Hoag Clinical Trials Attract Global Interest

Friday, June 25, 2021

Main News Photo

(Orange County Register)

Olav Ruud was out of options.

Since being diagnosed with pancreatic cancer a year earlier, he had part of his pancreas removed, followed by two rounds of chemotherapy. And yet scans were showing two new tumors.

The retired commodities broker started searching online to see if there were any pancreatic cancer therapy trials he could sneak into.

“I found an article on Senator Harry Reid and I go ‘Wow! This is for me.’”

The article was about an experimental natural killer cell therapy that stopped the former U.S. senator’s pancreatic cancer cold in two months.

Ruud kept digging and found that a natural killer cell trial for pancreatic cancer patients was about to start at Hoag Hospital in Newport Beach. He applied and got word this past March that he had been accepted.

Ruud packed up his belongings at his home in the San Juan Islands in Washington and headed to Newport Beach, where he is now renting an apartment near the hospital.

Today Ruud is in his third month in the trial. His tumor makers are stabilized.

“It’s going very well,” he says.“This is as good as it gets on this planet for what I need right now.”

Doctors Tara Seery, left, and Peter Chen, right, stand with patient Olav Ruud at the Hoag Cancer Center in Newport Beach on Thursday, June 3, 2021. The center is beginning a clinical trial on the use of natural killer cells to battle pancreatic cancer. (Photo by Mark Rightmire, Orange County Register/SCNG)

Dr. Tara Seery is Ruud’s gastrointestinal oncologist and is overseeing the trial. She’s the one who initiated Hoag’s partnership with ImmunityBio, the company that developed the natural killer cell therapy credited with saving Reid.

ImmunityBio is based in Culver City. Billionaire Dr. Patrick Soon-Shiong, who also owns the Los Angeles Times and San Diego Union-Tribune, is the company’s founder and executive chairman of the board.

“We’ve figured out a way to activate the patient’s own immune system,” Soon-Shiong says. “This is the first orchestration of a cancer vaccine to try and generate long-term control of the cancer without high-dose chemotherapy.”

After Reid’s cancer was contained, Soon-Shiong told The Washington Post that the senator should be considered “the first astronaut to the new universe” of immunotherapy.

Reid had been designated a compassionate use case, a FDA-approved option for patients who want to try an experimental therapy because all other treatments have failed.

About the time ImmunityBio saw the success with Reid and a handful of other compassionate use care designated patients, it received FDA approval to bring its natural killer cell therapy to trial. Hoag jumped at the chance.

“I want to bring in trials where our local patients can feel confident that they don’t have to travel long distances to get the latest cancer therapeutics,” says Dr. Burton Eisenberg, executive medical director of the Hoag Family Cancer Institute. “Particularly elderly patients.”

So what are natural killer cells?

Well, everyone has them. They are a critical part of our immune system, circulating in our blood stream, searching out and destroying viruses and cancer cells alike. But sometimes, particularly as we age, these natural killer cells can lose their mojo.

What ImmunityBio has done is taken some of these cells, put them in a lab and multiplied them, making millions. The company then added receptors to these cells, programming them to hunt down and kill cancer.

These “off-the-shelf” cells are then infused intravenously into patients to circulate in their own blood. Because these cells are trained to target cancer cells, and ignore normal cells, the side affects are few.

“So we can treat patients as outpatients,” Eisenberg says.

The therapy also ramps up a patient’s own natural killer, or NK, cells, recruiting them to join the fight.

According to Seery, about 60,000 people will be diagnosed with pancreatic cancer in 2021. And 48,000 pancreatic cancer patients will die of the disease.

The mortality rate is so high because this particular cancer has no symptoms until it has spread.

“That’s the saddest part,” Seery says. “You can get a clean bill of health and the next week be diagnosed with pancreatic cancer.”

She said her patients are getting younger too.

“I have a lot of patients in their later 40s,” she says. “I hate it. The majority are very healthy with no risk factors.”

Ruud, for one, is a very fit cross-country skier (who has traded his skis for a bike while he’s in Newport Beach).

With such a poor prognosis, pancreatic cancer patients are clamoring to get into the trial — from as far as Canada, London, Israel, Greece.

“It’s been crazy,” Seery says. “Patients from all over the world have relocated here. They did their research and searched us out.”

The first patient enrolled in the trial last July is a Pacific Palisades woman.

“She’s still in the trial,” Seery says. “She’s doing great. To be getting some exciting responses, it’s euphoric.”

Seery will present preliminary data at the American Society of Clinical Oncology conference in January.

“It’s looking very good,” she says. “Pancreatic cancer needs a winner; it hasn’t had a winner in its corner in a long time.”

Total enrollment for the trial (which ends in 2022) is 298. There are still 100 spots left. Patients wishing to inquire about the trial can email clinicalresearch@hoag.org.

Hoag is also accepting lung and triple negative breast cancer patients for two more large scale NK trials that they are launching later this summer. And just this week, Hoag launched another trial that could take the NK therapy to a whole other level.

Instead of off-the-shelf NK cells, this trial will use a patient’s own natural killer cells.

“We will take a patient’s blood, remove their own cells, grow them in the lab, enrich them with memory cytokines and give them back to the patient,” Seery says.

The hope is that these m-ceNK cells will be even more effective at killing the cancer

“The pre-clinical work at the National Cancer Institute has been very powerful,” Seery says.

Hoag is enrolling 20 patients in the m-ceNK trial to begin with.

“If it (proves) safe and successful we’ll open a larger trial,” Seery says.

Soon-Shiong says he is “pleased” with the partnership with Hoag.

ImmunityBio got FDA approval for the m-ceNK platform at the end of May. Just one month later and the trial is already underway.

“There’s not a lot of red tape here,” Seery says. “It usually takes forever to open a trial. Hoag moves things along very quickly. And the patients benefit.”

Dr. Deb Fridman, director of clinical research at Hoag, says she was hired to ramp up the hospital’s research program. When she arrived 7 years ago there were 30 trials underway. Now there are 180. Another 92 trials are in the pipeline, about half of those for cancer treatments.

“Usually you only see this in an academic setting or major, major, major institution,” Fridman says. “Hoag is a not-for-profit. It’s the commitment of the administration here to truly offer patients the best treatments available and there’s no way to do that without a strong research program.”

Hoag has also recently added one more cutting-edge weapon to its cancer-fighting arsenal: A ViewRay MRIdian Linear Accelerator, “the most advanced and accurate radiation oncology machine on the market.”

There are only 16 in the country, two in California. One is at UCLA.

“It combines radiation with an MRI machine so it’s very accurate,” says Eisenberg. Essentially, it gives doctors a better chance to pinpoint the cancer and avoid radiating surrounding healthy tissue.

A $9 million donation from best-selling “Master of Suspense” author (and Newport Beach local) Dean Koontz paid for it.

Seery calls the ViewRay a game changer in her line of work.

“It’s amazing,” she says. “I love that machine.”

Ruud has been in the machine four times so far and was so impressed he invested in the company.

“It’s incredible,” he says. “And Dr. Seery comes by every time I’m here. That gives you a real warm, fuzzy feeling.

“The fight goes on.”

Hoag is a platinum-level Leaders Circle partner of the Greater Irvine Chamber.

Category: Healthcare, Leaders Circle, Hoag, Orange County, Greater Irvine Chamber