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Kleo Pharmaceuticals to Present Preclinical Data Highlighting the Synergistic Potential of Kleo Asset KP1237 and Autologous NK Cells in the Treatment of Multiple Myeloma at the 2020 American Society of Clinical Oncology Virtual Meeting

Data support the initiation of an upcoming first-in-human trial for first-line, MRD+ multiple myeloma patients post-ASCT

New Haven, CT, May  14, 2020 – – Kleo Pharmaceuticals, Inc., a leading company in the field of developing next-generation, fully synthetic bispecific compounds designed to emulate or enhance the activity of biologics, today announced preclinical data for the company’s lead program, KP1237 in combination with autologous, cytokine-induced, memory-like (CIML) natural killer (NK) cells with low dose IL-2 in multiple myeloma (MM). KP1237 is a CD38-targeting antibody recruiting molecule (ARMTM). These data, to be presented as a poster at the 2020 American Society of Clinical Oncology (ASCO) Annual Meeting being held May 29–31, will support the initiation of an upcoming Phase 1/2 clinical trial for MM patients receiving an autologous stem cell transplant (ASCT), who remain minimum residual disease positive (MRD+)

This research, in collaboration with Dr. Rizwan Romee, Director of the Haploidentical Donor Transplantation Program at the Dana Farber Cancer Institute, will be presented as a poster and highlight the activity of the combination of KP1237 with CIML NK cells against CD38-expressing MM target cells. Several in vitro and ex vivo experiments show how KP1237 targets the NK cell therapy to the tumor cells and increases their cytotoxicity. These data led to the clinical exploration of this combination product in the high unmet medical need population of multiple myeloma patients who are MRD+ pre-ASCT.

“These data mark an important milestone for the ARM™ platform as we advance towards the first clinical trials for our growing company,” said Doug Manion, Kleo’s Chief Executive Officer and Chairman of the Board. “Initiation of these trials will allow us to demonstrate clinical proof of concept and, ultimately, facilitate the expansion of our technology platforms across indications. Additionally, this milestone moves us closer to our primary goal of having a meaningful impact on patient survival and quality of life.”

ARMs are unique, bispecific molecules composed of two active ends connected by a linker. One of the ends binds to a target molecule on a cancer cell, while the other end can bind to and thus recruit all endogenous IgG antibodies circulating in the body, which then bind to and activate NK cells. Therefore, ARMTM molecules behave similarly to chimeric antigen receptors to target immune cells to tumors, though their synthetic nature eliminates the need for genetic engineering of  the cells. KP1237,  by targeting CD38 expressed on the surface of multiple myeloma cells, facilitates NK-cell mediated killing of these tumor cells. The modular design enable ARMTM molecules to be broadly applicable as targeting tolls for all types of NK cell products across a range of tumor types.

Details of the poster presentation are as follows:

Title: A first-in-class ex vivo combination between cytokine-induced memory like (CIML) NK cells and a CD38 targeting antibody recruiting molecule (ARM) as a novel approach to target NK cells without cellular engineering for the treatment of multiple myeloma.

Session:  Hematologic Malignancies—Plasma Cell Dyscrasia

Abstract: #8523

This ASCO abstract is now available at https://meetinglibrary.asco.org/record/187657/abstract.  The poster presentation will include additional data not available in the abstract.

About Kleo Pharmaceuticals, Inc.

Kleo Pharmaceuticals is a unique biotechnology 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. Kleo’s compounds are designed to direct the immune system to destroy cancerous or virally infected cells and are currently in development for the treatment of various diseases, including multiple myeloma and COVID-19. Compared to biologics, Kleo’s compounds are smaller and more versatile, leading to potentially improved safety and efficacy. They are also much faster and more efficient to design and produce, particularly against novel targets. Kleo develops 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 specified biological targets and combined with existing cell- or antibody-based therapies. These include Antibody Recruiting Molecules (ARMs) 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

LifeSci Advisors (Investors)

Irina Koffler

646-970-4681

ikoffler@lifesciadvisors.com

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