BYU researchers develop MOTO-CAR macrophage therapy to target solid tumors in preclinical study

Brigham Young University researchers have developed MOTO-CAR, a macrophage-based immunotherapy designed to target solid tumors in preclinical studies, as cancer kills one person every 50 seconds in the U.S. The development comes amid broader advances in cancer immunotherapy, including intismeran autogene, the first neoantigen mRNA therapy to meet its Phase 3 endpoint, reducing recurrence or death risk by 42% compared to pembrolizumab alone in results presented at the European Society for Medical Oncology Congress in October 2026. The National Cancer Institute and Foundation for the NIH are launching a $200 million Therapeutic Cancer Vaccines Initiative to build infrastructure for personalized cancer vaccines, though challenges remain in regulatory pathways, reimbursement incentives, and coordinating the complex delivery chain across multiple organizations.

Intismeran autogene Phase 3 results

• ▪The Phase 3 results for intismeran autogene were presented at the European Society for Medical Oncology Congress in October 2026.
• ▪Gary Keblish is a New York City public school teacher who was diagnosed with high-risk melanoma in 2019.
• ▪Intismeran autogene is the first neoantigen and mRNA therapy to have met its Phase 3 endpoint in oncology.
• ▪A Phase 3 study of intismeran autogene showed the cancer vaccine reduced the risk of recurrence or death by 42% compared with pembrolizumab (Keytruda) alone.
• ▪Gary Keblish enrolled in an earlier trial of intismeran autogene after surgery for melanoma and is still teaching as of October 2026.

Regulatory framework for personalized therapies

• ▪The Therapeutic Cancer Vaccines Initiative aims to bring personalized cancer vaccines to patients within the decade.
• ▪Karen E. Knudsen serves as CEO of the Parker Institute as of October 2026.
• ▪The National Cancer Institute and Foundation for the NIH are launching a $200 million public-private partnership called the Therapeutic Cancer Vaccines Initiative to build clinical trial networks, data standards, and infrastructure for personalized cancer vaccines.
• ▪Karen E. Knudsen is the former CEO of American Cancer Society and its advocacy affiliate the ACS CAN.
• ▪Current regulatory pathways were designed for drugs that are identical and for devices and tests that perform the same function for every patient.

Fragmented delivery model challenges

• ▪Each step in the personalized cancer vaccine delivery chain belongs to a different organization, with its own contract, incentives, and economics, with no one accountable for the full delivery chain.
• ▪Personalized cancer vaccines require a tumor sample to be collected and preserved at surgery, followed by sequencing of the tumor and a blood sample, neoantigen identification, vaccine design, manufacturing, shipping, and administration on schedule, followed by years of monitoring.

Payer coverage misaligned incentives

• ▪Medicare does not face the same churn problem as other payers because Medicare covers many patients for life.
• ▪A health plan that expects members to churn within one to two years has little financial incentive to pay for an expensive cancer vaccine benefit that another plan will collect.
• ▪A cancer recurrence that becomes metastatic disease can mean years of costly immunotherapy, imaging, and hospital care.

Clinical guideline adaptation needs

• ▪Guideline bodies were built to evaluate a fixed product in a defined population.
• ▪Clinical guidelines determine what gets ordered, covered, and reimbursed in practice.
• ▪Many professional clinical guidelines still have not caught up with technological innovations that have come to market over the last 10-15 years, such as genetic and minimal residual disease testing.

BRCA testing access lessons

• ▪BRCA2 was discovered five years after BRCA1 was identified in 1990.
• ▪Othman Laraki is the co-founder and CEO of Color Health.
• ▪Mary-Claire King led a University of California, Berkeley team that identified the location of the BRCA1 gene, the first gene linked to hereditary breast cancer, in 1990.
• ▪Patents and price kept BRCA testing expensive for years after the first commercial test launched in 1996.
• ▪The first commercial test for BRCA1 and BRCA2 mutations hit the market in 1996.