On November 22, 2021 Catapult Therapeutics, a clinical-stage biopharmaceutical company developing novel cancer treatments, reported dosing of the first patient in the company’s Phase I clinical trial of CAP-100 in patients with relapsed and/or refractory chronic lymphocytic leukemia (CLL) (Press release, Catapult Therapeutics, NOV 22, 2021, View Source [SID1234595901]). The trial will enroll an estimated number of 25 patients and is performed in 3 Academic Sites in the US. CAP-100 is Catapult’s lead product candidate, an anti-CCR7 antibody with a unique mechanism of action interfering with the fundamental pathology of hematological malignancies. CAP-100 prevents cancer cells from entering and hiding in lymph nodes in addition to being able to kill the cancer cells directly. This unique mode of action is directly preventing cancers cells to escape into niches where they are more difficult to eradicate.
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"The dosing of the first patient with CAP-100 is an important step forward in the development of our lead product. The pre-clinical data of CAP-100 is very promising, and we are looking forward to receiving data that potentially confirms what we believe CAP-100 could become: an effective treatment for patients with hematological malignancies and with the potential to change the treatment paradigm for different cancers," says Dominik Höchli, MD, CEO of Catapult Therapeutics.
The first in-human clinical trial was designed in close collaboration with the Dana-Farber Cancer Institute in Boston. "The CCR7 signaling pathway is a major driver directing cells to the lymph node. Targeting this pathway with CAP-100 has the potential to lead to more rational and effective therapies for CLL and other malignancies," says Jennifer R. Brown, MD, PhD, Director of the CLL Center of the Division of Hematologic Malignancies at Dana-Farber Cancer Institute, Professor of Medicine at Harvard Medical School in Boston, Massachusetts and the principal investigator of the phase 1 study.
CAP-100 is an anti-CCR7 antibody with a unique and biologically independent therapeutic mechanism of action for treatment of CCR7-positive hematological malignancies. Preclinical studies have demonstrated CAP-100’s unique ability to treat primary tumor cells from patients with human CLL, and different non-Hodgkin lymphomas (NHL) at a fundamental point, by interrupting tumor cell migration to and survival in lymph nodes. In addition, CAP-100 provides strong cell killing while preserving normal blood cells and inhibition of survival of tumor cells in the lymph nodes. Furthermore, CAP-100 may also be an effective treatment for other CCR7-expressing B- and T-cell leukemias and lymphomas as well as for graft-versus-host disease.
About the study
Catapult Therapeutic’s Phase I clinical trial (clinicaltrials.gov #NCT04704323) 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 in earlier lines of CLL and in other malignancies either as monotherapy or in a combination setting.
About CCR7 & CAP-100
The chemokine receptor CCR7 is essential for the migration, maturation, and survival of CCR7 expressing 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 and inhibition of survival of tumor cells in the lymph nodes.
About CLL
Despite advances in therapy and improved outcome, in most instances CLL is an incurable disorder, and most patients relapse or become refractory to their treatment. CLL is the most common type of leukemia in Western countries, predominates in the elderly, and the incidence of the disease increases exponentially with age. Thus, the number of CLL patients is expected to rise in the future, given the increase in the aging population, bringing to light new clinical challenges and public health issues.