AVENTURA, FL and NATICK, MA, USA I December 9, 2022 I Cytovia Inc.(DBA Cytovia Therapeutics, Inc.), a biopharmaceutical company focused on unlocking the power of natural killer (NK) cell therapeutics through bispecific antibodies and TALEN® gene-edited, iPSC-derived NK (iNK) cells, today announced new preclinical data for its CD38-targeted Flex-NK™ bispecific antibody at the American Society of Hematology’s 64th Annual Meeting (ASH 2022) taking place in New Orleans, LA, and virtually December 10-13th, 2022.

“We’re delighted to see further progress on our CD38-targeted Flex-NK™ bispecific antibody program, with a pre-clinical package that supports clinical evaluation in 2023,” commented Cytovia CEO Dr. Daniel Teper. “The data presented at ASH suggests that CYT-338, our CD38-targeted Flex-NK™ Bispecific Antibody, has a differentiated profile compared to daratumumab, the leading CD38-targeted monoclonal antibody and that CYT-338 may have the ability to overcome NK cell exhaustion and dysfunction.

We believe that by redirecting and activating NK cells to kill myeloma cells, bispecific antibodies have the potential to offer new options for patients not responding to first lines of treatment.”

Details about the ASH poster presentation are as follows:

Title: Biological Characterization and Differential Gene Expression Analysis of CYT-338 NK Cell Engager (NKE) Against Multiple Myeloma (MM) Tumors
Abstract Number: 3142
Session Name: 651. Multiple Myeloma and Plasma Cell Dyscrasias: Basic and Translational: Poster II
Date and Time: Sunday, December 11th, 2022 (6-8PM CST)
Location: Ernest N. Morial Convention Center, Hall D, New Orleans, LA

The poster is available online on both the Cytovia Therapeutics and American Society of Hematology websites.

The presentations show that Cytovia’s bispecific antibody CYT-338 demonstrated it could increase the ability of both its iPSC-derived (iNK) and Peripheral Blood (PBNK) Natural Killer cells to kill Multiple Myeloma (MM) tumor spheroids in a dose dependent manner that peaked 2-3 days following of initiation of killing. Serial killing activity of iNKs and PBNKs against MM tumors declined over additional rounds of killing but the combination with CYT-338 maintained serial killing at high levels suggesting the ability of CYT-338 to overcome NK cell exhaustion.

CYT-338 showed potent dose dependent ADCP against MM tumors indicating an additional effector cell pathway targeted by CYT-338 and dose dependent CDC against MM tumors demonstrating an additional cytotoxicity pathway targeted by CYT-338. Gene expression analysis of autologous patient NK cell and MM co-cultures treated with CYT-338 or daratumumab showed similar and distinct gene expression profiles. The distinct lymphocyte activation gene expression pathways activated by CYT-338 may contribute to the increased NK cell redirected cytotoxicity of MM tumors compared to daratumumab. The above results support further development of CYT-338 as a potent NK cell engager that could also activate macrophages and complement to mediate its anti MM tumor effects.

The data has been developed in collaboration with Lynx Bio, a clinical-stage biotechnology company combining physiologically relevant suspension cell co-culture assays, automated microfluidics, and deep learning analytics with the goal of rapidly advancing drug candidates in oncology and bringing personalized cancer treatments to patients.

About Multiple Myeloma 
Multiple Myeloma is a currently incurable cancer, affecting a type of white blood cell known as plasma cells. It leads to an accumulation of tumor cells in the bone marrow, rapidly outnumbering healthy blood cells. Instead of producing beneficial antibodies, cancerous cells release abnormal proteins causing several complications. According to the World Cancer Research Fund, Multiple Myeloma is the 3rd most common blood cancer, with 176,404 new cases worldwide in 2020 including more than 50,000 cases in Europe, 35,318 in the US, and 31,890 in Eastern Asia. There have been more than 117,000 deaths worldwide in 2020 with a median overall survival of less than 12 month in patients refractory to standard of care.

Initial treatment comprises of a combination of different biological and targeted chemotherapies, and bone marrow transplants for eligible patients. Immunotherapy with monoclonal antibodies against CD38 such as daratumumab and isatuximab are the most rapidly growing treatment option.  Antibody-drug conjugates and Chimeric antigen receptor (CAR) T-cell therapy targeting BCMA and T-Cell Engager Bispecific Antibodies have recently been approved for Multiple Myeloma but high cost, limited product supply and the need for strict safety monitoring may limit their use.

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 iPSC-derived Natural Killer (iNK) cell and Flex-NK™ bispecific antibody platforms. The company is developing three types of 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 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 FacebookTwitterLinkedInYouTube, and Instagram.

SOURCE: Cytovia Therapeutics