Secondly, the FDA has yet to greenlight any of these treatments.
What’s more, some early trials of mRNA therapies have suffered major stumbling blocks on the road to market approval.
In January, CureVac reported disappointing results in a clinical trial of its new mRNA-based drug for prostate cancer. The company’s CV9014 drug did not boost the survival rates of men with metastatic prostate cancer or halt the disease’s progression, the two primary goals of the study.
CureVac founder Ingmar Hoerr, PhD, called the findings a temporary setback, noting CV9014 was shown to be safe and preclinical testing suggests it might prove effective if used with other immunotherapy drugs known as checkpoint inhibitors. These drugs, such as Merck’s Keytruda, Bristol-Myers Squibb’s Opdivo, and Roche’s Tecentriq, were not on the market when the CV9014 study began.
“We’re already planning with our partner, Boehringer Ingelheim, to start clinical trials of mRNA in combination with checkpoint inhibitors,” Hoerr told the European publication Labiotech.
The two companies are also partnering on another prospective mRNA vaccine for lung cancer.
But the setback for CureVac, which has been backed by Microsoft co-founder Bill Gates and German entrepreneur Dietmar Hopp, among others, is a reminder that mRNA faces significant hurdles as a therapeutic.
That’s particularly true when it comes to creating new treatments for the thousands of different types of cancer, each of which has its own set of challenges.
Maurie Markman, MD, says mRNA therapy holds promise. But he urges caution along with the optimism generated by the Moderna and Pfizer COVID-19 vaccines.
“The treatment of cancer is a different universe than preventing cancer through innovation,” notes Markman, president of medicine and science at the Cancer Treatment Centers of America.
“Unfortunately, we’re wrapped up in simple terms like RNA, DNA and vaccines, and we say, ‘Well, if we can treat one group of diseases, including viruses, and we are successful in this area, can’t we take the same technology, the same strategy, and work on another disease? And the answer is: Absolutely we should look, but to assume that we’re looking at things that are comparable is problematic.”