Taniraleucel (Celularity)

April 08, 2024 -- Celularity Inc. (NASDAQ: CELU) (“Celularity”), a biotechnology company developing placental-derived allogeneic cell therapies and advanced biomaterial products, announced today that it will present in vitro data from its investigational natural killer (NK) cell therapy programs at this year’s American Society of Gene and Cell Therapy (ASGCT) Annual Meeting. The preclinical data, which suggest that Celularity’s placenta-derived unmodified natural killer (NK) cells (CYNK-001) and genetically modified NK cells (CYNK-201) may serve as potent and selective senolytic agents for use in addressing age-related diseases, will be presented on May 9, 2024. Senescent cells are key drivers in the process of age-related cellular corruption at the heart of degenerative diseases, cancer and immuno-senescence (the progressive decline in immune function that occurs with age). These cells are unique in that they eventually stop multiplying but do not die; instead, they transform into the senescence associated secretory phenotype (SASP) and continue to release chemicals that can promote inflammation and tumor progression. Moreover, if not eliminated, these cells impair the normal regenerative process that restores function to organs and tissues. Celularity is building a broad technology platform that leverages the placenta’s unique immunobiology as a source of highly expandable, off-the-shelf cells, as well as a diverse portfolio of cell therapy investigational products to address age-related diseases, including cancer and degenerative diseases. Celularity believes these preclinical data demonstrate the potential of its assets to target and selectively remove damaged and abnormal cells expressing stress ligands, such as senescent, virally infected and cancer cells. “Celularity believes in the broad, but so far underrealized, potential of cell therapies. We continue to investigate cellular immunotherapy in age-related diseases, and these data are an important, continued step in demonstrating how our therapeutic assets may be used to eliminate senescent cells,” said Celularity’s CEO and Founder Dr. Robert Hariri, M.D., Ph.D. “Removing these aging, senescent cells, which we have termed ‘senoablation,’ may represent an important clinical approach to address the high societal cost of age-associated diseases and disabilities.” The ASGCT Annual Meeting will take place on May 7 through 11, 2024, in Baltimore, Md. Celularity Inc. (NASDAQ: CELU) is a regenerative medicine company developing and commercializing advanced biomaterial products and allogeneic, cryopreserved, placental-derived cell therapies, all derived from the postpartum placenta. Its therapeutic programs target aging-related diseases, including degenerative diseases, cancer, and immune disorders, using mesenchymal-like adherent stromal cells (MLASCs), T-cells engineered with CAR (CAR T-cells), and genetically modified and unmodified natural killer (NK) cells. Celularity believes that, by harnessing the placenta’s unique biology and ready availability, it can develop therapeutic solutions that address significant unmet global needs for effective, accessible, and affordable therapies. The content above comes from the network. if any infringement, please contact us to modify.

FLORHAM PARK, NJ, USA I April 27, 2023 I Celularity Inc. (Nasdaq: CELU), a biotechnology company developing placental-derived allogeneic cell therapies and biomaterial products, today announced preliminary results from its Phase 1 trial of CYNK-001, its investigational unmodified natural killer (NK) cell therapy in development for the treatment of R/R AML and MRD positive AML. Cohort 6B of the Phase 1 trial was comprised of patients with heavily pre-treated R/R AML who received a four-dose regimen consisting of 1.8 billion CYNK-001 cells per dose following enhanced lymphodepletion. Of these, two of four patients achieved an objective response, defined as a morphological leukemia-free state, or MLFS. Cohort 4A of the Phase 1 trial was comprised of patients with MRD positive AML. Of these, one of three patients achieved MRD negativity after treatment with a three-dose regimen consisting of 1.8 billion CYNK-001 cells per dose following enhanced lymphodepletion. Based on preliminary analysis of the Phase 1 trial data, this trial will now be closed to further enrollment as Celularity refines the trial design for subsequent studies with a next-generation NK product candidate. Celularity will continue to follow up with the trial participants. Treatment with CYNK-001 showed biological activity and was generally well-tolerated, with no dose-limiting toxicities observed with even the highest dose of CYNK-001. This trial also yielded important insights into the optimal approach to lymphodepletion, the role of IL-15 and IL-2 in NK-cell persistence, and the importance of baseline lymphoblast count in achieving better