Closely-held Kleo Pharmaceuticals received FDA clearance of its IND to initiate a safety and tolerability clinical study, combining its KP1237, a CD38-targeting antibody recruiting molecule, with patients’ own natural killer cells to treat multiple myeloma in post-transplant patients.
The single-arm study will be conducted in 25-to-30 patients with exploratory endpoints that assess the minimal residual disease conversion rate at 90-to-100 days after transplantation.
In a statement, the company said recent clinical trials have identified minimal residual disease negativity post-transplant as a potential surrogate of long-term remission in multiple myeloma. The trial is expected to begin enrollment in the first half of 2020, with topline data expected in the second half of 2021.
Kleo CEO, Dr. Doug Manion, said that approximately 30,000 individuals are diagnosed with multiple myeloma in the U.S. each year, with at least one third of those patients undergoing autologous stem cell transplants.
