GlobeNewswire Inc | Sep 8, 2020 08:30AM EDT

September 08, 2020

NEW HAVEN, Conn., Sept. 08, 2020 (GLOBE NEWSWIRE) -- 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-relapsed/refractory multiple myeloma patients, and in combination with autologous (the patients 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.

About Antibody-Redirecting Molecules (ARMs) Kleos bispecific, antibody-redirecting molecules (ARMs) are engineered with modular components that are readily interchangeable, giving the platform tremendous flexibility and rapid development times. ARMs are smaller than biologic therapies, which allows for enhanced tumor/tissue penetration, reduced immunogenicity, administration of higher dose levels with improved safety profiles, and the potential for oral bioavailability. The ARM platform is also being used to redirect NK cell-based therapies to disease targets without chimeric engineering.

About Multiple MyelomaMultiple myeloma is a type of blood cancer that affects plasma cells. In multiple myeloma, malignant plasma cells accumulate in bone marrow, the soft, spongy tissue at the center of a persons bones, and crowd out normal plasma cells that help fight infection. The American Cancer Society estimates that approximately 32,270 new cases will be diagnosed, and 12,830 deaths will occur in 2020 from multiple myeloma.

About Kleo Pharmaceuticals, Inc. Kleo Pharmaceuticals is a targeted immunotherapy company that develops fully synthetic bispecific therapies to redirect, enhance or replace antibodies. The company was founded on the groundbreaking research of its scientific founder Dr. David Spiegel at Yale University. Kleos synthetic immunotherapy platform uses two chemistry-based approaches antibody-redirecting molecule (ARM) and multitargeted antibody therapy enhancer (MATE) - that help redirect and stimulate key components of the immune system to eradicate cancer cells and virulent pathogens. Kleos compounds are smaller and more versatile than biologic therapies, which allows for enhanced tumor/tissue penetration, reduced immunogenicity, administration of higher dose levels with improved safety profiles, more efficient production and the potential for oral bioavailability. They can be optimized against specified biological targets or combined with existing cell- or antibody-based therapies.

Kleos lead program, KP1237, is entering Phase 1 clinical studies in 2020 in multiple myeloma in multiple settings. The companys second program targeting COVID-19, a human globulin mimic (HGM), is funded with $5 million grant from the Bill & Melinda Gates Foundation and expected to begin clinical testing in early 2021, with additional COVID-19 treatments in development. Kleo investors include Biohaven Pharmaceutical Holding Company (NYSE:BHVN) and PeptiDream Inc. (Nikkei:PPTDF). For more information, visit www.kleopharmaceuticals.com.

CONTACT INFORMATION LifeSci Advisors (Investors) Irina Koffler 646-970-4681ikoffler@lifesciadvisors.com

Susan Kinkead (Media)415-509-3610susan@kinkeadcomm.com