responses. A trend toward better outcomes was observed in patients with lower lymphoblast counts in R/R AML patients in the trial. “In a very challenging clinical environment of treatment-resistant disease, where the optimized cellular immunotherapy regimen has yet to be determined, this trial has given us valuable insight into our unmodified NK-cell therapy, CYNK-001, as well as how we should identify those AML patients who might benefit most from therapy and the best approach to modifying NK cells in order to optimize their efficacy in treating AML,” said Adrian Kilcoyne, M.D., M.P.H., M.B.A., Celularity’s Chief Medical Officer. “As we look to the future, these results, as well as recent important learnings from the broader scientific community, will support the development of CYNK-301, Celularity’s next-generation genetically modified NK cell therapy candidate in AML.” “Given the rapidly emerging landscape in NK-cell science overall, we felt it important to evaluate our unmodified CYNK-001 trial now to identify trends and opportunities and guide our next steps. This update from our CYNK-001 study, as well as relevant, recently published data from other trials, provides valuable insight into the optimal companion lymphodepletion and the role of IL-15 in the treatment of AML. It also will guide development of our next-generation NK cell candidate, CYNK-301,” said Robert J. Hariri, M.D., Ph.D., Celularity’s Chairman, Founder and CEO. “Our goal is to develop a fully allogeneic NK cell therapy for AML optimized to fit into combination therapies.” Data from the CYNK-001 Phase 1 trial will be submitted for inclusion at an upcoming scientific conference. About CYNK-001 CYNK-001 is a cryopreserved, allogeneic, off-the-shelf, natural killer (NK) cell therapy candidate derived from placental hematopoietic stem cells as a potential treatment option for various hematologic cancers, solid tumors, and infectious disease. NK cells are a unique class of immune cells, innately capable of targeting cancer cells and interacting with adaptive immunity. In preclinical studies, CYNK-001 demonstrated a range of biological activities expected of NK cells, including expression of perforin and granzyme B, cytolytic activity against hematological tumors and solid tumor cell lines, and secretion of immunomodulatory cytokines such as IFN-γ in the presence of tumor cells. CYNK-001 cells express NKG2D and CD94, as well as NK activating receptors DNAM1, NKp30, NKp46, and NKp44. CYNK-001 AML Trial Design The primary objective of the study is to determine the maximum tolerated dose or maximum planned dose of CYNK-001 and to assess the safety of multiple infusions of CYNK-001 administered using a flat, non-weight-based dose as assessed by the frequency and severity of adverse events (AE). About CYNK-301 CYNK-301 is a pre-clinical investigational next-generation chimeric antigen receptor-transduced natural killer (CAR-NK) cell therapy candidate that has the potential to overcome some of the challenges faced by NK therapies in treating R/R AML, including minimizing the burden of lymphodepletion while optimizing proliferation, persistence and efficacy. CYNK-301 incorporates membrane-bound IL-15 to enhance NK cell activation, proliferation and persistence, together with marrow homing and a targeted CAR to further enhance potential efficacy. About AML Leukemias are cancers that start in cells that would normally develop into different types of blood cells. Acute myeloid leukemia (AML) starts in the bone marrow (the soft inner part of certain bones, where new blood cells are made), but most often it quickly moves into the blood as well. It can sometimes spread to other parts of the body including the lymph nodes, liver, spleen, central nervous system (brain and spinal cord), and testicles. Most often, AML develops from cells that would turn into white blood cells (other than lymphocytes), but AML can develop in other types of blood-forming cells as well. About Celularity Celularity Inc. (Nasdaq: CELU) headquartered in Florham Park, N.J., is a biotechnology company leading the next evolution in cellular and regenerative medicine by developing allogeneic cryopreserved off-the-shelf placental-derived cell therapies, including therapeutic programs using mesenchymal-like adherent stromal cells (MLASCs), T-cells engineered with CAR (CAR T-cells), and genetically modified and unmodified natural killer (NK) cells targeting indications in autoimmune, infectious and degenerative diseases, and cancer. Celularity also develops, manufactures and commercializes innovative biomaterial products also derived from the postpartum placenta. Celularity believes that by harnessing the placenta’s unique biology and ready availability, it can develop therapeutic solutions that address significant unmet global needs for effective, accessible, and affordable therapies. To learn more, visit celularity.com SOURCE: Celularity