Cytovia Therapeutics Presents New Data on TALEN® Gene-Edited iNK Cells and GPC3-Targeted Flex-NK™ Bispecific Antibodies at 2022 SITC Annual Meeting

AVENTURA, Fla. and NATICK, Mass., Nov. 7, 2022  /PRNewswire/ -- Cytovia Therapeutics, Inc., a biopharmaceutical company empowering natural killer (NK) cells to fight cancer through stem cell engineering and bispecific antibodies, today announced new preclinical data for its TALEN® gene-edited, iPSC-derived NK (iNK) cells and GPC3-targeted Flex-NK™ bispecific antibodies. The data will be presented at the Society for Immunotherapy of Cancer's 37^th Annual Meeting (SITC 2022) taking place in Boston, MA, and virtually November 8-12th, 2022.

"We're delighted to see further progress on our lead GPC3-targeted Flex-NK™ bispecific antibody program, with a pre-clinical package that supports clinical evaluation in 2023," commented Cytovia CEO Dr. Daniel Teper. "Additionally, we have now generated TALEN® gene-edited iNK cells and demonstrated enhanced antitumor activity. Cytovia is the first company to develop both its own immune cell engagers and natural killer cells, with the potential for enhanced efficacy in cancers with significant unmet medical needs such as Hepatocellular Carcinoma." 

The presentations show that Cytovia's allogeneic iNK cell product CYT-100 demonstrated increased time-dependent killing of Hep3B tumor spheroids and sensitivity to cytokine activation & expansion potential. Cytovia's GPC3-targeted bispecific antibody CYT-303 demonstrated potent ADCP and CDC against Hep3B tumors as well as Hep3B tumor spheroid and serial killing activities in the presence Cytovia's allogeneic iNK cell product CYT-100 and PBNKs in a dose-dependent manner. Preclinical pharmacokinetics and safety study results in monkeys fully support CYT-303 clinical development.

Cytovia's next-generation iNK cell platform combined with TALEN® gene-editing robustly and reliably generated single-cell edited iPSC clones, which were expanded and differentiated into functionally improved iNK cells. The data shows that iNK cells edited with an IL-15 knock-in and TGFβR2 knock-out result in enhanced antitumor activity. The editing and manufacturing process will enable clinical evaluation of these product candidates, both alone in combination with CYT-303.

Details about the SITC poster presentations are as follows:

Title: Preclinical Characterization of CYT-100 iPSC-Derived NK Cells Alone and in Combination with CYT-303 NK Cell Engager for Hepatocellular Carcinoma (HCC)
Abstract Number: 177
Time: 11/10/2022, 9:00 am - 9:00 pm EST
Location: Poster Hall

Title: TALEN®-Based Gene-Edited iPSC-Derived NK (iNK) Cells Demonstrate Enhanced Antitumor Activity
Abstract number: 323
Time: 11/10/2022, 9:00 am - 9:00 pm EST
Location: Poster Hall

Title: Non-Clinical Characterization of CYT-303 FLEX-NK™ Engager Antibody Supports Clinical Evaluation
Abstract Number: 1320
Time: 11/11/2022, 9:00 am - 9:00 pm EST
Location: Poster Hall

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 iPSC-derived NK-cell and Flex-NK™ bispecific antibody platforms. The company is developing three types of iPSC-derived NK (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. 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, the National Cancer Institute, and the University of California San Francisco (UCSF).

Cytovia has developed a strategic partnership with CytoLynx Therapeutics 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.

Hepatocellular carcinoma (HCC) is the most common primary liver malignancy and a leading cause of death worldwide, with 800,000 new cases diagnosed globally every year. The incidence in Asia is amongst the highest in the world (75%) with 400,000 in China alone. According to the American Cancer Society, it is estimated that there were close to 40,000 new HCC cases in the US in 2022, with almost 30,000 deaths from the disease, which continues to be on the rise. The major risk factors for HCC include non-alcoholic fatty liver disease (NAFLD), non-alcoholic steatohepatitis (NASH), chronic alcohol consumption, hepatitis B, and hepatitis C.

Despite advances in immunotherapy, with current treatment options including multi-kinase inhibitors (TKI) and checkpoint inhibitors, life expectancy for patients diagnosed with HCC remains very low. The disease is often diagnosed at an advanced stage, with a median survival of approximately 6 to 20 months following diagnosis, and a 5-year survival rate below 10% in the US. Fortunately, new options including cell therapy and bispecific antibodies offer promise towards a cure for liver cancer.

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