Moderna and Merck said on Wednesday that their experimental personalized cancer vaccine showed positive results in its first-ever Phase 3 trial. The news pushed Moderna shares up more than 120% in morning trading. Moderna’s stock is soaring after major cancer vaccine news.
The cancer vaccine is being developed by Moderna and Merck. The treatment combines Moderna’s personalized mRNA cancer vaccine with Merck’s cancer drug Keytruda. The patients had higher-risk melanoma, a serious form of skin cancer, that had been removed through surgery but still carried a risk of returning. The treatment met the main goal of the trial. The vaccine-plus-Keytruda combination significantly increased the amount of time patients lived without their melanoma coming back, compared with patients who received Keytruda alone. The treatment also lowered the risk of the cancer spreading. The new treatment is designed to target each patient’s specific cancer. Unlike a traditional one-size-fits-all treatment, the vaccine is personalized for the mutations found in an individual patient’s tumour. Every tumour can have different mutations. That is why Wednesday’s results are so important for Moderna.
The Phase 3 trial involved more than 1,100 patients. The positive Phase 3 data give investors evidence that the company’s personalized mRNA cancer vaccine technology can work in a late-stage clinical trial.
The combination reduced the risk of melanoma spreading to distant parts of the body, according to the companies. Healy said that even patients who have the same type of cancer can have different sets of mutations in their tumours. Analysts said Moderna’s valuation before Wednesday’s jump already reflected hopes that the personalized cancer vaccine could eventually work against multiple types of cancer , not just melanoma.
The positive Phase 3 results have given Moderna a major boost, strengthening hopes that its personalized mRNA cancer vaccine could become an important part of its future.
However, more trial data and regulatory steps are still needed before the treatment can reach patients in the US.
The early Phase 3 results suggest that the personalized vaccine combined with Keytruda could become a new treatment option for some melanoma patients. Melanoma accounts for only about 1% of skin cancers, but it causes the large majority of deaths from skin cancer, according to the report. The companies have not announced a specific date for filing applications with US regulators.
It is not yet clear when the vaccine will be submitted for approval in the US. Dr. Melanoma is a small part of all skin cancers but causes many deaths.
Dean Li, president of Merck Research Laboratories, told CNBC’s Squawk Box that the companies will likely begin discussions with regulatory agencies about the treatment and its safety within the next few months.
