New Haven, CT (Press Release) – Kleo Pharma­ceu­ticals, Inc. (Kleo), an immuno-oncology com­pany devel­op­ing next-generation syn­thet­ic bispecific com­pounds designed to emulate or en­hance the activity of biologics, announced today that CD38-ARM, a CD38 targeting anti­body recruiting molecule (ARM™) to treat multiple myeloma, will be its first prod­uct can­di­date to move into the clinic with antic­i­pated human studies to commence in 2020.

CD38-ARM is designed to recruit endogenous anti­bodies to multiple myeloma cancer cells, targeting them for destruction by natural killer (NK) cells and macrophages. CD38 is a val­i­dated multiple myeloma target, which is also overexpressed in chronic lym­pho­cytic leukemia and other cancers. The molecule was chosen after showing pos­i­tive signals to­wards safety and efficacy in pre­clin­i­cal models. This is the first can­di­date to emerge from Kleo's strategic alliance with PeptiDream Inc., (Tokyo:4587).

"We're excited to announce CD38-ARM as the first clin­i­cal can­di­date for Kleo, which is also the first clin­i­cal can­di­date resulting from our col­lab­o­ration agree­ment with PeptiDream," said Douglas Manion, MD, CEO of Kleo. "PeptiDream's PDPS tech­nology and Kleo's ARM plat­form together have created a prod­uct can­di­date we in­tend to ad­vance into the clinic next year. CD38-ARM is being devel­oped to en­hance, complement or replace cur­rently mar­keted anti-CD38 multiple myeloma drugs through better safety and efficacy. We are hopeful CD38-ARM will be the first of a series of novel clin­i­cal can­di­dates to emerge from our inno­va­tive devel­op­ment plat­forms."

"PeptiDream takes great pride in being a strong leader in transforming peptides into new effective treat­ment options using our Peptide Discovery Platform System (PDPS)," stated Patrick Reid, PhD, CEO of PeptiDream. "We are pleased to partner with Kleo in CD38-ARM's ad­vancement into the clinic recognizing its poten­tial in becoming the next generation of first-in-class and best-in-class immuno­therapies."

About Kleo Pharma­ceu­ticals, Inc.

Kleo Pharma­ceu­ticals is a unique immuno-oncology com­pany devel­op­ing next-generation syn­thet­ic bispecific com­pounds designed to emulate or en­hance the activity of biologics. Similar to complex biologic drugs, Kleo's com­pounds recruit the immune sys­tem to destroy cancer cells, with the ad­van­tage of being smaller and more versatile, leading to poten­tially im­proved safety and efficacy over biologics. They are also much faster and less costly to design and produce, particularly against novel targets. The com­pany is ad­vanc­ing several drug can­di­dates based on its pro­pri­e­tary tech­nology plat­forms, all of which are modular in design and enable rapid generation of novel immuno­therapies that can be optimized against certain cancers, or en­hance the properties of existing immuno­therapies. These in­clude Anti­body Recruit­ing Molecules (ARMs), Syn­thetic Anti­body Mimics (SyAMs) and Mono­clonal Anti­body Ther­apy En­hancers (MATEs). For more in­for­ma­tion visit http://kleopharmaceuticals.com.

About PeptiDream

PeptiDream Inc. is a public (Tokyo Stock Exchange 1st Section 4587) bio­pharma­ceu­tical com­pany founded in 2006 employing our pro­pri­e­tary Peptide Discovery Platform System (PDPS), a state-of-the-art highly versatile discovery plat­form which enables the pro­duc­tion of highly diverse (trillions) non-standard peptide libraries with high efficiency, for the identi­fi­ca­tion of highly potent and selective hit can­di­dates, which then can be devel­oped into peptide-based, small molecule-based, or peptide-drug-conjugate-based thera­peutics. PeptiDream aspires to be a world leader in drug discovery and devel­op­ment to address unmet medical needs and im­prove the quality of life of patients world­wide. Further in­for­ma­tion re­gard­ing PeptiDream can be found at: http://www.peptidream.com

Forward-Looking Statements

This news release in­cludes for­ward-looking state­ments within the meaning of the U.S. federal se­cu­ri­ties laws. These for­ward-looking state­ments involve sub­stan­tial risks and un­cer­tain­ties, in­clud­ing state­ments that are based on the current ex­pec­ta­tions and assump­tions of the Company's man­agement. All state­ments, other than state­ments of historical facts, in­cluded in this press release re­gard­ing the Company's plans and objectives, ex­pec­ta­tions and assump­tions of man­agement are for­ward-looking state­ments. The use of certain words, in­clud­ing the words "estimate," "project," "intend," "expect," "believe," "antic­i­pate," "will," "plan," "could," "may" and similar ex­pres­sions are in­tended to identify for­ward-looking state­ments. The Company may not actually achieve the plans, intentions or ex­pec­ta­tions disclosed in the for­ward-looking state­ments and you should not place undue reliance on the Company's for­ward-looking state­ments. Various im­por­tant factors could cause actual results or events to differ ma­teri­ally from those that may be ex­pressed or implied by our for­ward-looking state­ments in­clud­ing receipt of regu­la­tory approvals and mar­ket con­di­tions. The for­ward-looking state­ments are made as of this date and the Company does not under­take any obli­ga­tion to update any for­ward-looking state­ments, whether as a result of new in­for­ma­tion, future events or other­wise.

Source: Kleo Pharma­ceu­ticals.