In part one of our series on mRNA innovation, we looked at how the promise of mRNA is driving a flurry of acquisitions and partnerships within Life Sciences. In this installment, we dig into the explosive growth in mRNA clinical activity and the implications for Life Sciences and beyond. Whether you're in a commercial role with a product under threat from mRNA, a marketing role, innovation role, or a strategy role, mRNA presents both opportunities and threats. The volume of mRNA activity is almost certain to impact your business at some point in the next few years.
At a glance, ClinicalTrials.gov data shows over 100 new mRNA clinical trials started in the first 8 months of 2021. 80% of all mRNA trials in progress are in phase one or phase two. That’s a ton of fresh clinical activity. Many of the trials are related to COVID vaccines, but even excluding the inflammation and immunology category where COVID vaccines reside, 2021 year-to-date has witnessed a tenfold increase in the number of new mRNA-related trials versus the average over the past three years. The trials outside inflammation and immunology cover everything from HIV to rare diseases like sickle cell. But if clinical trial activity can be read as tea leaves, chances are the biggest breakthrough will be in oncology. There is widespread enthusiasm around research into mRNA cancer vaccines that can be used to treat various forms of cancer. This includes melanoma, non-small cell lung cancers, gastrointestinal cancer, ovarian cancer, pancreatic cancer, and others.
Now, cancer-related mRNA clinical trials have been going on for two decades. In fact, cancer-related trials were second only to inflammation and immunology-related mRNA trials. But in 2021 alone, we’ve seen at least a dozen cancer-related mRNA clinical trials starting up. This count is significantly higher than the total number of mRNA clinical trials in the previous four years.
The rise in cancer-related mRNA trials is no surprise. Grail Insights has been monitoring the oncology space for many years, where there’s been steady interest in mRNA. What’s changed? The success of the mRNA-based COVID vaccines (thank you Pfizer and Moderna!). The pandemic arrived just as mRNA innovators were beginning to solve a critical component in the technology: how to deliver those “messages” in mRNA into human cells. Now that this has been solved, everyone seems to want in on mRNA. In particular, there’s growing interest in the medical community around mRNA vaccines for cancers of the blood (leukemia), brain (glioblastoma) and breast (ductal and lobular carcinomas). If there’s a silver lining to the pandemic for humanity, it will be that large scale clinical trials for mRNA COVID vaccines rapidly proved the delivery mechanism, accelerating the development of life-saving mRNA therapies we will all benefit from in our lifetimes.
At Grail Insights, we believe mRNA has the potential to profoundly transform the way the pharmaceutical industry works. The boom in mRNA trials holds notable advantages for drug manufacturers. It represents a tremendous opportunity to bring products to market faster than with traditional therapies. As we’ve all witnessed, mRNA-based vaccines can be produced quickly. Clinical trials can also be conducted quickly. We believe the rapid pace of mRNA drug development will drive further decentralization of traditional clinical trial research. Government regulatory agencies will become increasingly more accepting of hybrid clinical trials involving Real World Data (RWD). This includes electronic health records, medical claims, patient registries, and patient-generated data. RWD will expedite mRNA breakthroughs.
What’s also exciting is that within the realm of cancer trials, mRNA technology is agnostic to cancer type. Its application is already transitioning from an “off-the-shelf" treatment model where vaccines are designed to search and destroy proteins that appear on the surface of certain cancer tumors, to a more customized mRNA cancer vaccine specifically designed for an individual’s exact genetic code. It is entirely possible that we'll see pharma companies in the business of manufacturing medicines specific to individuals. Imagine the demand for clinical trial RWD when personalized mRNA medicines become a reality.
Customized mRNA treatments may be a bit further (though not that much further) off. But mRNA trials already in progress hold the promise of treatments for everything from flus to cancers. For pharma brand leaders, we think this could well mean a boom in product launches. Heads-up to marketing and sales! Start thinking about an educational component of mRNA and developing messaging and collateral to build trust with HCPs and their patients. Perhaps Innovation teams have the most to celebrate, with RWD having the potential to shave years off the development cycle.
Grail monitors transformative changes in Life Sciences and helps drug and device manufacturers navigate these changes throughout the entire product lifecycle, from early-stage innovation to commercialization and product launch. Whether claims research, pipeline monitoring, unmet need analysis, or asset vetting, Grail can help you stay on top of what is shaping up to be a breakneck pace of development over the next several years.
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Stay tuned for part three in the series which looks at the potential of mRNA to transform the patient experience.
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