L.A.-AREA FIRM’S COVID VACCINE OK’D FOR TRIAL

Biotech ImmunityBio to begin Phase 1 human testing of its candidate

ImmunityBio, an El Segundobased biotech firm headed by Dr. Patrick Soon-Shiong, said Thursday it had received approval from the Food and Drug Administration to begin preliminary testing of the company’s COVID-19 vaccine candidate.

Hoag Hospital Newport Beach will start recruiting 35 adult volunteers this month for the Phase 1 trial, which is designed to monitor the safety and possible side effects of the vaccine. Dosages will vary per candidate and be administered in two shots three weeks apart, the company said in a news release.

An estimated 213 laboratories around the world are trying to develop a vaccine, and three dozen have advanced to human trials, according to tracking by the Milken Institute. ImmunityBio is the first company headquartered in the Los Angeles area to reach this milestone. Soon-Shiong, the company’s chairman and chief executive, also owns the Los Angeles Times and The San Diego Union-Tribune.

San Diego’s life science community is involved in at least 12

COVID-19 vaccine efforts. Two of the leading local biotech firms are Inovio Pharmaceuticals, which used its San Diego lab to develop the second-ever COVID-19 vaccine to begin clinical testing, and Arcturus Therapeutics, which is developing a vaccine in partnership with the Singaporean government.

Both vaccines are in early-stage trials, though Inovio had been on track to begin a late-stage study before the FDA asked the biotech for additional information about its planned trial. Inovio has said it will send the FDA a response by the end of October, at which point the agency will have 30 days to greenlight or nix the trial.

Phase 1, typically lasting about two months, is the earliest point at which humans are injected with vaccine candidates.

If the FDA allows ImmunityBio to proceed to Phase 2 and Phase 3 trials with increasing number of participants, the company may begin to get a signal as to whether the vaccine protects against COVID-19. Soon-Shiong said he hoped to begin Phase 2 — or a combined Phase 2 and 3 — by the first quarter of 2021.

Nine vaccines are currently in Phase 3 trials around the world with tens of thousands of participants, according to the Milken tracker.

AstraZeneca and Johnson & Johnson, which are using a similar platform for their vaccines as ImmunityBio, recently paused their Phase 3 trials after volunteers came down with unexplained illnesses. “The fact that there are so many scientists around the world working on vaccines and have found vaccine candidates that are plausible and getting into clinical trials is very exciting,” said Dr. William Schaffner, an infectious disease expert at Vanderbilt University and the medical director of the National Foundation for Infectious Diseases.

ImmunityBio’s announcement comes as infection rates are rising in the Midwest and epidemiologists are warning about a second wave of infections this winter. Since the Centers for Disease Control and Prevention confirmed the first case of the novel coronavirus in Washington state in January, more than 216,000 American have died of the disease.

The vaccine uses a genetically engineered adenovirus to deliver two proteins of the novel coronavirus into the body, triggering an immune response that can protect against future infections.

Although other companies are also using the adenovirus, most are delivering only one component of the novel coronavirus: the S, or spike protein, which coats the virus’ surface and allows it to enter cells.

But the challenge presented by the adenovirus, Soon-Shiong said, is that it is a common cold virus, and many people have already developed antibodies against it. Those antibodies would attack the adenovirus before the immune system had an opportunity to develop a response.

But by delivering not just the S protein, which studs the outside of the coronavirus, but also an additional protein from inside the virus, ImmunityBio believes that its vaccine candidate will provide longer lasting immunity.

“While there are a number of vaccine candidates in development, we believe most are limited by their sole focus on antibody responses to the monovalent spike protein, which may be insufficient to activate the full potential of the immune system to fight the coronavirus,” Soon-Shiong said in a statement.

ImmunityBio had been researching the adenovirus in the course of developing cancer treatments when the pandemic started. The privately held company is sharing the cost of development, manufacturing and marketing with its publicly traded aff iliate, NantKwest, for which Soon-Shiong also serves as chairman and chief executive.

The company is also working on formulations of its vaccine that could be kept at room temperature, which would make the vaccine easier to roll out in communities and countries that have limited access to specialized freezers.