NewLink Using the Human Body to Develop Vaccine to Fight Cancer
By Grayson Schmidt
Dr. Charles Link looks forward to work every day because he likes doing something that matters in the world and impacts people’s lives. And creating a vaccine for cancer just seems to fit that description.
“Not everyone has the opportunity to get up in the morning and go out and do something you can be excited about,” he told the Ames Tribune on Friday.
Link is the CEO and chief scientific officer of NewLink Genetics, an Ames-based biopharmaceutical company that specializes in immuno-oncology, in which the body’s own immune system is used to fight cancer. He and Dr. Nicholas Vahanian started the company in 1999 after realizing immunotherapy was rather untouched by the biotech field.
After 15 years, the company has expanded from one building to a 60,000-square-foot campus with more than 160 employees at the main site at the Iowa State University Research Park, with other locations in Austin, Texas, and Boston. NewLink’s expansion is not limited to just size and location. It has dipped into other fields as well, a major one being the vaccine for the Ebola virus, which it worked on with the Department of Defense, Canadian government, Biomedical Advanced Research and Development Authority and World Health Organization.
Still, cancer research and immuno-oncology remain NewLink’s primary focus, and have been for 15 years. But Link said the treatment has only started to gain popularity in the biotech industry within the past five years.
“A number of laboratories around the word have found this basic science, immuno-therapy, (to be) working really well in animal models and those antibodies were made into drugs that could be used in humans,” he said. “So you have to sort of take the basic science stuff, and then do all of the FDA regulatory process, which is quite deep and complex.”
NewLink is in the final stages of its most advanced study in the HyperAcute Immunotherapy Platform, the immunotherapy for pancreatic resectable cancer survival study, or IMPRESS. The study monitors the effects of an immunotherapy called Algenpantucel-L, which combines pancreatic cancer cells genetically modified to express a carbohydrate known as alpha-gal.
According to Link, humans and other old-world primates do not produce alpha-gal, so it is taken from lower mammals, such as pigs. Since humans do not produce it, it is recognized as foreign to the body, triggering the immune system to attack the carbohydrate and the cancerous cells surrounding it.
NewLink eventually wants to pair this with the other major platform in immuno-oncology, IDO pathway inhibitors, which disable the defense mechanism of tumor cells so they can no longer evade the body’s immune system and spread, which is why they are testing them with metastatic breast and prostate cancer.
“To see these scientific ideas, that were just animal experiments, go into human beings and start to show promise makes for a really exciting time,” Link said.
But right now, IMPRESS is the most advanced study. It started in 2010 and is now in the last phase of human trials.
A random group of patients is monitored, with half receiving regular chemotherapy and half receiving the algenpantucel-L plus chemo. Link said the average life expectancy of a pancreatic cancer patient is about 20 months, and in order to get this therapy FDA approved, the results have to show that the subjects’ lives increased by an average of 20 percent to 25 percent.
Though he has seen some statistics, the final results will not be collected until sometime in 2016, Link said.
He has not seen specific numbers, and he doesn’t know results from individual patients, but he has seen that on a blended curve of vaccine and non-vaccine patients, the median number of months survived has run into the high 20s.
“We believe that the final analysis of the trial will turn positive,” Link said. “We don’t know (for sure), but we believe that. And if we look at the scientific evidence here, we think the drug is working.”
Along with IMPRESS, NewLink also has PILLAR (pancreatic immunotherapy with algenpantucel-L for locally advanced non-resectable disease), which focuses on borderline resectable and unresectable pancreatic cancer, and studies in non-small cell lung cancer, melanoma and prostate cancer.
As exciting as scientific discovery and the possibility of creating a cancer cure are, Link has stayed focused on the real reason he started NewLink Genetics.
“In the end, if we are not doing this for people, then what are we doing?”
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