Kleo Pharmaceuticals Presents Preclinical Data Supporting Development of its CD38-ARM™, a Novel Immuno-therapeutic, at American Society of Hematology (ASH) Annual Meeting

NEW HAVEN, Conn., Nov. 6, 2019 /PRNewswire/ -- 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 two abstracts have been accepted for presentation at the 61st annual American Society of Hematology (ASH) meeting and exposition being held December 7-10 in Orlando, FL.

The posters will showcase the strong preclinical data of Kleo's most advanced Antibody Recruiting Molecules (ARM) in development, which target CD38, a cell surface protein that is highly expressed by malignant plasma cells in multiple myeloma (MM) patients. ARMs are bispecific molecules that redirect a patient's own polyclonal antibodies to target tumor cells. They are comprised of a proprietary antibody-binding domain linked to a highly specific tumor-binding domain. They work by creating a bridge between antibodies and cancer cells that leads to immune-mediated killing of the tumor.

"Kleo is honored to present preclinical proof-of-concept data for our CD38-ARMs at ASH, which supports the advancement of this exciting and novel technology platform into the clinic," said Doug Manion, Kleo's Chief Executive Officer. "Our highly modular ARM platform has demonstrated clear differentiation from therapeutic monoclonal antibodies and broad applicability in a number of oncology and non-oncology indications. We are scheduled to file our first investigational new drug (IND) application in 1Q 2020."

Details of the poster presentations are as follows:

Title: A Novel Class of Bifunctional Immunotherapeutic That Exploit a Universal Antibody Binding Terminus (uABT) to Recruit Endogenous Antibodies To Cells Expressing CD38 Demonstrates Anti-Multiple Myeloma Activity in vitro and ex-vivo Against Patient Tumor Cells
Date & Time: Monday, December 9, 2019 from 6:00 p.m. - 8:00 p.m.
Session: 652. Myeloma: Pathophysiology and Pre-Clinical Studies, excluding Therapy: Poster III
Abstract: 4411
Location: Orange County Convention Center, Hall B
Presenter: Ann Marie Rossi

According to multiple lines of evidence including ex vivo data in patient bone marrow samples, Kleo's CD38–ARMs are able to kill MM cells by antibody dependent cellular cytotoxicity (ADCC) without depleting CD38-expressing immune cells, unlike existing antibodies such as Daratumumab. Combined with the in vivo efficacy data presented elsewhere, these data establish the therapeutic potential of CD38-ARM, and for the first time, the ARM platform's ability to generate therapeutic agents tailored to a specific indication.

Title: A Novel Class of Bifunctional Immunotherapeutic That Exploits a Universal Antibody Binding Terminus (uABT) to Recruit Endogenous Antibodies To Cell Expressing CD38 Demonstrate in vivo Efficacy in Three Distinct Animal Models
Date & Time: Saturday, December 7, 2019, 5:30 p.m. – 7:30 p.m. 
Session: 652. Myeloma: Pathophysiology and Pre-Clinical Studies, excluding Therapy: Poster I
Abstract: 1820
Location: Orange County Convention Center, Hall B
Presenter: Anna Bunin

This presentation outlines how CD38-ARM compounds are therapeutically active in three distinct in vivo models. This data provides strong evidence for the CD38-ARM's capacity to engage both macrophage and NK cells effector functions, providing a foundation to advance Kleo's compounds towards the clinic. The results also showed that CD38-ARM compounds engage a variety of effector mechanisms involved in tumor clearance and tumor growth delay, indicating therapeutic potential across a wide range of clinical settings. Overall, the data demonstrated the value of ARM compounds as a platform to develop compounds tailored to a specific indication.

These ASH abstracts are now available at www.hematology.org. The poster presentations will include additional data not available in the abstract.

About Kleo Pharmaceuticals, Inc.
Kleo Pharmaceuticals is a unique immuno-oncology company developing next-generation bispecific compounds designed to emulate or enhance the activity of biologics based on the groundbreaking research of its scientific founder Dr. David Spiegel at Yale University.  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. Kleo 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). Biohaven Pharmaceutical Holding Company (NYSE:BHVN) and PeptiDream Inc. (Nikkei:PPTDF) are investors in Kleo Pharmaceuticals.  For more information visit http://kleopharmaceuticals.com.

Forward-Looking Statements
This news release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. 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 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.

CONTACT INFORMATION
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Maureen McEnroe, CFA (Investors)
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Ingrid Mezo (Media)
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SOURCE Kleo Pharmaceuticals, Inc.

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