CD38-Targeting Molecule To Be Evaluated In Multiple Patient Populations

New Haven, CT (Press Release) – 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 …

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 (Press Release) – 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 …