After its striking success with COVID-19, BioNTech is now looking at cancer vaccines. The company has just started a Phase 2 trial of the BNT111 cancer vaccine for advanced melanoma — a vaccine that they hope will help patients fight off advanced tumors and prevent recurrencies.
Before it was catapulted onto the global stage by its COVID-19 vaccine (the first widely approved vaccine developed in the pandemic, BioNTech was an early-stage biotech company firmly focused on cancer vaccines. The company planned to start both a phase 2 and a phase 3 trial of their BNT111 vaccine in 2020 — but with the pandemic coming in and BioNTech sweeping in to create not just the first COVID-19 vaccine (alongside Pfizer), but the world’s first mRNA vaccine, the plans had to be delayed — although the company can’t exactly be upset with the success.
But after the COVID-19 detour, it’s time for the company to return to its initial goal — and BioNTech seems excellently positioned to do so. Not only have they proven they can develop a quick vaccine using mRNA technology, but several mRNA vaccines targeting different types of cancers are already queued in the company’s product pipeline. Now, one of them has started Phase II trials.
The mRNA vaccine BNT111 will be tested in combination with an antibody-drug (Libtayo), targeting patients with relapsed Stage III/ IV melanoma. The vaccine is aimed at four tumor-associated antigens. Over 90% of all melanoma tumors are thought to contain at least one of these four antigens.
The Phase II trials are enrolling 120 patients from Spain, Germany, Italy, Poland, the US, the UK, and Australia after regulatory review. The first patient has now been dosed.
The company’s management appears confident in the vaccine. Özlem Türeci, Managing Director and Chief Medical Officer of BioNTech explained in a statement that BNT111 has already shown a favorable safety profile and encouraging preliminary results in early clinical evaluation. “With the start of patient treatment in our Phase 2 trial, we are encouraged to continue on our initial path to realize the potential of mRNA vaccines for cancer patients,” he added.
Previously, vaccine efficacy was assessed in a subset of 42 patients treated with the shot — either without any other treatment or alongside an anti-PD-1 drug. Out of these, 25 were treated with the vaccine alone. Out of these 25, one patient had a complete remission, three had partial remissions, and seven saw their disease stabilize. The combination group of 17 patients had six partial responses. The company is now looking to show that the mRNA vaccines can serve their intended purpose of fighting cancer.
“We were able to demonstrate the potential of mRNA vaccines in addressing COVID-19,” added Özlem Türeci, co-founder and chief medical officer of BioNTech. “We must not forget that cancer is also a global health threat, even worse than the current pandemic,” she added.
According to Türeci, preventing cancer recurrence is the “ideal setting” for mRNA technology, because after a tumor has been removed (or largely removed) through surgery, a vaccine can help produce T cells that can outnumber and control cancerous cells. Essentially, the goal is to train these T cells to recognize cancer and keep it in check.
The possibilities reach even farther, as mRNA is excellently suited for developing personalized vaccines. Because cancerous tumors can be different, BioNTech aims to be able to produce a customized vaccine within 45 days after the patient’s surgery. The idea would be to carry out a biopsy and send it to a lab, and then have a computer algorithm analyze the mutations caused by cancer, looking for the ones that trigger T cell production. But the company is also developing premade, “off the shelf” treatments, especially for people who can’t wait 45 days.
It’s harder to make a cancer vaccine than one for COVID-19, though. With COVID-19, the genetic code of the virus leads you directly to the vaccine candidate — whereas with cancer, you need to sequence the tumor’s genes and look for the useful ones. But the pandemic experience has helped the process, not just with experience, but with production infrastructure as well, Türeci told USA Today.
“I, in my wildest dreams … would never have imagined that we’d be making the quantities and quality of mRNA molecules we’re making now with. If you had told me we were going to be doing this, I’d have said you are completely crazy,” she said, praising the engineers. “Every time I think, ‘Oh my God, we can’t do any better than that,’ they surprise me.”
Whether or not the drug will be successful remains to be seen, but for now, one thing seems clear: when it comes to vaccines, mRNA is just getting started.