Data published online in the journal Cytotherapy demonstrate that CRISPR-mediated tissue factor gene knockout (TFKO) in allogeneic stromal cells (ASCs) leads to significantly lower tissue factor (TF) expression, activity, and thrombotic effects, providing a feasible strategy potentially to improve the safety of ASC-based cell therapy FLORHAM PARK, N.J., June 01, 2023 (GLOBE NEWSWIRE) -- Celularity Inc. (Nasdaq: CELU) (“Celularity”), a biotechnology company developing placental-derived allogeneic cell therapies and biomaterial products, announced today the online publication of preclinical data in Cytotherapy, the official journal of the International Society of Cell and Gene Therapy (ISCT). The paper, “Characterization of CRISPR/Cas9-edited human placental allogenic stromal cells with low tissue factor expression and reduced thrombotic effects,” (Huang, et al.)1 examined methods to reduce the tissue factor expressed by allogeneic stromal cells (ASCs), which has been regarded as a safety concern in clinical applications as it may trigger thrombosis when ASCs are administered intravenously. Thrombogenic risk has been identified in association with intravenous administration of mesenchymal stem cells (MSCs), both allogeneic and autologous. These cells express procoagulant activity linked to the expression of tissue factor that, when in contact with blood, initiates coagulation. Mitigating thrombotic risk is of significant clinical importance.2 Placenta ASCs are MSC-like cells, cultured and expanded from full-term human placenta with a defined phenotype, demonstrate immunomodulation and pro-regenerative activities and have been investigated in clinical trials of Crohn’s disease, diabetic foot ulcer, and multiple sclerosis. The authors characterized and compared in vitro and in vivo activities of ASCs with CRISPR/Cas9-mediated TF gene knockout to non-edited ASCs with the goal of improving ASC clinical safety. Using CRISPR gene editing of ASCs, the study demonstrated that efficient TFKO can be achieved, generating ASCs with significantly reduced TF activity without affecting the critical features and functions of the cells. The authors concluded that the TF gene knockout provides a feasible strategy which may improve the clinical safety features of ASC-based cell therapies. “We are very encouraged by these results with an edited version of one of our cell therapy candidates,” said Robert J. Hariri, M.D., Ph.D., Celularity’s CEO, Chairman and Founder. “These data advance our understanding of the potential for ASCs to safely address human diseases. These data also are guiding our investment decision to progress our novel genetically modified allogeneic placental-derived mesenchymal-like adherent stromal cells (MLASCs), APPL-001, in diseases like Crohn’s disease, facioscapulohumeral muscular dystrophy (FSHD), and to explore a range of other clinical indications.” 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. To learn more, visit celularity.com 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 express or implied statements regarding Celularity’s approach to cellular medicine, the potential therapeutic benefit of gene edited MLASCs, and Celularity’s ability to progress APPL-001 into clinical studies for Crohn’s disease, among others. Many factors could cause actual results to differ materially from those described in these forward-looking statements, including but not limited to: the inherent risks in biotechnological development, including with respect to the development of novel biomaterial products and cellular therapies, and the clinical trial and regulatory approval process; and risks associated with Celularity’s current liquidity, as well as developments relating to Celularity’s competitors and industry, along with those risk factors set forth under the caption “Risk Factors” in Celularity’s annual report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 31, 2023, and other filings with the SEC. These risks and uncertainties may be amplified by current economic situations, including inflation, supply chain issues and overall economic uncertainty. If any of these risks materialize or underlying assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that Celularity does not presently know, or that Celularity currently believes are immaterial, that could also cause actual results to differ from those contained in the forward-looking statements. In addition, these forward-looking statements reflect Celularity’s current expectations, plans, or forecasts of future events and views as of the date of this communication. Subsequent events and developments could cause assessments to change. Accordingly, forward-looking statements should not be relied upon as representing Celularity’s views as of any subsequent date, and Celularity undertakes no obligation to update forward-looking statements to reflect events or circumstances after the date hereof, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws. 1 https://www.isct-cytotherapy.org/article/S1465-3249(23)00131-7/fulltext 2 Cells. 2019 Oct; 8(10): 1160. Coppin, et al Celularity Contact:Paul Graves, Chief Communications OfficerCelularity Inc.paul.graves@celularity.com

