Commercial Biomaterials Business, Degenerative Disease Programs Continue to Gather Momentum
Animal and Preclinical Data Support Significant Opportunities in Osteoarthritis for Biomaterial-Cell Therapy Combination Approach
“Celularity’s novel business model leverages a diversified portfolio of therapeutic technologies all derived from a single source material — the post-partum placenta. As the Company that pioneered the use of placental-derived stem, progenitor and immune cells, and as an innovator in placental biomaterial product development, Celularity’s business model is to generate commercial revenue from both cellular and regenerative therapeutics, including technologies that combine cellular and regenerative therapeutics. Already this year, we’ve been presented with a series of unique opportunities, and the environment continues to be extremely favorable,” said
Advanced Biomaterial Products
Celularity’s advanced biomaterial products include:
- Biovance®, a decellularized, dehydrated human amniotic membrane derived from the placenta of a healthy, full-term pregnancy. Biovance® is an intact, extracellular matrix structure that is indicated for use in
the United States as a natural scaffold to support the body’s wound healing process. - Biovance® 3L and Biovance® 3L Ocular, tri-layer human amniotic membrane products focused on the surgical and ocular markets and available in both sheet and disk form.
- Interfyl®, a human connective tissue matrix derived from the placenta of a healthy, full-term pregnancy. It is indicated for use in
the United States to replace or supplement damaged or inadequate integumental tissue resulting from wounds, trauma, or surgery. - CentaFlex®, a decellularized human placental matrix derived from the umbilical cord that is indicated for use in
the United States as a surgical covering, wrap or barrier to protect and support the repair of damaged tissue.
Opportunities in Osteoarthritis for Advanced Biomaterials and
Combination Biomaterial-Cell Therapies
In a preclinical in vivo study of Celularity’s placental extracellular matrix (ECM) product candidate in a joint destructive, acid-derived osteoarthritis (OA) model, a 31-40 percent improvement of chondrogenic properties at Day 60 was observed. Additionally, a reduction in the number of pro-inflammatory cytokines at Day 60, including Monocyte Chemoattractant Protein-1 (MCP-1), was observed.
Celularity’s initial focus is osteoarthritis of the knee, which accounts for 80 percent of the total OA burden worldwide according to the
Degenerative Diseases
- Crohn’s Disease.
Celularity previously announced its re-analysis of long-term follow-up data from three legacy Phase 1, Phase 1b/2a and Phase 1b studies of its legacy placental-derived mesenchymal-like adherent stromal cell (MLASC) therapy in patients with moderate-to-severe Crohn’s disease, which showed clinically meaningful and durable benefit for up to two years in the limited number of patients studied. The Company will continue to assess MLASC therapy for this condition using its next-generation MLASC therapeutic candidate, as well as pursuing development partnering opportunities. - Fasculoscapulohumeral Muscular Dystrophy (FSHD). FSHD is one of the most common genetically defined progressive muscular dystrophies. The Company will investigate its next-generation placental-derived MLASCs with their anti-inflammatory, immune-modulatory, and regenerative properties to potentially bring a novel treatment approach to FSHD. Importantly, FSHD also serves as a model for potential age-related loss of muscle mass.
T-cell Programs
- Hematologic Cancers and Solid Tumors.
Celularity will continue to develop CYCART-19, an allogeneic placental-derived T-cell therapy engineered with a CD19 chimeric antigen receptor (CAR) with T-cell receptor (TCR) knockout that has demonstrated potent anti-tumor activity both in vitro and in vivo. The Company continues to work to address FDA questions on its IND and anticipates commencing its Phase 1 trial in 2023. Celularity will continue to partner withImugene Ltd. (ASX: IMU) to utilize its novel onCARlytics (CF33-CD19) technology to prime solid tumor cells to express CD19, making them a target for CD19 CAR-T therapy.Celularity also will continue to advance other select innovative T-cell programs through preclinical development.
Other Oncology Programs
- Acute Myeloid Leukemia (AML).
Celularity continues to review emerging cohort data from its CYNK-001 unmodified natural killer cell trial for the treatment of Relapsed Refractory (rrAML) and minimal resistant disease AML. This trial has progressed through to Cohort 6b in patients with rrAML and continues to successfully achieve its objective of evaluating safety and biological activity, understanding the optimal lymphodepletion regimen and the roles of both IL-15 and IL-2 in achieving NK-Cell persistence. The trial data also continue to provide important insights which will enable us to optimize our genetically modified NK cell and CAR-NK platforms moving forward to address the significant unmet medical need for patients. - Glioblastoma Multiforme (GBM).
Celularity has worked with investigators to gain further insight into the optimal approach for utilizing cell therapies in the management of GBM.Celularity has determined not to pursue this trial, which uses only unmodified NK cells, at this time. The Company will continue to strategically enhance its NK platform, including modified and unmodified NK cells, to address some of the very significant challenges posed in treating this devastating disease. - HER2+ Gastric Cancer.
Celularity continues to believe that genetically modified NK cells will be an important option to improve the current standard of care. However, given the Company’s strategic review, it will deprioritize this study while it continues to optimize its modified and unmodified NK cell platform.
As part of Celularity’s reprioritization efforts, the Company has notified a substantial portion of its workforce that their employment may be impacted in order to achieve its strategic objectives. While
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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 the effects of recent distribution partnerships on Celularity’s business objectives and its ability to establish a presence and operate in the
Celularity Media Contact:
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Celularity Investor Contact:
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