From research lab to startup company

Originally published in the Fall 2014 issue of  ARVONews     

Justin Hanes, PhD, caught the entrepreneurial bug as a graduate student.

Under the direction of Massachusetts Institute of Technology Professor Bob Langer, he had a front-row seat at the creation of a small biotech company that grew from a promising project in the lab. Now, as the Lewis J. Ort Professor of Ophthalmology at Johns Hopkins University, Hanes has taken advantage of that experience to create a few startup companies. The most recent company, GrayBug, has received three NIH Small Business Innovation Research (SBIR) grants. Below, Hanes discusses with ARVONews the research and resources
currently behind GrayBug.

ARVONews: What can you tell us about the initial research in the lab that got you thinking about forming a startup company?

Hanes: When you inject regular poly(lactic-co-glycolic acid) (PLGA) microspheres into the eyes, you can get
inflammation. This was a major problem to solve because it’s the most attractive polymer to use for controlled release in the eye. When we changed the types of PLGA we were using with our formulation methods and added some excipients, we were able to eliminate the inflammation. 

So we felt that we were onto something that could be really helpful to the industry and therefore to patients.
In parallel, I was approached by Peter Campochiaro, MD, who was working with Gregg Semenza, MD, PhD, of Johns Hopkins. They had done a screen of more than 3,000 molecules that could be potent against angiogenesis. They found a few hits, but needed a way to make them last a lot longer. We found that we could make some very potent, very long-lasting drugs that down-regulated multiple pro-angiogenic signals.

With those two significant advances, we thought a good thing to do would be to start a company and try to develop this further. And that’s what we’ve done at GrayBug.

ARVONews: What is GrayBug currently working on?

Hanes: We’re working primarily in the ocular neovascularization space, and our lead drug is for wet AMD. The drug we’re using is a very potent inhibitor of the vascular endothelial growth factor (VEGF) and platelet-derived growth factor (PDGF) pathways. The major players — Lucentis, Avastin, Eylea — block VEGF.

Fovista, which is on the horizon, blocks PDGF. We know that blocking either of those pathways provides a significant benefit, but blocking both VEGF and PDGF is even more effective. 

Our lead drug, if eventually approved, holds the promise of doing that in a single agent, which would have three main benefits: 1) you wouldn’t need two injections, 2) it will likely be less expensive compared to paying for separate VEGF and PDGF therapies and 3) we expect it to last a lot longer than the current drugs or other biologics in the pipeline. If we’re successful, patients won’t have to come in every one to two months. We’re hoping they come in two, maybe three times a year at most. And we do not expect there to be a big change in the way doctors treat their patients in the sense that our drug is also injectable. If successful, our drug is just going to last a lot longer and be more effective than any current monotherapy.

ARVONews: What is the timeline for testing your lead drug?

Hanes: We hope to start that clinical trial in late 2015, but the date depends on the timing of our current financing. One of the things with potentially breakthrough delivery technologies that can make drugs last as long as ours does is that the timelines are somewhat longer than they are for traditional drugs.

ARVONews: In building your NIH SBIR applications, what did you think you needed to show the NIH in order to get the funding?

Hanes: I’m hesitant to say there’s a magic formula, because there really isn’t one. For us, we felt good because we had brought the molecules quite far along the preclinical path, through in vivo proof-of-concept in multiple animal models. We also have a tremendous team with unusual scientific depth and product development experience.

ARVONews: What are your other notable sources of funding? 

Hanes: We’ve been funded by angel and venture funding, and we’ve won some awards, including the Invest Maryland Challenge where we were selected as the most promising out of a pool of 68 companies in the healthcare category. We’ve raised a little more than $3 million so far, and we’re looking to raise a significantly larger chunk of money to take us through Phase II human clinical trials of the lead product.

ARVONews: The skillset one develops to be successful in academia is not identical to the skillset needed to be successful in the business world. How have you gone about developing those business-specific skills?

Hanes: When you’re the head of an academic lab, you wear a lot of the same hats that you wear in industry. You are the chief scientific officer, chief financial officer, you build the team and manage it, etc.

So, you really do have a lot of experience that can be helpful to a startup. To supply those other skillsets, you can partner up with someone who has done it successfully before. Then you learn a lot about the other aspects required.