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

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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 IMPACTTM platform, 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.

Contacts

Investors
John R. Haines
EVP, Chief Administrative Officer & Corporate Secretary
john.haines@celularity.com

Media
Christiana Pascale
W2O Group
cpascale@w2ogroup.com

First Clinical Results Evaluating Allogeneic, Off-The-Shelf, Placental-Derived Cells to be Presented by Celularity at 2019 AACR Annual Meeting

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WARREN, N.J.–(BUSINESS WIRE)–Celularity, Inc., a clinical-stage cell therapeutics company developing allogeneic cellular therapies harnessed from human placentas, today announced it will present first-ever clinical and pre-clinical results from its comprehensive placental hematopoietic stem cell derived natural killer (PNK) cells oncology program at the 2019 American Association for Cancer Research (AACR) Annual Meeting being held from March 29 – April 3, 2019 in Atlanta, Georgia. Investigational PNK-007 is a fully allogeneic, off-the-shelf cell therapy product developed as a potential treatment option for various hematological cancers and solid tumors.

“Combining the unique biologic properties of placental-derived cells with our proprietary IMPACT™ cell therapy development platform, Celularity is working to develop next-generation, off-the-shelf immunotherapies that could be safer, more accessible, and more affordable than currently available approaches,” said Robert J. Hariri, M.D., Ph.D., Celularity’s Founder, Chairman and CEO. “These data are an important and validating milestone of our IMPACT™ platform. We believe the emergent positive profile marks the unveiling of a potential new immuno-oncology option, one capable of turning cells from this abundant, highly scalable and versatile source—the placenta leftover after a healthy birth—into meaningful therapies for patients with cancer and other serious diseases.”

Data highlights at AACR include:

Presentation (Abstract #CT108): A Phase I study of PNK‐007, allogeneic, off the shelf NK cell, post autologous transplant in multiple myeloma. Monday, April 1, 1:00pm – 5:00pm EST. Location: Georgia World Congress Center, Exhibit Hall B, Poster Board Number 7.

Presentation (Abstract #CT079): A Phase 1 Study of PNK-007, Allogeneic, Off the Shelf NK Cell in Relapsed/Refractory AML. Monday, April 1, 1:00pm – 5:00pm EST. Location: Georgia World Congress Center, Exhibit Hall B, Poster Board Number 3.

Poster Presentation (Abstract #LB-070): Immune monitoring of PNK-007, an allogeneic, off the shelf NK cell in a Phase I study of acute myeloid leukemia. W. van der Touw, Ph.D. Monday, April 1, 8:00am – 12:00pm EST. Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 41, Poster Board Number 15.

Oral Presentation (Abstract #5318): Genetic modification potentiates the anti-tumor activity of human placental CD34+ cells-derived NK cells. J. Li, Ph.D. Sunday, March 31, 3:00pm – 5:00pm EST. Location: Georgia World Congress Center, Room B405.

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 hematological 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 for patients with 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 IMPACTTM platform, Celularity is the only company harnessing the purity and 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.

Contacts

Investors
John Haines
EVP, Chief Administrative Officer & Corporate Secretary
John.haines@celularity.com

Media
Jon Pappas
W2O pure
jpappas@purecommunications.com

Celularity Acquires CariCord, Inc., Adds Important Biosourcing Assets, Strategic Relationship with the University of Colorado’s ClinImmune Labs

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WARREN, N.J., Aug. 31, 2018 /PRNewswire/ — Celularity, an allogeneic immuno-oncology and placental cell therapeutics company, today announced it entered into a definitive agreement to acquire CariCord, the family cord blood bank established by the University of Colorado and ClinImmune Labs. Through its exclusive ClinImmune Labs relationship, CariCord is the first, and so far the only family cord blood bank to operate inside a FDA Licensed Laboratory. ClinImmune Labs is an academic component of the School of Medicine at the University of Colorado at Denver and Health Sciences Center. Financial details of the transaction were not disclosed.

The acquisition will advance Celularity as an innovation leader through CariCord’s strategic relationship with Clinimmune Labs, which operates the University of Colorado Cord Blood Bank (UCCBB), an AABB-accredited, FDA-licensed allogeneic cord blood bank supporting stem cell transplantation worldwide.

