The latest trial results from Moderna have brought a personalized cancer vaccine within striking distance of reality. The risks are real, but the potential is undeniable: What will it mean if this therapy actually crosses the finish line?
It's easy to question last week's massive rally, considering Moderna's ongoing profitability challenges and difficulty breaking out of the respiratory vaccine box. And in a sector where investors may not understand the scientific nuances-as evidenced by past speculative surges around hantavirus and Ebola-narratives are paramount.
Researchers at Merck and Moderna have been developing a cancer vaccine for nearly a decade, well before the Covid outbreak thrust Moderna into the spotlight.
Their top candidate, intismeran autogene, draws on Moderna's flagship mRNA platform. Though controversial, the technology has a track record established through the widespread use of of Covid vaccines. Claims by skeptics like Health and Human Services Secretary Robert F. Kennedy Jr. that mRNA vaccines cause "new mutations" are scientifically unfounded.
While most analysts remain on the sidelines, the intismeran readout triggered a wave of upgrades from firms including BofA Securities and William Blair. Wolfe Research became the latest to lift its rating on Tuesday, as analyst Alexandria Hammond upgraded the stock to Peer Perform from Underperform.
Hammond noted that many investors likely misunderstood the definition of a cancer vaccine, which could have contributed to the stock move. A survey from the firm shows many non-specialist and retail investors view cancer vaccines as preventive measures for high-risk individuals, suggesting a larger potential market than the population targeted in the latest trial.
The 1,100 trial participants received the injection after having their melanomas excised. The treatment helped patients stay cancer-free longer than Merck's Keytruda, the current standard of care, alone.
The results marked a major Phase 3 success for the field of personalized cancer vaccines-an important milestone, and a promising sign of things to come. Barclays analyst Eliana Merle believes the vaccine is more likely than not to make it through the regulatory process, though it still has a ways to go.
Questions linger around the size of the market opportunity. Leerink Partners analyst Daina Graybosch projects intismeran could generate annual sales in the low-single-digit billions by 2032, while Merck forecasts roughly $6 billion by 2035.
While a $10 billion sales peak supports about $40 billion in total market value between the two drugmakers, both Moderna and Merck gained over $40 billion each in a single day last Wednesday. That surge suggests much of the commercial potential may already be priced in.
Moreover, intismeran has yet to prove its efficacy in other cancer types. Success in melanoma doesn't necessarily guarantee victory across nine other ongoing trials in solid tumors, though analysts generally view the recent data as a positive read-through for cancers of the lung, kidney, and pancreas, among others.
For optimists, those hard numbers and uncertainties are counterbalanced by the vaccine's promise. Existing immunotherapies, Keytruda included, are standardized treatments that are not tailored to recognize and target a patient's specific tumors.
Intismeran, meanwhile, targets up to 34 patient-specific neoantigens, or abnormal proteins on cancer cells that help the immune system recognize and attack tumors. These targets are identified by sequencing an individual's surgically removed tumor to map its unique mutations.
This approach shows promise against small volumes of cancer cells, which is why the latest trial evaluated patients at high risk of recurrence following surgery. If ultimately approved, the drug would mark Moderna's entry into hyper-specialized, "market-of-one" treatments-an emerging field that could represent the next frontier for rare and genetic diseases.
Commercialization would be just as consequential for Merck, which has been searching for its next blockbuster ahead of the loss of exclusivity for Keytruda, its longtime top moneymaker. The intismeran readout rekindled interest in Merck's pipeline, prompting Morgan Stanley to upgrade the stock to Overweight last week while noting that its business development strategy could help sustain returns through the upcoming patent cliff.
On Tuesday, both Wolfe Research and Argus hiked their price targets on Merck shares to reflect pipeline strength. At Wolfe, Hammond noted that the injectable version of Keytruda could reduce patient burden when used in combination with intismeran, which is given intramuscularly.
Merck says it has streamlined the production process for intismeran across all clinical trials. Crucially, patients don't have to wait idle: it takes about six weeks from collecting a patient's cell sample to delivering the personalized vaccine. In that window, patients can begin Keytruda while their custom treatment is being manufactured.
Intismeran builds on the foundation laid by previous breakthroughs in cancer treatment. Keytruda itself represented a paradigm shift when it was released over a decade ago, as an early PD-1 inhibitor-a type of immunotherapy that blocks a protein on immune cells-approved by regulators.
Could a powerful, life-lengthening cancer vaccine shift public opinion more broadly, turning mRNA skeptics into believers? That remains a high bar. But for the technology's longtime champions, this readout is just the latest sign that mRNA has reached a tipping point.