Personalized mRNA Cancer Vaccine OncoVax Receives FDA Approval: A Custom Vaccine for Every Patient Based on Tumor Gene Mutations

Personalized mRNA Cancer Vaccine OncoVax Receives FDA Approval: A Custom Vaccine for Every Patient Based on Tumor Gene Mutations

BioNTech today announced that its personalized mRNA cancer vaccine OncoVax has received FDA approval for adjuvant treatment of post-surgical stage II-III melanoma and non-small cell lung cancer. This is the world's first approved personalized mRNA cancer vaccine.

The OncoVax preparation process begins with the patient's surgically resected tumor tissue. Through whole-exome sequencing and tumor neoantigen prediction algorithms, the system selects the 20-40 neoantigens most likely to elicit an immune response from hundreds of mutations. The mRNA sequences encoding these neoantigens are then encapsulated in lipid nanoparticles to create a vaccine unique to that patient.

Phase III clinical trial results showed: in melanoma patients, the OncoVax group achieved a 3-year recurrence-free survival rate of 78.4%, compared to 54.2% for the control group (standard adjuvant therapy only), reducing recurrence risk by 52%. In non-small cell lung cancer patients, recurrence-free survival rates were 65.1% and 41.8% respectively, reducing recurrence risk by 43%.

Ugur Sahin, BioNTech co-founder and CEO, said: "OncoVax proves the ultimate form of personalized medicine — every patient receives treatment that is unique, because every patient's cancer is unique."

Regarding preparation time and cost, it takes approximately 4 weeks from tumor tissue sampling to vaccine preparation completion. The preparation cost per patient is approximately $100,000, with BioNTech stating that through process optimization and scale expansion, the target is to reduce this to $30,000 by 2032. On insurance coverage, U.S. Medicare has already included OncoVax in its reimbursement scope.

On side effects, the most common adverse reactions were injection site pain (72%), fatigue (58%), and mild fever (34%), all grade 1-2, resolving spontaneously within 1-3 days. No serious immune-related adverse events were observed.

Professor Padmanee Sharma, Director of Tumor Immunology at MD Anderson Cancer Center, commented: "OncoVax's approval marks a fundamental shift in the cancer treatment paradigm. We have moved from 'one drug for everyone's same cancer' into an era where 'everyone has their own personalized weapon against cancer.'"

BioNTech plans to expand indications to colorectal and pancreatic cancer in 2031 and is exploring combination regimens of OncoVax with immune checkpoint inhibitors.