FT536 / Fate Therap - LARVOL DELTA

Fate Therapeutics Announces Presentation of FT819 Proof-of-Concept Data for B cell-mediated Autoimmune Diseases at ASGCT Annual Meeting (GlobeNewswire) - "Fate Therapeutics...announced that two presentations will be featured at the American Society of Gene and Cell Therapy (ASGCT) 27th Annual Meeting....The Company will present data of key therapeutic mechanisms of activity for autoimmune diseases, including B cell depletion, tissue infiltration and immune reconstitution, from its Phase 1 study of FT819 in relapsed / refractory B-cell malignancies....In addition, the Company will highlight preclinical data from its off-the-shelf, iPSC-derived, CAR T-cell product platform for solid tumors, with an oral presentation of a novel MICA/B-targeted CAR T-cell product candidate that is designed to target a broad array of tumor types and to overcome immune cell evasion by shedding of stress ligands."

P1 data • Preclinical • B Acute Lymphoblastic Leukemia • Chronic Lymphocytic Leukemia • Lymphoma

FT536 Monotherapy and in Combination With Monoclonal Antibodies in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=5 | Terminated | Sponsor: Fate Therapeutics | Trial completion date: Apr 2027 ➔ Aug 2023 | Active, not recruiting ➔ Terminated | Trial primary completion date: Jun 2024 ➔ Aug 2023; This study was terminated by the Sponsor.

Combination therapy • Metastases • Monotherapy • Trial completion date • Trial primary completion date • Trial termination • Breast Cancer • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hepatology • HER2 Breast Cancer • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • BRAF • EGFR • HER-2 • KRAS • MET • NRAS • PD-L1

FT536 Monotherapy and in Combination With Monoclonal Antibodies in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=5 | Active, not recruiting | Sponsor: Fate Therapeutics | Recruiting ➔ Active, not recruiting | N=322 ➔ 5

Combination therapy • Enrollment change • Enrollment closed • Metastases • Monotherapy • Breast Cancer • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hepatology • HER2 Breast Cancer • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • BRAF • EGFR • HER-2 • KRAS • MET • NRAS • PD-L1

Combining FT536, a pan-tumor targeting CAR NK cell therapy, with CD16 engagers provides a coordinated targeting strategy to overcome tumor heterogeneity (SITC 2022) - P1 | "We hypothesize that multi-antigen targeting of solid tumors could provide a novel approach to minimize antigen selection and immune escape. Conclusions To assess the clinical translation potency of multi-antigen targeting and combinatorial therapeutic application of FT536 in humans, a phase I first-in-human, dose-escalation clinical study of FT536 as monotherapy and in combination with tumor-targeting mAb therapy, including amivantamab, for the treatment of multiple solid tumor indications was designed and is currently enrolling ( NCT05395052 )."

Heterogeneity • IO biomarker • Pan tumor • Hematological Malignancies • Oncology • Solid Tumor • EGFR • HER-2 • MET

High-Density Cryopreservation of Off-the-Shelf CAR-NK Cells Facilitates On-demand Treatment Access (ASH 2022) - "HD-fill of FT536 showed comparable CAR specific cytotoxicity against CaSki cervical carcinoma cells at E:T ratio of 5:1 and ADCC with cetuximab at E:T ratio of 3:1 in the single round and re-stimulation killing assays. HD-Fill of FT596 also showed similar cytolytic potency against Nalm6 leukemia cells compared to the standard dose...In summary, we demonstrate the successful generation of HD-fill CAR-iNK cells without interfering with drug product integrity, identity, and function. HD-fill for off-the-shelf immunotherapies will enable flexibility to clinicians and patients in the out-patient setting for the treatment of hematologic and solid tumors."

IO biomarker • Cervical Cancer • Hematological Disorders • Hematological Malignancies • Leukemia • Oncology • Solid Tumor

GT Biopharma to Present New Data on Novel Dual-Antigen Targeting Approach Against AML at Upcoming 2022 ASH Annual Meeting (GlobeNewswire) - "GT Biopharma, Inc...announced the presentation of new data at the American Society of Hematology's 64th Annual Meeting...The study utilized a combination of GT Biopharma’s investigational GTB-3650, a CD33 targeting Tri-specific Killer Engager (TriKE), and Fate Therapeutics’ multiplexed-engineered, iPSC-derived, CAR NK cells targeting the α3 domain of MICA and MICB. Preclinical data to be presented demonstrate that iPSC-derived, MICA/B-targeted CAR NK cells induced potent activity against the AML cell line HL60, and that further enhancement of activity was achieved in combination with GTB-3650 through antibody-dependent cellular cytotoxicity."

