Moderna and Merck shares soar on mRNA cancer vaccine

Moderna and Merck shares soared on Wednesday after the companies said a personalized mRNA treatment hit its target of preventing skin cancer from recurring or spreading in a late-stage clinical trial.

Why it matters: The results come at a pivotal moment for Moderna and mRNA research, after Trump administration health officials cut federal funding for new vaccines and asserted the technology poses more risks than rewards.

• The customized therapy, which could see a commercial launch next year, could also be adapted for other cancers of the kidney, bladder and pancreas.

The big picture: The results could lead to a remarkable turnaround for Moderna, whose market value plummeted more than 90% after demand for its COVID vaccine declined post-pandemic. The company this month also won Food and Drug Administration approval for a new mRNA seasonal flu vaccine.

• "People will experience this as ... the COVID company now [takes on] cancer," Moderna president Stephen Hoge told Axios. "But for those of us that live in it, it's like the cancer company that pivoted on a dime to help with COVID has pivoted back and really finally come home."

Driving the news: Moderna's experimental therapy, called intismeran, was tested in combination with Merck's cancer drug Keytruda in more than 1,100 patients with high-risk melanoma that had been surgically removed.

• The combination demonstrated a "clinically meaningful improvement" over treating the skin cancers with Keytruda alone.
• The mRNA-based drugs essentially train the immune system to find mutations in a patient that cause tumors. That's a contrast to chemotherapy, which damages or destroys cancer cells.

"We may be entering an era where a patient's individual tumor biology can be used to design a therapy specifically for them," William Soliman, founder and CEO of the Accreditation Council for Medical Affairs, said in an email.

The latest: The full results of the trial will be released at an upcoming medical meeting.

• But Wall Street has already responded enthusiastically, with shares of Moderna surging 177% Wednesday, while Merck shares closed up 12.6%.
• "This is a landmark moment," TD Cowen analysts wrote in an investor note. "We view the result as a significant validation of the ... platform."

Between the lines: The safety profile of the combination treatment was consistent with earlier studies and showed no new risks.

• The findings showed early cancers might be treated more aggressively than with prior treatments that were more toxic to the body, Hoge said.

What we're watching: Whether the potential success of an mRNA-based cancer therapy could help lift the bigger cloud hanging over the technology.

• Political backlash following the pandemic — including the Trump administration pulling nearly $500 million in federal funding for mRNA research — raised questions about the field's long-term prospects.
• The FDA initially refused to review Moderna's mRNA flu vaccine before changing course.
• "I do hope that this will move people away from pigeonholing mRNA as a vaccine platform, or maybe even more incorrectly, tying it to the things they didn't like about the pandemic era that had nothing to do with the technology," Hoge said.
• "I hope this starts to move us past that because it is, we think, a transformational moment in cancer."