ideasIdea
Personalised vaccines given only when the blood test turns positive
Custom cancer vaccines take weeks to make and work best when there is very little disease. Making one at surgery and giving it when a blood test turns positive matches both facts.
An individualised mRNA neoantigen vaccine produced immune responses and prolonged recurrence-free survival in a randomised phase 2 in ctDNA-positive resected pancreatic and colorectal cohorts, and adjuvant melanoma data support the setting. Manufacturing time is the practical constraint, which a manufacture-at-surgery, deploy-on-ctDNA-positivity design resolves, and it concentrates cost on the minority who will relapse.
Hypothesis
Vaccine manufactured at surgery and administered on first ctDNA positivity produces higher ctDNA clearance and longer relapse-free survival than vaccination of all resected patients, at a third of the cost per patient treated.
Rationale
Vaccine efficacy depends on low antigen burden and an intact immune system, both of which hold at the moment of molecular relapse. Deferring administration also avoids vaccinating the majority who are already cured.
What would test it
A three-arm randomised trial: vaccinate all, vaccinate on ctDNA positivity, or observe with standard care; endpoints are relapse-free survival, ctDNA clearance and cost per relapse prevented.
Maturity
early clinical
Who has to act
industry
Cost to try
Large (over $50M)
Years to first evidence
6
Bottlenecks it attacks
- Dormant cells and minimal residual disease · After a 'successful' treatment, cells can sleep for years then relapse. We can barely detect them and cannot target them.
- Prices and value · New cancer drugs routinely cost over $150,000 a year, often for months of benefit. Systems cannot afford them and patients go bankrupt.
- Manufacturing cost and time for living and radioactive medicines · Cell therapies take weeks to make for one patient and cost hundreds of thousands of dollars. Isotopes run short.