Benzinga | Sep 8, 2020 08:37AM EDT

Biohaven Pharma Investment, Kleo Pharma, Reports Orphan Drug Designation For KP1237 In Multiple Myeloma

Kleo Pharmaceuticals, a targeted immunotherapy company developing fully synthetic bispecific therapies to redirect, enhance or replace antibodies, announced today that its lead compound, KP1237, has received Orphan Drug designation from the U.S. Food and Drug Administration (FDA) in multiple myeloma. KP1237 is an antibody-redirecting molecule (ARM?) that targets CD38, a clinically validated target for multiple myeloma.

"We are pleased to receive this Orphan Drug designation for KP1237, which is advancing to Phase 1 clinical testing in the fourth quarter of 2020," said Doug Manion, MD, CEO of Kleo Pharmaceuticals. "Based on compelling preclinical data, we will evaluate KP1237 in potentially three different clinical programs where KP1237 can have the greatest impact in patients whose options may be severely limited."

Orphan Drug designation qualifies KP1237 for a number of development incentives, including tax credits for certain clinical costs, a waiver of the new drug application fee and a designated period of market exclusivity following approval.

Kleo is evaluating KP1237 both as a systemic therapy for Darzalex(r)-relapsed/refractory multiple myeloma patients, and in combination with autologous (the patient's own) natural killer (NK) cells in newly diagnosed multiple myeloma patients who are minimum residual disease-positive (MRD+) post-autologous stem cell transplant. Clinical trials to support both these programs are planned to begin in the fourth quarter of 2020. A third clinical program in multiple myeloma using KP1237 in combination with allogeneic (off-the-shelf) NK cells is also under development.

In addition to multiple myeloma, Kleo has an active COVID-19 program, whose first clinical candidate is expected to enter clinical testing in early 2021.