NY-338 / NAYA Therapeutics - LARVOL DELTA

NAYA Therapeutics Enters into Definitive Agreements to Regain Full Rights to Next-Generation Cancer Immunotherapies As It Advances Towards Clinical Milestones (ACCESSWIRE) - "NAYA Therapeutics...has regained its status as a privately-held company, separating from its recent merger with INVO Bioscience. This strategic decision enables NAYA Therapeutics to optimize its portfolio development strategy for value maximization and market attractiveness as it advances towards clinical development milestones for its portfolio of first and potential best-in-class candidates....Enrollment of HCC patients for Phase I/II clinical trials of NY-303, which shows unique potential to unlock the biology of checkpoint inhibitor non-responders, is expected in 2025. Next, we are aiming to initiate Phase I/II clinical trials of NY-500, positioned to be the first PD-1/VEGF to market in HCC, in 2026. Finally, NY-338, which shows a differentiated profile to daratumumab and T-cell engagers, is anticipated to commence enrolling patients in its Phase I/II clinical trials in multiple myeloma in 2026."

Commercial • Trial status • Hepatocellular Cancer • Multiple Myeloma

INVO Bioscience and NAYA Biosciences Close Merger, Combined Company to Operate as NAYA Biosciences (NASDAQ: NAYA) (GlobeNewswire) - "INVO Bioscience...announced it has closed its merger with NAYA Biosciences...The combined company expects to change its name to NAYA Biosciences and trade on the NASDAQ under the 'NAYA' ticker. The combined company will continue to operate the revenue-generating fertility business as well as expand its focus to the development of first-in-class clinical-stage assets in oncology and autoimmune diseases...'We are excited about the growth potential of NAYA as a public company with improved access to capital and shared resources to accelerate the development of its pipeline.'....Under the terms of the amended and restated merger agreement, INVO acquired 100% of the outstanding equity interests in NAYA by means of a reverse triangular merger of a wholly owned subsidiary of INVO with and into NAYA, with NAYA surviving as a wholly owned subsidiary of INVO (the 'Merger')."

M&A • Gastrointestinal Cancer • Hematological Malignancies • Hepatocellular Cancer • Multiple Myeloma • Oncology • Solid Tumor

CYT-338 NK Cell Engager Mutispecific Antibody Engagement of NKp46 Activation Receptor Overcomes Anti-CD38 Mab Mediated Fratricide of NK Cells and Accords Enhanced Cancer Immunotherapy (ASH 2023) - "The unique NKp46 activation mechanism provided by CYT-338 for reducing NK cell fratricide and maintaining NK cell levels together with the enhanced potency including reversal of NK cell dysfunction makes it an attractive best-in-class anti-CD38 therapeutic against MM compared to daratumumab. These results support the development of CYT-338 in both monotherapy and combination with other complementary immunotherapy agents being developed or approved for MM. A first-in-human Phase 1 study targeting patients with relapsed/refractory MM is in development in the U. S."

Hematological Malignancies • Multiple Myeloma • Oncology • ANXA5

NAYA Biosciences Announces Publication of New Data for its CD38-targeted Flex-NK Bispecific Antibody in the American Society of Hematology’s Blood Journal (PRNewswire) - "NAYA Biosciences Inc...announced that new data for its CD38-targeted Flex-NK™ Bispecific Antibody (NY-338, formerly CYT-338) for the treatment of Multiple Myeloma (MM) was published as an abstract in the 2023 American Society of Hematology's ...The data presented for NY-338 demonstrates a differentiated profile from daratumumab, with best-in-class potential, and supports the initiation of clinical trials in 2024...the conclusions show that the unique NKp46 activation mechanism provided by NY-338 for reducing NK cell fratricide and maintaining NK cell levels together with the enhanced potency including reversal of NK cell dysfunction makes it an attractive best-in-class anti-CD38 therapeutic against MM compared to daratumumab. These results support the development of CYT-338 in both monotherapy and combination with other complementary immunotherapy agents being developed or approved for MM....A first-in-human Phase 1 study targeting patients with...MM is in development in the U.S."

New P1 trial • Preclinical • Hematological Malignancies • Multiple Myeloma • Oncology

Biological Characterization and Differential Gene Expression Analysis of CYT-338 NK Cell Engager (NKE) Against CD38 Expressing Tumors Including Multiple Myeloma (MM) (ASH 2022) - "CYT-338 mediates potent anti- tumor activity against MM cell lines and patient tumors in the presence of effector cells (PBNK, iNK or MM patient NK cells). Evidence for additional CYT-338 effector function invoking macrophages and complement mediated MM tumor killing was obtained. Differential gene expression analysis provides mechanistic clues for a distinct cytotoxicity profile for CYT-338 from daratumumab that supports further evaluation of this potent anti-CD38 antibody."

IO biomarker • Hematological Malignancies • Multiple Myeloma • Oncology • CCL8 • CD2 • CD31 • CD38 • CD96 • CXCL1 • IFI35 • KIR3DL2 • PECAM1 • SDC1 • TIGIT

Cytovia Therapeutics Presents New Data on CD38-Targeted Flex-NK Bispecific Antibody at 2022 American Society of Hematology Annual Meeting (PRNewswire) - "Cytovia Inc...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....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....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."

