Catapult Therapeutics has 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 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."

The planned Phase I clinical trial will investigate the safety and efficacy of increasing doses of CAP-100 in relapsed or refractory patients to at least two prior standard systemic treatment regimens for CLL or SLL (small lymphocytic lymphoma) and having no available therapies known to provide clinical benefit. The trial will be divided into two phases. The aim of the Phase Ia (dose escalation) is to define the Recommended Phase 2 Dose (RP2D). Phase Ib of the trial (expansion phase) will evaluate the safety and preliminary clinical benefit of CAP-100 at RP2D, to support the design of future trials investigating CAP-100 either as monotherapy or in a combination setting with approved treatments for CLL.

The chemokine receptor CCR7 is essential for migration of immune cells to lymphoid organs. This pivotal receptor is over-expressed in hematological malignancies with lymph node involvement, such as CLL and diffuse large B-cell lymphoma (DLBCL) amongst others. Anti-hCCR7 antibody CAP-100 offers a unique and biologically independent therapeutic mechanism to treat these hematological cancers at a fundamental point, by interrupting tumor cell migration to lymph nodes. In addition, CAP-100 provides strong cell killing (ADCC) and inhibition of survival of tumor cells in the lymph nodes.