Catapult Therapeutics receives FDA Clearance of Investigational New Drug (IND) Application for CAP-100, an innovative first-in-class humanized anti-CCR7 antibody
Catapult Therapeutics, a biopharmaceutical company developing novel cancer treatments, 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.
“The FDA clearance of the IND for CAP-100 represents another important milestone for Catapult Therapeutics, and we look forward to initiating the clinical trial shortly” said Wim Mol, PhD, Chief Executive Officer of Catapult Therapeutics. “We are excited to take the next step in the development of an antibody we believe will fulfill a significant unmet medical need: an effective treatment of hematological malignancies with the potential to change the treatment paradigm and provide new treatment options for patients”.
Source: Catapult Therapeutics (Press release)