Celularity Announces Results of Phase 1 Studies of PNK-007, an Allogeneic, Off-the-Shelf, Placental-Derived Cell Therapy, at AACR Annual Meeting 2019

March 29, 2019 Off By BusinessWire

First-ever Results to be Presented from Multiple Studies Evaluating
Company’s PNK Allogeneic Cell Therapy in Patients with Acute Myeloid
Leukemia and Multiple Myeloma

WARREN, N.J.–(BUSINESS WIRE)–Celularity, Inc. (“Celularity” or the “Company”), a clinical-stage cell
therapeutics company developing allogeneic cellular therapies harnessed
from human placentas, today announced results from two Phase 1 studies
of PNK-007, an investigational allogeneic off-the-shelf natural killer
(NK) cell therapy, in patients with acute myeloid leukemia (AML) and in
patients with multiple myeloma (MM).

Translational immunotherapy study results from the Company’s
late-breaking presentation in AML showed that PNK-007 persisted in the
blood and marrow for up to one month, providing evidence of expansion
and further maturation of the PNK-007 in HLA (Human Leukocyte Antigen)
unmatched patients.

“Our first Phase 1 studies of PNK-007 in AML and MM demonstrated an
encouraging safety profile, and in MM specifically, we monitored minimal
residual disease (MRD) status in patients as an exploratory efficacy
endpoint,” said Xiaokui Zhang, Ph.D., Executive Vice President and Chief
Scientific Officer. “Based on these studies, we believe PNK-007 offers a
novel modality to improve the treatment outcome for patients, and
further validates Celularity’s proprietary IMPACT™ platform in a
clinical setting,” added Nassir Habboubi, M.D., Executive Vice President
and Chief Medical Officer.

The Company plans to initiate a Phase 1b/2a study in AML patients and a
Phase 2 study in MM patients during the second half of 2019. These
studies will investigate the safety and efficacy of CYNK-001, the
cryopreserved successor product to PNK-007.

“The positive results from these first-in-human studies of PNK-007
confirm our unique approach of deriving cell therapy from placental
cells, and suggest this investigational immunotherapy has the potential
to become an important new immuno-oncology option for patients with
serious blood cancers, including those who were heavily pretreated and
failed previous lines of therapy, or who have undergone autologous stem
cell transplant,” said Robert J. Hariri, M.D., Ph.D., Celularity’s
Founder, Chairman and CEO. “Given the challenges associated with
currently available patient-sourced and adult donor cell therapies, we
believe there is an important need for next-generation, allogeneic,
off-the-shelf immunotherapies that are more tolerable, accessible, and
affordable to patients and the healthcare system.”

In addition to results from the PNK-007 studies, Celularity will also
present pre-clinical data in an oral session evaluating its proprietary
genetically-modified allogeneic NK cells (GM-NK) derived from human
placental CD34+ progenitors for the treatment of a broad spectrum of
blood cancers and solid tumor cancers. Results from early pre-clinical
studies showed that this genetic modification of PNK led to a two to
four-fold increase in anti-tumor activity against a range of hematologic
and solid cancer cell lines as well as primary tumor cells.

“We look forward to advancing this important program, as it will pave
the way for genetically modified NK cell therapy as another option for
cancer patients,” Dr. Hariri continued.

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 CYNK-001
CYNK-001 is the only cryopreserved,
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.

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^TMplatform, Celularity is the only company
harnessing the versatility of placenta-derived cells to develop and
manufacture innovative and 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.