Celularity Announces Phase 1 Data Showing That MLASC Therapy in Patients With Crohn’s Disease May Be a Therapeutic Option to Manage Inflammatory Bowel Diseases and Prevent Fistula Formation

2023-05-22

细胞疗法AACR会议临床结果ASH会议

Early-stage data presented at the 26th Annual Meeting of the American Society for Gene and Cell Therapy demonstrate that therapy with placental-derived mesenchymal-like adherent stem cells (MLASCs) results in alterations in gene and protein signatures associated with inflammation and fistula formation in patients with Crohn’s disease

Celularity continues to investigate its novel MLASC candidate, APPL-01,in Crohn’s disease

Celularity Inc.(Nasdaq: CELU) (“Celularity”), a biotechnology company developing placental-derived allogeneic cell therapies and biomaterial products, announced results from an exploratory analysis of Phase 1 data evaluating alterations in gene and protein signatures associated with reduced inflammation and fistula formation resulting from therapy with mesenchymal‐like adherent stromal cells (MLASCs) in adult patients with Crohn’s disease (CD). These data were presented at the 26th Annual Meeting of the American Society of Gene & Cell Therapy, which is being held May 16-20th in Los Angeles.

(Placental‐Derived Mesenchymal‐Like Adherent Stromal Cell (MLASC) Therapy Results in Alterations in Gene and Protein Signatures Associated with Inflammation and Fistula Formation in Patients with Crohn’s Disease, Kilcoyne, et al., Poster Session 1111.)

In this study, two patient groups were evaluated: patients who responded to MLASC therapy (n=12) and patients who received placebo (n=12). For each of the 24 patients, mRNA gene expression data and proteomics data were provided at early pre‐treatment, at pre‐treatment baseline, at early post‐treatment) and at later post‐treatment.

The results of this analysis showed that in CD, MLASC treatment resulted in alterations in gene and protein signatures associated with inflammation and fistula formation. This analysis provides some insight into pathways associated with severity of CD and suggests that gene and protein profiling of blood plasma might be useful for assessing disease severity and treatment response. It also suggests that MLASCs may be a potential therapeutic option in both managing the disease but also, importantly, in limiting fistula formation.

“Crohn’s disease is a devastating condition for patients, and we believe these data help us begin to see the potential role that cell therapy may play in its treatment,” said Robert J. Hariri, M.D., Ph.D., Celularity’s CEO, Chairman and Founder. “Furthermore, these results validate our decision to progress our novel genetically modified allogeneic placental-derived MLASC, APPL-01, in Crohn’s disease, where this cell therapy candidate has the potential to make a significant difference. Celularity’s unique technology platform is grounded in our use of the post-partum placenta as the source of cells and biomaterials, enabling independent but complementary product opportunities in cellular and regenerative medicine. We’re moving forward with confidence to assess the potential immunomodulatory and pro-regenerative therapeutic benefits of MLASCs as we advance the development of therapeutic options for patients.”

About Crohn’s Disease

Crohn’s disease (CD) is a chronic idiopathic inflammatory bowel disease. The goal of treatment is to control the inflammation and induce a clinical remission and reduce the incidence of the associated fistula formation, which has proved challenging. Fistulae, caused by epithelial‐to‐mesenchymal transition (EMT), occur in up to 50 percent of patients and often require surgery. Transforming growth factor‐beta (TGF‐β) is the most important inducer of EMT as it regulates invasion via loss of epithelial and gain of mesenchymal markers.

About MLASCs

MLASC are proprietary culture expanded, undifferentiated mesenchymal‐like adherent stromal cells derived from full term placental tissue that have immuno‐modulatory and anti‐inflammatory properties. Depending on the environment in which they are located, MLASCs secrete numerous factors and thus act paracrine and autocrine, performing trophic, immunomodulatory, and antimicrobial effects.

About Celularity

Celularity Inc. (Nasdaq: CELU) headquartered in Florham Park, N.J., is a biotechnology company leading the next evolution in cellular and regenerative medicine by developing allogeneic cryopreserved off-the-shelf placental-derived cell therapies, including therapeutic programs using mesenchymal-like adherent stromal cells (MLASCs), T-cells engineered with CAR (CAR T-cells), and genetically modified and unmodified natural killer (NK) cells. These therapeutic programs target indications in autoimmune, infectious and degenerative diseases, and cancer. In addition, Celularity develops, manufactures, and commercializes innovative biomaterial products 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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