Preclinical • Hematological Malignancies • Multiple Myeloma • Oncology

Cytovia Therapeutics To Present New Data on CD38 Flex-NK Cell Engager Bispecific Antibodies for Multiple Myeloma at 2022 ASH Annual Meeting (PRNewswire) - "Cytovia Therapeutics...announced today that it will be presenting new preclinical data for its CD38-targeted Flex-NK™ cell engager antibodies at the American Society of Hematology's 64th Annual Meeting (ASH 2022) taking place in New Orleans, LA, and virtually December 10-13th, 2022."

Preclinical • Hematological Malignancies • Multiple Myeloma • Oncology

NOVEL MULTIFUNCTIONAL TETRAVALENT CD38 NKP46 FLEX-NK ENGAGERS ACTIVELY TARGET AND KILL MULTIPLE MYELOMA CELLS (EHA 2022) - "Cytokine release assessment of CYT-338 in the human PBMC assay showed no evidence of cytokine release while high levels of cytokine release was observed with daratumumab, anti-CD28 (TGN1412) and CD3 antibody controls. Conclusion These results suggest that the CYT-338 engager has a favorable NK cell engager profile for targeting CD38 expressing multiple myeloma distinct from daratumumab."

Hematological Malignancies • Multiple Myeloma • Oncology

Cytovia Therapeutics presents antitumor activity of its CD38-Targeting Flex-NK Cell Engager antibody at EHA 2022 Congress (PRNewswire) - "CYT-338 pharmacokinetics and pharmacodynamics was studied using in vitro and in vivo multiple myeloma models. CYT-338 showed 3-fold higher dose-dependent binding to CD38 expressing MM cell lines compared to daratumumab. Epitope mapping studies indicated that CYT-338 binds to a different CD38 epitope compared to daratumumab. CYT-338 showed greater dose dependent NK cell redirected cytolysis, degranulation, and cytokine production against MM1S cells compared to daratumumab. CYT-338 showed minimal immune subset depletion, NK cell fratricide, and cytokine release compared to daratumumab in vitro. CYT-338 showed tumor growth inhibition and improved survival in in vivo models of multiple myeloma. These results support further development of CYT-338 as a therapeutic for targeting CD38 expressing multiple myeloma cells distinct from daratumumab."

Preclinical • Hematological Malignancies • Multiple Myeloma • Oncology

Cytovia Therapeutics to Present In Vivo Multiple Myeloma Data of its CD38-Targeting Flex-NK Cell Engager at EHA 2022 Congress (PRNewswire) - "CYT-338 is a tetravalent IgG1-like multifunctional NK cell engager antibody with a novel FLEX-linker that simultaneously binds CD38-expressing cells and NK cells via the activation receptor NKp46. The in vitro and in vivo activity of CYT-338 was studied in myeloma models. CYT-338 showed specific dose-dependent binding to CD38 expressing MM cells with ~ 2-fold higher mean fluorescence intensity than daratumumab."

Preclinical • Hematological Malignancies • Multiple Myeloma • Oncology

Cytovia Therapeutics Reports Preclinical Activity of its iPSC-derived NK (iNK) Cells and Flex-NK Cell Engagers at the 2022 AACR Annual Meeting (PRNewswire) - "Cytovia Therapeutics...announced today that the novel data it is presenting at the American Association of Cancer Research's annual meeting in New Orleans on April 12th, 2022 is now available on both the AACR and Cytovia websites....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."

Preclinical • Gastrointestinal Cancer • Hematological Malignancies • Hepatocellular Cancer • Liver Cancer • Multiple Myeloma • Oncology • Solid Tumor

Cytovia Therapeutics to Present Preclinical Data for iPSC-derived NK Cells and Flex-NK Engager Multispecific Antibodies at 2022 AACR Annual Meeting (GlobeNewswire) - "Cytovia Therapeutics...announced today that it will present two posters at the upcoming American Association for Cancer Research (AACR) Annual Meeting, to be held in New Orleans April 8-13.'We are pleased to present preclinical validation of our two proprietary technology platforms (unedited inducible pluripotent stem cell derived NK (iNK) cells and Flex-NK™ engager multispecific antibodies) as well as their potential synergy for the treatment of glypican-3 (GPC3) expressing tumors and CD38 expressing multiple myeloma"

Preclinical • Gastrointestinal Cancer • Hematological Malignancies • Hepatocellular Cancer • Multiple Myeloma • Oncology • Solid Tumor

Cytovia Therapeutics Files New Patents for its Natural Killer Cell Engager Multifunctional Antibodies (FLEX-NK) for the Treatment of Hematological and Solid Tumors (GlobeNewswire) - "Cytovia Therapeutics...announced today that it has filed two provisional composition of matter patent applications for its FLEX-NK® platform, consisting of NKp46-based NK cell engager multifunctional antibodies targeting GPC3 for the treatment of solid tumors, including Hepatocellular carcinoma, and CD38 for the treatment of hematological malignancies, including Multiple Myeloma...'Cytovia is committed to building a strong intellectual property portfolio to support further development of our first-in-class NK engager candidates, with clinical trials starting in the first half 2022'."

New trial • Patent • Gastrointestinal Cancer • Hematological Malignancies • Hepatocellular Cancer • Multiple Myeloma • Oncology • Solid Tumor