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“Navigating Regulatory Uncertainties: Cancer Vaccine Evaluation in the Era of AI”

As promising cancer vaccines, such as Moderna and Merck’s mRNA-4157, approach pivotal trial milestones, Dr. Peter Marks, the FDA’s vaccines leader, affirmed the agency’s readiness to evaluate these treatments, despite uncertainties linked to artificial intelligence (AI).

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Cancer Vaccine

Addressing attendees at the 2024 World Vaccine Congress (WVC), Marks, the director of the FDA’s Center for Biologics Evaluation and Research, assured, “We are ready to review—we’re open for business,” regarding cancer vaccines.

Discussing the regulatory approach, Marks likened the evaluation process for therapeutic cancer vaccines to that of other innovative treatments like CAR-T cell therapies.

Although the FDA has previously greenlit a cancer vaccine, such as Dendreon’s Provenge for prostate cancer, the emergence of next-generation therapeutic cancer vaccines poses novel regulatory challenges due to their innovative technology.

Unlike traditional approaches such as CAR-T therapies and Provenge, which manipulate a patient’s immune cells, mRNA-4157 utilizes AI to tailor an individualized vaccine formulation to combat cancer.

The mRNA-4157 platform analyzes a patient’s tumor and healthy tissue, employing AI to identify relevant tumor-specific mutational signatures. These unique neoantigens form the foundation of the vaccine, with resulting protein compositions varying between patients. The objective is to stimulate an immune response against tumors bearing these distinctive biomarkers.

Given AI’s integral role, Moderna anticipates FDA scrutiny of its algorithm as part of the review process for mRNA-4157, also referred to as V940, according to Kyle Holen, Moderna’s head of therapeutics and oncology development.

Holen emphasized the meticulous precautions taken to preserve the algorithm’s integrity throughout the clinical trial, including securely locking it down to prevent any modifications that could influence trial outcomes.

However, the evolving nature of AI algorithms presents a regulatory conundrum: determining the permissible extent of algorithmic changes before considering the vaccine as a fundamentally new product remains uncertain.

“We don’t know,” Holen admitted. “Nobody knows. We’re in, like, no-man’s land here because no one’s ever done this.”

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