Celularity Publishes New Data in Frontiers in Immunology Demonstrating Placental-derived Natural Killer Cells (CYNK) Recognized and Eliminated Influenza A Virus (IAV)-infected Cells In Vitro
Florham Park, NJ, – September 26, 2022 – Celularity Inc. (Nasdaq: CELU) (Celularity), a clinical-stage biotechnology company developing placental-derived allogeneic cell therapies, today announced publication of a study in Frontiers in Immunology describing the antiviral role of its placental-derived natural killer (NK) cells (CYNK) in IAV infections.
Celularity’s NK platform propagates placenta-derived hematopoietic stem cells (HSCs) and differentiates them into NK cells. Celularity’s therapeutic candidate CYNK-001 is an allogeneic placental-derived unmodified NK cell that is being developed as an off-the-shelf cryopreserved product. The study demonstrated how IAV sensitizes infected cells for targeting by CYNK-001 via multiple stress ligand and NK receptor activating pathways. Therapeutically, CYNK-001 may offer a benefit to patients with IAV and other viral infections, including its use a treatment for infectious disease for patients with limited treatment options. NK cells, an innate immune component, are important in defense against IAV infection by killing IAV-infected cells and producing cytokines as part of the innate immune response.
According to the U.S. Centers for Disease Control and Prevention (CDC), there were 35 million influenza illnesses in the United States during the 2019-2020 flu season resulting in 360,000 hospitalizations and 20,000 deaths. The CDC estimates influenza costs the United States USD 10.4 billion annually in direct costs for hospitalizations and outpatient visits for adults.
While yearly vaccines limit IAV’s spread, they do not prevent all infections and therapeutic treatments for patients who experience severe infection are limited. “Influenza is a major public health concern,” according to 2018 testimony by then U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, M.D., who added, “Influenza viruses are highly unpredictable. Each year, they can present new challenges for vaccine manufacturers, public health agencies, providers, and patients.”
Robert Hariri, M.D., Ph.D., Founder, Chairman and Chief Executive Officer of Celularity and a co-author of the study, said, “The data published by Celularity scientists demonstrate that CYNK possesses antiviral function against IAV and support continued investigation of adoptive NK cell therapies against viral infections.” Andrew Pecora, MD, FACP, CPE, co-Chairman of Celularity’s Scientific Advisory Board, said, “It is important for us to identify novel effective antiviral therapies that are capable of remaining active despite viral mutations, and NK cells such as CYNK may fill that need.”
An earlier publication by Celularity scientists demonstrated that CYNK-001 displays protective functions against IAV via its anti-inflammatory and immunomodulating activities, which leads to alleviation of disease burden and progression in a severe IAV-induced acute lung injury mice model (Hum. Vaccin. Immunother., 18(5):2055945).
CYNK-001 has also been investigated in non-IAV viral infections. In April 2020, Celularity received FDA clearance of an investigational new drug (IND) application for CYNK-001 in the treatment adults with COVID-19 infection. CYNK-001 is believed to be the first immunotherapy to have received this clearance by the FDA for treatment of COVID-19.
Gunasekaran M, Difiglia A, Fitzgerald J, Hariri R, van der Touw W and Mahlakõiv T (2022) Human placental hematopoietic stem cell-derived natural killer cells (CYNK) recognize and eliminate influenza A virus- infected cells. Front. Immunol. 13:900624. doi: 10.3389/fimmu.2022.900624.
Celularity’s lead therapeutic program based on its placental-derived unmodified NK cell type is CYNK-001, an allogeneic unmodified NK cell being developed as a treatment for hematologic malignancies, solid tumors, and infectious diseases. CYNK-001 is a cryopreserved allogeneic off-the-shelf cell therapy enriched for CD56+/CD3- NK cells expanded from human placental CD34+ cells. The safety and efficacy of CYNK-001 have not been established, and CYNK-001 has not been approved for any use by the FDA or any other analogous regulatory authority.
Celularity Inc. (Nasdaq: CELU) headquartered in Florham Park, N.J., is a clinical stage biotechnology company leading the next evolution in cellular medicine by developing allogeneic cryopreserved off-the-shelf placental-derived cell therapies, including therapeutic programs using unmodified natural killer (NK) cells, genetically modified NK cells, T-cells engineered with a CAR (CAR-T cells), and mesenchymal-like adherent stromal cells (ASCs). These therapeutic programs target indications in cancer, infectious and degenerative diseases. In addition, Celularity develops and manufactures innovative biomaterials 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.
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