Moderna shares soar 90% after personalized cancer vaccine tests positive

Moderna announces preliminary results of successful cancer vaccine Reuters Moderna's shares soared 90% in pre-market trading this Wednesday (19) after the company announced positive results from a personalized therapy against melanoma, a type of skin cancer. Developed in partnership with Merck, the treatment uses mRNA technology to help the immune system identify and fight tumor cells. ?? Called autogene intismeran, the vaccine is different from those used to prevent infectious diseases: instead of protecting against cancer before it appears, it is custom-made to treat a tumor that already exists, based on that patient's specific genetic mutations. In the study, it was tested in combination with Keytruda (pembrolizumab), a Merck immunotherapy already used to treat melanoma -- an aggressive type of skin cancer. According to the company, the treatment achieved two main objectives: Significantly prolong the survival time of patients without melanoma recurrence, compared to treatment with Keytruda alone. It also reduces the risk of cancer spreading to other parts of the body. The vaccine, called intismeran autogene, was tested on patients with melanoma — the most lethal form of skin cancer — who had undergone surgery to completely remove the tumor, but were still at risk of the disease returning. Patients who received both treatments together had fewer disease recurrences and fewer cases of distant metastasis than those treated with Keytruda alone. Brazil registers patent for vaccines made from mRNA How the vaccine works Unlike vaccines used to prevent infectious diseases, intismeran does not protect against cancer before it appears: it is custom-made to treat a tumor that already exists, based on each patient's specific genetic mutations. And how does this happen? A sample of the tumor is sequenced to identify these mutations — a kind of molecular “fingerprint” of that cancer. From there, an mRNA molecule capable of encoding up to 34 targets (neoantigens) present in that tumor alone is produced. Injected into the patient, it teaches the immune system to recognize these mutations and attack the cells that carry them. Keytruda works in another way: it blocks a protein (PD-1) that tumors use to escape the immune system's surveillance, allowing T lymphocytes to act more efficiently. The combination seeks to unite the two mechanisms — one points to the target, the other removes the brake on the immune response. What did the study find? The current study included 1,137 patients with cutaneous melanoma. Two-thirds received the combination of the vaccine with Keytruda, and one-third received just the immunotherapy, for about a year. In an interim analysis — carried out before the expected end of the study — the group that received the combination showed statistically superior results in both recurrence-free survival and distant metastasis-free survival. The information was released in a statement from the companies this Wednesday. The study is still ongoing and has not been published. Moderna and Merk did not disclose the exact percentages of risk reduction observed in this new analysis. In a mid-phase study of high-risk melanoma patients undergoing surgery, the same combination had reduced the risk of recurrence or death by 49% after five years, a result consistent with three-year follow-up data presented in 2023. The safety profile of the combination, according to the release, was consistent with that observed in previous studies, with no new risk signals identified. Technology is being tested on other types of cancer The study released this Wednesday deals specifically with melanoma, but the technology behind the vaccine is being tested on other types of tumor. The research program, called INTerpath, brings together nine ongoing Phase 2 and Phase 3 studies, including non-small cell lung cancer, bladder cancer and renal cell carcinoma. There are also early-stage studies for pancreatic, stomach and other types of lung tumors. The technology behind it is the same mRNA platform used by Moderna to develop its Covid-19 vaccine. The company has sought to transform its mRNA platform into a broader and longer-lasting franchise, applying it to other frameworks. What to expect with this technology? For oncologist Stephen Stefani, personalized treatments like this occupy an increasingly relevant space in the medical literature, but the results announced this Wednesday still need to advance through other stages before changing clinical practice. He considers that the strategy of using customized vaccines against cancer has already been discussed by the scientific community for a long time, but that transforming this knowledge into a widespread treatment depends on factors that cannot yet be assessed based on what has been disclosed so far. "The good news is that yes, we are advancing in terms of new knowledge. Now, the fact of transforming this into a widespread and institutionalized practice will depend on many aspects that are not yet available to evaluate. This strategy of treating patients with this vaccine model has been talked about for a long time. And, obviously, if I have any data that showed an increase in overall survival, it has to be looked at carefully", he explains.