Catapult Therapeutics, a biopharmaceutical company developing novel cancer treatments, today announced the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for its lead product candidate CAP-100, an innovative first-in-class humanized anti-CCR7 antibody for treatment of hematological malignancies.
Catapult Therapeutics is now poised to initiate a Phase 1 clinical trial in patients with relapsed or refractory CLL (chronic lymphocytic leukemia). Expected to begin in the second quarter of 2021, the clinical trial is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of CAP-100. The study will be performed at Dana-Farber Cancer Institute in Boston, where startup activities are currently underway, and two other leading clinical sites in the USA.