Three and a half decades after Michael Hanna Jr. began exploring the concept of using the body's own immune system to fight cancer, the idea is driving Baltimore's latest biotechnology promise.
The company Vaccinogen, drawing on research that Hanna began when he was director of a National Cancer Institute lab in Frederick, is developing a vaccine that uses colon cancer patients' own tumor cells to train their bodies to fight off a recurrence of the disease.
The company moved to Baltimore from Frederick a week ago in search of skilled workers, high-tech connections and eventually, perhaps, space for a manufacturing facility.
The move comes amid a surge in attention to vaccines and immunotherapy treatments as possible weapons to fight cancer.
Vaccine science is establishing a foothold in Baltimore's biotechnology industry. As Vaccinogen moves in, Emergent BioSolutions is launching an expansion of its East Baltimore manufacturing facility.
Profectus BioSciences and Paragon Bioservices are working on Ebola vaccines, among other projects, and Gliknik is focusing on vaccines for cancer, as well as for immune disorders.
That sort of critical mass is important to entrepreneurs who are looking to share ideas and find qualified and experienced employees, said Philip Schiff, CEO of the Tech Council of Maryland.
"I think that's probably what's attracting them," he said. "From our perspective, looking at how a vaccine industry is developing here, it really is a good thing."
There have been few successes in the field of cancer vaccines, even after decades of research. But company leaders say they are a step ahead of competitors because their vaccine, OncoVAX, has proved effective in clinical trials. Now they are looking to capitalize on the concentration of vaccine research in Baltimore.
They have the backing of some prominent local leaders. Former Johns Hopkins neurosurgeon Dr. Ben Carson joined Vaccinogen's board as its chairman in August, the Abell Foundation is investing in the company, and company leaders have the attention of city and state economic development officials as they look to grow.
The company is starting with a focus on colon cancer, but could eventually broaden its scope, CEO Andrew Tussing said.
"It's a process and not a drug," Tussing said. "We can apply it to any number of cancers."
Each dose of the vaccine is created for an individual patient, after surgery to remove a tumor. Vaccinogen transports the tumor with the same care given to transplant organs, the company says, washing it with saline solution, storing it in a jar with fluid that keeps the cells alive and viable, and carrying it in a cooler to company labs in the Netherlands.
In a clean room, the tumor cells are divided into at least nine vials — two for each of four injections the patient will receive, and one for quality control — and mixed with a weakened bacteria that is also used in tuberculosis immunizations. Together, they aim to teach the body to launch an immune response to the tumor cells.
If all goes right, the response is visible. At the end of a six-month course of the four injections, patients should show red rashes around the sites of each inoculation, one on each thigh and biceps.
"We're teaching the immune system to do the rest of the work," Tussing said. "The immune system does a better job than we ever could.
The science behind OncoVAX has had a bumpy ride. Hanna formed his own company to commercialize it. Seattle-based company Intracel Corp. acquired it in 1997 but filed for bankruptcy in 2001.
Vaccinogen picked up the technology in 2007 when it acquired intellectual property and other assets from Intracel. By then, the science behind OncoVAX had been shown to significantly reduce recurrence of colon cancer in patients who had tumors removed before the disease spread to the lymph nodes.
Now Vaccinogen is preparing for one more round of clinical trials over the next two years, potentially leading to sales after that.
The company employs nine people and seven contractors in a 10,000-square-foot facility in Fells Point, and another dozen employees and contractors mostly in the Netherlands. Tussing said he expects the Baltimore workforce to grow to 25 by the end of the year.
An $80 million investment from a group led by Swedish entrepreneur Anders Halldin, is helping to fuel the growth. The company has received $20 million since the investment was announced in August.
The Abell Foundation joined with a commitment to buy up to $5 million in stock, according to filings with the Securities and Exchange Commission.
The company has accumulated a deficit of $109 million, according to the filings.
Though the theory behind cancer vaccines has long been considered promising, its viability has been difficult to prove. The Food and Drug Administration has approved only one such vaccine for use in the United States: Provenge, used to treat metastatic prostate cancer, was approved in 2010.
Another vaccine, Oncophage, tested in patients with kidney cancer, was approved in Russia in 2008 but is still under FDA review.
Vaccines to treat more than a dozen types of cancer are in clinical trials, according to the National Cancer Institute. But all of the projects must solve complex biological puzzles.
They require not just targeting cancer cells but also influencing the complex environment surrounding the cells, said Dr. Lei Zheng, an assistant professor of oncology at Johns Hopkins Medicine who is also working on vaccines for various types of cancer.
Cancer vaccines must address complex interactions between cancer cells and the immune system, which often doesn't recognize the cancer cells as pathogens. Cancer cells can sometimes adapt so they stop giving off signals that the immune system recognizes, and can even give off chemicals that prevent the body from mounting a response, according to the National Cancer Institute.
Lessons about those interactions have been slow to translate into effective cancer vaccines, Zheng said.
"Cancer vaccines and immunotherapy are being recognized as really a very important area for cancer treatment I would say only in the last 20 years," he said.
Vaccinogen's leaders said they plan to begin studying options this summer for a manufacturing facility of its own. Tussing said he wants to set up the facility near BWI Marshall Airport and open it as early as mid-2017.
Some networking within Baltimore's burgeoning vaccine industry already has been fruitful for Vaccinogen. One of its newest scientists is a former Johns Hopkins postdoctoral researcher who became acquainted with the company through Abell Foundation President Robert Embry, as he was vetting the company for investment.
Jason Howard, now director of Vaccinogen's epitope-based vaccine project, also had a brief introduction to Carson, but not in the neurosurgeon's capacity as Vaccinogen chairman. Carson spoke as Howard accepted Hopkins' John G. Rangos Sr. Award for Creativity in Cancer Discovery in 2013, for his research on how to use a vaccine for human papillomavirus to train the body to fight off cancer cells.
The work at Vaccinogen was a perfect next step, Howard said.
"We're not fighting biology," he said. "We're employing it."