Hans Keirstead has gotten his band back together—and now he has a date.
The Irvine-based stem cell researcher and entrepreneur plans to start second-phase clinical trials early next year for immunotherapy targeting ovarian cancer.
His newly formed AiVita Biomedical, which started operations in May, will partner with Newport Beach-based Hoag Memorial Hospital Presbyterian to enroll 99 patients in the trials.
Second-phase clinical trials evaluate a drug as a therapy for a specific disease in a patient pool that’s significantly larger than first-phase trials. A first-phase trial includes a small number of healthy participants to assess safety and to find an optimal drug dose.
AiVita’s focus on ovarian cancer marks a recent turn for Keirstead, who bought back the core technology of his new company from Basking Ridge, N.J.-based Caladrius Biosciences Inc. early this year. The deal came after Caladrius announced plans to focus on developing cell therapy treatment for type 1 diabetes.
Keirstead had been working on a stem cell therapy for treating advanced skin cancer based on technology he sold to Caladrius in 2014. The technology led to a skin-care cream—an aesthetic product as opposed to therapeutic—called Provoque, which AiVita has licensed.
Keirstead’s new effort has shifted its therapeutic research focus to ovarian cancer, “but we didn’t have to start from scratch,” he said. “The beauty of the buyback [was] we benefitted tremendously from all the work Caladrius did. We are starting from a position much more advanced than when we first sold the company, and we gained all the data from the 18 months Caladrius ran this program.”
Keirstead proposed the idea of a buyback—“more of a license-back program, a series of licensings”—in November 2015. He completed the transaction in May when he formed AiVita.
Keirstead sold the company, then called California Stem Cell Inc., to Caladrius, which was known as NeoStem Inc. at the time. The deal was worth up to $124 million with milestones. The stem cell-based therapy received FDA approval for a third phase of clinical trials in advance of the acquisition, and already had fast-track status, which accelerates the approval process of drugs undergoing clinical trials.
The stem cell technology removes and purifies cancer stem cells and also dendritic cells, one of the primary defense cells of the immune system found in the bloodstream.
“On average, only 1%, sometimes up to 3%, of your cancer tumor is cancer cells,” Keirstead said. “The rest is a mesh of every cell in your body.”
AiVita extracts and isolates “purified” cancer stem cells from patients’ tumors. The process draws blood and also isolates the dendritic cells, which are “educated” to identify the purified cells. The dendritic cells eventually are pumped back into patients and will attack cancer cells but not any other types. The technology is designed to target active and dormant cancer cells. The dormant cells are responsible for tumor growth and metastasis—the development of malignant cancer in locations away from where the original cancer developed.
“We have a technology that has proven to be successful in a Phase II clinical. We have a higher-than-average cancer survival rate of 72% [for advanced skin cancer,]” Keirstead said. “The next phase for us is personalized medicine. A cancer stem cell is a cancer stem cell, but every person is slightly different. The same [type of cancer] can have [between] 100 to 1,000 unique mutations.”
Keirstead said initial results from trials on advanced skin cancer will provide a basis for fine-tuning treatment of ovarian cancer.
He said AiVita has overcome two main challenges that had slowed the development of stem cells—the viability of extraction processes at the core of the technology, and how to scale manufacturing operations.
“We have that,” he said. “Now we are applying that technology to both cancer and commercial products.”
The company employs 12—mostly researchers who moved with Keirstead from Caladrius. It now is looking to build its sales team for commercial products, which hold the potential for a shorter route to revenue.
The commercial market’s potential is based on the regenerative nature of stem cells and their ability to differentiate—or develop into different cells, such as skin cells and hair cells. AiVita plans to launch an antiaging facial cream and possibly hair regrowth product next year, additions that would join the Provoque facial serum in its commercial product lineup.
The therapeutic side of the business will keep Keirstead at the heart of stem-cell research and development, a role that started in the early 2000s when he was a professor at the University of California-Irvine. While there he transplanted stem cells into animals with spinal cord injuries to study the potential improvement of limb movement.
