BioGenerator Company Accuronix Targets Pancreatic Cancer

Pancreatic Cancer causes 40,000 deaths each year, with available chemotherapy regimens providing only an average of 6-11 months survival. WashU-born company Accuronix, founded by Dr. William Hawkins and Robert Mach, PhD. (now of the University of Pennsylvania), is taking on this difficult disease by developing novel therapies to selectively target cancer cells, increasing effectiveness and decreasing toxicity.

President and CEO of Accuronix, Dennis Schafer brings more than 30 years experience as a serial BioTech entrepreneur, participating in 12 startups throughout his career.

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We spoke with Schafer about why Accuronix was targeting pancreatic cancer specifically, what makes BioTech companies unique and how the STL ecosystem has helped shape his company.

How did you become involved with Accuronix?

I serve as an Entrepreneur in Residence at BioGenerator, and in that role, I met Bill Hawkins of Washington University. I’d heard about the technology [of Accuronix], liked it a lot, and thought there was a company opportunity.

So with BioGenerator’s support we did significant due diligence on the technology and decided to start a company. We raised our first financing round in December 2015.

Give us the Accuronix pitch.

Our mission as a company is to develop new and effective cancer drugs. The technology we’re using to do that is a platform technology—it has the potential to be used in a number of drugs.

The technology allows us to target drugs to cancer cells selectively by using ligands (a molecule that bonds to another larger molecule) to the sigma-2 receptor. The sigma-2 receptor is expressed on the surface of cancer cells in large quantities, but almost not at all on the surface of other cells. So this is a selective targeting tool.

Our first drug candidate, which we call ACXT-3102, is for pancreatic cancer. And again as a platform technology, if we get proof of concept through our work with pancreatic cancer it will allow us to address other tumors as well.

Why target pancreatic cancer first?

Well there are a few reasons. First, It’s a really tough cancer. There aren’t a lot of patients, there are only 45,000 new cases a year, but it’s the fourth-leading cause of cancer death in the US, on it’s way to being the second leading cause of cancer death in the US.

So it’s a tough diagnosis, and the current therapies are inadequate—there’s a strong need for new therapies. The “warhead” of our lead drug candidate, its active part that treats pancreatic cancer, is a novel drug candidate with a lot of promise. But it faced the problem that it couldn’t get inside cells, and it needed to get inside cells to work. Our technology enables that drug candidate to enter cells and therefore to work more effectively. Our technology gave us a way of dramatically improving an already very promising drug candidate for pancreatic cancer.

A final, really important reason, is that one of our founders, Bill Hawkins, is a nationally-recognized expert in pancreatic cancer research, so we have a strong technical basis for working on pancreatic cancer.

Talk about some of the challenges you’ve faced.

As you know, drug development is a very challenging business. The success rate for drugs at this stage is diminishingly small.

The challenge in evaluating this opportunity and deciding it was viable for financing and starting a company, was to really carefully vet the technology and the drug candidate that we had available through Washington University.

We went through a very detailed process of evaluating the chemistry, making sure that it was capable of being developed commercially, evaluating the biology and making sure that it made sense, and evaluating the research done at Washington University, which I have to say was just superb—we had outside reviewers look at the data and they were extraordinarily impressed by what had been done by WashU.

How do you think St. Louis and its BioTech community has affected Accuronix as it’s grown?

I don’t live in St. Louis, but I’ve known and worked in the city for quite a few years, worked on previous projects here, and worked with investors from here. So I’ve followed the BioTech sector in St. Louis with a lot of interest, and the amazing things going on right now are centered around BioSTL and BioGenerator. 

What BioGenerator has done is to engage the pool of talent that remained in St. Louis when Pfizer left. They had located their Global Inflammation Research Unit in St. Louis and when they moved it, a lot of really good people stayed. 

BioGenerator has proven to be a nucleating agent for that group of people, and so we’re working with a lot of ex-Pfizer folks. They’re leading our chemistry efforts and they were the people involved in our due diligence.

BioGenerator’s ability to bring together the talent that is in the pharmaceutical industry in St. Louis has really been amazing.

I’ve worked extensively in the Southeast and the Midwest, and for example I’ve watched the same process happen in the Research Triangle area. It’s my opinion that St. Louis is doing as good a job of supporting its talent base to start new companies as any of the emerging BioTech centers in the Midwest or Southeast.

How do you see a Biotech startup compare to a traditional tech company?

One difference is the timelines. With a technology startup you can move pretty rapidly. You might hope to be selling a product in a year. In BioTech you’re developing drugs, and the average timeline for developing a new drug is 12-15 years.

So right from the start you know that your little start-up is not likely to finish the job alone. You are in a complex network of companies and investors who will participate in moving the project forward to success.

The second difference is simply the cost. The total cost of an average new drug, including the cost of capital, is estimated these days to be more than $2.5 billion. That’s an enormous financial undertaking.

The third big difference is the probability of success. For any individual new drug it’s diminishingly small. The issue in the pharmaceutical industry is not only the cost of new drugs, it’s the high level of risk involved in drug discovery and drug development.

That doesn’t mean it’s a bad area for investment. In fact, for venture capital, it’s been one of the most attractive investment sectors over the years. It simply means that this is a very complex undertaking and you really have to make sure you’re doing it right.

And what will Accuronix have coming up in 2016?

We are focusing primarily on the development of our pancreatic drug candidate.

Over the first six months of the year, we are doing some basic chemistry to prepare the molecule for scalability and manufacturing that would support early clinical trials. That’s going pretty well, and we’re confident we’re going to see success there.

The second thing we’re doing is repeating some of the animal efficacy studies that were done at WashU, doing the study at several different doses so we can see the effect of different doses on the outcomes. That will allow us to prepare to move into toxicology, because then we’ll know what dose we need to use.

The second half of the year, we will be moving toward IND enabling toxicology studies. That will require a concentrated focus on chemistry, getting the process scaled up and getting ready to manufacture enough of our drug candidate to do those studies.