“CariCord’s national reputation, coupled with ClinImmune’s world-class translational research and cell manufacturing capabilities, will add important building blocks in our continued growth and expansion,” said Robert J. Hariri, M.D., Ph.D., Celularity’s Founder and CEO. “Celularity proprietary technology recovers critical cell populations and tissues from post partum placentas, which is fundamental to our transformative immuno-oncology, cell therapeutics, and functional regeneration applications. Now CariCord, in combination with our legacy business, LifebankUSA, will connect families to many of these same platform technologies, to create their own family bank from their newborn’s placenta and cord blood after birth.”

“CariCord and Celularity share a vision of a future in which saving the abundant resources in a newborn’s placenta after birth is the norm, sparking a sea change in the way we think about longevity and health span,” said Calvin Cole, President and CEO of CariCord. “We’re immensely excited to become a part of Celularity’s transformation of immuno-oncology and cell therapeutics.”

The acquisition, which is expected to close during the Fourth Quarter 2018, is subject to regulatory approval and customary closing conditions. Until this is complete, each company will continue to operate independently.

About Celularity, Inc.
Celularity (www.celularity.com), based in Warren, New Jersey, is a biotechnology innovation leader, harnessing the power of placental-derived cell populations to deliver transformative, allogeneic off-the-shelf immunotherapies and cell therapies for cancer and other serious diseases. Visit www.celularity.com to learn more about Celularity.

About CariCord, Inc:
CariCord, Inc., based in Aurora, Colorado, is a leading family cord blood bank established in 2013 by ClinImmune Labs and the University of Colorado. It is associated with the University of Colorado Cord Blood Bank, the United States’ second-largest allogeneic cord blood bank. For more information please visit www.CariCord.com.

Legal Notice Regarding Forward-Looking Statements:
This release contains forward-looking statements. Forward-looking statements are generally identifiable by the use of words like “may,” “will,” “should,” “could,” “expect,” “anticipate,” “estimate,” “believe,” “intend,” or “project” or the negative of these words or other variations on these words or comparable terminology. The reader is cautioned not to put undue reliance on these forward-looking statements, as these statements are subject to numerous factors and uncertainties outside of our control that can make such statements untrue, including, but not limited to, the asset purchase transaction not being timely completed, if completed at all; prior to the completion of the asset purchase transaction, CariCord’s or Celularity’s respective businesses experiencing disruptions due to transaction-related uncertainty or other factors making it more difficult to maintain relationships with employees, business partners or governmental entities; and the parties being unable to successfully implement integration strategies or realize the anticipated benefits of the acquisition, including the possibility that the expected synergies and cost reductions from the proposed acquisition will not be realized or will not be realized within the expected time period. We undertake no obligation to publicly update or revise our forward- looking statements as a result of new information, future events or otherwise.

Contact: celularity@factorypr.com

SOURCE Celularity

Celularity Announces $250M in Funding to Deliver Treatments for Cancer, Inflammatory and Degenerative Diseases, and Functional Regeneration

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WARREN, N.J., Feb. 15, 2018 /PRNewswire/ — Celularity has been created through the contribution and acquisition of extensive intellectual property, clinical-stage assets, basic and clinical research, and product development expertise including:

  • First proprietary allogeneic “off-the-shelf” immunotherapeutic platform
  • Proprietary clinical stage Placental Natural Killer (PNK) Cell Program
  • IND-ready CD38 CAR-T program
  • Innovative allogeneic CD38 CAR NK program
  • Phase 3-ready placental adherent cell products for serious Crohn’s Disease
  • Sorrento Therapeutics G-MAB™ Library of 50+ fully-human antibody-CAR constructs
  • Unparalleled IP position: 800+ issued patents in cell therapy and regenerative medicine; dominating position worldwide for placental stem cells
  • World-class cell and biomaterials manufacturing capabilities
  • Commercial-stage functional regeneration products Biovance® and Interfyl®, and late-stage pipeline assets across broad disease indications
  • LifeBankUSA, pioneering stem cell biobanking business with two decades’ operating expertise

Celularity, a biotechnology company founded by stem cell pioneer Robert Hariri, MD, PhD, is announcing the formation of the company with $250M in funding with contributions from Celgene (NSDQ: CELG), United Therapeutics (NSDQ: UTHR), Sorrento Therapeutics (NSDQ: SRNE), Human Longevity, Inc., Genting Group, the Dreyfus Family Office, Section 32, and Heritage Group. Celularity is co-founded with Vice Chairman, Peter H. Diamandis, MD, alongside Dr. Hariri, and has a board of industry luminaries including Vice Chairman, John Sculley, formerly of Apple and Pepsi-Cola, Bill Maris of Section 32 (previously founder and CEO of Google Ventures), and Andrew von Eschenbach, former commissioner of the US Food and Drug Administration.

