FT596 / Fate Therap - LARVOL DELTA

Induced pluripotent stem-cell-derived CD19-directed chimeric antigen receptor natural killer cells in B-cell lymphoma: a phase 1, first-in-human trial. (PubMed, Lancet) - P1 | "FT596 was well tolerated as monotherapy or with rituximab and induced deep and durable responses in patients with indolent and aggressive lymphomas and the RP2D was preliminarily identified to be 1·8 × 109 cells for three doses per cycle. This study supports that cell therapy using iPSC-derived, gene-modified NK cells is a potent platform for cancer treatment and suggests that such a platform might address limitations of currently available immune cell therapies, including manufacturing time, heterogeneity, access, and cost."

Journal • P1 data • B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • IL15

FT596 Phase 1 Clinical Data in Relapsed / Refractory B-cell Lymphoma (GlobeNewswire) - P1 | N=98 | NCT04245722 | Sponsor: Fate Therapeutics | "Fate Therapeutics...presented initial clinical...data from the Company’s Phase 1 study...at the American College of Rheumatology (ACR) Convergence....The completed study enrolled 68 heavily pre-treated patients (median of 4 prior lines of therapy) with late-stage disease (84% with Stage IV disease)....FT596 demonstrated a favorable safety profile, with no events of ICANS or GvHD and low incidence of low grade CRS (Grade 1 = 10%; Grade 2 = 4%; Grade ≥3 = 0). There were no FT596-related adverse events resulting in study discontinuation or death. Durable responses across histologies were observed, with an overall and complete response rate of 100% and 85%, respectively, and median duration of response of 16.9 months, in relapsed / refractory follicular lymphoma (n=13); and an overall and complete response rate of 38% and 25%, respectively in relapsed / refractory large B-cell lymphoma (n=32)..."

P1 data • Diffuse Large B Cell Lymphoma • Follicular Lymphoma

FT596 With Rituximab as Relapse Prevention After Autologous HSCT for NHL (clinicaltrials.gov) - P1 | N=7 | Completed | Sponsor: Masonic Cancer Center, University of Minnesota | Active, not recruiting ➔ Completed

Trial completion • Bone Marrow Transplantation • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Transplantation • BCL2 • BCL6 • MYC

FT596 as a Monotherapy and in Combination With Anti-CD20 Monoclonal Antibodies (clinicaltrials.gov) - P1 | N=98 | Terminated | Sponsor: Fate Therapeutics | Trial completion date: May 2039 ➔ Sep 2023 | Active, not recruiting ➔ Terminated | Trial primary completion date: May 2024 ➔ Sep 2023; The study was terminated by the Sponsor.

Combination therapy • Monotherapy • Trial completion date • Trial primary completion date • Trial termination • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD19 • CD20

FT596 in Combination With R-CHOP in Subjects With B-Cell Lymphoma (clinicaltrials.gov) - P1b | N=0 | Withdrawn | Sponsor: Fate Therapeutics

Combination therapy • New P1 trial • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Indolent Lymphoma • Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

FT596 as a Monotherapy and in Combination With Anti-CD20 Monoclonal Antibodies (clinicaltrials.gov) - P1 | N=98 | Active, not recruiting | Sponsor: Fate Therapeutics | Recruiting ➔ Active, not recruiting | N=552 ➔ 98

Enrollment change • Enrollment closed • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD19 • CD20

Off-the-Shelf, Multiplexed-Engineered iPSC-Derived NK Cells Mediate Potent Multi-Antigen Targeting of B-Cell Malignancies with Reduced Cytotoxicity Against Healthy B Cells (ASH 2021) - P1 | "Treatments for B - cell malignancies have improved over the past several decades with clinical application of the CD20-specific antibody rituximab and chimeric antigen receptor (CAR) T cells targeting CD19. Further, these data suggest that iDuo NK cells may have an additional advantage over anti-CD19 CAR T cells by discriminating between healthy and malignant B cells. The first iDuo NK cell, FT596, is currently being tested in a Phase I clinical trial (NCT04245722) for the treatment of B-cell lymphoma."

