BioNTech SE (NASDAQ:BNTX) stock is trading higher on Wednesday. Investors are probably reacting to Merck & Co Inc. (NYSE:MRK) and Moderna, Inc. (NASDAQ:MRNA) topline data from individualized cancer therapy for advanced skin cancer.
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.
BioNTech’s Individualized mRNA Cancer Therapy
Investors should note that BioNTech is developing Autogene cevumeran (BNT122/RO7198457), an individualized mRNA cancer immunotherapy candidate encoding patient-specific tumor neoantigens aiming to induce an immune response against the patient’s individual tumor.
The mechanism of action is similar to Merck/Moderna’s melanoma therapy.
The therapy is in collaboration with Genentech, a Roche Holding AG (OTC:RHHBY) unit. It is currently in two phase 2 trials for advanced colorectal cancer and adjuvant pancreatic ductal adenocarcinoma.
Long-Term Autogene Cevumeran Data
In April 2024, BioNTech shared three-year follow-up data from a Phase 1 trial of autogene cevumeran.
The data showed polyspecific T cell responses up to three years and delayed tumor recurrence in patients with resected pancreatic ductal adenocarcinoma.
In 8 of 16 patients, autogene cevumeran elicited high-magnitude T cells specific to the encoded neoantigens.
98% of the T cells targeting individual neoantigens on the tumor and induced by autogene cevumeran were de novo in that they were not detected in blood, tumors, and adjacent tissues prior to administration of the investigational treatment.
Over 80% of the vaccine-induced neoantigen-specific T cells could still be detected up to three years post-administration in patients with an immune response. These patients showed a prolonged median recurrence-free survival compared to non-responders.
6 of 8 patients with an immune response to autogene cevumeran remained disease-free during the three-year follow-up period, while 7 of the 8 patients without an immune response to the treatment during the trial showed tumor recurrence.
BioNTech Prepares For Multiple Late-Stage Cancer Readouts
In March, BioNTech announced plans for its co-founders to transition into a new venture focused on next-generation mRNA innovations to maximize value for patients and shareholders alike.
The company also said that 2026 will be the first year in which BioNTech expects multiple late-stage data readouts across major cancer types. The clinical trials and resulting data will inform regulatory and launch plans.
BNTX Stock Price Activity: BioNTech shares were up 20.77% to $112.01 at the time of publication on Wednesday, according to Benzinga Pro data.
Photo via Shutterstock
