Shop Talk: Q&A with Dr. Eric von Hofe, Antigen Express
Before a blockbuster drug is born there must first be years of lab work and clinical trials. Worcester-based Antigen Express, which is a subsidiary of Toronto-based Generex Biotechnology Corp., is in that trial period for its particular niche of biotechnology — immunotherapy. The company, led by President Eric von Hofe, has a vaccine that it has developed to prevent the recurrence of breast cancer. Here, he discusses the latest clinical trial results for the breast cancer vaccine as well as the implications for Antigen’s technology on flu prepraredness.
How did you first get into laboratory science?
I started working in a lab when I was 15 doing cancer research. My first publication was in 1972 in the “Archives of Surgery.” I had that opportunity as part of a program in Los Angeles that put students interested in science in the lab. The first project I worked on involved trying to increase the amount of radiation you can give to someone with stomach cancer.
What do you like most about your job?
Getting other people excited about what we're doing. That's fun, because the more you clear hurdles, the more people get excited. We're seeing other people that are taking another look. Immunotherapy has been a tough field, there have been a lot of failures, but there have been some recent successes. That's been a real shot in the arm for the whole industry.
Can you explain in layman’s terms how Antigen’s breast cancer vaccine works?
What we’re using is basically vaccine technology. The way a traditional vaccine works is you get a small fragment of the virus and present that fragment to the person in an inoculation. The innoculation stimulates the immune system to recognize that virus fragment and thereby recognize whatever invading organism has that fragment associated with it. What we’re trying to do is to cause the immune system to recognize a breast cancer cell as foreign and attack it. What we’ve done is taken a fragment of a protein that is expressed in breast cancer, modified that protein and then used that as an immunotherapeutic vaccine. In our Phase II clinical trials, we’ve given that vaccine to patients who had breast cancer and who are at high risk for recurrence.
What was the result of the trial?
This was an interim analysis. It was a median check up at 13 months. The full trials extends 24 months. Of the patients that received the vaccine, there were zero out of 49 who relapsed. In the control group, five out of 71 relapsed. The risk of relapse in the population we’re studying is roughly 20 percent after two years. The goal of our trial is to cut that relapse rate by at least by a half.
How is the vaccine delivered?
It’s a subcutaneous injection. The patients are given it on the upper thigh. They get two injections that are 10 centimeters apart.
Is it delivered once?
No. It’s given six times. Once a month for six months.
Those trial results must be very exciting…
It’s great. We’re very excited about it. Drug delivery is a tough business. It’s hard to develop drugs. I think the statistics are something like 90 percent that go into a Phase I, fail. Just when you start off you know the dice are loaded against you.
How are you hoping to apply immunotherapy to flu vaccinations?
Another project we have is focused on potentially pandemic influenza viruses like H1N1. As you know, people were slow getting the H1N1 vaccine out. Creating a vaccine from traditional egg-based or cell-cultures is a very laborious process that’s more prone to errors. What we do, with synthetic peptides is really much simpler. We could make hundreds of kilograms of synthetic vaccine by a very straightforward process. We’re not literally breaking eggs and purifying stuff out of eggs to make the vaccine.
What’s the time horizon on your cancer vaccine being on the market?
Realistically, something on the order of 5 to 8 years. We’ve got another couple of years with the Phase II trials. Phase III’s clearly take time. If something looks really, really good in Phase II it can go on to be approved. But that’s roughly the time frame.
Is there any hope that this vaccine could be used to prevent cancer to begin with?
Ultimately yes, but with that, the FDA needs to see that you're on the market as a therapeutic and then you could think about becoming a prophylactic.
Where do you produce your vaccine?
It's made under contract by peptide manufacturers. It's a fully synthetic process, so there's no bioreactor. It's a machine where you can dial in the peptide sequence and the machine makes it.
Isn't it difficult to keep plugging away at something that's so far reaching?
It's great, I got to say. You know that the odds are kind of against you, but you keep clearing hurdles. Now that we're at Phase II, we're actually starting to see efficacy. What we've done so far, will be helpful in terms of developing immunotherapies. We've already done some good. You want to get a drug out there that makes billions of dollars, but you can see that as you're running the race you're really accomplishing something. You're doing something that has value for the whole field.
Have you been impacted by the overall economic malaise?
Sure. It was a hard year. Generex is a publicly traded company. When the whole financial situation gets as difficult as it has been, it's very hard to raise money.
What's your passion outside of the lab?
I play the piano. Classical, actually.
How do you have time for that?
I've also got three kids, 10, 13 and 15, so I'm really busy. For a longtime, I didn't have the time. But now I've started doing it and I find it has a good effect on the house, so I think maybe I'm getting a couple of birds with one stone.
Do you miss being in the lab?
Not too much. I actually got into the lab about a year ago and I truly enjoyed that. There are lots of little things that need to be attended to. That's probably the hardest part of any exec management position. You have to shift gears a lot. But it also keeps things interesting.
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