By Julie Steenhuysen and Michael Erman
CHICAGO (Reuters) - An experimental cancer vaccine from Moderna (NASDAQ:MRNA) Inc based on the messenger RNA (MRNA) technology used in successful COVID-19 vaccines has been shown to work against melanoma, sending Moderna shares more than 20% higher and driving up of other biotechs working on similar treatments.
A combination of Moderna's personalized cancer vaccine and Merck & Co's blockbuster immunotherapy Keytruda cut the risk of recurrence or death of the most deadly skin cancer by 44% compared with Keytruda alone in a mid-stage trial, the companies said on Tuesday.
The result was considered a "statistically significant and clinically meaningful improvement," the companies said.
Moderna shares were up nearly 23% at $202.80 on Tuesday, while Merck's shares rose 1%. Shares of BioNTech SE (NASDAQ:BNTX), which also has successful mRNA vaccine technology, were up 6%, and tiny Gritstone Bio Inc, which has a cancer vaccine in development, jumped 20% to $3.09.
The study is the first randomized trial to show that combining mRNA vaccine technology with a drug that revs up the immune response would offer a better result for melanoma patients and potentially for other cancers.
"It's a tremendous step forward in immunotherapy," Eliav Barr, Merck's head of global clinical development and chief medical officer, said in an interview.
Paul Burton, Moderna's chief medical officer, said in a separate interview that the combination "has the capacity to be a new paradigm in the treatment of cancer."
The ongoing study involved 157 patients with stage III/IV melanoma whose tumors were surgically removed before being treated with either the drug/vaccine combo or Keytruda alone with the aim of delaying disease recurrence.
The combination was generally safe and demonstrated the benefit compared with Keytruda alone after a year of treatment. Serious drug-related side effects occurred in 14.4% of patients who received the combination compared with 10% with Keytruda alone.
A PROMISING FIELD
In October, Merck exercised an option to jointly develop and commercialize the treatment, known as mRNA-4157/V940, sharing costs and any profits equally. Merck and Moderna plan to discuss the results with regulatory authorities and start a large Phase III study in melanoma patients in 2023.
The Merck/Moderna collaboration is one of several combining powerful drugs that unleash the immune system to target cancers with mRNA vaccine technology. They are designed to target highly mutated tumors.
The personalized vaccine works in concert with Merck's Keytruda, a so-called checkpoint inhibitor designed to disable a protein called programmed death 1, or PD-1, that helps tumors to evade the immune system.
To build the vaccine, researchers took samples of patients' tumors and healthy tissue. After analyzing the samples to decode their genetic sequence and isolate mutant proteins associated only with the cancer, that information was used to design a tailor-made cancer vaccine.
When injected into a patient, the patient's cells act as a manufacturing plant, producing perfect copies of the mutations for the immune system to recognize and destroy.
Moderna's personalized vaccine can be made in about eight weeks, a time frame the company eventually hopes to halve, Burton said.
Barr said the companies intend to study the approach in other highly mutated cancers, such as lung cancer. Other such cancers include bladder cancers and some breast cancers.
Moderna mRNA rival BioNTech has several cancer vaccine trials in the works including one with Memorial Sloan Kettering Cancer Center in New York testing a personalized vaccine in combination with Roche's Tecentriq in patients with pancreatic cancer.
Gritstone is testing a personalized, self-amplifying mRNA vaccine in combination with Bristol Myers (NYSE:BMY) Squibb's immunotherapies Opdivo and Yervoy in a midstage trial in patients with advanced solid tumors.
Experts said the personalized vaccines were among several promising cancer vaccine ideas in the works after many failures in the field.
“In general, I think cancer vaccines are kind of at a tipping point, and there are going to probably be a lot of vaccines coming down the pipeline in the next five years,” said Dr. Mary Lenora Disis, director of the UW Medicine Cancer Vaccine Institute in Seattle.
Although the COVID-19 pandemic demonstrated the speed, ease and safety of mRNA vaccines, they came out of years of cancer vaccine research, Disis said.