Preclinical • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

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

FT536 Monotherapy and in Combination With Monoclonal Antibodies in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=322 | Recruiting | Sponsor: Fate Therapeutics

Combination therapy • Monotherapy • New P1 trial • Breast Cancer • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hepatology • HER2 Breast Cancer • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • EGFR • HER-2 • KRAS • MET • NRAS

FT536: A First-of-Kind, Off-the-Shelf CAR-iNK Cell Product Candidate for Solid Tumors Designed to Specifically Target MICA/B Stress Proteins and Overcome Mechanisms of Tumor Evasion (ASGCT 2022) - "Figure 1: FT536 contains a novel pan-tumor targeting CAR and displays significant in vivo efficacy(A) MICA/B CAR containing primary T cells demonstrated pan-tumor reactivity and superior IFNγ cytokine responses compared to control and NKG2D CAR containing primary T cells. (B) FT536 significantly reduced the number of lung and liver (not shown) metastases compared to CAR negative iNK control cells in a murine metastatic melanoma model using B16/F10 cells engineered to overexpress human MICA."

Hematological Disorders • Hematological Malignancies • Melanoma • Oncology • Solid Tumor • IFNG • MICA • NKG2D

Fate Therapeutics Reports First Quarter 2022 Financial Results and Highlights Operational Progress (GlobeNewswire) - "...In the second quarter of 2022, the Company plans to submit a new clinical protocol to the FT596 Investigational New Drug (IND) application to assess the safety and activity of adding FT596 to R-CHOP, the standard first-line immunochemotherapy for patients with aggressive lymphomas....FT516 Multi-disciplinary RMAT Meeting Planned for mid-2022....The Company plans to hold a multi-disciplinary meeting with the FDA in mid-2022 to discuss key CMC topics and pivotal study design in patients who have progressed or relapsed following prior treatment with FDA‑approved CD19‑directed chimeric antigen receptor (CAR) T-cell therapy....On-track for First Patient Treatment with FT536 CAR MICA/B-targeted NK Cell Product Candidate....the study’s first clinical site to initiate enrollment in the second quarter of 2022."

Enrollment status • FDA event • IND • New P3 trial • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor

Fate Therapeutics Announces FDA Clearance for FT536, a First-in-class MICA/B-targeted CAR NK Cell Product Candidate for the Treatment of Solid Tumors (GlobeNewswire) - "Fate Therapeutics, Inc...announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for FT536, an off-the-shelf, multiplexed-engineered, iPSC-derived, chimeric antigen receptor (CAR) NK cell product candidate...The Company plans to initiate clinical investigation of FT536 as a monotherapy and in combination with tumor-targeting monoclonal antibody therapy for the treatment of multiple solid tumor indications....The Phase 1 clinical protocol allows for administration of FT536 initially in up to two, 30-day cycles, with each cycle consisting of three days of conditioning chemotherapy and three weekly doses of FT536."

Clinical protocol • IND • Oncology • Solid Tumor

FT536 Path to IND: Ubiquitous targeting of solid tumors with an off-the-shelf, first-of-kind MICA/B-specific CAR-iNK cellular immunotherapy. (SITC 2021) - "Conclusions Collectively, these studies demonstrate that FT536 is a highly potent, multi-tumor targeting CAR-iNK cell product that is uniform in composition and can be effectively and safely used off-the-shelf for on-demand treatment of multiple solid and hematological malignancies. An IND submission is planned for 2021, with an initial Phase 1 clinical trial to follow."

IO biomarker • Hematological Malignancies • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

FT536 Path to IND: Ubiquitous targeting of solid tumors with an off-the-shelf, first-of-kind MICA/B-specific CAR-iNK cellular immunotherapy. (SITC 2021) - "(C-D) FT536 alone, and in combination with Herceptin, demonstrate significant tumor growth inhibition (TGI) compared to Herceptin alone in an orthotopic xenograft model of human lung adenocarcinoma. Conclusions Collectively, these studies demonstrate that FT536 is a highly potent, multi-tumor targeting CAR-iNK cell product that is uniform in composition and can be effectively and safely used off-the-shelf for on-demand treatment of multiple solid and hematological malignancies. An IND submission is planned for 2021, with an initial Phase 1 clinical trial to follow."

