About six years ago, Dr. Protul Shrikant had what he describes as a "eureka moment." His serendipitous discovery is now the basis behind Roswell Park Cancer Institute's research study of a vaccine designed to kill cancer.
Roswell's new NY-SEO-1 dendritic cell vaccine aims to not only destroy cancer cells but also prevent cancer from reoccurring. The development is thanks to Shrikant's discovery of an alternative use for rapamycin, a compound normally used to prevent rejection in an organ transplant.
Shrikant stumbled upon what he considered a previously unknown and striking observation – rapamycin has the ability to produce immune cells with memory. This "enhanced memory generation" makes the immune cells capable of remembering that cancer cells are bad and should be destroyed.
"It doesn't really matter what kind of cancer you have; as long as the target [of the NY-SOE-1 protein] is correct, we can deter it," Shrikant said. "By generating memory, we can maintain the deterrents against the reoccurrence of the tumor."
The vaccine will be tested to treat multiple types of cancer – including bladder, brain, breast, esophageal, gastrointestinal, hepatocellular, kidney, lung, melanoma, ovarian, prostate, sarcoma, and uterine tumors.
The Phase I clinical trial is set for 18 to 20 patients who have cancers expressing the NY-SOE-1 antigen. It will start "as soon as possible," but an exact time is hard to predict, according to Shrikant. The clinical trial is set to run for two years.
"It's a long road," said Dr. Yeong "Christopher" Choi, director of Roswell's therapeutic cell production facility. "I think this trial means there is tremendous promise, and I think, for patients, we're cautiously optimistic, but there are still many stages before we can bring this vaccine to the market."
The vaccines being used for this trial will be manufactured under Choi's direction in Roswell's Xvivo system, a custom-made barrier isolator (a physical barrier between a lab technician and a work process to eliminate interference and ensure favorable conditions). Choi said the barrier isolator is the first of its kind in the use of cellular therapies. The facility's unique design and construction is due to guidance and advice received from the Food and Drug Administration, according to Choi.
The NY-SEO-1 vaccine will be custom-made for each patient. The barrier isolator will be used to manipulate cells taken from patients over the course of nine days – these cells will then be injected back into the patients in a series of four doses.
What makes the chamber revolutionary is that it mimics the optimal physiological conditions for the entire time cells are outside of the body. In other cellular therapies, the cells are manipulated outside of optimal conditions, and then put back into incubators.
"It's kind of like sushi, or food, when you take it out, and put it back in, take it out, and put it back in – it loses its freshness," Choi said. "It may still work, but it's not the best tasting or the most optimal."
Roswell's will be the first study that will test a dendritic cell vaccine given in combination with rapamycin.
Dr. Kunle Odunsi, director of Roswell Park's center for immunotherapy, created the vaccine and is the study's principal investigator. He has already evaluated the success of the vaccine in dealing with ovarian cancer.
In one of Odunsi's trials, a patient, who initially faced about an 80 percent chance of the cancer's return, is currently cancer-free, according to a Roswell press release. The patient's immune system responded to the vaccine, and it has experienced no side effects.
Choi expressed great gratitude and thanks to the people of Buffalo for their support in this new effort in the fight against cancer.
Shirkant hopes his discovery, along with the trial being run by Roswell, will demonstrate the facility's capacity to conduct cellular therapies.
"Sometimes, science moves by a feeling or a striking observation, or feelings you have – some gut feelings," Shrikant said. "In my career of 35 years, [this is] one of the few notions to actually pan out."
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