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, N.J., Sept. 26, 2022 (GLOBE NEWSWIRE) -- 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.

Study Citation

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.

About CYNK-001

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.

About Celularity

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 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.

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Forward-Looking Statements

This press release includes “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995, as well as within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts are “forward-looking statements,” including those relating to future events. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “believe,” “can,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “forecast,” “intends,” “may,” “might,” “outlook,” “plan,” “possible,” “potential,” “predict,” “project,” “seek,” “should,” “strive,” “target,” “will,” “would” and the negative of terms like these or other comparable terminology, and other words or terms of similar meaning. The forward-looking statements in this press release include statements regarding CYNK-001’s ability to offer a benefit to patients with IAV and other viral infections, including its use a treatment for infectious disease, as wellas Celularity’s plans for continued development of CYNK-001, among others. Many factors could cause actual results to differ materially from those described in these forward-looking statements, including but not limited to the inherent risks in biotechnological development, including with respect to the development of novel cellular therapies, and the clinical trial and regulatory approval process; and risks associated with Celularity’s current funding, as well as developments relating to Celularity’s competitors and industry, along with those risk factors set forth under the caption “Risk Factors” in Celularity’s annual report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 31, 2022, as amended on July 15, 2022 and other filings with the SEC. These risks and uncertainties may be amplified by the COVID- 19 pandemic, recent downturn in the U.S. capital markets and inflation. If any of these risks materialize or underlying assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that Celularity does not presently know, or that Celularity currently believes are immaterial, that could also cause actual results to differ from those contained in the forward-looking statements. In addition, these forward-looking statements reflect Celularity’s current expectations, plans, or forecasts of future events and views as of the date of this communication. Subsequent events and developments could cause assessments to change. Accordingly, forward-looking statements should not be relied upon as representing Celularity’s views as of any subsequent date, and Celularity undertakes no obligation to update forward-looking statements to reflect events or circumstances after the date hereof, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

Celularity Investor Contacts:

Carlos Ramirez SVP, Investor Relations

Celularity Inc.