IO biomarker • Hematological Malignancies • Lung Adenocarcinoma • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Fate Therapeutics Reports Third Quarter 2021 Financial Results and Highlights Operational Progress (GlobeNewswire) - "At the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC), the Company plans to present IND-enabling preclinical data for FT536, its off-the-shelf, multiplexed-engineered, iPSC-derived NK cell product candidate that incorporates a novel CAR targeting the alpha-3 domain of the pan-tumor associated stress antigens MICA and MICB....FT596 Oral and FT516 Poster Presentations to Highlight Updated Phase 1 Data for R/R Lymphoma at ASH on Monday, December 13; Eight Abstracts Accepted for Presentation."

P1 data • Preclinical • Hematological Malignancies • Lymphoma • Oncology • Solid Tumor

Fate Therapeutics Announces Presentations at the Society for Immunotherapy of Cancer 2021 Annual Meeting (GlobeNewswire) - "Fate Therapeutics, Inc...announced that one oral and four poster presentations for the Company’s induced pluripotent stem cell (iPSC) product platform were accepted for presentation at the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) being held November 10-14, 2021...The oral presentation will highlight preclinical data for FT536...chimeric antigen receptor (CAR) NK cell product candidate that uniquely targets the α3 domain of the MHC class I related proteins A (MICA) and B (MICB)...The Company expects to submit an Investigational New Drug (IND) application for FT536 in the fourth quarter of 2021 for the treatment of advanced solid tumors, including in combination with monoclonal antibody therapy...Poster presentations at SITC will include preclinical data on new functional elements that the Company is evaluating for incorporation into its iPSC-derived cell product candidates for solid tumors."

Clinical data • IND • Preclinical • Oncology • Solid Tumor

Fate Therapeutics Reports Second Quarter 2021 Financial Results and Highlights Operational Progress (GlobeNewswire) - "The Company plans to submit an IND application to the U.S. Food and Drug Administration (FDA) in the second half of 2021 to initiate a Phase 1 clinical trial of FT536 for the treatment of solid tumors."

IND • Oncology • Solid Tumor

[VIRTUAL] FT536: Preclinical development of a novel off-the-shelf CAR-MICA/B NK cell immunotherapy combined with radiation and antibody treatments as a first-of-kind pan-cancer targeting strategy (AACR 2021) - "Furthermore, ADCC, induced in combination with cetuximab or trastuzumab, enhanced the potency of FT536 against various solid tumor lines (p <0.05). Ongoing work is focused on the development of in vivo models that combine FT536 with in situ tumor irradiation and mAbs in order to promote durable responses and the elimination of resistant and heterogenous cancer cells. These data demonstrate successful targeting of MICA/B positive tumors by FT536 can be augmented by mAb and radiation therapies as first-of-kind combinatorial strategies to broadly target escape-prone tumors."

IO biomarker • Pan tumor • Preclinical • Breast Cancer • Oncology • Solid Tumor • EGFR • IL15 • NKG2D

[VIRTUAL] FT536 – An iPSC-Derived, Off-the-Shelf Multiplexed Engineered CAR MICA/B NK Cell Product Targeting Solid Tumors (CELLICON 2021) - No abstract available

Oncology • Solid Tumor

[VIRTUAL] Sequential CRISPR-Mediated Engineering and Clonal Banking for the Generation of Multiplexed Engineered Master Pluripotent Cell Lines for the Mass Manufacture of Off-the-Shelf Immune Cells Targeting Solid Cancers (ASGCT 2021) - "The generated engineered iPSC subclones are currently being screened for specific targeting of the CAR-MICA/B into the safe harbor locus and other critical quality attributes (including maintenance of pluripotency and genomic stability) to nominate the final iPSC master cell bank. This master cell bank will serve as the starting material for clinical investigation of FT536, an off-the-shelf pan-cancer targeting CAR NK cell immunotherapy with potential therapeutic application to multiple hematopoietic and solid tumors."

Preclinical • Hematological Malignancies • Oncology • Solid Tumor • IL15

[VIRTUAL] FT536 – An iPSC-derived, Multiplexed Engineered CAR MICA/B NK Cell Product Targeting Solid Tumors (IO-360 2021) - "CAR-MICA/B is a novel pan-tumor targeting strategy. FT536 is an off-the-shelf NK cell uniformly consisting of four anti-tumor modalities that uniquely synergize with other therapeutic approaches such as mAbs and radiation therapy for an effective elimination of various solid tumors"

Oncology • Solid Tumor

Fate Therapeutics Reports Fourth Quarter 2020 Financial Results and Highlights Operational Progress (GlobeNewswire) - "The Company plans to submit an IND application in the second half of 2021 to initiate a Phase 1 clinical trial of FT536 for the treatment of solid tumors."

IND • Oncology • Solid Tumor