Clinical • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • FCGR3A • IL15

FT596 With Rituximab as Relapse Prevention After Autologous HSCT for NHL (clinicaltrials.gov) - P1 | N=3 | Active, not recruiting | Sponsor: Masonic Cancer Center, University of Minnesota | Terminated ➔ Active, not recruiting | Trial completion date: Feb 2023 ➔ Feb 2024

Enrollment closed • Trial completion date • Bone Marrow Transplantation • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Transplantation • BCL2 • BCL6 • MYC

FT596 With Rituximab as Relapse Prevention After Autologous HSCT for NHL (clinicaltrials.gov) - P1 | N=3 | Terminated | Sponsor: Masonic Cancer Center, University of Minnesota | N=50 ➔ 3 | Trial completion date: Oct 2025 ➔ Feb 2023 | Suspended ➔ Terminated | Trial primary completion date: Oct 2025 ➔ Feb 2023

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Bone Marrow Transplantation • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Transplantation • BCL2 • BCL6 • MYC

FT596 With Rituximab as Relapse Prevention After Autologous HSCT for NHL (clinicaltrials.gov) - P1 | N=50 | Suspended | Sponsor: Masonic Cancer Center, University of Minnesota | Recruiting ➔ Suspended

Trial suspension • Bone Marrow Transplantation • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Transplantation • BCL2 • BCL6 • MYC

"Stifel removes FT596 (discontinued) and FT576 too from its $FATE model. Investment case now highly leveraged on... FT819 (CD19 Car) $JNJ" (@JacobPlieth)

CD19

Fate Therapeutics Announces Termination of Collaboration Agreement with Janssen, Pipeline Prioritization, Next-Generation Programs, and Key 2023 Initiatives (GlobeNewswire) - "Fate Therapeutics...announced today that it has declined a proposal from Janssen Biotech, Inc. ('Janssen') for continuation of the collaboration and option agreement between the parties on revised terms and conditions and, as a result, the agreement has been terminated and all collaboration activities will be wound down in the first quarter of 2023....IND Submission Planned in Mid-2023 for NHL in Combination with CD20-targeted mAb; FT596 Product Candidate to be Discontinued....2023 IND Submission under Ono Collaboration Planned for FT825/ONO-8250 HER2-targeted CAR T-cell Product Candidate; Solid Tumor Program Incorporates Seven Novel Synthetic Controls Designed to Promote Effector Cell Function, Trafficking, and Resistance to Immunosuppressive Tumor Microenvironment."

Discontinued • IND • Licensing / partnership • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor

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

Safety and Efficacy of FT596, a First-in-Class, Multi-Antigen Targeted, Off-the-Shelf, iPSC-Derived CD19 CAR NK Cell Therapy in Relapsed/Refractory B-Cell Lymphoma (ASH 2021) - P1 | "Conditioning chemotherapy (fludarabine 30 mg/m 2 and cyclophosphamide 500 mg/m 2 on Days -5 to -3) is administered followed by a single dose of FT596 as monotherapy (Regimen A) or combined with rituximab (R) 375 mg/m 2 (Regimen B1) or obinutuzumab 1000 mg/m 2 (Regimen B2) on Day -4. FT596 monotherapy or in combination with R was well tolerated and demonstrated activity in pts with R/R BCL, including in pts previously treated with CAR T-cell therapy. Administration of a second FT596 treatment cycle was well tolerated with evidence of continuing clinical benefit. Dose escalation of FT596 is ongoing."

Clinical • Anemia • Bone Marrow Transplantation • Chronic Lymphocytic Leukemia • Fatigue • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Immunology • Inflammation • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Transplantation • CD19 • IL15

FT596 as a Monotherapy and in Combination With Anti-CD20 Monoclonal Antibodies (clinicaltrials.gov) - P1 | N=552 | Recruiting | Sponsor: Fate Therapeutics | N=285 ➔ 552

Combination therapy • Enrollment change • Monotherapy • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD19 • CD20

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 Reports Fourth Quarter and Full Year 2021 Financial Results and Highlights Operational Progress (GlobeNewswire) - "FT596+R Multi-dose, Multi-cycle Escalation Cohort Enrolling at 900 Million Cells per Dose: The Company plans to initiate multiple disease-specific, dose-expansion cohorts in the first quarter of 2022."

Trial status • Hematological Malignancies • Oncology

Fate Therapeutics Showcases Positive Interim Phase 1 Data from FT596 Off-the-shelf, iPSC-derived CAR NK Cell Program for Relapsed / Refractory B-cell Lymphoma at 2021 ASH Annual Meeting (GlobeNewswire) - P1, N=285; NCT04245722; P1, N=75; NCT04023071; Sponsor: Fate Therapeutics; "Fate Therapeutics...today showcased positive interim Phase 1 data from the Company’s FT596 program for patients with relapsed / refractory B-cell lymphoma (BCL) at the 63rd American Society of Hematology (ASH) Annual Meeting and Exposition...as of the data cutoff date of October 11, 2021. These 25 patients had received a median of four prior lines of therapy and a median of two prior lines containing CD20-targeted therapy. Of the 25 patients, 15 patients (60%) had aggressive B-cell lymphoma, 15 patients (60%) were refractory to most recent prior therapy, and 8 patients (32%) were previously treated with autologous CD19-targeted CAR T-cell therapy."

