October 10, 2024

Member Spotlight: MeCo Diagnostics

How MeCo Diagnostics’ Predictive Biomarker Test Could Connect Breast Cancer Patients to New Therapies

Dr. Adam Watson knows first-hand what it’s like to have a loved one diagnosed with incurable cancer. While he was in graduate school, his aunt, Val, received a diagnosis of advanced-stage cancer. Despite having a solid health insurance policy—she was formerly a hospital executive—she incurred over a hundred thousand dollars in out-of-pocket expenses due to non-reimbursable, experimental treatments which became the only options after standard-of-care treatments failed to halt her disease. Adam is determined to ensure that no other patients will have to endure what his family went through. His company, MeCo Diagnostics, just reached a major milestone on the path toward providing low-cost, low-toxicity, high-efficacy treatment for the most common subtype of breast cancer—in the early stage, when it’s still curable.

As a trained cancer biologist, Adam, along with Dr. Gus Mouneimne, his Ph.D. advisor at the University of Arizona, invented the MeCo Score—a predictive biomarker test for breast cancer patients to match patients to a new therapy. For the past 10 years, they have researched how their test can potentially identify patients who could benefit from antifibrotic therapy. They both co-founded MeCo Diagnostics and recently published a landmark 10-year study in Clinical Cancer Research, revealing the first clinical success of antifibrotic therapy for breast cancer—a fundamentally new therapeutic option.

In honor of Breast Cancer Awareness Month, we spoke with Adam about his journey as a cancer researcher and entrepreneur, the potential benefits of the MeCo Score as a predictive biomarker test for patients, and, most importantly, how it may help address the significant financial burdens faced by many cancer patients.

When did you get your start in the life science industry? Did you always know that you wanted to be a scientist?

Several of my family members have been or are scientists. I was the first person in five generations of my family that didn’t go to the University of Toronto, which is where my mom’s side is from [laughs]. My father is a mathematician—he actually invented the secondary algorithm for our [MeCo’s] technology—and my brother is an engineer.

I’ve wanted to do this ever since I was a kid. When I was young, I found some patents that my paternal grandfather had, inventions he made during World War II. I found that fascinating and I wanted to invent something one day. It just seemed like a righteous thing to do with one’s life, to pursue a life of science.

What role did your aunt’s diagnosis play in wanting to start your own company? Did you feel you could make a bigger impact in cancer research and treatment this way instead of staying in academia?

It wasn’t the motivation for me to start my own company, but it certainly has been the motivation to not quit. Startups are notoriously difficult—90% of them apparently fail. If you don’t have a strong personal reason that drives you to continue doing it every day, then chances are higher that you’ll quit. If you want to be in the 10% that succeeds, you need a strong sense of determination and resilience, and one of the best ways is to mind your emotional response to whatever you’re working on.

Give us an overview of the MeCo Score and how the predictive biomarker test works in breast cancer patients.

The MeCo predictive biomarker test examines breast tumor tissue and doesn’t require an additional procedure. During the diagnosis of breast cancer, some tissue is taken from a biopsy or fine-needle aspirate, and the pathologist examines it and classifies it. That piece of tissue can be used for lots of different tests down the line. We can use a small portion of an existing breast biopsy and then we do some RNA sequencing (next-generation sequencing) using Illumina technology. Our secret sauce is a proprietary algorithm that we use to evaluate the RNA sequencing data and that gives us the MeCo Score.

Our test shows that patients with a high MeCo Score, roughly the top 50% of all patients as classified by our Phase 2 study, may substantially benefit from antifibrotic therapy versus standard-of-care therapy alone [chemotherapy alone].

Tell us more about your Phase 2 study, which was recently accepted for publication in Clinical Cancer Research.

Our study was a 130-patient Phase 2 study and we have 10-year survival follow up. They were randomized into two different treatment arms: patients who received antifibrotic therapy plus chemotherapy and patients who received chemotherapy alone.

What we found in our 10-year survival follow-up is that patients that had high MeCo scores at the beginning before treatment tripled their relapse-free survival rate over 10 years compared to the patients with high MeCo scores that just got the chemotherapy alone.

What makes our technology essential for antifibrotic therapy to be deployed is that low MeCo Score patients—50% of all the patients in the trial—did not benefit from antifibrotic therapy whatsoever. It’s essential to have a predictive biomarker test like the MeCo Score, which is now the first and only clinically validated predictive biomarker test for antifibrotic therapy in any disease, because it identifies the patients who are likely to benefit.

Why treat breast cancer with the same antifibrotic drugs that are used in treating lung cancer?

Fibrosis essentially means scarring or scarification. It’s not a big deal when your skin—the outer dermis or epidermis—scars, but if your lungs start to scar, for example, they can’t absorb oxygen and this is fatal. There are two drugs that have been FDA approved to treat and extend the lifespan of people that have lung scarification or lung fibrosis. We’re researching antifibrotic drugs, specifically nintedanib, as there is already evidence that it can benefit breast cancer patients, who were enrolled in a Phase I clinical trial.

Fascinatingly, fibrosis is actually the oldest observation in oncology. The first observation recorded of cancer in human history is Queen Atossa [of Persia], who had a lump in her breast. The lump implies an area of stiffness and fibrosis. We’ve known since the beginning of our understanding of cancer, or our observation of cancer, that fibrosis is this ubiquitous element of the disease.

