CyCART-19 / Celularity, Sorrento - LARVOL DELTA

Celularity Completes Strategic Review of 2023 Initiatives, Including Anticipated Biomaterials Production Ramp-Up and Pipeline Prioritization of Next-Generation Product Candidates (GlobeNewswire) - "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."

New P1 trial • Hematological Malignancies • Oncology • Solid Tumor

Imugene’s onCARlytics combination with Celularity’s placental-derived off-the-shelf allogeneic CYCART-19 T cells preclinical data presented at SITC Annual Meeting (GlobeNewswire) - "Imugene Limited...and Celularity...are pleased to announce that data from preclinical studies of Imugene’s onCARlytics (CF33-CD19) oncolytic virus in combination with Celularity’s placental-derived off-the-shelf allogeneic CYCART-19 T cells was presented at the renowned Annual Meeting of the Society for Immunotherapy of Cancer (SITC)....CYCART-19 demonstrated efficacy in preclinical models against MDA-MB-468 expressing CD19t following onCARlytics infection....CYCART-19 treatment 7 days post onCARlytics infection showed significant tumor regression compared to onCARlytics or T cells alone in a mouse xenograft model of triple-negative breast cancer."

Preclinical • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Celularity Reports Second Quarter 2022 Financial Results and Corporate Update (GlobeNewswire) - "CYCART-19 for the Treatment of B-Cell Malignancies: Celularity is in the process of working with the FDA to resolve the agency’s questions as promptly as possible, and, if the IND is cleared, plans to commence a Phase 1/2 clinical trial of CYCART-19 in B-cell malignancies in 2023."

New P1/2 trial • Hematological Malignancies • Oncology

Celularity Reports First Quarter 2022 Financial Results and Provides Corporate Update (GlobeNewswire) - "Celularity submitted an Investigational New Drug (IND) application to FDA to investigate CYCART-19 for the treatment of B-cell malignancies in the first quarter of 2022 and in April 2022, received email notification from FDA that it will be requesting additional information before Celularity can proceed with the planned Phase 1/2 clinical trial. Celularity anticipates a formal written communication by late May 2022 and plans to work with the FDA in an effort to resolve its questions as promptly as possible and, if the IND is cleared, commence a Phase 1/2 clinical trial of CYCART-19 in B-cell malignancies in the second half of 2022."

FDA event • IND • Hematological Malignancies • Oncology

Celularity Reports Third Quarter 2021 Financial Results and Corporate Update (GlobeNewswire) - "Third Quarter Corporate Highlights:...Entered into a research collaboration with Oncternal Therapeutics...to evaluate placental derived-cellular therapies targeting receptor-tyrosine kinase-like Orphan Receptor 1 (ROR1) in preclinical studies. The collaboration will initially explore the use of Oncternal’s ROR1-targeted chimeric antigen receptor (CAR) gene modification as part of Celularity’s CYNK natural killer cell and CyCART platforms. The partnership will also explore the use of monoclonal antibody, cirmtuzumab, in combination with Celularity’s CYNK natural killer cells."

Licensing / partnership • Oncology

Imugene and Celularity Announce an Exclusive Strategic Partnership to Develop a Novel Oncolytic Virus - Allogeneic CAR T-Cell Immunotherapy Combination for the Treatment of Solid Tumors (GlobeNewswire) - "Imugene Ltd...and Celularity...announced they have entered into a research collaboration in 2021. As part of the partnership, Imugene and Celularity will initially collaborate to develop the combination of Imugene’s CD19 oncolytic virus technology and Celularity’s CD19 targeting allogeneic chimeric antigen receptor (CAR) T cellular therapy, CyCART-19, for the treatment of solid tumors...Nonclinical in vitro and in vivo combination studies to commence in 2021. Celularity’s off-the-shelf allogeneic CD19 therapy has shown sustained T-cell growth with continuous killing of tumor cells in vivo."

Licensing / partnership • Preclinical • Oncology • Solid Tumor

Celularity and GX Acquisition Corp. Announce Merger Agreement to Create a Publicly Listed Leader in Allogeneic Cellular Therapy (PRNewswire) - "Celularity plans to submit its initial CYNK-101 investigational new drug ('IND') application in the first half of 2021...The Phase 1/2a clinical trial will commence in 2021...CyCART-19 is in development initially for the treatment of B-cell malignancies...Celularity plans to file its initial CyCART-19 IND application and to commence a Phase 1/2a clinical trial in the first half of 2021."

IND • New P1/2 trial • Diffuse Large B Cell Lymphoma • Gastric Cancer • Gastrointestinal Cancer • Hematological Malignancies • Oncology • Solid Tumor