NEW YORK – Aileron Therapeutics said on Monday that it has enrolled the first patient in its Phase IB/II trial evaluating whether pretreating TP53-mutated small-cell lung cancer patients with its investigational drug ALRN-6924 can reduce the chemotherapy-induced toxicities associated with topotecan.
Prior to enrollment, patients must have either recurred or relapsed on chemotherapy or immunochemotherapy and have their TP53 mutation status confirmed by next-generation sequencing.
Patients enrolled in the trial will be treated with second-line topotecan following the administration of ALRN-6924, which is designed to work with the p53 protein to trigger cell cycle arrest in healthy cells and prevent off-target effects of chemotherapy. This, in turn, is expected to enhance the anti-cancer effects of chemotherapy in p53-mutant tumor cells.
"Chemotherapy remains a critical cornerstone treatment for millions of cancer patients. Unfortunately, in the process of killing cancer cells, chemotherapy inadvertently harms healthy cells, too. This leads to a multitude of common, damaging, severe toxicities," Aileron CEO Manuel Aivado said in a statement. "We treat healthy cells ahead of chemotherapy to prevent those toxicities, importantly, without interrupting chemotherapy's potent onslaught against cancer cells. ALRN-6924 could dramatically improve patients' quality of life by improving their tolerance to chemotherapy."
Aileron plans to report topline data from the Phase IB/II study in the fourth quarter of 2020.