mRNA Cancer Vaccine Begins Trials for Non-Small Cell Lung Cancer

An mRNA vaccine has entered human trials as a treatment for lung cancer. Unlike traditional cancer vaccines such as the HPV vaccine, BNT116 is a therapeutic cancer vaccine designed to reduce tumor growth in patients with cancer or prevent its recurrence. BNT116 contains the genetic code for six molecules frequently seen in non-small cell lung cancers, which make up 80 to 85 percent of lung cancer diagnoses. Exposure to these six molecules primes immune cells to recognize these molecules on cancer cells and eliminate them.

Intended for use in advanced non-small cell lung cancer, BNT116 is being studied in the clinical trial to assess its safety and preliminary efficacy on a small group of patients, with a target enrollment size of 130 across seven countries. Beyond confirming patient safety, the Phase I trial is intended to determine the optimal dose of the drug before initiating larger Phase II and III trials. “You have to start somewhere, and just to get to a Phase I trial, many drugs fall by the wayside. And if patients respond to this, they’re actually going to benefit; it can be lifesaving, even in a Phase I trial,” said Stuart Edmonds, executive vice president of mission, research and advocacy at the Canadian Cancer Society.

Traditionally, cancer treatment has been comprised of three pillars: chemotherapy, radiation and surgery. Poisoning, zapping and shaving off cancer cells were the only available options to eliminate tumors, often sacrificing healthy cells in the process. But, now, oncologists consider immunotherapy to be a fourth pillar of cancer treatment. Immunotherapy not only includes cancer vaccines but represents a broader category of treatment, including tools such as immune checkpoint inhibitors, which reinvigorate immune cells to become better killers of cancer cells. The common thread among these treatments is the use of the human immune system’s ability to kill cancer cells in a more targeted way. This works because of a key vulnerability of cancer cells, which express antigens not normally seen on healthy cells, allowing them to be identified and targeted by the immune system.

BNT116 is also being studied in different combinations with more conventional treatments, cemiplimab and docetaxel. Cemiplimab is an immune checkpoint inhibitor, under the same umbrella of immunotherapy as cancer vaccines. Docetaxel, on the other hand, is a standard chemotherapy drug. A separate Phase II trial is also under way to compare how effective BNT116 is in combination with cemiplimab versus cemiplimab alone.