细胞疗法临床研究临床结果基因疗法免疫疗法

2023-05-19

·BioSpace

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

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 FLORHAM PARK, N.J., May 19, 2023 (GLOBE NEWSWIRE) -- 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. To learn more, visit celularity.com 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 express or implied statements regarding progressing APPL-001 into clinical studies and its potential for Crohn’s disease, the benefits of Celularity’s approach to cellular medicine, and Celularity’s ability to advance its technology platform to develop therapeutic options for patients, among others. Many factors could cause actual results to differ materially from those described in these forward-looking statements, including but not limited to: the inherent risks in biotechnological development, including with respect to the development of novel biomaterial products and cellular therapies, and the clinical trial and regulatory approval process; and risks associated with Celularity’s current liquidity, as well as developments relating to Celularity’s competitors and industry, along with those risk factors set forth under the caption “Risk Factors” in Celularity’s annual report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 31, 2023, and other filings with the SEC. These risks and uncertainties may be amplified by current economic situations, including inflation, supply chain issues and overall economic uncertainty. If any of these risks materialize or underlying assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that Celularity does not presently know, or that Celularity currently believes are immaterial, that could also cause actual results to differ from those contained in the forward-looking statements. In addition, these forward-looking statements reflect Celularity’s current expectations, plans, or forecasts of future events and views as of the date of this communication. Subsequent events and developments could cause assessments to change. Accordingly, forward-looking statements should not be relied upon as representing Celularity’s views as of any subsequent date, and Celularity undertakes no obligation to update forward-looking statements to reflect events or circumstances after the date hereof, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws. Celularity Contact: Paul Graves, Chief Communications Officer Celularity Inc. paul.graves@celularity.com

细胞疗法临床1期AACR会议临床结果ASH会议

2023-05-01

·GlobeNewswire-Health Care

Celularity Announces Acceptance of Presentation at 26th Annual Meeting of the American Society of Gene and Cell Therapy

Data will be presented demonstrating that therapy with placental-derived mesenchymal-like adherent stem cells (MLASC) results in alterations in gene and protein signatures associated with inflammation and fistula formation in patients with Crohn’s disease who responded to Celularity’s MLASC treatmentFLORHAM PARK, N.J., May 01, 2023 (GLOBE NEWSWIRE) -- Celularity Inc. (Nasdaq: CELU) (“Celularity”), a biotechnology company developing placental-derived allogeneic cell therapies and biomaterial products, announced today that Adrian Kilcoyne, M.D., M.P.H., M.B.A., Celularity’s Chief Medical Officer, will present data at the upcoming 26th Annual Meeting of the American Society of Gene & Cell Therapy, which will be held May 16-20th in Los Angeles. The title of Dr. Kilcoyne’s abstract is, “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.” “We have had a long interest in the role of cell therapy in autoimmune diseases and look forward to presenting our MLASC data in Crohn’s disease at the upcoming ASGCT annual meeting,” said Robert J. Hariri, M.D., Ph.D., Celularity’s CEO, Chairman and Founder. “In light of our clinical observations described in a previous release, these data provide a possible mechanism of action leverageable in a broad range of immune-mediated diseases and will help guide the investment decision to progress our novel genetically modified allogeneic placental-derived MLASC, APPL-01, in Crohn’s disease. We believe this cell therapy candidate could make a significant difference as a therapeutic option for patients. 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 regarding the potential therapeutic benefits of MLASCs as we advance the development of therapeutic options for patients,” said Hariri. About the Poster Presentation Thursday, May 18, 12:00 noon – 2:00 pm Pacific Time, Board No. 1111 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 A. Kilcoyne, S. Koppisetti, B. Glover, W. VanDerTouw, C. Daly, V. Jankovic, R. Hariri. Celularity, Florham Park, NJ, Regeneron, Tarrytown, NY Disclosures on file. 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. To learn more, visit celularity.com 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 express or implied statements regarding progressing APPL-001 into clinical studies and its potential for Crohn’s disease and the benefits of Celularity’s approach to cellular medicine, and Celularity’s ability to advance its technology platform to develop therapeutic options for patients, among others. Many factors could cause actual results to differ materially from those described in these forward-looking statements, including but not limited to: the inherent risks in biotechnological development, including with respect to the development of novel biomaterial products and cellular therapies, and the clinical trial and regulatory approval process; and risks associated with Celularity’s current liquidity, as well as developments relating to Celularity’s competitors and industry, along with those risk factors set forth under the caption “Risk Factors” in Celularity’s annual report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 31, 2023, and other filings with the SEC. These risks and uncertainties may be amplified by current economic situations, including inflation, supply chain issues and overall economic uncertainty. If any of these risks materialize or underlying assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that Celularity does not presently know, or that Celularity currently believes are immaterial, that could also cause actual results to differ from those contained in the forward-looking statements. In addition, these forward-looking statements reflect Celularity’s current expectations, plans, or forecasts of future events and views as of the date of this communication. Subsequent events and developments could cause assessments to change. Accordingly, forward-looking statements should not be relied upon as representing Celularity’s views as of any subsequent date, and Celularity undertakes no obligation to update forward-looking statements to reflect events or circumstances after the date hereof, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws. Celularity Contact:Paul Graves, Chief Communications OfficerCelularity Inc.paul.graves@celularity.com

细胞疗法临床研究

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