BioNTech Shares Surge Wednesday on Positive Merck/Moderna Cancer Therapy Data

BioNTech SE shares traded higher on Wednesday. Investors may be reacting to top-line data from Merck & Co. Inc. and Moderna, Inc.'s personalized cancer therapy for advanced skin cancer.

In a pre-planned interim analysis, the investigational combination therapy achieved statistically significant and clinically meaningful improvements in recurrence-free survival and distant metastasis-free survival compared with standard Keytruda alone.

BioNTech's Personalized mRNA Cancer Therapy

Investors should note that BioNTech is developing Autogene cevumeran, a personalized mRNA cancer immunotherapy candidate that encodes patient-specific tumor neoantigens, designed to induce an immune response against a patient's individual tumor.

Its mechanism of action is similar to the Merck/Moderna melanoma therapy.

The therapy is a collaboration with Genentech, a subsidiary of Roche Holding AG. It is currently in two Phase II clinical trials, targeting advanced colorectal cancer and adjuvant pancreatic ductal adenocarcinoma.

Long-Term Data for Autogene Cevumeran

In April 2024, BioNTech published three-year follow-up data from the Phase I clinical trial of Autogene cevumeran.

The data showed that in patients with resected pancreatic ductal adenocarcinoma, multispecific T-cell responses could persist for three years, with delayed tumor recurrence.

In 8 of 16 patients, Autogene cevumeran induced high-level T cells targeting encoded neoantigens.

98% of the T cells induced by Autogene cevumeran targeting individual neoantigens on the tumor were de novo, meaning they were not detected in blood, tumor, or adjacent tissues prior to administration of the investigational treatment.

In patients who mounted an immune response, over 80% of vaccine-induced neoantigen-specific T cells remained detectable three years after administration. These patients showed prolonged median recurrence-free survival compared with non-responders.

During the three-year follow-up, 6 of 8 patients with an immune response to Autogene cevumeran remained disease-free, while 7 of 8 patients who did not mount an immune response during the trial experienced tumor recurrence.

BioNTech Poised for Multiple Late-Stage Cancer Data Readouts

In March, BioNTech announced plans for its co-founders to transition to a new venture focused on next-generation mRNA innovation, to maximize value creation for patients and shareholders.

The company also stated that 2026 will be the first year in which BioNTech expects to receive multiple late-stage data readouts across major cancer types. Clinical trials and the resulting data will inform regulatory and launch plans.

BNTX Price Action: BioNTech shares rose 20.77% to $112.01 at the time of Wednesday's data release.