In Conversation: Kevin Combs, CEO of Molecular Biologicals
Kevin Combs, the CEO of Molecular Biologicals out of Charlottesville, Virginia, had a front-row seat to the BioHealth Capital Region’s (BHCR) ascendancy. He is now a vital part of the rise of CVille, the life science cluster within the BHCR that is blossoming in and around the University of Virginia (UVA).
Combs was recruited to join MedImmune by then CEO Dave Mott, becoming the company’s Executive Director of National Vaccine Sales in 2006. He has gone on to have a highly successful career as a life science executive, a serial entrepreneur, and an angel investor. He is a founding member of the Charlottesville Angel Network (CAN).
Combs currently serves as an Entrepreneur in Residence at UVA and is the CEO of Molecular Biologicals, a leading skin and wound care company that is on a mission to transform wound care. Molecular Biologicals has three approved products—KeragelⓇ, KeragelTⓇ, and KeramatrixⓇ, all of which are based on the company’s Keratin molecule platform.
We recently caught up with Combs to discuss Molecular Biologicals’ history, vision, and future plans, as well as the excitement and enthusiasm about the CVille bio hub percolating in the region.
What are Molecular Biologicals’ origin story and history?
The company was founded in 2015. Molecular Biologicals’ origins can be traced back to two companies, Keratac, a company from New Zealand, and Keraplast out of San Antonio, Texas. These companies had both developed a process of removing Keratin from the wool of sheep that contained peptides that could heal wounds. Keraplast had a huge number of Keratin-based patents, and they eventually acquired Keratac, merging the two companies.
They tried to run the business in New Zealand but couldn’t get any traction. Eventually, two Keraplast board members decided the U.S. market was a better fit and founded Molecular Biologicals to extract the tremendous value they saw for their IP in the skin and wound care market.
I signed on as a consultant in the summer of 2018 to help commercialize and expand the market for the company’s products. That first year my focus was on preparing the market. Then, in 2019, we conducted a clinical use trial that included about 285 doctors using our matrix and gel products. We gathered a lot of very positive data from the trial.
By 2020, we were ready to execute our strategy, so I agreed to come onboard as CEO. We knew we needed to raise some cash to execute commercially, so we secured $2M in funding, but then COVID hit and started to really impact us in early April. With elective procedures and Veteran’s Affairs being a big part of our customer base, we had to pivot, and so we turned our attention back to development in May. We moved our manufacturing back to the U.S. and partnered with a U.S. manufacturing firm. The future is characterizing peptides as products with the FDA, not as devices, so we’re actively developing a CMC package for our peptides.
Tell us about Molecular Biologicals’ mission and the company’s vision for advancing skin and wound care.
Our mission is to provide better products to skin and wound care patients. Patients are our central focus. I’ve always made it a point to work for companies that are driven by patient benefits regardless of profit.
“About 30% of chronic wounds just don’t close. Diabetic Foot Ulcers (DFU) are a major challenge. We had a woman that had a chronic DFU that would just not close for over a year. We were able to connect with her through her doctor that was in our clinical use trial, and we learned our product was able to close her wound. That’s what this is all about, that’s the value; we were able to give this woman a better quality of life.”
We estimate that the market for chronic wound treatments is somewhere around $6B. That’s a lot of unmet need. We see our annual market potential between $150-$200M. We have the products and the data. Now we need to engage the payers to get our products to more people and to grow the business.
What is the science behind the company’s Keratin Platform?
There are essentially four phases of wound care, but in the end it comes down to closing the wound from South to North and then from East to West. There are a lot of products that do a good job from South to North but falter during what is called the proliferation stage or going from East to West. This is where our products excel, in the final stage of closing the wound.
Our products deliver bioactive keratin to the skin or wound site. This activates keratinocytes, or skin cells, which promote skin cell growth and healing. We have three products, two of which are delivered by a gel (Keragel and KeragelT) and one that is a dressing or matrix (Keramatrix).
There are a number of matrix products in the market, but what makes Molecular Biologicals different is that our gels can be self-administered. Unlike a matrix that needs to be applied by a physician, our company’s gel products can be self-administered or administered by caregivers after a wound is debrided by a physician.
With COVID, multiple trips to the doctor’s office are very risky, particularly for seniors. After the initial debriding, some patients that use our products won’t have to return to the doctor five or six times; they or their caregiver can deliver treatment at home or at a long term care facility. This also allows physicians to treat more patients given the reduction in the number of visits required to treat a wound.
We’ve seen a big uptick in telemedicine and home health care during the pandemic. This is where our gel products are not only highly effective but also reduce other risks posed by multiple visits to the physician’s office.
We really feel our products provide great value and can fill a big unmet need.
What has it been like growing a business in the Charlottesville biotech/life science community?
I’ve been in pharma for 35 or so years. I was at MedImmune in the early days and worked in Cambridge, Massachusetts as well.
In 2011, I ran a small pharmaceutical company in Charlottesville and built the company from just a few million into an $85M organization that we sold for a few hundred million.
I realized in 2015 that I could stay in Charlottesville and be successful. Charlottesville offers such a great lifestyle and it’s a wonderful place to raise a family. Over the last five or so years, the CVille area has become a legitimate hub, thanks in part to the great work being done by the CVilleBioHub. Nikki Hastings and her team have really brought the Charlottesville life science community together.
There are quite a few high net worth individuals in Charlottesville and a number of investment groups that make CVille a fertile funding environment. There are so many talented people here, including experts in data analytics, pharmacology, as well as some of the top doctors in the world. There’s also a lot of tech transfer opportunities emerging from UVA, which I have some insight into as a UVA Entrepreneur in Residence.
In many ways, being in CVille reminds me of my time at MedImmune back when the region was just starting to take off. It seems like that same rising tide lifts all boats mentality exists in Charlottesville as it did in Montgomery County back then. I see the same focus on translational medicine and on moving from the clinic to commercialization. CVille has the financial, regulatory, tech transfer, and talent assets to be something special.
The area is starting to spread its wings.
What’s next for Molecular Biologicals?
We have a well-defined path for moving forward that includes two orphan diseases that will soon be evaluated by the FDA; we could see products emerge for these indications within the next 24 months. We’re also actively exploring other potential products.
We expect to raise more funds in 2021 while we will continue to drive the value of our current portfolio by focusing on home health and our self-administered products.
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