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(REUTERS)
Moderna said Wednesday that a personalised mRNA cancer vaccine reduced the risk of recurrence and spread of melanoma in a late-stage trial, a major success in a new field of cancer treatment that sent the drugmaker's shares surging as much as 160%.
Moderna developed the vaccine with Merck and tested it together with immunotherapy drug Keytruda, a widely used treatment for melanoma. Thousands of patients who have undergone surgery to remove high-risk melanomas could benefit as soon as next year if regulators approve the tumours vaccine, Moderna President Stephen Hoge said in an interview.
This is the first positive late-stage trial result for an mRNAcancer vaccine, which trains a patient's immune system to fight tumours by targeting specific mutations in those cells, and the first such study to show that adding a treatment to Keytruda worked better than that therapy alone. Similar approaches are being tested against lung, breast, and pancreatic cancers.
Karen Knudsen, CEO of the Parker Institute for Cancer Immunotherapy, said the Moderna results could signal a new era for treating solid-tumour cancers.
“The positive hit here leads us into truly this next phase in immunotherapy,” Knudsen said. "This is an auspicious beginning - this is where things begin."
The results indicated a reversal of fortune for Moderna, which has struggled to generate new products beyond its COVID-19 vaccine and faced pushback over its mRNA technology from President Donald Trump's administration.
Moderna shares surged to multiyear highs, adding nearly $40 billion to the company's market capitalisation. Merck climbed 11% on hopes the vaccine will expand its prospects in cancer as Keytruda, once the world's best-selling drug, faces patent expiration later this decade.
The trial results attracted new investor interest in the biotech sector broadly. The Nasdaq Biotechnology Index climbed 4.4% to a record high, compared with a 0.4% gain in the benchmark S&P 500.
The .vaccine- which is a personalised treatment - could be difficult to make and scale up commercially, although Hoge said Moderna is confident it can meet demand over the next few years.
Interim results of the ongoing study, released on Wednesday, found the treatment, Intismeran, met both its primary target of reducing cancer recurrence and its secondary goal of preventing tumours from spreading to other parts of the body, compared with Keytruda alone. The companies did not provide detailed results, which they said would be shared at an upcoming medical meeting.
Merck said the companies are already in talks with regulators about the treatment.
Hoge said given thevaccine's breakthrough therapy design, it could be available as soon as next year. He called the result a landmark.
JP Morgan analysts said the launch of Intismeran in adjuvant melanoma will be key to Moderna returning to profitability. The cancer treatment combines Merck's Keytruda with a made-to-order mRNA vaccine from Moderna that is based on an analysis of mutations found in the patients' own tumours.
The trial enrolled 1,137 high-risk patients with stage IIB-IV melanoma that had been surgically removed.