Celularity sources, develops, and deploys transformative therapies derived from the placenta for treatment of complex medical conditions including hematological and solid tumors, autoimmune disease, diabetes, as well as degenerative effects of aging. By combining synergistic assets from Celgene, United Therapeutics, Sorrento Therapeutics, and Human Longevity Inc., Celularity is accelerating the development of cell and tissue regenerative products to address unmet medical needs. These treatments have the potential to reverse life-threatening diseases and extend the healthy human lifespan.

“My goal is to make it so the next generation grows up in a world where cancer is managed just like the common cold, and the body’s natural regenerative engine remains empowered throughout our lives,” said Dr. Hariri, Founder, Chairman and Chief Executive Officer of Celularity. “Celularity is a new biotechnology company model founded to harness the placenta as a platform for discovery and therapeutics, ultimately with a goal of amplifying the body’s ability to fight disease, restore function and extend the healthy lifespan. It is my vision that the cellular medicines we derive from the placenta will lead to abundant and affordable treatments.”

Celularity has assembled an industry-leading intellectual property portfolio of more than 800 issued patents, which attain a dominating position around placental-derived stem and progenitor cells. Celularity is also the first to own and deploy the full value chain ranging from sourcing placental stem cells to delivering patient treatment. The company is built on three key pillars: Cell Therapy, Functional Regeneration, and Biosourcing:

  • Cell Therapy: Celularity has developed five clinical stage cell therapy candidates currently being evaluated for cancer, and immunological and degenerative diseases
  • Functional Regeneration: Celularity is addressing serious wounds, burns, orthopedic, and other surgical indications including reconstructive and aesthetic applications with a broad range of placental biomaterials. Derived from placental tissue, Celularity’s BIOVANCE® and Interfyl® were the first biomaterial products introduced to the market to enhance the body’s regenerative processes
  • Biosourcing: Celularity owns and operates LifeBankUSA, the world’s only repository that allows families to bank their newborn’s placental cells and biomaterials for future therapeutic and regenerative use

Celularity is the only company with an allogeneic placental cell platform. Placental stem cells are uniquely immunoprivileged, therefore treatments do not require cells to be engineered or matched for each individual patient. Celularity is focused on this highly-scalable platform of technology to optimize economics and access to these cutting-edge therapies, including immuno-oncology. These placental stem cells allow for unprecedented scalability for Celularity’s CAR-T and CAR-NK platforms.

“Celularity’s technology has the potential to augment human immunity and longevity,” said Dr. Peter H. Diamandis, Co-Founder and Vice-Chairman of Celularity. “The company’s ultimate vision is to make 100 years old the new 60, providing people with maximal cognition, mobility and aesthetics as they age. The 20 years of science, research, and intellectual property pioneered by Dr. Bob Hariri has the highest potential to become the cornerstone for this vision.”

Andrew von Eschenbach, MD, among the founding members of the Celularity Board of Directors, and the former United States Food and Drug Administration (FDA) Commissioner and Director of the National Cancer Institute, said, “The pioneering work of Celularity founder Bob Hariri has unleashed the unique properties of placental derived stem cells, which have renewed hope for creating safe and effective therapies for the most challenging degenerative diseases.” Dr. von Eschenbach added, “Celularity, with its focus on accelerating innovation in regenerative medicine, can become the leading catalyst for cell therapy to address many of the world’s unmet medical needs.”

“Our investment in Celularity brings together its proprietary allogeneic placental platform and Sorrento’s best in class CAR-T products and cGMP manufacturing capabilities,” said Henry Ji, another founding member of Celularity’s Board of Directors and Chairman, President and CEO of Sorrento Therapeutics. “Together, we can deliver these health solutions at scale to treat exponentially more people than we ever thought possible.”

More information can be found by visiting www.celularity.com.

About Celularity:                 
Celularity (www.celularity.com) is a biotechnology company that harnesses the power of placenta-derived cells and tissue to create regenerative health solutions. These therapies have the potential to rid the body of life threatening disease and ultimately extend the human lifespan. Celularity’s intellectual property and research portfolio consists of 800 patents as well as pre-clinical and clinical assets, including CAR constructs for allogeneic CAR-T/NK products, licenses to 100+ immunotherapy assets, and commercial stage biosourcing and functional regeneration businesses.

Media Contact:
FACTORY PR
celularity@factorypr.com 
212-941-9394

SOURCE Celularity