P1 data • Hematological Malignancies • Lymphoma • Oncology

"Sad $FATE FT-596 data was so boring that we can't get @evaluatevantage reporting on it? @JacobPlieth Hoping you circle back around to it!" (@pulcini522)

Fate Therapeutics to Host Virtual Event at the 2021 ASH Annual Meeting (GlobeNewswire) - "Fate Therapeutics, Inc...announced that management will host a virtual event entitled 'B -cell Lymphoma Franchise Update' on Tuesday, December 14, 2021 at 8:00 AM ET. The event will highlight interim Phase 1 clinical data from the Company’s FT516 and FT596 programs for the treatment of relapsed / refractory B-cell lymphomas."

P1 data • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology

"Ft596 is the only one that matters! $fate" (@retailbiotech)

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 Eight Presentations at the 2021 ASH Annual Meeting (GlobeNewswire) - "Fate Therapeutics, Inc...announced that three oral and five poster presentations for the Company’s induced pluripotent stem cell (iPSC) product platform were accepted for presentation at the 63rd American Society of Hematology (ASH) Annual Meeting and Exposition being held from December 11-14, 2021...The oral presentations will include updated Phase 1 clinical data of FT596...The poster presentations will include updated Phase 1 clinical data of FT516...Additional presentations will include an oral presentation describing preclinical and clinical translational data of FT596; a poster presentation describing the making of the clonal engineered master iPSC line for FT819...and a poster presentation describing the preclinical activity of multiplexed-engineered, iPSC-derived T cells incorporating three distinct tumor-targeting modalities (CAR, TCR and hnCD16)."

P1 data • Preclinical • Hematological Malignancies • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology

[VIRTUAL] Initial Clinical Activity of FT596, a First-in-Class, Multi-Antigen Targeted, Off-the-Shelf, iPSC‑Derived CD19 CAR NK Cell Therapy in Relapsed/Refractory B-Cell Lymphoma (ASH 2020) - P1 | "Induced pluripotent stem cell (iPSC)-derived immune effector cells offer distinct advantages over existing patient- and donor-derived therapeutic approaches, including the use of a clonal master engineered iPSC line as a renewable source for the mass production of immune cells, which are available off-the-shelf for broad patient access...FT596 is currently being investigated as a monotherapy and in combination with the anti-CD20 mAbs rituximab and obinutuzumab in a multicenter, Phase I clinical trial for the treatment of relapsed/refractory B-cell lymphoma and chronic lymphocytic leukemia...The patient received fludarabine and cyclophosphamide lympho-conditioning followed by a single administration of 30 million cells of FT596 as monotherapy...Additional clinical, pharmacokinetic, and pharmacodynamic data from this patient will be provided at the time of the meeting. The Phase I trial is ongoing and is registered on clinicaltrials.gov: NCT04245722."

Clinical • Chronic Lymphocytic Leukemia • CNS Disorders • Diffuse Large B Cell Lymphoma • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Hypertension • Immunology • Infectious Disease • Leukemia • Lymphoma • Nephrology • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Transplantation • CD19 • IL15 • IL2

Fate Therapeutics Announces Positive Interim Clinical Data from its FT596 and FT516 Off-the-shelf, iPSC-derived NK Cell Programs for B-cell Lymphoma (GlobeNewswire) - P1, N=285; NCT04245722; P1, N=75; NCT04023071; Sponsor: Fate Therapeutics; "Fate Therapeutics...highlighted positive interim clinical data from the Company’s FT516 and FT596 programs for patients with relapsed / refractory B-cell lymphoma...10 of 14 Patients in FT596 Single-Dose Escalation Cohorts 2 and 3 Achieved Objective Response; 7 Patients Achieved Complete Response, including 2 of 3 Patients Treated with FT596 in Combination with Rituximab Following Autologous CD19 CAR T-cell Therapy...8 of 11 Patients in FT516 Multi-Dose Escalation Cohorts 2 and 3 Achieved Objective Response, including 6 Patients that Achieved Complete Response; 5 of 8 Responders Continue in Ongoing Response at Median Time of 5.2 Months."

P1 data • Hematological Malignancies • Lymphoma • Oncology