IO Biotech’s cancer vaccine Cylembio narrowly misses Phase III primary endpoint in advanced melanoma, but company eyes FDA filing in 2025

Cylembio; IO Biotech; melanoma; Phase 3; pivotal trial; progression-free survival (PFS); hazard ratio 0.77; p-value 0.056; Keytruda (pembrolizumab); FDA BLA; overall survival (OS) trend; IOB-013/KN-D18; NCT05155254; imsapepimut; etimupepimut; stock drop

Scientists Protest FDA’s Rejection of Replimune’s Tumor Destroying Therapy

Replimune; RP1; FDA rejection; oncolytic immunotherapy; melanoma; clinical trial; IGYNTE study; scientist protest; drug approval; patient heterogeneity

Replimune’s Shares Plunge After FDA Rejects Melanoma Drug Application

Replimune; RP1; FDA rejection; melanoma; cancer drug; Complete Response Letter; clinical trial design; objective response rate; share price drop

BioNTech and Regeneron Achieve Significant Response Rate Success in Phase 2 Trial for mRNA Cancer Immunotherapy BNT111

BioNTech, Regeneron, mRNA immunotherapy, BNT111, Phase 2 trial, melanoma, cancer treatment, PD-1 checkpoint inhibitor, cemiplimab, FixVac platform, uridine mRNA-LPX technology