Analysis-Moderna, Merck Breakthrough Could Usher in Wave of Cancer Vaccines

• Merck and Moderna announced that their personalized mRNA vaccine successfully met its goals in a late-stage trial by preventing skin cancer from returning in high-risk melanoma patients. • While the results have been met with enthusiasm from observers, the companies have not yet released the full data from the ongoing study.

• Merck and Moderna announced that an experimental cancer vaccine-drug combination shows promise in preventing the recurrence of melanoma in high-risk patients. • While full trial data has not yet been published, previous research presented in June at the American Society of Clinical Oncology meeting indicated the treatment halved the risk of recurrence over five years for 157 patients.

• The Democratic Republic of the Congo is facing its deadliest Ebola outbreak in history, with the death toll now exceeding 2,300 people. • Official data reveals a total of 4,945 recorded cases and 2,325 deaths, marking a significant escalation in the disease's impact.

• NanoViricides, Inc. (NYSE American: NNVC) announced on August 18, 2026, that it will soon begin a Phase II clinical trial for NV-387 oral gummies. • The trial aims to treat the Bundibugyo Ebola virus during what is described as the largest and most rapidly expanding outbreak to date in the Democratic Republic of Congo.

• President Trump has nominated Heidi Overton, a known opponent of abortion, to serve as the chief of the Food and Drug Administration (FDA). • Democrats have criticized the appointment, labeling Overton a "sycophant" after she appeared alongside Trump during an August 10, 2026, event where he made false claims regarding vaccines.

• Merck and Moderna announced that their Phase 3 INTerpath-001 trial met primary endpoints for recurrence-free survival (RFS) and distant metastasis-free survival (DMFS) in patients with completely resected stage IIB-IV melanoma. • The study found that combining KEYTRUDA with intismeran autogene—an mRNA-based individualized neoantigen therapy tailored to a patient's specific tumor mutations—provided statistically significant improvements over using KEYTRUDA alone.

• The FDA's Center for Devices and Radiological Health released a discussion paper on Tuesday regarding the future of generative AI-enabled medical devices. • The agency is seeking early input from stakeholders to inform potential regulatory frameworks for these emerging technologies.

• Saloni Dattani and Works in Progress examine the current state of medical progress and the systemic barriers hindering the development of new treatments. • The authors highlight that the process of running clinical trials has become increasingly slow and complicated, requiring rigorous successive stages of data collection.

• NanoViricides, Inc. (NASDAQ:NNVC) has announced the launch of a Phase II clinical trial for NV-387, an oral gummy treatment designed to combat Ebola viruses. • The trial is being conducted in the Democratic Republic of the Congo (DRC) and is led by Prof. Patrick Katoto, a distinguished researcher and Fogarty Fellow.

• Measles cases are reaching record highs as immunization rates drop across various parts of the United States. • Health officials warn that measles is one of the most contagious diseases in history and is typically the first to resurface when vaccine coverage declines.

• The FDA has approved a novel regimen featuring iberdomide, a cereblon E3 ligase modulator (CELMoD), for the treatment of relapsed/refractory multiple myeloma (RRMM). • The treatment, used in combination with daratumumab and dexamethasone, is specifically effective for patients who have previously failed immunomodulatory drugs like lenalidomide and pomalidomide.