagglutinin, the spike protein in influenzas, which would be bio manufactured for vaccine makers. “Insulin is the target for the launch, given the market and the need for it, but biomanufacturing is a big thing we need more of in the United States, so I anticipate us being able to branch out by the end of this year for sure,” he said. Currently, rBIO is focused on raising capital to build out operations to manufacture insulin at scale. Owen said he is looking for rBIO to be a disruptor in the insulin space by making insulin in the U.S. for a much lower cost. He estimates that the rBIO process can lower cost by as much as 30%.

Owen said he has had “quite a bit” of investor interest but that the fundraise has only begun this month because rBIO were finalizing the details of their agreement with Washington University, which gives rBIO exclusive licensing rights. “There's never a bad time to raise money when you've got a good product and a good idea,” he said. “I'm a little biased, but I think we've got a really good product and a really good idea.” ■