FT500 / Fate Therap, University of Minnesota - LARVOL DELTA

Freeze-thaw aging increases the toxicity of microplastics to earthworms and enriches pollutant-degrading microbial genera. (PubMed, J Hazard Mater) - "Results showed that FT 50 µm PE-MPs significantly increased reactive oxygen species (ROS) by 5.78-9.04 % compared to pristine 50 µm PE-MPs (41.80-45.05 ng/mgprot), whereas FT 500 µm PE-MPs reduced ROS by 7.52-7.87 % compared to pristine 500 µm PE-MPs (51.44-54.46 ng/mgprot)...FT-PE-MPs affected membrane translocation by up-regulating lipids and lipid-like molecules, whereas FT-PP-MPs changed xenobiotic biodegradation and metabolism by down-regulating organoheterocyclic compounds compared to the pristine PE- and PP-MPs. This study concludes that FT-aged MPs cause greater toxicity to earthworms compared to pristine MPs."

Journal

Remineralization potential of apacider mangosteen adhesive pastes on artificial carious lesions. (PubMed, J Dent Sci) - "However, decreasing in depth of carious lesions was evinced with using AMAP more than FT1000 and FT500. AMAP was recommended as a potential remineralization material for handling initial caries."

Journal

Long-term, Non-interventional, Observational Study Following Treatment With Fate Therapeutics FT500 Cellular Immunotherapy (clinicaltrials.gov) - P=N/A | N=20 | Terminated | Sponsor: Fate Therapeutics | Trial completion date: Dec 2037 ➔ Aug 2023 | Active, not recruiting ➔ Terminated | Trial primary completion date: Feb 2034 ➔ Aug 2023; This study was terminated by the Sponsor.

Trial completion date • Trial primary completion date • Trial termination • Breast Cancer • Cervical Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hematological Malignancies • Hepatocellular Cancer • Hepatology • HER2 Breast Cancer • HER2 Positive Breast Cancer • Lung Cancer • Lymphoma • Melanoma • Merkel Cell Carcinoma • Microsatellite Instability • Neuroendocrine Tumor • Non Small Cell Lung Cancer • Non-melanoma Skin Cancer • Oncology • Pancreatic Cancer • Renal Cell Carcinoma • Skin Cancer • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma • Urothelial Cancer

Results of a Phase I trial of FT500, a first-in-class, off-the-shelf, iPSC‑derived NK cell therapy combined with PD-1/PD-L1 checkpoint blockade therapy and IL-2 in patients with advanced solid tumors (SITC 2022) - "Methods Treatment consisted of 2 days of outpatient conditioning chemotherapy (cyclophosphamide 300 mg/m 2 and fludarabine 25 mg/m 2 ), followed by two 29-day cycles of 3 once–weekly doses of 300 million FT500 cells/dose with subcutaneous IL-2 (6 MIU), and nivolumab, pembrolizumab, or atezolizumab administered at standard dose and schedule. Ethics Approval This study is being conducted in accordance with the Declaration of Helsinki and was approved by all Institutional Review Boards from each clinical site participating in the study. Specific approval numbers can be provided upon request."

Checkpoint inhibition • Clinical • P1 data • Hematological Malignancies • Hodgkin Lymphoma • Lung Cancer • Lymphoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • IL2

Long-term, Non-interventional, Observational Study Following Treatment With Fate Therapeutics FT500 Cellular Immunotherapy (clinicaltrials.gov) - P=N/A | N=20 | Active, not recruiting | Sponsor: Fate Therapeutics | Recruiting ➔ Active, not recruiting | N=76 ➔ 20

Enrollment change • Enrollment closed • Breast Cancer • Cervical Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hematological Malignancies • Hepatocellular Cancer • Hepatology • HER2 Breast Cancer • HER2 Positive Breast Cancer • Lung Cancer • Lymphoma • Melanoma • Merkel Cell Carcinoma • Microsatellite Instability • Neuroendocrine Tumor • Non Small Cell Lung Cancer • Non-melanoma Skin Cancer • Oncology • Pancreatic Cancer • Renal Cell Carcinoma • Skin Cancer • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma • Urothelial Cancer

