Bill Hearl's company, Immunomic Therapeutics Inc., creates vaccines using DNA engineering. The vaccines employ the Lysosome Associated Membrane Protein platform, or LAMP for short. LAMP directs vaccine agents to the right location within cells, making them optimally effective.
Originally based in Gaithersburg, Md., Immunomic Therapeutics in 2010 relocated to Lancaster to work with the Life Sciences Greenhouse of Central Pennsylvania, a state-funded nonprofit devoted to promoting biotech startup companies. The Greenhouse has made investments totaling $750,000 in the company.
Hearl, 54, has a bachelor's degree at East Tennessee State Universityand a Ph.D. in biochemistry from the University of Tennessee. A Brooklyn native, he lives in Damascus, Md., with his wife of 33 years. They have three grown children.
Q: The Business Journal profiled Immunomic Therapeutics in June 2010. What has the company been up to since then?
A: As you know, we created a vaccine against Japanese red cedar. Over the past 12 months we manufactured the vaccine in clinical doses and tested it in model animals as the FDA requires prior to (human) clinical studies. About three weeks ago, we filed our Investigational New Drug application to start a clinical study. Hopefully, we'll be starting that study sometime in May.
Why the focus on allergies?
We looked at LAMP and said, "What's the best way for us to interact with the FDA and get a product registered as quickly as possible?" … Allergies seemed like a pretty logical target for us because the cost of the clinical study is so much smaller than a cancer clinical study or an infectious disease clinical study.
Our total clinical trial cost will be about $1.5 million. That low cost has enabled us to fund everything through a combination of angel investors and the Life Sciences Greenhouse. … The other thing about an allergy vaccine is it allows for a compressed timeline as far as a Phase I safety study. It only needs to be 90 days. A cancer study, to be successful, needs to go on for two to three years.
Hopefully we'll be able to license this Japanese red cedar product next year and create a fair amount of liquidity for our investors.
There seems to be a lot of controversy over how well American patent law and investment law function for companies trying to innovate. What do you think?
To me it's been a positive the way the patent law has evolved. I thought it was really unfair that large companies could just go in and take large swaths of genes and just patent them without doing anything. … Those types of patents were not really helpful. They were really blocking patents for new drugs and, in our case, new vaccines.
The Patent Office has taken the position that things in nature are not patentable. In our case, every one of our vaccine products is something that doesn't occur naturally. So they're all well within the realm of new patents.
Let me ask you the same thing about the FDA approval process. Do you think it properly balances patient safety and innovation?
I don't really have anything negative to say about the FDA. They've been very helpful to us. Yes, the process is tedious, but wouldn't you rather know a product is safe and effective before it goes on the market?
Tell me about partnering with the Life Sciences Greenhouse of Central Pennsylvania.
We could not have done it without them. They were really the lead domino that we needed, in terms of credibility. They did a really extensive due diligence, especially in terms of analyzing our IP (intellectual property). That endorsement really carried a lot of weight with other investors. So they've been a great resource for us.
This year the plan is to establish our manufacturing facility in Pennsylvania. They've given us enough support to make that happen. It's going to bring new jobs.
Weren't you originally going to outsource that part?
Yes, we were. But after going through the process of having it made for this first product, we realized that if we set up our own laboratory, it would pay for itself in one run.
There are a number of incubators in midstate Pennsylvania that might be good locations.
Yes, that's exactly what we're going to be looking at. We just signed a deal with a top-five pharma company — I can't say who it is yet — to make five vaccines for veterinary use over the next 12 to 18 months. So part of the manufacturing capacity is going to be used to bring out these animal health vaccines.
Weren't you using a lab at Franklin & Marshall College?
Our lease expired. It would've been a good spot to put this production laboratory, but they hired a new faculty member and needed lab space. So that's why we need to find a new location for the manufacturing lab.
The other thing we're looking at is to take the (LAMP) technology that's been applied to cancer research and begin a collaboration with Lancaster General Health. I have this idea for a leukemia center in Lancaster that would utilize our technology as well as the latest studies. There's a possibility of that coming together over the next six to eight months.
What advice do you have for startup companies like yours?
I was at a symposium recently, and I noticed in the other talks, everybody presented several different ideas about how they were going to go, which products they were going to develop. I really feel you have to get out there with a (single) concept and a product that's your lead. You establish it as your lead, people can see you have a clear plan to develop this product and get it to market and create value for the shareholders. …
The second thing is, how do you give investors some sense of when they're going to get their money out? Whether it's by dividend, or by selling off small elements of your company to partners, if you can create short-term paths to getting some sort of return, they'll like that.
The third thing is, put out milestones that are aggressive enough to make people realize you're trying to do something, but not so aggressive that you can't make them.