2024-04-11 18:16:24
The era of personalized cancer vaccines, which are considered a ‘game changer’ in cancer treatment, is expected to soon begin. This is because the U.S. Food and Drug Administration (FDA) has reorganized related systems to launch Moderna’s cancer vaccine, which is being developed at the fastest pace. Compared to the United States, which is actively taking action, only basic discussions are still taking place on domestic routes, and related industries are pointing out that “a more proactive review of the system is needed.”
Peter Marks, director of the U.S. Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER), discussed personalized cancer vaccines at the World Vaccine Congress (WVC) held in Washington, D.C. for three days starting on the 1st of this month (local time). “The FDA is ready to review (approval review, etc.) to open the related market,” he said. This is the first time that the FDA has made such a direct comment on the cancer vaccine approval system.
Personalized cancer vaccines are ‘therapeutic’ vaccines that allow immune cells to attack cancer cell surface proteins (neoantigens) that each person has differently.
Cancer is basically caused by genetic mutation. Depending on the type of cancer, there are genetic mutations that many patients have in common, while there are also genetic mutations that are completely different from person to person. Until now, targeted treatments targeting common genetic mutations have been developed, but recently, personalized cancer vaccines that eliminate different neoantigens for each patient are being developed. Business Research Insight, a global market research firm, predicted that the global cancer vaccine treatment market will grow to $480.9 million (approximately KRW 650 billion) by 2028.
Currently, Moderna and BioNTech are developing at the fastest rate. Both companies have been developing personalized cancer vaccines using mRNA even before developing a new coronavirus infection (COVID-19) vaccine.
Currently, Moderna is conducting phase 3 clinical trials with Merck (MSD) in the United States for patients with melanoma and non-small cell lung cancer, respectively. This is a clinical trial evaluating the combined administration of Moderna’s cancer vaccine ‘mRNA-4157’ and MSD’s cancer immunotherapy drug ‘Keytruda’. In a phase 2b clinical trial targeting melanoma patients, mRNA-4157 reduced the risk of distant metastasis or death by 62% compared to Keytruda alone. The company plans to launch a personalized cancer vaccine by 2030.
BioNTech, in collaboration with global pharmaceutical company Roche, is conducting a phase 2 clinical trial of ‘Autogene Cebumeran (BNT122)’ for patients with pancreatic ductal cell carcinoma (PDAC). We plan to evaluate co-administration with Roche’s immunotherapy drug ‘Tecentriq’.
Cancer vaccines from major bio companies are entering late-stage clinical trials, and each country is preparing support measures for clinical trials and rollout. In February of this year, the US FDA prepared a draft system called the ‘Advanced Manufacturing Technology Designation Program’ and announced that it would support cancer vaccines through this system. According to this system, drugs produced using technologies designated as advanced manufacturing technologies do not need to undergo additional approval procedures. Last year, the UK signed a long-term partnership with BioNTech to allow up to 10,000 domestic patients to participate in cancer vaccine clinical trials by 2030.
On the other hand, Korea still has insufficient relevant systems. The Ministry of Food and Drug Safety prepared and announced guidelines for cancer vaccine development last year, but did not include information on safety evaluation or product approval. A domestic oncology medical staff member said, “For carcinomas that lack treatments, such innovative treatments are desperately needed,” adding, “The government needs to actively improve the system.” The Ministry of Food and Drug Safety said, “The United States has not yet applied the system, so we are also watching the situation,” and added, “There is room for review.”
〈Major development status of personalized cancer vaccines〉
| company | Target disease | clinical stage | vaccine method |
| Moderna | Melanoma, non-small cell lung cancer | Clinical 3award | mRNA |
| BioNTech | Pancreatic ductal cell carcinoma | Phase 2 clinical trial | mRNA |
| Ativa Biomedical | glioblastoma | Phase 3 clinical trial | Immune cells (dendritic cells) utilization |
| Genius Therapeutics | colon cancer | Clinical 2·3award | DNA plasmid |
Source: Each company websiteReporter Choi Ji-won [email protected]
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2024-04-11 18:16:24