BioNTech Doses First Patient with Personalized mRNA Cancer Vaccine

Boris Roessler/picture alliance via Getty Images

First COVID-19, now cancer. BioNTech made history when its COVID-19 mRNA vaccine with partner Pfizer became the first ever approved. Now the German biotech has returned to its first love, mRNA-based cancer vaccines, treating the first colorectal cancer patient with candidate BNT122 this week. 

This Phase II trial will enroll about 200 patients in the U.S., Germany, Spain and Belgium. The patients have all undergone surgery and chemotherapy to treat their cancer. But those standard-of-care treatments have proven to grant time, not remission for many patients with colorectal cancer.  

Those identified as “high risk” of experiencing tumor recurrence after surgery and three to six months of chemo will be treated with the vaccine. The control group will be those under the “watchful waiting” approach with a primary endpoint of disease-free survival, with secondary endpoints of relapse-free survival and overall survival. With the watch-and-wait approach, many patients experience recurrence within two to three years. 

BioNTech’s Chief Medical Officer Özlem Türeci said, “Many cancers progress in such a way that the patient initially appears tumor-free after surgery, but after some time tumor foci that were initially invisible grow and form metastases. In this clinical trial in patients with colorectal cancer, we aim to identify high-risk patients with a blood test and investigate whether an individualized mRNA vaccine can prevent such relapses.” 

Colorectal cancer is the second leading cause of cancer death in the United States for men and women combined. The overall five-year survival rate is around 63%. 

BioNTech currently has two therapies in clinical trials using the mRNA technology from the company’s highly effective COVID-19 vaccine. BNT111 is an “off the shelf” cancer treatment for tumors with similar genetic makeup. It’s currently in a Phase II trial in combination with Regeneron’s checkpoint inhibitor, Libtayo, to treat melanoma.  

The BNT122 colorectal vaccine is precision medicine, tailored to match individual tumor characteristics for each patient. This type of treatment will cost more due to personalization, but costs should come down as advancements in automation occur. 

“Once we have a toolbox, we can ask what part of the toolbox can be repurposed,” Dr. Uğur Şahin, BioNTech CEO, said. “We have a very strong immune response in advanced cancer care. We have a powerful platform.” 

Pre-pandemic, the mRNA technology had been researched for 20 years. After decades of scientific doubt, SARS-CoV-2 finally gave it a chance to prove itself.  And now BioNTech is taking it to the next level with its personalized, precision approach. 

“There is now a huge opportunity to build on the success of this technology,” Şahin said.