Cytovia Therapeutics Reports Preclinical Activity of its iPSC-derived NK (iNK) Cells and Flex-NK™ Cell Engagers at the 2022 AACR Annual Meeting

• First in vivo data demonstrates anti-tumor activity of Glypican-3 (GPC3) Flex-NK™ cell engager (CYT-303) in combination with iNK cells in an animal model of Hepatocellular carcinoma (HCC)
• First in vitro data evaluating CD38 Flex-NK™ cell engager (CYT-338) demonstrates a favorable profile compared to daratumumab

AVENTURA, Fla. and NATICK, Mass., April 8, 2022 /PRNewswire/ -- Cytovia Therapeutics, Inc., a biopharmaceutical company empowering natural killer (NK) cells to fight cancer through stem cell engineering and multispecific antibodies, announced today that the novel data it is presenting at the American Association of Cancer Research's annual meeting in New Orleans on April 12^th, 2022 is now available on both the AACR and Cytovia websites.

"We are very pleased with the decisive progress of Cytovia's R&D team towards the manufacturing and preclinical validation of its two synergistic platforms," commented Dr. Daniel Teper, CEO and Chairman of Cytovia Therapeutics. "The data presented at AACR supports the advancement of our lead GPC3-targeting hepatocellular carcinoma (HCC) program towards clinical trials and our differentiated CD38-targeting multiple myeloma program to IND-enabling studies. Cytovia is the first company to combine its own iPSC-derived natural killer (iNK) cells and multispecific, NK cell-engaging antibodies and is building a pipeline that encompasses both hematological malignancies and solid tumors."

"Cytovia's GPC3-directed NK-engager in combination with iPSC-derived NK cells demonstrated impressive anti-tumor activity in mice that merits clinical development," added Dr. Michael Friedman, a member of Cytovia's Board of Directors. "For the large number of hepatocellular cancer patients who currently have such limited, poor clinical options, a novel tumor antigen-directed NK engager is needed.  It would be a welcome addition to a physician's armament, with high potential for numerous combinations. The early CYT-338 data, showing superiority over daratumumab in several in vitro assays, is similarly impressive and warrants further preclinical development in my opinion."

Highlights from Posters Presented at the AACR Annual Meeting

CYT-303

• The FLEX-NK^TM tetravalent, multifunctional antibody CYT-303 directed against NKp46 and GPC3 demonstrated in vitro and in vivo activity against HCC tumor targets.
• iNK cells expressed a favorable combination of multiple activation and few inhibitory receptors that corresponded to more potent cytolytic activity against HCC targets.
• The combination of the FLEX-NK^TM and iNK platforms demonstrated greater in vitro and in vivo anti-tumor activity in HCC models than iNK cells alone, with a favorable in vitro cytokine release and immune cell subset safety profile.
• These preclinical proof of concept studies with CYT-303 alone or in combination with iNK cells in HCC warrant clinical development.

CYT-338

• The FLEX-NK^TM multifunctional engager antibody CYT-338 directed against NKp46 and CD38 demonstrated in vitro activity against multiple myeloma tumor targets.
• An analysis of binding sites on CD38 indicates CYT-338 binds an epitope that is distinct from daratumumab.
• The binding, cytokine release, cytotoxicity, and fratricide profiles of CYT-338 were superior to daratumumab.
• These data support further development of CYT-338 as a therapeutic for targeting CD38 expressing multiple myeloma cells.

For details on in-person poster presentations, please see the following:

Title: Preclinical characterization of FLEX-NKTM tetravalent NKp46 engager directed against GPC3 (CYT-303) alone or in combination with iPSC derived Natural Killer cells (iNKs) against hepatocellular carcinoma (HCC)
Presenter: Antonio Arulanandam
Session Title:  Adoptive Cell Therapy
Session Date and Time:   Tuesday, Apr 12, 2022, 9:00 AM - 12:30 PM
Location: New Orleans Convention Center, Exhibit Halls D-H, Poster Section 30
Poster Board Number:  8
Permanent Abstract Number: 2752
Abstract Link

Title: Novel multifunctional tetravalent CD38 NKp46 FLEX NKTM engagers actively target and kill multiple myeloma cells
Presenter: Liang Lin
Session Title: Combination Immunotherapies / Therapeutic Antibodies
Session Date and Time: Tuesday, Apr 12, 2022, 1:30 PM - 5:00 PM
Location:  New Orleans Convention Center, Exhibit Halls D-H, Poster Section 32
Poster Board Number:  17
Permanent Abstract Number: 3436
Abstract Link

About Cytovia Therapeutics
Cytovia Therapeutics aims to accelerate patient access to transformational cell therapies and immunotherapies, addressing several of the most challenging unmet medical needs in cancer. Cytovia focuses on harnessing the innate immune system by developing complementary and disruptive NK-cell and NK-engager antibody platforms. The company is developing three types of iPSC-derived (or iNK) cells: unedited iNK cells, TALEN® gene-edited iNK cells with improved function and persistence, and TALEN® gene-edited iNK cells with chimeric antigen receptors (CAR-iNKs) to improve tumor-specific targeting. The second complementary cornerstone technology is a quadrivalent multifunctional antibody platform designed to engage natural killer cells by targeting NKp46 using Cytovia's proprietary Flex-NK™ technology.

These two technology platforms are being used to develop treatment for patients with solid tumors such as HCC and glioblastoma as well as hematological malignancies such as refractory multiple myeloma.

Headquartered in Aventura, FL., Cytovia has research and development laboratories in Natick, MA., and a GMP cell manufacturing facility in Puerto Rico. The company's own R&D work is augmented through scientific partnerships with Cellectis, CytoImmune, the Hebrew University of Jerusalem, INSERM, the New York Stem Cell Foundation and the University of California San Francisco (UCSF).

Cytovia has recently formed CytoLynx Therapeutics, a strategic partnership focused on research and development, manufacturing, and commercialization activities in Greater China and beyond.

Find out more at www.cytoviatx.com and follow us on Facebook, Twitter, LinkedIn, YouTube, and Instagram.

About GPC3
Glypican-3 (GPC3) is a cell-surface heparan sulfate proteoglycan. It is expressed in the liver and kidney of fetuses but is hardly expressed in adults, except in the placenta. However, it is highly expressed in HCC and other pediatric and adult solid tumors. GPC3 promotes Wnt-dependent cell proliferation and it has been strongly suggested that it is related to the malignant transformation of HCC, making it a promising target for cancer immunotherapy.

About CD38
Cluster of differentiation 38 (CD38) is a type II receptor membrane glycoprotein that plays a role in cell adhesion, migration, and signal transduction. Additionally, CD38 is an ectoenzyme involved in generation of nucleotide metabolites, such as ADP-Ribose that regulate cell metabolism. CD38 is highly expressed in multiple myeloma (MM) on malignant plasma cells and is also moderately expressed on normal T, B, NK and myeloid cells. Antibodies targeting CD38, such as daratumumab and isatuximab, are FDA approved for the treatment of MM as monotherapy and in combination.

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SOURCE Cytovia Therapeutics