BioNTech SE (BNTX) shares are having a very good Wednesday, and it's not hard to see why. The stock is up more than 20% as investors digest some encouraging news from two of its rivals in the personalized cancer vaccine space.
Merck & Co Inc. (MRK) and Moderna, Inc. (MRNA) just released topline data from their individualized cancer therapy for advanced skin cancer, and the results are turning heads. At a pre-planned interim analysis, the investigational combination delivered statistically significant and clinically meaningful improvements in recurrence-free survival and distant metastasis-free survival compared to standard Keytruda alone.
Now, you might be wondering: why would BioNTech benefit from Merck and Moderna's success? Well, it's all about the science. BioNTech is developing its own individualized mRNA cancer immunotherapy, called autogene cevumeran (BNT122/RO7198457), which works in a very similar way. The therapy encodes patient-specific tumor neoantigens, aiming to induce an immune response against the patient's individual tumor. In other words, it's the same concept: train the immune system to recognize and attack cancer cells that are unique to each patient.
So when Merck and Moderna show that this approach can work in a large, late-stage trial, it's a strong vote of confidence for the entire field, including BioNTech's own efforts.
BioNTech's Own Cancer Vaccine Candidate
Autogene cevumeran is being developed in collaboration with Genentech, a unit of Roche Holding AG (RHHBY). It's currently in two phase 2 trials: one for advanced colorectal cancer and another for adjuvant pancreatic ductal adenocarcinoma. These are tough cancers to treat, so any progress here could be significant.
But BioNTech isn't just starting from scratch. Back in April 2024, the company shared three-year follow-up data from a Phase 1 trial of autogene cevumeran in patients with resected pancreatic ductal adenocarcinoma. The results were pretty compelling.
In 8 of 16 patients, the therapy elicited high-magnitude T cells specific to the encoded neoantigens. And here's the kicker: 98% of those T cells were de novo, meaning they weren't detected in the blood, tumors, or adjacent tissues before the treatment was given. So the therapy was actually creating new immune responses, not just boosting existing ones.
Even better, over 80% of the vaccine-induced neoantigen-specific T cells could still be detected up to three years after administration in patients who had an immune response. Those patients also showed a prolonged median recurrence-free survival compared to non-responders.
Digging into the numbers: 6 of 8 patients with an immune response remained disease-free during the three-year follow-up period, while 7 of the 8 patients without an immune response saw their tumors come back. That's a stark difference, and it underscores the potential of this approach.
What's Next for BioNTech
BioNTech is gearing up for a big year. In March, the company announced plans for its co-founders to transition into a new venture focused on next-generation mRNA innovations, a move designed to maximize value for patients and shareholders alike.
More importantly, the company said that 2026 will be the first year in which it expects multiple late-stage data readouts across major cancer types. These clinical trials and the resulting data will inform regulatory and launch plans. So investors are clearly betting that the Merck/Moderna news is a harbinger of good things to come for BioNTech's own pipeline.
At the time of publication on Wednesday, BioNTech shares were up 20.77% to $112.01, according to market data. It's a big move, but for a company with this much riding on its cancer vaccine platform, it's not hard to see why traders are excited.
