RESEARCH TRIANGLE PARK – Earlier this year, GeneCentric Therapeutics closed $7.5 million in an equity fundraising round, after closing $1.2 million in debt at the beginning of the year.  The genomics startup also landed an investor-partnership deal with Labcorp, which company CEO Dr. Michael Milburn discussed with WRAL TechWire in October.

WRAL TechWire connected with Dr. Milburn recently to discuss the company, the industry, and the trends that Milburn is watching in the new year.  A lightly edited transcript of the interview appears below.

 

WRAL TechWire (TW): Dr. Milburn, how has the company’s trajectory changed since you joined as chief scientific officer in November 2018?

Dr. Michael Milburn, CEO, GeneCentric (Milburn): GeneCentric was founded by Myla Lai-Goldman, along with UNC researchers Chuck Perou and Neil Hayes, with a vision to develop cancer tests to match a drug to an individual patient and the goal to maximize the efficacy of cancer treatments and reduce adverse events. Since joining the company, I wouldn’t say that our trajectory has changed dramatically. I think it’s more that we have refocused on pharmaceutical partnering and diagnostic reference lab partnering with our RNA-based cancer diagnostics. Through those partnerships, we’re working to advance the next generation of cancer immunotherapies and chemotherapies as quickly and accurately as possible using with our novel RNA gene expression signatures.

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TW: Tell us more about the company’s technology, and the difference between DNA and RNA.

Milburn: Traditional approaches for identifying treatment responders, such as DNA mutation analysis, fall short in predicting all patients who will respond to a specific cancer therapy. Although DNA has produced profound precision medicine solutions, and will continue to be important, the low-hanging fruit has been picked and there is a need for data that more dynamically reflects the complexities of response. Other drivers of response appear buried deep within tumor biology.

Without getting too complicated, our technology is focused on developing RNA-based companion diagnostics for cancer therapies. Where we differ from a DNA approach is that we’ve developed a proprietary software, informatics, data science and machine learning approach to developing these RNA-based gene expression signatures that are highly transportable to any RNA diagnostics platform.

TW: Why is RNA is the future of biomarkers and diagnostics?

Milburn: I think there are a number of advantages to RNA-based diagnostics for guiding cancer therapies. To offer an example, DNA is more of signpost that a patient will respond to a drug, while RNA is comparable to a high-resolution GPS map. The RNA tests we’re developing uniquely provide a dynamic range for how well a patient is going to respond to a particular therapy. I think another big advantage driving a lot of interest and excitement for RNA-based diagnostics is that they could also identify more patients for a particular therapy.

Our platform focuses on developing robust RNA-based diagnostics for hundreds of different types of cancer therapies, and we’re currently applying the platform to lung, head and neck, bladder and pancreatic cancer. We’ve cultivated much of our technology in collaboration with our co-founders from the UNC Lineberger Cancer Center, and we’ve built upon 10 years of informatics technology and software for developing these types of diagnostics.

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TW: Based on what we’ve learned in the past decade, what might the next decade look like?

Milburn: New treatment approaches such as immunotherapy and other molecularly targeted therapies have begun to change the landscape for cancer treatment. These have resulted in dramatic improvements in long-term survival rates compared with conventional chemotherapy, but the benefit has only been realized in a subset of patients.

At the same time, many promising cancer therapeutics are failing in late-stage clinical trials. However, pronounced effects seen in small numbers of study participants suggest that by better identifying responders we could drive greater success. We think this opens a tremendous opportunity to better serve patients.

TW: What are the current trends in drug therapies – what are you watching and paying attention to in the next year?

Milburn: Most biopharma companies today are developing companion diagnostics or biomarkers for their cancer therapies – sometimes referred to as precision medicine, which applies treatment customization for each patient based on an individual’s cancer. This is a dramatic change from how patients were treated 10 years ago with a one-drug-fits-all model.

We hope that GeneCentric’s RNA-based tests will be the next generation of genomic-guided precision medicine. Working with our reference lab partners like Labcorp, as well as pharmaceutical and biotech companies, these new companion diagnostics are an innovative approach for guiding cancer therapies and one that we believe will be highly beneficial to patients.

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TW: Talk to me about the funding environment right now for life science companies, who is investing, and why now?

Milburn: GeneCentric closed an oversubscribed $7.5 million-dollar Series B1 round in early November, and we are grateful for the support and enthusiasm of our investors. I think, though, it’s starting to become more challenging to fund a biotech company, because there’s so much out there right now and it’s harder to get the attention of investors. You really must have a robust technology, a compelling business case and validation from external partners that are using, or want to use, your technology or product.

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TW: Should the Triangle and surrounding region now be considered a top hub for life science and biotechnology companies? What are the existing challenges?

Milburn: The Triangle is clearly an exciting place right now for starting a biotech company, or really any technology company. We’ve seen the region become the national hub for gene therapy manufacturing in just a few years. I’m also excited to see Raleigh adding a biotech corridor in the Midtown area with much-needed lab and biomanufacturing space.

The Triangle is a highly attractive environment to draw scientists or technologists who want a reasonable cost of living with excellent school systems, as well as increasing job opportunities. My experience has been that once you bring a scientist into the Triangle, they stay here because it’s a wonderful place to be.

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TW: What’s the outlook for next year, from your perspective, both for the company and the industry? 

Milburn: I think GeneCentric‘s on track to have an exciting year in 2022. We will continue growing our company and pharmaceutical partnering business, as well as launch one or two RNA-based tests with clinicians and make them available to patients. That’s our focus right now.