New Mayo Clinic venture to focus on developing new biologics

Mayo Clinic is expanding its commitment to biological medicine by partnering with a California-based startup focused on accelerating the development of new breakthroughs in space.

The initiative with National Resilience Inc. includes a collaborative lab space in Rochester, a combined effort to attract biotech companies to sponsor clinical trials of biologics at Mayo Clinic, and a potential future business incubator.

Many researchers consider biologics — drugs made from a living organism — to be the next frontier in medicine. Biological medicines are partially extracted from cells, blood, enzymes, tissues, genes or genetically engineered cells.

The clinic said it aims to “establish Rochester as a center for bioproduction of regenerative technologies.”

Mayo’s efforts will have a special focus on complex and rare diseases. Biologics can target specific parts of your immune system and therefore hold promise to target conditions that would otherwise be difficult to treat.

Gene therapy and cell therapy are two well-known examples. Biologics are increasingly being used to treat cancer because they can attack specific cancer cells. Insulin, essential for diabetic patients, was first discovered in 1921, but was reclassified as organic by the US Food and Drug Administration in 2020.

“We don’t just want to treat (patients) for the rest of their lives,” said Julie Allickson, the family director of Michael S. and Mary Sue Shannon of Mayo Clinic’s Center for Regenerative Medicine. “We may have the potential with the biologics to cure them.”

San Diego-based National Resilience focuses on technology to improve the bioproduction process. It was founded in 2020 but has already raised more than $2 billion in equity financing.

The startup has 11 facilities in North America with more than 1 million square feet of production space and more than 1,600 employees.

Rahul Singhvi, CEO of Resilience, said: “Our mission is to democratize access to medicine.”

Mayo and National Resilience will not form a joint venture, but will have a collaborative space in the Two Discovery Square building in downtown Rochester. They will collaborate on biomanufacturing for early stage cell and gene therapy.

Mayo’s strength is developing a drug or biological and getting it into early stage clinical trials, but then it would probably license drugs to biotech or pharmaceutical companies.

“I really think we’re at the point where we need to be able to partner with industry to accelerate discovery work. I see a lot of industry and Big Pharma looking to partner with academic health centers like Mayo Clinic,” said Allickson.

Mayo already has numerous biologics in the pipeline. It has about 30 active clinical trials in regenerative biotherapeutics. Allickson said Mayo Clinic has 11 manufacturing cleanrooms in Rochester. Mayo Clinic has additional cleanrooms in both Arizona and Florida.

A report by Dublin-based Research and Markets estimated the global biologics market at $294 billion in 2021, expected to grow to $502 billion by 2027. The report said the growth is being driven by an increase in diagnosis. of chronic diseases, creating a demand for more advanced medicines.

Neil Schauer, owner of Schauer Biologics Consulting in Milford, Massachusetts, has 35 years of experience in the biopharmaceutical industry. His company works with startups in the field.

“The potential is huge,” Schauer said of the medical possibilities of biologics.

Schauer cited Enbrel, a drug to treat rheumatoid arthritis made by California-based Amgen, as a prime example of a recognizable biologic. Another is Humira, which is used to treat arthritis and other conditions. Both Enbrel and Humira are injectable medications.

Boston and San Francisco are currently the top hubs for emerging organic companies, Schauer said.

A startup company generally needs about $160 million to put a drug through three rounds of clinical trials before launching it on the market. It will also take up to 10 years to get through that process, Schauer said.

Complex and rare diseases bring their own challenges.

“The challenge with [complex and rare diseases] is that sometimes it’s hard for the industry to move forward to treat those conditions where there’s only a small population of patients,” Allickson said. “But at the Mayo Clinic, we have that opportunity.”

Mayo itself can produce biological products on a small scale for a smaller group of patients.

Frank Jaskulke, vice president of intelligence for the Medical Alley Association trade group, said Minnesota doesn’t have many companies working to develop new biologics.

“It’s a big, big opportunity for the region,” Jaskulke said.

Leave a Comment