The ongoing Covid-19 pandemic has yielded an unexpected advancement in the pharmaceutical industry with the approval of the first mRNA vaccines, which GlobalData expects will soon impact other indications.

This historical landmark could have significant implications, primarily in the oncology market since mRNA vaccines were being exclusively investigated in infectious and oncology diseases prior to the pandemic. Historically, mRNA vaccines were of interest in the oncology setting because multiple biomarkers could be targeted by this novel mechanism.

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Given the current role of immunotherapies in oncology, mRNA vaccines pose a novel approach to trigger immune reactions against cancer cells. However, the novelty of mRNA vaccines has raised regulatory and manufacturing questions in addition to clinical limitations.

Covid-19 approvals showcase potential of mRNA vaccines

The recent approvals of Pfizer / BioNTech’s and Moderna’s mRNA vaccines in healthy patients, complemented by the historically unmatched magnitude to reach healthy patients worldwide, has helped surpass many barriers for mRNA vaccines while highlighting this novel mechanism of action. GlobalData expects this will propagate a new epicenter of interest in pursuing this drug class in oncology.

Currently, there are 44 ongoing clinical trials exploring mRNA vaccines, of which 23 are investigating infectious diseases. This includes Covid-19, which accounts for 60% of those clinical trials. Interestingly, only four out of the 44 clinical trials have made it to Phase III as a result of the sudden and immense demand to prevent the spread of Covid-19.

From an oncology viewpoint, the current pandemic will still serve to provide essential real-world data about the tolerability and effects of mRNA vaccines, since despite their approval and initial vaccination rollout, the long-term efficacy and side effects are still to be understood. As more data are gathered on these vaccines, GlobalData expects an increasing interest in bringing them into the oncology sector.

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Key opinion leaders (KOLs) interviewed by GlobalData have repeatedly shown interest in novel mechanisms of action, particularly in immunotherapy. Prior to the pandemic, mRNA vaccines were one of many promising drug classes that were being explored equally with each other, with no expectation about which would be the next to impact the market. However, the sudden rise of mRNA vaccines makes it a prime candidate since there is a current spotlight on this drug class.

A supporting argument for the interest in mRNA vaccines is that out of the 21 ongoing non-infectious disease clinical trials that are exploring mRNA vaccines, all are being developed for oncology indications. Of these 21 trials, only seven are in Phase II, which demonstrates the relatively early stage of mRNA vaccines in oncology. Interestingly, the most represented company in these clinical trials is BioNTech, with seven of the 21 trials, followed by Roche/Genentech with three clinical trials and Moderna Inc with two clinical trials.

Big Pharma: the mRNA race in oncology

GlobalData expects that large pharmaceutical companies will look to enter the race for the first mRNA vaccine approval in oncology. Given the current role of both BioNTech and Moderna in the Covid-19 mRNA vaccines market, GlobalData assumes these companies will be heavily sought out for marketing deals in the oncology market as well. BioNTech is already involved in licensing deals for its mRNA vaccine BNT-122 with Genentech and Roche, the latter being of great significance since it explores a combination with Roche’s Tecentriq (atezolizumab).

Similarly, Moderna has a deal with Merck & Co., which has led to the co-development of two mRNA vaccines: mRNA-4157, a personalized cancer vaccine, and mRNA-5671, a KRAS vaccine. Pfizer’s involvement with BioNTech during the pandemic may provide it with an advantage over other companies that may be interested in entering this novel market.

Therefore, GlobalData expects that a novel competitive landscape will emerge in the oncology immunotherapy market, which will help identify which indications better benefit from this approach and eventually give rise to the first therapeutic mRNA vaccine in oncology.