[VIRTUAL] Preliminary results of an ongoing phase I trial of FT500, a first-in-class, off-the-shelf, induced pluripotent stem cell (iPSC) derived natural killer (NK) cell therapy in advanced solid tumors (SITC 2020) - P1 | "Treatment consists of 2 days lympho conditioning (fludarabine 25 mg/m2 and cyclophosphamide 300 mg/m2) followed by 2 cycles of 3 once weekly doses of FT500 as monotherapy or combined with 1 of 3 approved ICIs (nivolumab, pembrolizumab, or atezolizumab) in patients who have failed prior ICI therapy. Ethics Approval This study is being conducted in accordance with the Declaration of Helsinki and was approved by all Institutional Review Boards from each clinical site participating in the study. Specific approval numbers can be provided upon request"

P1 data • Hematological Malignancies • Hodgkin Lymphoma • Lung Cancer • Lymphoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor

FT500 as Monotherapy and in Combination With Immune Checkpoint Inhibitors in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=37 | Completed | Sponsor: Fate Therapeutics | Active, not recruiting ➔ Completed

Checkpoint inhibition • Combination therapy • Metastases • Monotherapy • Trial completion • Breast Cancer • Cervical Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hematological Malignancies • Hepatocellular Cancer • Hepatology • HER2 Breast Cancer • HER2 Positive Breast Cancer • Immune Modulation • Inflammation • Lung Cancer • Lymphoma • Melanoma • Merkel Cell Carcinoma • Microsatellite Instability • Neuroendocrine Tumor • Non Small Cell Lung Cancer • Non-melanoma Skin Cancer • Oncology • Pancreatic Cancer • Renal Cell Carcinoma • Skin Cancer • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma • Urothelial Cancer • IL2

FT500 as Monotherapy and in Combination With Immune Checkpoint Inhibitors in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=37 | Active, not recruiting | Sponsor: Fate Therapeutics | Recruiting ➔ Active, not recruiting | Trial completion date: Jul 2023 ➔ Nov 2022 | Trial primary completion date: Mar 2022 ➔ Oct 2022

Checkpoint inhibition • Combination therapy • Enrollment closed • Monotherapy • Trial completion date • Trial primary completion date • Breast Cancer • Cervical Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hematological Malignancies • Hepatocellular Cancer • Hepatology • HER2 Breast Cancer • HER2 Positive Breast Cancer • Immune Modulation • Inflammation • Lung Cancer • Lymphoma • Melanoma • Merkel Cell Carcinoma • Microsatellite Instability • Neuroendocrine Tumor • Non Small Cell Lung Cancer • Non-melanoma Skin Cancer • Oncology • Pancreatic Cancer • Renal Cell Carcinoma • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma • Urothelial Cancer • IL2

Fate Therapeutics to Present Clinical and Preclinical Data for iPSC Product Platform at the Society for Immunotherapy of Cancer 37th Annual Meeting (GlobeNewswire) - "Fate Therapeutics...announced that the Company will present clinical and preclinical data for the Company’s induced pluripotent stem cell (iPSC) product platform at the Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting being held in Boston, MA, and virtually, November 8-12, 2022."

P1 data • Preclinical

FT500 as Monotherapy and in Combination With Immune Checkpoint Inhibitors in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=37; Recruiting; Sponsor: Fate Therapeutics; N=76 ➔ 37; Trial completion date: Jun 2022 ➔ Jul 2023

Checkpoint inhibition • Clinical • Combination therapy • Enrollment change • Monotherapy • Trial completion date • Breast Cancer • Cervical Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hematological Malignancies • Hepatocellular Cancer • Hepatology • HER2 Breast Cancer • HER2 Positive Breast Cancer • Immune Modulation • Inflammation • Lung Cancer • Lymphoma • Melanoma • Merkel Cell Carcinoma • Microsatellite Instability • Neuroendocrine Tumor • Non Small Cell Lung Cancer • Non-melanoma Skin Cancer • Oncology • Pancreatic Cancer • Renal Cell Carcinoma • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma • Urothelial Cancer • IL2

