GDA-501 / Ayrmid - LARVOL DELTA

Data To Be Presented on Gamida Cell Natural Killer (NK) Cell Therapy Candidate GDA-201 at the International Society for Cell & Gene Therapy 2023 Annual Meeting (Businesswire) - "Gamida Cell Ltd...announced that an oral presentation highlighting Gamida Cell’s investigational natural killer (NK) cell therapy candidate GDA-201 will be shared at the International Society for Cell and Gene Therapy (ISCT) 2023 Annual Meeting. The meeting takes place May 31-June 3 in Paris, France. Additionally, a poster will be presented with data from Gamida Cell’s pre-clinical NK cell therapy candidate GDA-501, an engineered intrinsic NK cell with a CAR modification targeting the HER2 protein...Batch-to-batch variability of 18 batches of cryopreserved formulation of GDA-201 from 18 donors demonstrated an overall variability of ≤25% in critical parameters including viability, phenotyping and cytotoxicity...Compared with non-engineered NK cells cultured with NAM, GDA-501 cells displayed increased cytotoxicity against HER2+ tumor cells. When TRAIL was neutralized on GDA-501, a decrease in cytotoxicity was observed."

Clinical • Preclinical • Oncology • Solid Tumor

Gamida Cell Reports Full Year 2022 Financial Results and Provides Company Update (Businesswire) - "Reduce operating expenses in order to extend its cash runway: The company will discontinue the development of its engineered NK cell therapy preclinical pipeline, including GDA-301, GDA-501 and GDA-601, while maintaining the IP to these candidates. It will implement a headcount reduction of 17%, with the majority of impacted headcount tied to the discontinuation of the pre-clinical NK cell therapy candidates....These changes are expected to extend the company’s cash runway through Q3 2023....Research and development expenses, net were $42.7 million in 2022, compared to $50.2 million in 2021. The decrease was primarily due to a $9.6 million decrease in clinical and operational activities relating to the conclusion of our Phase 3 study of omidubicel, offset by an increase of $1.1 million in T&E and other expenses as well as a $1.0 million decrease in Israeli Innovation Authority grants."

Commercial • Discontinued • Oncology

GDA-501: Engineered NAM-NK cells with HER2-CAR expression demonstrate increased cytotoxicity against HER2-expressing solid tumors (SITC 2022) - "Methods HER2-CAR-NK cells were developed based on a single-chain variable fragment (scFv) of the widely used humanized monoclonal antibody trastuzumab. Informed consent has been approved by the ECs. The Israeli template of informed consent is in used and it includes study specific information (e.g. study goal, design, method, duration, risks, etc.)."

IO biomarker • Gastric Cancer • Oncology • Ovarian Cancer • Solid Tumor • HER-2 • LAMP1 • TNFA

GDA-501, NAM enabled NK Cell Therapy, Demonstrates Promising Antitumor Activity Against HER2+ Cancers (Businesswire) - "Gamida Cell Ltd...announced encouraging preclinical data on GDA-501, a genetically modified NAM (nicotinamide) Natural Killer (NK) pre-clinical cell therapy candidate from Gamida Cell’s expanding pipeline of cell therapy candidates. The data will be presented at the Society for Immunotherapy of Cancer’s 37th Annual Meeting taking place in Boston, MA from November 10-12, 2022....Cryopreserved GDA-501 significantly inhibited tumor growth of a HER2+ solid tumor model in vivo. These preclinical data demonstrate potent antitumor activity and suggest that GDA-501 represents a unique potential treatment option using an allogeneic NAM-enabled cell therapy candidate for this poor prognostic group of patients with cancers that express HER2."

Preclinical • Oncology • Solid Tumor

Gamida Cell Reports Third Quarter 2021 Financial Results and Provides Company Update (Businesswire) - "Data from early-stage studies of GDA-501 demonstrated enhanced potency and cytotoxicity against a HER2-expressing tumor cell line. Data presented on GDA-301 showed cytotoxic activity against a chronic myelogenous leukemia cell line (K562) and a multiple myeloma cell line (RPMI). These data were presented at the 13th Annual Protein and Antibody Engineering Summit (PEGS) in Barcelona, Spain November 2-4, 2021."

Preclinical • Chronic Myeloid Leukemia • Hematological Malignancies • Multiple Myeloma • Oncology

Gamida Cell to Present NAM-Enabled, Genetically Modified NK Cell Therapy Pipeline and Update on GDA-201 at Today’s Virtual R&D Day (Businesswire) - "The initiation of the planned Phase 1/2 trial of GDA-201 may be delayed beyond the end of 2021….Update Regarding NK Cell Therapy Programs:…Descriptions of Gamida Cell’s genetically modified NK cell immunotherapy programs (GDA-301, GDA-401, GDA-501 and GDA-601), which utilize CAR- and CRISPR-mediated strategies to increase targeting, potency and persistence against hematologic malignancies and solid-tumors. Discuss a research collaboration with the Dana-Farber Cancer Institute studying the in vitro natural killer (NK) cell killing activity of GDA-601, Gamida Cell’s nicotinamide (NAM)-enabled genetically modified NK cell therapy in multiple myeloma….Phase 1 data on the safety and efficacy of GDA-201…has produced positive clinical results in the treatment of diffuse large B cell lymphoma and follicular lymphoma, both of which have significant unmet need."

Clinical • New P1/2 trial • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Multiple Myeloma • Oncology • Solid Tumor