Personalized Cancer Vaccine NeoVax-7 Enters Phase III: 68% Response Rate Against Solid Tumors

Personalized Cancer Vaccine NeoVax-7 Enters Phase III: 68% Response Rate Against Solid Tumors

On March 5, 2028, BioNTech and Memorial Sloan Kettering Cancer Center (MSKCC) jointly announced that the personalized mRNA cancer vaccine NeoVax-7 achieved positive results in a Phase III clinical trial for advanced solid tumors. Data showed NeoVax-7 achieved a 68% objective response rate (ORR) across non-small cell lung cancer, colorectal cancer, and pancreatic cancer, with a complete response rate of 23%.

NeoVax-7 works by first sequencing the patient's tumor genome, identifying tumor-specific neoantigens, then using AI algorithms to design mRNA sequences targeting those neoantigens, and finally producing a personalized vaccine within 48 hours.

BioNTech CEO Ugur Sahin stated: 'NeoVax-7 is not a broad-spectrum cancer drug — it's a precision weapon custom-built for each patient. Each vaccine targets only the unique antigens on that patient's tumor cells.'

Clinical Data

The Phase III trial was conducted across 47 centers globally, enrolling 2,180 patients across 14 solid tumor types. At 18-month median follow-up:

• Objective response rate (ORR): 68% vs. 31% for standard chemotherapy
• Complete response rate (CR): 23% vs. 5%
• Median progression-free survival (PFS): 14.2 months vs. 6.8 months
• Serious adverse event rate: 12% (comparable to control)

MSKCC's oncology chief said: 'The most exciting data is in the pancreatic cancer subgroup — traditional treatment yields a 5-year survival rate below 10%, but NeoVax-7 achieved a 52% 18-month survival rate.'

Production and Pricing

NeoVax-7 production takes 14 days from tumor biopsy, including gene sequencing (3 days), AI antigen prediction (1 day), mRNA synthesis (5 days), and quality control (5 days). BioNTech has built a dedicated production line in Marburg, Germany, with annual capacity of 500,000 doses.

BioNTech expects single-course pricing between $150,000 and $200,000. The company is negotiating with health insurance agencies in various countries to explore outcome-based installment payment models.

China Progress

The Shanghai Institute of Materia Medica at the Chinese Academy of Sciences has launched a localization collaboration for NeoVax-7. The institute director said: 'We are developing neoantigen prediction models based on Chinese population tumor genetic profiles, expecting to enter clinical trials by late 2028.'