Long-term, Non-interventional, Observational Study Following Treatment With Fate Therapeutics FT500 Cellular Immunotherapy (clinicaltrials.gov) - P=N/A; N=76; Recruiting; Sponsor: Fate Therapeutics; Trial completion date: Dec 2034 ➔ Dec 2037

Clinical • Trial completion date • Breast Cancer • Cervical Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hematological Malignancies • Hepatocellular Cancer • Hepatology • HER2 Breast Cancer • HER2 Positive Breast Cancer • Lung Cancer • Lymphoma • Melanoma • Merkel Cell Carcinoma • Microsatellite Instability • Neuroendocrine Tumor • Non Small Cell Lung Cancer • Non-melanoma Skin Cancer • Oncology • Pancreatic Cancer • Renal Cell Carcinoma • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma • Urothelial Cancer

[VIRTUAL] Preliminary results of an ongoing phase I trial of FT500, a first-in-class, off-the-shelf, induced pluripotent stem cell (iPSC) derived natural killer (NK) cell therapy in advanced solid tumors (SITC 2020) - P1 | "Treatment consists of 2 days lympho conditioning (fludarabine 25 mg/m2 and cyclophosphamide 300 mg/m2) followed by 2 cycles of 3 once weekly doses of FT500 as monotherapy or combined with 1 of 3 approved ICIs (nivolumab, pembrolizumab, or atezolizumab) in patients who have failed prior ICI therapy. Ethics Approval This study is being conducted in accordance with the Declaration of Helsinki and was approved by all Institutional Review Boards from each clinical site participating in the study. Specific approval numbers can be provided upon request"

P1 data • Hematological Malignancies • Hodgkin Lymphoma • Lung Cancer • Lymphoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Fate Therapeutics Reports Third Quarter 2020 Financial Results and Highlights Operational Progress (Fate Therapeutics Press Release) - "FT500 Dose Expansion Ongoing in Solid Tumors Resistant to Checkpoint Inhibitor Therapy. At the Society for Immunotherapy of Cancer (SITC) annual meeting being held virtually from November 9-14, 2020, the Company plans to present previously disclosed clinical data from the dose-escalation stage of the Company’s Phase 1 clinical trial of FT500 (NCT03841110)....In the fourth quarter of 2020, the Company plans to initiate a multi-center Phase 1 clinical trial of FT819, the first-ever off-the-shelf, allogeneic CAR T-cell therapy derived from a clonal master iPSC line, for patients with B-cell lymphoma, chronic lymphocytic leukemia, or acute lymphoblastic leukemia."

New P1 trial • P1 data • Oncology • Solid Tumor

Fate Therapeutics Announces Twelve Presentations at the 2020 ASH Annual Meeting (Fate Therapeutics Press Release) - "Accepted abstracts include a clinical case study of a patient treated with FT596 at the first dose level (30 million cells) as a monotherapy in the Company’s Phase 1 clinical trial for the treatment of relapsed / refractory B-cell lymphoma (NCT04245722)....In addition, the Company plans to host a virtual investor event entitled 'The Power of hnCD16' to highlight the unique therapeutic features and functionality of its novel hnCD16 Fc receptor, a core component incorporated in its iPSC-derived NK cell product candidates."

Clinical data • P1 data • Acute Myelogenous Leukemia • Hematological Malignancies • Lymphoma • Multiple Myeloma • Oncology

Fate Therapeutics Announces Presentations at the 2020 Society for Immunotherapy of Cancer Annual Meeting (Fate Therapeutics Press Release) - “Fate Therapeutics, Inc…announced that five abstracts for the Company’s induced pluripotent stem cell (iPSC) product platform were accepted for presentation at the Society for Immunotherapy of Cancer (SITC) annual meeting being held virtually from November 9-14, 2020. Accepted abstracts include clinical data from 15 patients in the dose-escalation stage of the Company’s Phase 1 clinical trial of FT500 in advanced solid tumors (NCT03841110), which includes nine patients in Regimen A (three once-weekly doses of FT500 for up to two 30-day cycles as monotherapy) and six patients in Regimen B (three once-weekly doses of FT500 for up to two 30-day cycles in combination with checkpoint inhibitor therapy).”

