Celularity Presents Pre-Clinical and Clinical Data from its Allogeneic, Placental-Derived, Off-the-Shelf Cell Therapy Platform at the 2019 ASH Annual Meeting

  • Pre-clinical data demonstrates tumor-killing activity of novel allogeneic, placental-derived, genetically-modified NK- and T cell-based therapy programs
  • Long-term safety and efficacy results from the Phase 1 Study of PNK-007 demonstrate the feasibility of the first fully allogeneic, off-the-shelf investigational cell therapy in multiple myeloma

WARREN, N.J.–(BUSINESS WIRE)–Celularity, Inc. (“Celularity”), a clinical-stage cell therapeutics company focused on the development of innovative allogeneic cellular therapies derived from post partum human placentas, announced data introducing an extensive platform in genetically-modified NK- and T cell-based programs, and highlighting long-term safety and efficacy results from the Phase 1 study of PNK-007 in patients with multiple myeloma (MM). These data were announced at the 61st American Society of Hematology (ASH) Annual Meeting in Orlando, F.L.

In pre-clinical studies, Celularity’s allogeneic, placental-derived CD19 CAR T cell-based product candidate demonstrated in vivo anti-tumor efficacy in a lymphoma tumor model. Additionally, the Company’s CD38 CAR NK cell-based product candidate showed in vitro and in vivo anti-tumor activity against CD38+ lymphoma and multiple myeloma cell lines without any on-target, off-tumor effect. Moreover, the Company’s allogeneic, placental CD34+ cell-derived NK product candidate overexpressing a CD16 variant demonstrated its versatile combination potential with monoclonal antibodies to elicit in vitro and in vivo enhanced antibody-dependent cell mediated cytotoxicity (ADCC) function against lymphoma cell lines.

Results from a Phase 1 clinical study evaluating PNK-007 in patients with multiple myeloma demonstrated a single infusion of PNK-007 was well tolerated after autologous stem cell transplant (ASCT) for up to one year. PNK-007 is a first-generation investigational allogeneic off-the-shelf NK cell therapy. No serious adverse events (AEs) were attributable to PNK‐007, and no dose-limiting toxicity, graft-verse-host disease (GvHD), cytokine release syndrome (CRS), graft failure or graft rejection was observed.

“We are excited about the pre-clinical and clinical findings presented at ASH this year which adds to a growing body of evidence about the range and versatility of our allogeneic, off-the-shelf, placental-derived cell therapy platform, and its potential uses against a range of devastating cancers which today have limited treatment options,” said Robert Hariri, M.D., Ph.D., Founder, Chairman and CEO at Celularity. “At Celularity we believe the next evolution in immunotherapy for cancer demands scalable, high quality and economical solutions which provide fully allogeneic, off-the-shelf products. The Celularity technology platform can provide that solution. We look forward to rapidly advancing multiple placental-derived NK- and T cell-based product candidates with potential as more tolerable, more accessible immunotherapies.”

About PNK-007

PNK‐007 is the only allogeneic, off-the-shelf NK cell therapy being developed from placental hematopoietic stem cells as a potential treatment option for various hematologic cancers and solid tumors. NK cells are a unique class of immune cells, innately capable of targeting cancer cells and interacting with adaptive immunity. When derived from the placenta, these cells offer intrinsic safety and versatility, allowing potential use across a range of organs and tissues. PNK cells are currently being investigated as a treatment for acute myeloid leukemia (AML) and multiple myeloma (MM).

About Celularity

Celularity, headquartered in Warren, New Jersey, is a clinical-stage cell therapeutics company delivering transformative allogeneic cellular therapies, engineered from the postpartum human placenta. Using proprietary technology in combination with its IMPACT™ platform, Celularity is the only company harnessing the purity and versatility of placental derived cells to develop and manufacture innovative, highly scalable off-the-shelf treatments for patients with cancer, inflammatory and age-related diseases. To learn more, please visit www.celularity.com.

Forward-Looking Statements

This press release contains forward-looking statements. These forward-looking statements are based on expectations and are subject to certain factors, risks and uncertainties that may cause actual results, outcome of events, timing and performance to differ materially from those expressed or implied by such statements. The information contained in this press release is believed to be current as of the date of original issue. Celularity expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.


John R. Haines

EVP & Chief Administrative Officer

[email protected]

Sheryl Seapy

W2O Group

[email protected]

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