But it wasn’t until recently in the last 20 to 25 years that we’ve started to understand that it’s not just a consequence of cancer. Fibrosis can drive the disease forward in a lot of ways. That’s what I spent my Ph.D. researching how the presence of fibrosis can sometimes cause cancer cells to behave in a much more destructive way to your body. We hypothesized early on that if we could reduce the fibrosis in certain patients selectively, it would prevent their disease from metastasizing and spreading throughout the body.

Our test shows that patients with a high MeCo Score, roughly the top 50% of all patients as classified by our Phase 2 study, may substantially benefit from antifibrotic therapy versus standard-of-care therapy alone.

What type of breast cancer could benefit most from the antifibrotic therapy?

The MeCo Score and antifibrotic therapy is most effective for patients with luminal breast cancer—hormone receptor-positive and HER2-negative—which makes up about 70 percent of all early-stage breast cancers. This is a group of patients that does not seem to respond well to immunotherapy. There are other drugs that have recently become approved for this group, like CDK inhibitors, but the magnitude of benefit for those drugs is not very good comparatively.

The study we are publishing now shows we reduced the risk of recurrence by 65% over 10 years post-therapy. We’ve doubled the efficacy of the best available treatment currently approved for early stage luminal breast cancer patients. And then, of course, the fact that the drug we are leveraging (nintedanib) is generic-emergent and thus soon to be inexpensive is just the cherry on the top. But the most important thing that people are interested in is efficacy—can we get better drugs? And it looks like, yes, we absolutely have a better drug than the best available drug approved currently for these patients.

We’re talking about what is potentially the first low-cost, low-toxicity, targeted therapy for breast cancer. It’s a watershed moment. This has never happened in the history of breast oncology. But it only works for patients with a high MeCo Score.

How could antifibrotic therapy potentially save patients money?

Out-of-pocket expenses, even for insured patients, are getting higher every year. This is exactly why generic drug repurposing, like what we’re doing, is a fantastic option.

What I really want people to know—because I didn’t know this until my family went through it—is that well-insured patients are not shielded from the financial toxicity of having cancer. Even the best health insurance plan does not prevent you from experiencing financial distress as a result of your disease and sadly, people only realize that when they need it the most.

Most people are not familiar with the range of benefits in their plan; you learn about them when you get sick and oftentimes that’s too late. You might have $10,000 in out-of-pocket expenses. Or none of the approved drugs are working, but there’s some experimental drugs that are off-label that insurance won’t cover.

That’s what happened to my aunt. She ended up spending nearly $200,000 out-of-pocket because none of the approved and covered drugs were working and she took a gamble with a prescribed immunotherapy that wasn’t reimbursed for her condition. This is how people go bankrupt from breast cancer or any cancer: they’re given an option from their oncologist to either live the best of their remaining days or remortgage their house in order to try a drug that isn’t reimbursed. It’s very difficult for people to be put in that position, but this is what’s happening to families all across America.

The projected cost of nintedanib is estimated to be $700 a month in a few years, over 10-fold less expensive than any currently approved targeted therapy for breast cancer. We think we can make a big improvement in both ameliorating the financial toxicity of cancer and improving the survival of patients.

What is your biggest challenge right now?

We are a still a seed-stage startup. However, along with our high-impact publication of our 10-year clinical study, our first patent was recently allowed and is now set for issuance. These are big milestones for a small startup like ours. So, while scientifically and clinically we are very de-risked, there’s a lot of other aspects when it comes to the potential success of a startup that’s doing diagnostics or therapeutics. One aspect is working in a highly regulated environment that is becoming even more complex because of changes to the law—there are lot of moving parts in order to bring a new diagnostic test to market now.

Secondly, our startup is run by two scientists with limited business background, so there is a lot of difficulty in being able to assemble the right team without a lot of early capital. We’re currently in discussions with numerous VCs and they would love for us to have another full-time executive with a strong business background. Of course, that makes sense, but the difficulty is having the liquidity to attract the best person.

This is something that a lot of scientific founders struggle with: being able to build the team in a way that makes it attractive enough for institutional investment. We have to be able to do that in creative ways because we don’t have a lot of liquidity right now. Nonetheless, we are expanding our executive team and our board, and we’re confident that we’ll be able to incentivize everyone well enough—including our investors.

What advice do you have for a young person who wants to get into the life science industry today? And what advice do you have for someone who wants to be an entrepreneur in this field?

To avoid some of the pitfalls that I went through, the best advice I can give is to not be shy about asking for help. I was a bit reluctant to ask for help early on, but that cost us some crucial time and money.

I learned this while mentoring at the University of California, San Diego. For over a year now, I’ve been working with some master’s students in engineering who have an exciting new technology that can help with cardiac surgery. While I don’t have a background in cardiac physiology, what they needed was guidance in how to take an idea from the lab and make some early progress as a startup.

What I realized during this process is that even a small amount of help can make an enormous difference, and I’m more than happy to do it—and there a lot of other people like me out there who want to help. Find someone who has the technical skill or business experience that you need, or seek out nonprofit organizations, like Biocom or Connect, that host supportive events for startups. Those resources will make things a lot easier for you and give you the confidence you need to keep going.