AIVITA Biomedical Inc. is charging into the New Year with all cylinders firing.
The Irvine-based stem cell therapy firm late last month completed a $25 million round of financing with plans to use proceeds to fund several cancer vaccines, as well as a COVID-19 vaccine that it hopes can be released by early next year.
How does the company manage its many business endeavors?
“We run clinical trials for a living,” Chief Executive Hans Keirstead told the Business Journal last week.
“AIVITA Biomedical has 17 hospitals running clinical studies for us.”
Keirstead is well known among local health executives. He is the founder of the Bill and Sue Gross Stem Cell Clinic at the University of California-Irvine and previously ran California Stem Cell Inc., a stem cell therapy firm that sold for about $124 million in 2014.
“I’ve got a great, mature team with in-house expertise in clinical trial operations, regulatory, manufacturing and quality systems,” he said, noting that many of his employees have been with him for over 20 years.
AIVITA has about 36 employees and plans to hire a dozen more this quarter.
Investors in the Series B-2 round included Matthew Katz, founder of payment processor Verifi, which was sold last year to Visa for an undisclosed amount; and Ci:z Holdings Co., a Tokyo-based firm with a line of skincare products, which last year was acquired by Johnson & Johnson for about $2.1 billion.
Cancer Therapies
AIVITA has several ongoing trials for the personalized treatment of skin, brain and ovarian cancers.
The company last month revealed promising results for its glioblastoma (GBM), or brain cancer therapeutics, following Phase 2 trials.
Its trials demonstrated the GBM drug reduces the risk of disease progression or death by 38% at any stage, said AIVITA. GBM has a five-year relative survival rate between 6% and 22%, according to the American Cancer Society.
“GBM is the real killer,” Keirstead said. “A higher percentage of people die the fastest from GBM.”
AIVITA is also working on ovarian and melanoma therapies in the U.S. and pursuing commercial approval of its melanoma treatment in Japan via an expedited regenerative medicine regulatory pathway.
Japan has the most advanced regenerative medicine pathway in the world, according to Keirstead, who has helped that country and others create regulatory pathways.
He is also a founding member of the California Institute for Regenerative Medicine.
COVID Vaccine
The company’s COVID-19 vaccine uses its platform technology, which takes patients’ blood cells and matures them into dendritic cells that process and present antigen material to the immune system.
“Think of dendritic cells as the general of the army, telling all the different divisions—the army, the navy, the infantry—to kill this thing,” Keirstead explained.
“In the case of COVID-19, we load the dendritic cells SARS-CoV-2 antigens.”
Because the technology uses patients’ immune cells, there are zero side effects to the vaccine, Keirstead said.
In addition, the company’s COVID-19 vaccine test kit can be assembled at any site that can operate a syringe at the point of care. This means assembly plants and pharmacies alike can assemble and distribute the kit, he said.
This not only allows countries to return vaccine costs to their own economies by enlisting assembly plants and workers in their own countries, but also mitigates supply chain issues, Keirstead said.
The company is currently in Phase 2/3 trials for the vaccine. It hopes to have the vaccine available to the public this year.
“I feel very good about being part of a second wave of COVID vaccines,” he added.
“It doesn’t matter who gets there first; better medicine always prevails. I see a bright future for our vaccine.”
AIVITA Aesthetics Predicts Revenue Ramp
AIVITA Biomedical’s skincare line will make its direct-to-consumer debut in the U.S. this month.
The “Root of Skin” brand, sold via AIVITA Aesthetics, will feature a facial serum that retails for $50, with add-on products that treat other problem areas such as the neck and eyes.
Keith Manning, a former executive vice president of marketing at El Segundo-based Guthy-Renker, will lead the launch as the new general manager of the aesthetics subsidiary.
AIVITA has partnered with Guthy-Renker on its advertising strategy.
Guthy-Renker is “the best storyteller in skincare in the world” and its brands generally make between $100 million and $150 million in second-year annual revenues,” according to AIVITA’s CEO Hans Keirstead.
“Root of Skin” products previously sold for a higher price point through several hundred dermatologist clinics in the U.S. and via direct-to-consumer channels Japan.
The company broke several records on the QVC channel in Japan, including selling out in the fastest amount of time—eight minutes in an hour-long segment.
An added benefit of the line: “Net proceeds will support the treatment of cancer and will supplement the vaccine company,” Keirstead said.
—Jessie Yount
