Moderna and Merck’s Skin Cancer Vaccine Trial Shows Favorable Results

On December 13, 2022, the COVID-19 vaccine developer Moderna and pharmaceutical company Merck announced a progressive advancement in forming vaccination for melanoma, known as one of the most fatal types of skin cancer.

Moderna is collaborating with Merck to study and create a feasible melanoma vaccine among patients who had surgery for their cancer. The study combines an mRNA vaccine strategy and a drug to expedite the immune system and bring favorable results for melanoma patients.

What is the feasible skin cancer vaccine?

With the vaccine and Merck's immunotherapy Keytruda, the team saw a notable difference in the patient's survival rate. “We are very excited, we are moving very quickly with Merck onto phase 3 for this study,” shared Moderna CEO Stephane Bancel with CNBC. Phase 3 is typically the most costly stage of research before the drug gets officially approved.

The research found that the patient group that took the potential vaccine and Keytruda discerned a 44 percent depletion in the recurrence of cancer and also the risk of death. The study and treatments have been ongoing for about a year, aside from patients who dealt with severe side effects or recurrence.

157 patients with stage 3 and 4 melanoma were involved in the research, whose tumors were removed surgically before beginning the trial. The combination of the two was overall safe, but some drug-related side effects occurred in 14.4 percent of participants who received combination treatment and 10 percent in those who only received Keytruda.

Moderna and Merck are planning on beginning Phase 3 in 2023, and wish to further their study of other types of tumors. The two pharmaceutical giants unified to work in 2016, and the two aim on sharing costs and profits from their work.

"It's a tremendous step forward in immunotherapy," said Merck’s head of global clinical development and chief medical officer Eliav Barr. “This is the first time we see a really strong signal with a cancer vaccine. This is the first time we can show that with the removal of the brakes on immune responsiveness that Keytruda provides, plus an extraordinarily good vaccine, we engender a great immune response.”

Moderna's chief medical officer Paul Burton also added that the combination of mRNA vaccine technology and Keytruda "has the capacity to be a new paradigm in the treatment of cancer."

To create the potential vaccine, researchers took the patients' tumors and healthy tissue to analyze samples and decipher their genetic sequence. Then, they secluded the mutant proteins linked with cancer, which were then used to build a custom cancer vaccine. When the vaccine is injected into a patient, the cells are to create impeccable copies of the mutations for the immune system to acknowledge and demolish. They hope to be able to create the vaccine in an eight-week time frame.

What does vaccine creation look like?

When creating new vaccines, there are vigorous testing and approval processes to ensure safety for the community. From research to clinical studies, developing new vaccines takes a long time. In most cases, there are a couple of cycles when generating new vaccines.

First is the exploratory stage, where all the fundamental research begins. This step can last for two to four years and is usually federally funded to help with a disease.

Then arrives the pre-clinical stage, where tissue-culture or cell-culture systems and animal testing come into the picture. This stage gives researchers more information and ideas on how cells would potentially respond in humans. Numerous vaccine applicants fail at this stage since they do not create the necessary immune response. This stage can last anywhere from one to two years. If the potential vaccine passes the preclinical stage, it moves onto clinical development, which has three phases.

During Phase 1, a small group of people receives the trial vaccine. In Phase 2, the study broadens and is disposed to specific people groups, such as age and physical health groups. This phase is when the potential vaccine is tested more for safety and potency. In Phase 3, the essential goal is to safely distribute the vaccine to a large group of individuals to test thoroughly. Multiple factors are also taken into consideration during Phase 3, including its efficacy.

If it all goes well, it is now time for regulatory review and approval. The company developing the potential vaccine is to now submit a Biologics License Application to the Food and Drug Administration (FDA) and begin its inspection. If licensure is provided, the FDA will continue to track the vaccine and ensure its safety. After its approval, vaccines can begin manufacturing and begin the quality control step.


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