Date : 02/06/2020
Company Name : Kleo Pharmaceuticals Inc
Headquarter : United States
KP1237, a CD38-Targeting Antibody Recruiting Molecule (ARM™), to Be Tested in Combination with NK Cells to Treat Post-Transplant Multiple Myeloma Patients
New Haven, CT, February 6, 2020 – Kleo Pharmaceuticals, Inc., an immuno-oncology company developing next-generation, fully synthetic bispecific compounds designed to emulate or enhance the activity of biologics, announced today that it has received Investigational New Drug (IND) authorization to proceed from the U.S. Food and Drug Administration (FDA) to initiate a safety and tolerability clinical study combining KP1237, a CD38-targeting antibody recruiting molecule (ARM™), with patients’ own Natural Killer (NK) cells to treat multiple myeloma (MM) in post-transplant patients.
The single-arm study will be conducted in 25-30 patients with exploratory endpoints that assess the MRD (minimal residual disease) conversion rate at 90-100 days after transplantation. Recent clinical trials have identified MRD negativity post-transplant as a potential surrogate of long-term remission in MM. The trial is expected to begin enrollment in the first half of 2020, and topline data are expected in the second half of 2021.
“We are excited to have clearance to initiate a clinical trial in the US that addresses a significant unmet medical need in newly diagnosed, post-transplant multiple myeloma patients,” said Kleo CEO Doug Manion, MD. “Approximately 30,000 individuals are diagnosed with multiple myeloma in the United States each year, with at least 1/3 of those patients undergoing autologous stem cell transplants.”
In this trial, KP1237 is being investigated as a “cell homing” molecule to target the patient’s activated NK cells to the CD38-expressing tumor. Current anti-CD38 therapeutic antibodies kill NK cells and are not approved for use in this clinical setting[i].
Nonclinical efficacy data presented at the 2019 American Society of Hematology (ASH) Annual Meeting demonstrated that CD38-ARMs are able to kill multiple myeloma cells by antibody-dependent cellular cytotoxicity without depleting CD38-expressing immune cells. Nonclinical data also demonstrated that the CD38-ARM molecule did not induce complement-dependent cytotoxicity (CDC) suggesting it is not likely to cause CDC in humans. Kleo’s 2019 ASH posters can be viewed here and here.