New investments will help a biomedical startup in Irvine, California, push ahead with vaccines for cancer and Covid-19 and help fund the consumer launch of the company’s skin-care product.
Founded in 2016, Aivita Biomedical said it has raised $25 million in Series B-2 funding for what it expects will be a busy year ahead. In two previous rounds, the company raised $21 million.
First up is a direct-to-consumer marketing campaign for a line of skin-care products based on Aivita’s stem-cell research, said Dr. Hans Keirstead, founder, chairman and CEO of Aivita. The line, called Root of Skin MD, has been available in the U.S. through dermatologists. Starting this month, it will be sold directly to consumers through a partnership with specialty marketing firm Guthy Renker, whose clients include a skin-care brand sold by singer/actor Jennifer Lopez.
Root of Skin MD was made available to consumers in Japan last year through the QVC television channel and has been selling well, Keirstead said.
Proceeds from product sales benefit the company’s clinical research, which is focused on vaccines that target brain, skin and ovarian cancers. The company also is developing a Covid-19 vaccine that it believes will be easier to distribute than some of the vaccines already in use from the likes of Moderna, Pfizer and BioNTech.
“Those larger companies that have their emergency use authorizations have taught us a lot,” Keirstead said in a phone interview. “They have also taught the public a great deal so they have allowed us to refine our marketing message and differentiation points.”
The company’s vaccines are based on a personalized approach to immunotherapy. The company draws blood from a patient, primes it to target tumor-initiating cells and then re-injects it. The Covid-19 vaccine works on the same principle and comes as a kit that can be assembled distributed and deployed relatively easily, Keirstead said.
Cancer vaccines are a promising form of immunotherapy that operates often in conjunction with existing therapies and many companies are pursuing them. BioNTech is among them, with its CEO saying this week that its messenger RNA technology offers promise for oncology.
Many vaccine candidates, however, inject new material designed to fire up a patient’s immune response. Aivita relies on a patient’s own blood cells, making it potentially safer, said Keirstead, a stem-cell scientist.
“What we’re actually giving the patient as their drug is nothing that didn’t come from them,” he said. “It’s their immune system that has been primed in the dish to tackle the tumor-initiating cells.”
The most promising results have come from a clinical trial for patients with glioblastoma, an aggressive and usually fatal form of brain cancer. Phase 2 data from 57 patients shows that the Aivita’s vaccine increased survival rates by 38% compared to the standard of care, Keirstead said.
A vaccine for ovarian cancer is currently in a phase 2 trial enrolling roughly 99 patients. A phase 1B trial for a melanoma vaccine is in the works and will study the vaccine in combination with another therapy, anti-PD1 monoclonal antibodies. Aivita also plans to seek commercial approval in Japan for its melanoma immunotherapy through an expedited pathway for regenerative medicines.
Aivita Covid-19 vaccine – called AV-COVID-19 – is wrapping up a phase 2 trial in Indonesia and gearing up for phase 3, with interim data expected in March, Keirstead said. Once a patient’s blood is drawn, the dendritic cells are isolated out and loaded with multiple recombinant SARS-CoV-2 spike antigens. A week later, the patient’s antigen-loaded cells are re-injected.
“There is no foreign protein in there and that’s why our safety is so extraordinarily high,” said Keirstead, who is hoping to launch U.S. trials of the vaccine in the first quarter of 2021.
Keirstead declined to name the company’s latest investors. But previous rounds included California Technology Ventures; Matthew Katz, founder and CEO of payment software company Verifi Inc.; and a South Korean investment firm called SFC Co. Ltd.
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