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Keirstead Plans Sale Of Aivita Biomedical

Biotech firm treats cancer, COVID-19

After being honored during the Business Journal’s Innovator of the Year Awards on Sept. 8, Dr. Hans Keirstead revealed he’s in the process of selling the current biotechnology company where he is chief executive, Irvine-based Aivita Biomedical Inc.

“I’m dealing with several buyout offers, both regional and global,” Keirstead told the Business Journal.

“We’re still looking for the right partner to sign on the dotted line.”

If completed, it will mark the latest notable exit for Keirstead, who has previously started and sold four high-tech health companies, each to larger pharmaceutical companies, while providing a return of up to 9.5 times for those companies’ financial backers.

The internationally known stem cell expert plans to next move to Immunis Inc., a new venture in Irvine he hopes will revolutionize the aging process.

A Vaccine Edge

Aivita Biomedical develops personalized vaccines against cancer and COVID-19.

On the former front, trials to treat advanced cancers are going well, Keirstead said.

Regarding COVID-19, Aivita aims to become a world leader in providing a “true” vaccine to battle the virus.

The company’s vaccine has three big advantages over the current manifestations by Pfizer and Moderna, he said.

“Don’t get me wrong,” Keirstead said. “I’m a big fan [of their vaccines]. Those two companies and the vaccines they produced have saved millions of lives.”

However, their vaccines are “transient,” meaning they wear off, he said.

By contrast, Aivita will take blood from a person and incubate an immune cell. A week later, the person will receive a vaccine injected with that immune cell.

“What we put back into you is your own immune system that is now educated against” COVID-19, he said. “No foreign protein is put into you. That’s why there are virtually no side effects.”

He said the efficacy from catching the virus is 97%.

“That is a true vaccination, and it lasts a long, long time. It works against all of the variants.”

Point of Care

Another uniqueness is that Aivita sells a kit rather than the vaccine itself, so the product is made at the point of care, he said.

The only pathogen that has been eradicated from the Earth is smallpox, he said. Although that vaccine wasn’t particularly efficacious or safe, it had one characteristic—it was made at point of care, Keirstead noted.

“Every hospital, every little clinic in the world is our manufacturing site,” he said.

The most important advantage is that rivals must store their vaccines at a temperature between minus 60 degrees Celsius and minus 90 degrees Celsius, for which many developing countries don’t have the capability.

Aivita’s vaccine is stored at 4 degrees Celsius, which means a regular refrigerator could suffice.

“I designed this vaccine for the emerging nations,” he said. “We can ship it everywhere.”
As a result, he estimates Aivita’s vaccine is the “cheapest in the world.”

“I suspect that Aivita is going to very soon be acquired either in part or whole.”
The company, whose last reported funding round was for $25 million in 2020, has completed studies for its COVID-19 vaccine in Indonesia.

Immunis on Deck

Keirstead has more than three decades of experience in regenerative medicine, including restoring function to people with quadriplegic spinal cord injuries, and a treatment for cancer that has saved the lives of people with melanoma, brain cancer and ovarian cancer.

Previously, he was a professor at the University of California, Irvine, where he founded, directed and raised the money to build the $77 million Sue and Bill Gross Stem Cell Research Center.

After he sells Aivita, Keirstead anticipates becoming CEO of Immunis, where he is currently chairman. The company thus far has raised $12 million, including a $10 million Series A round in August.

His latest company is studying how immune systems decline with age. He said every aging event in a body—from diseases affecting the brain to the heart to muscular atrophy—is related to immunity.

“I don’t like saying it’s an anti-aging company because it associates us with 99 out of 100 stories on longevity that are 100% snake oils. The longevity field is full of ridiculous lies.”

Immunis develops human stem cells that contain 690 proteins associated with naturally occurring immune levels similar to a 27-year-old, which typically is the peak age for immunity in humans.

“By giving a general booster of your immune system as healthy as it was when you were 27 years old prophylactically stops the onset of all manifestations of aging, which we haven’t shown yet in humans,” he said.

“In animal models, it stopped every
manifestation of aging that we tested.”

The FDA has approved Immunis for a Phase 1/2a trial, which will enroll up to 18 patients to assess the safety and tolerability in patients with muscle atrophy related to knee osteoarthritis. Immunis last week began recruiting patients for the trial, which will be held at the UCI Medical Center.

He predicted a relatively fast timetable of 18 months when he finishes Phase 3 trial, which is when he expects to sell the research company.

He anticipates widespread use of the booster.

“What I envisaged for this, is everyone
will get [a shot] every quarter to keep you young.”

Peter J. Brennan
Peter J. Brennan
Peter J. Brennan has been a journalist for 40 years. He spent a decade in Latin America covering wars, narcotic traffickers, earthquakes, and business. His resume includes 15 years at Bloomberg News where his headlines and articles sometimes moved the market caps of companies he covered by hundreds of millions of dollars. His articles have been published worldwide, including the New York Times and the Washington Post; he's appeared on CNN, CBC, BBC, and Bloomberg TV. He was awarded a Kiplinger Fellowship at The Ohio State University.
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