Scientists closer to first cancer vaccine

Scientists in the search of a cure and better diagnosis and treatment for cancers with Moderna’s melanoma vaccine have been given ‘breakthrough’ drug status by United States Food and Drug Administration (FDA) and the vaccine could be approved in months.

In another study, experts say new blood test for prostate cancer could end ordeal of biopsies for thousands of men and that trendy intermittent fasting may raise risk of infections, heart disease and cancer.

Also, researchers completed what is believed to be the first phase I trial of intravenous mistletoe extract in the United States (U.S.) aimed at determining dosing for subsequent clinical trials and to evaluate safety.

Indeed, health chiefs, paving the way for a fast-tracked approval, have given a cancer vaccine made by Moderna a “breakthrough therapy” status. The shot, given alongside an immunotherapy drug made by Merck, is used to treat patients recovering from advanced melanoma who are at risk of tumours returning.

A phase two trial showed the combination reduced the chance of relapse or death in sufferers after surgery by 44 per cent, compared to the immunotherapy drug on its own.

The promising results prompted the United States Food and Drug Administration (FDA) to issue the designation yesterday – which could slash the time it takes to be approved to up to eight months.

More than one million Americans are living with melanoma, the most serious form of skin cancer, roughly four per cent of who have advanced forms of the disease. The experimental therapy is comprised of Moderna’s shot and Merck’s immunotherapy drug Keytruda.

The new ‘breakthrough’ tag means the FDA believes the vaccine may ‘address unmet medical need in the treatment of serious or life-threatening conditions’. In practical terms, it means the agency will hold frequent meetings with Moderna about the progress of the shot throughout its development.

The move also makes the therapy eligible for accelerated approval and priority review by the FDA, if Moderna submits a further application for this. The FDA would respond to this within 60 days.

If granted, priority review would mean the regulator would make a decision on approving the therapy within six months of Moderna submitting its application, rather than 10 months under standard review.

DailyMail.com understands that Moderna has not yet submitted the therapy to the FDA for approval, but is planning on starting the phase 3 trials later this year. Most drugs or vaccines need to go through phase three trials before they can be approved for mass use.

But in special circumstances, if the treatment appears to be both safe and effective in phase one and two trials, it can be authorised before that point. The new vaccine harnesses mRNA technology that uses pieces of genetic code from patients’ tumors to teach the body to fight off the cancer.

A vaccine — developed at the famous Mount Sinai hospital in Manhattan, New York — rapidly melts away the primary tumor and teaches the body to hunt and kill cancer cells that have spread elsewhere.

The vaccine is given to people post-surgery to prevent the tumor from returning, and it is tailored to each patient, meaning no two shots will be the same. Merck and Moderna said they plan to initiate a phase three study into the therapy this year, where it will be tested on potentially thousands of patients.

Meanwhile, a blood test for prostate cancer could spare thousands of men from unnecessary biopsies. Experts say the breakthrough offers ‘great promise’ for detection of the disease, which is the most common cancer among men in the United Kingdom (UK), affecting one in eight during their lifetime.

Men who visit their General Practitioner (GP) with symptoms receive a blood test called a PSA test, which can be inaccurate. A new check was found to pick up 91 per cent of positive cases in 210 men with suspected prostate cancer.

It produced zero false positive results for men who do not have prostate cancer, so could spare thousands a painful biopsy or Magnetic Resonance Imaging (MRI) scan which they may have been sent for based on a wrong PSA result.

The new liquid biopsy works by picking up tumour cells from prostate cancer in the blood. A team including researchers from India and Imperial College London tried it on men with signs of suspected cancer, like an enlarged prostate or urinary symptoms.

A third of these men were later found to have prostate cancer, while two-thirds had benign prostate conditions. Among the 68 men with the cancer, the test was positive for 56 and gave a result which was less clear but unlikely to be negative for six of them. It provided a negative result for all 142 men who did not have prostate cancer.

Also, a new study suggests intermittent fasting may increase the risk of developing heart disease or cancer. In a study on mice, Mount Sinai researchers found skipping breakfast caused white blood cell count to fall by up to 90 percent. These cells help fight disease, control inflammation and eliminate damaged cells from the body.

An immunologist at the New York City hospital who led the study, Dr. Filip Swirski, said: “Because immune cells are so important to other diseases like heart disease or cancer, understanding how their function is controlled is critical.”

