Clinic business

New Mayo Clinic venture will focus on developing new biologics

Mayo Clinic is expanding its commitment to biological medicine by launching a new collaboration with a California-based startup aimed at accelerating the development of new breakthroughs in space.

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

Many researchers see biologics – which are pharmaceuticals made from a living organism – as the next frontier in medicine. Biologic drugs are extracted in part from cells, blood, enzymes, tissues, genes or genetically modified cells.

The clinic said it aspires to “make Rochester a center for regenerative biomanufacturing technologies.”

Mayo’s effort will focus particularly on complex and rare diseases. Biologics can target specific parts of your immune system and therefore offer the promise of treating 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, which is essential for diabetic patients, was first discovered in 1921, but was reclassified as a biologic in 2020 by the United States Food and Drug Administration.

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

San Diego-based National Resilience focuses on technology to improve the biomanufacturing process. It was founded in 2020 but has already raised over $2 billion in equity funding.

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

Rahul Singhvi, CEO of Resilience, said, “Our mission is to democratize access to medicines.

Mayo and National Resilience are not forming a joint venture but will have a collaboration space in the Two Discovery Square building in downtown Rochester. They will work together on biofabrication for early-stage cell and gene therapies.

Mayo’s strength is developing a drug or biologic and moving it to early-stage clinical trials, but then it’s likely to license drugs to biotech or pharmaceutical companies.

“I really think we’re at a time where we need to be able to collaborate with industry to accelerate discovery work. I see a lot of industries and big pharma looking to be able to collaborate with health centers academics such as the Mayo Clinic,” Allickson said.

Mayo already has many organic products in the works. It has about 30 active clinical trials in regenerative biotherapy. Allickson said Mayo Clinic has 11 manufacturing clean rooms in Rochester. Mayo Clinic has additional cleanrooms in Arizona and Florida.

A report by Dublin-based Research and Markets estimated the global organics market to be worth $294 billion in 2021, which is expected to reach $502 billion by 2027. The report says growth is driven by an increase diagnosis of chronic diseases, creating demand for more advanced drugs.

Neil Schauer, owner of Schauer Biologics Consulting in Milford, Mass., has 35 years of experience in the biopharmaceutical industry. His firm 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 good example of a recognizable biologic. Another is Humira, which is used to treat arthritis and other conditions. Enbrel and Humira are injectable medications.

Boston and San Francisco are currently major hubs for emerging biologics companies, Schauer said.

A start-up will typically need around $160 million to get a drug through three rounds of clinical trials before it hits the market. It will also take up to 10 years to get through this process, Schauer said.

Complex and rare diseases present their own challenges.

“The challenge with [complex and rare diseases] is that it is sometimes difficult for the industry to move forward to treat these disorders where there is only a small patient population,” Allickson said. “But at the Mayo Clinic, we have that opportunity.

Mayo itself can produce biologics on a small scale for a small group of patients.

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

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