P1 data • Preclinical • Oncology • Solid Tumor

Stem cells join the battle against COVID-19 (University of Minnesota Medical School) - "'One of the NK cell killing mechanisms is ADCC - antibody-dependent cellular cytotoxicity,' McKenna said. 'If you're just giving NK cells that's one of the main mechanisms they would use to fight a tumor or a virus.' In its new product, FT516, Fate altered the NK cell-surface receptor molecule CD16 to make it bind to therapeutic antibodies ever tighter, boosting the NK cell's ADCC power to kill. 'The unique thing about this particular product is that it is engineered to have a high-affinity antibody attachment to CD16, so they’re really going to be relying more on an efficacious ADCC than other NK cell killing mechanisms,' McKenna said."

Media quote

"PR suggests it's all novel (new) assets. So FT500, 516, 596 should be excluded." (@BiotechPerson)

Fate Therapeutics announces clinical data from landmark phase 1 studies of first-ever universal, off-the-shelf, iPSC-derived NK Cell cancer immunotherapy programs (GlobeNewswire, Fate Therapeutics, Inc.) - P1, N=76; NCT03841110; Sponsor: Fate Therapeutics; "Safety. No DLTs, FT500-related SAEs or FT500-related Grade ≥3 AEs, and no incidents of cytokine release syndrome, neurotoxicity, or graft-versus-host disease, have been reported in 12 patients; Tolerability. All 12 patients completed the first FT500 treatment cycle of three once-weekly doses. Nine of 11 patients initiated a second FT500 treatment cycle, with eight of nine patients having completed the second FT500 treatment cycle. One patient is currently pending initiation of a second FT500 treatment cycle. The multi-dose, two-cycle treatment schedule was well-tolerated, and no treatment discontinuations were due to AEs."

Clinical data • Enrollment status • Preclinical

Fate Therapeutics announces six presentations at the 2019 ASH Annual Meeting (GlobeNewswire, Fate Therapeutics, Inc.) - "Fate Therapeutics...announced today that two oral and four poster presentations covering the Company’s off-the-shelf, induced pluripotent stem cell (iPSC)-derived natural killer (NK) cell and chimeric antigen receptor (CAR) T-cell product candidates will be featured at the 61st American Society of Hematology (ASH) Annual Meeting and Exposition. The meeting will be held December 7-10, 2019 in Orlando, Florida."

Clinical

Fate Therapeutics Reports Third Quarter 2019 Financial Results and Highlights Operational Progress (GlobeNewswire, Fate Therapeutics, Inc.) - "...'We look forward to the ASH annual meeting in December, where we have had six abstracts accepted and will be sharing our first-in-human insights into the clinical safety and tolerability of FT500, the first-ever iPSC-derived cell therapy to be administered off-the-shelf in multiple doses over multiple cycles'."

Clinical data

Fate Therapeutics announces the opening of its cGMP manufacturing facility dedicated to iPSC-derived cell therapies (GlobeNewswire) - "Fate Therapeutics...announced today that the Company has opened its current Good Manufacturing Process (cGMP) compliant manufacturing facility for the clinical production of its off-the-shelf natural killer (NK) cell and chimeric antigen receptor (CAR) T-cell product candidates."

Clinical

Long-term, Non-interventional, Observational Study Following Treatment With Fate Therapeutics FT500 Cellular Immunotherapy (clinicaltrials.gov) - P; N=76; Recruiting; Sponsor: Fate Therapeutics

Clinical • New trial

Fate Therapeutics Reports Second Quarter 2019 Financial Results and Highlights Operational Progress (GlobeNewswire, Fate Therapeutics, Inc.) - No FT500 DLTs Reported at Second Cell Dose Level in Monotherapy Arm or at First Cell Dose Level in Checkpoint Inhibitor Combination Arm in Solid Tumor Study. “The early safety and tolerability signals observed in patients receiving multiple doses of FT500, the first iPSC-derived cell therapy to undergo clinical investigation in the United States, are very encouraging.

Clinical data