Researchers also said the study is among the first to show that skipping meals triggers a stress response in the brain that negatively affects immune cells. While some studies have claimed that intermittent fasting may be linked to longevity, recent research has suggested it may have the opposite effect.

Intermittent fasting was one of the hottest dieting trends of the 2010s. The diet sees a person limit their caloric intake to either certain hours or the day – or days of the week – to lose weight and control eating habits.

Popular iterations include the 14:10 plan – where a person eats only within a 10-hour window each day and the 16:8. Others use alternative day fasting strategies, like the 4/3 or 5/2 diets.

In both plans, a person eats normally four to five days per week, then severely restricting their food intake to 500 to 600 calories on the other two or three days. Among celebrities who swear by the diet is Jennifer Aniston, who revealed in 2019 that she only consumes liquids in the mornings — saving her first meal until midday. Mark Wahlberg is also a fan of the diet, limiting himself to only eating food between 12pm and 6pm every day.

Supporters suggest the diet prompts weight loss, lowers inflammation levels and can help people live longer.

A study of 24,000 Americans over 40 found those who ate one meal per day were 30 percent more likely to die from any cause in 15 years than those who ate three. Swirski said: “There is a growing awareness that fasting is healthy, and there is indeed abundant evidence for the benefits of fasting.

“However, our study provides a word of caution as it suggests that there may also be a cost to fasting that carries a health risk. “This is a mechanistic study delving into some of the fundamental biology relevant to fasting. The study shows that there is a conversation between the nervous and immune systems.”

In the paper, published in the journal Immunity, scientists split mice into two groups. One group received breakfast — the rodents’ largest meal of the day — while the other group went without.

Scientists drew blood from mice at the start of the study, and at four, eight and 24 hours into the experiment. Samples were tested for monocytes — white blood cells made in the bone marrow that fight infections, heart disease and cancer.

At the outset, all the lab rodents had the same number of these cells in their bloodstreams. But after four hours, the fasting group saw 90 percent of these cells disappear.

Meanwhile, researchers completed what is believed to be the first phase I trial of intravenous Helixor M in the United States (U.S.) aimed at determining dosing for subsequent clinical trials and to evaluate safety.

Mistletoe extract has been widely used to support cancer therapy and improve quality of life, but there has been a lack of clinical trials and data to support its use. Researchers at the Johns Hopkins Kimmel Cancer Center completed what is believed to be the first phase I trial of intravenous Helixor M in the U.S. aimed at determining dosing for subsequent clinical trials and to evaluate safety.

The findings from the small study were reported online February 9 in Cancer Research Communications. The trial’s purpose was to evaluate the drug’s safety, but the researchers, led by Channing Paller, M.D., associate professor of oncology, also documented improved quality of life and some disease control.

Mistletoe extract (ME), known as Helixor M, was studied in 21 patients with advanced and treatment-resistant cancers of various types. The phase I trial used dose escalation to determine the maximum dose that could be safely tolerated by patients. ME was delivered intravenously three times per week until disease progression or until toxicity. The study concluded that dose to be 600 milligrams of ME.

The median follow-up duration on mistletoe was 15.3 weeks. Stable disease was observed in five patients and lasted, on average, for 15 weeks. Tumors in three participants decreased in size, and remained stable for two to five months, however, this did not meet official criteria for partial response. Patients also reported overall improved quality of life via a questionnaire. The most common side effects reported were fatigue, nausea, and chills and they were noted as manageable.

“Intravenous mistletoe demonstrated manageable toxicities with disease control and improved quality of life in this group of patients, who had already received multiple cancer therapies,” says Paller, adding that additional phase II studies in combination with chemotherapy are the next step, pending additional funding.

In addition, Paller says, laboratory research to better decipher ME’s mechanisms are needed, as the cytokines (cell-signaling proteins) measured in this study are preliminary and hypothesis-generating.

Mistletoe extract is a semi-parasitic plant with several active ingredients that, in preclinical studies, appear to directly cause the death of tumor cells and stimulate an immune response. It has been used in Europe for several decades as a complementary medicine approach to cancer treatment alone or in combination with chemotherapy and radiation therapy, but it has not been evaluated in clinical trials. ME is not currently FDA approved for cancer treatment in the U.S. but is listed in the Homeopathic Pharmacopoeia and is offered in integrative care clinics.