KAIST Professor Shin Eui-cheol's Year-Old Prediction of 'Moderna Cancer Vaccine Imminent Commercialization' Re-examined

BioNTech, originally a company researching cancer vaccines, presented its RNA-based personalized cancer vaccine research through two papers published in Nature in 2017. This research confirmed that personalized RNA mutanome vaccines could activate immune responses against cancer cells. This demonstrates that mRNA technology had great potential in the field of cancer treatment even before the development of COVID-19 vaccines.

mRNA vaccines have the advantage of being produced more quickly than other types of vaccines. For patient-specific cancer vaccines, where a patient's genetic sequence needs to be analyzed in a day to create a customized vaccine, it would be difficult to see an effect if it took a year like traditional vaccines. mRNA vaccines make this process possible in just one week, fulfilling a critical requirement for personalized treatment.

While mRNA vaccine design itself takes less than a month, the clinical trial process typically takes about 10 months. This is significantly faster than the 2-3 years required for traditional vaccine development. Notably, the COVID-19 pandemic led to widespread validation of mRNA vaccine technology, increasing public acceptance of the technology and positively impacting cancer vaccine research and development.

The success of cancer vaccine development heavily relies on next-generation sequencing (NGS) and neoantigen prediction technologies. NGS technology accurately identifies mutation sites in cancer cells, and based on this, antigen regions that can induce an immune response are predicted and formulated into mRNA vaccines. Such personalized vaccines can achieve synergistic effects when co-administered with immune checkpoint inhibitors, maximizing therapeutic efficacy.

Moderna announced clinical trial results for patients with malignant melanoma in 2024, comparing a group treated with an immune checkpoint inhibitor alone and a group treated with a cancer vaccine in combination. The blue graph shows the results for the group treated only with the immune checkpoint inhibitor pembrolizumab (anti-PD1), while the red graph shows the results for the group treated with both the cancer vaccine and pembrolizumab. The data indicates a positive trend in improved survival rates in the combination therapy group, and based on this scientific evidence, data is being submitted to the FDA. This is considered a significant advance in cancer vaccine development. This data suggests a clinically meaningful effect and shows potential as a new therapeutic approach. It is an important step in proving that combination therapy can yield better results than monotherapy. These findings have the potential to change the paradigm of cancer treatment in the future.

Despite some successful clinical results, cancer vaccines still require several more years until actual commercialization. The critical challenge is to improve the accuracy of neoantigen prediction. Currently, only a minority of the 10 antigens induce an immune response, but technology must advance to a level where most antigens can be accurately predicted and identified. As this accuracy increases, the vaccine's efficacy and applicability can expand.

The high anticipated cost of personalized cancer vaccines, if successful, is a major concern for the industry. The estimated cost for a single dose of a personalized cancer vaccine is currently around 500,000 USD (approximately 750 million Korean Won). Such high costs could limit patient access and lead to low sales, potentially hindering commercial success. Nevertheless, the direction of the technology itself is considered firm.

Scientists warn that even with logical reasoning and promising results in the clinical stage, many clinical trials ultimately fail at the last minute. Therefore, it is important to observe carefully until the final commercialization stage, without being swayed by a specific company's stock price or promotions. Current positive data indicates potential, but it is difficult to definitively assert ultimate success.

Professor Shin predicted that patient-specific cancer vaccines would be the key means to conquer cancer. This is similar to how vaccines played a decisive role in conquering infectious diseases in the past. Overcoming patient-specific variations observed in current clinical results remains a future challenge, but personalized vaccine technology is expected to lead the future of cancer treatment. He emphasized focusing on the direction of technological advancement itself rather than the success of a particular company.

Professor Shin emphasized the importance of collaboration among researchers with diverse academic backgrounds in medical science laboratories. Non-medical students excel in technical proficiency, such as gene introduction, while medical students leverage their clinical experience to provide medical significance and applicability. Since complete research cannot be conducted by one side alone, the greatest synergy can be achieved when individuals with diverse expertise work together.