NEW YORK – Aston Sci. said on Tuesday that it will evaluate the investigational ovarian cancer vaccine AST-201 in a US-based Phase II clinical trial.
The US Food and Drug Administration approved an investigational new drug application, giving the Seoul, South Korea-based firm the go-ahead to evaluate its cancer vaccine as a treatment for ovarian cancer patients whose tumors are homologous recombination proficient, as determined by an FDA-approved test.
The Phase II clinical trial, dubbed CornerStone-004, will take place at the University of Washington and will include 98 patients with newly diagnosed stage III epithelial ovarian, peritoneal, or fallopian-tube cancer. Following surgical resection, patients will be randomized to receive either AST-201 plus chemotherapy and the granulocyte-macrophage colony stimulating factor therapy (rhuGM-CSF) or chemotherapy, rhuGM-CSF, and a placebo.
Researchers' primary aim in the trial is to compare patients' progression-free survival in the two treatment arms. They will also track patients' overall survival, adverse events, and AST-201-specific immunogenicity, among other secondary endpoints.
The plasmid-based DNA vaccine is designed to induce Th1-cell immunity against IGFBP-2.
"Our dedicated efforts are focused on delivering a safer and more advanced treatment option for ovarian cancer patients," Hun Jung, Aston Sci.'s head of R&D, said in a statement. "We are committed to sharing our results at the earliest opportunity [and] will expand clinical research across various indications and reaffirm our expertise in the field of cancer vaccine development."
In 2022, Aston Sci. also received FDA IND clearance to evaluate its investigational AST-301 vaccine in HER2-low breast cancer patients in a Phase II trial.