FATE-NK100 / Fate Therap, University of Minnesota - LARVOL DELTA

FATE-NK100 as Monotherapy and in Combination With Monoclonal Antibody in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=44; Completed; Sponsor: Fate Therapeutics; Active, not recruiting ➔ Completed; N=100 ➔ 44; Trial completion date: Oct 2022 ➔ Dec 2020

Clinical • Combination therapy • Enrollment change • Monotherapy • Trial completion • Trial completion date • Breast Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hepatocellular Cancer • Hepatology • HER2 Breast Cancer • HER2 Positive Breast Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • EGFR • HER-2

[VIRTUAL] APOLLO: A phase I study of adaptive memory natural killer (NK) cells in recurrent ovarian cancer. (ASCO 2020) - P2 | " FATE-NK100 via IP port was tested using 3 dose cohorts ([DC]; 1 × 107 cells/kg; >1 × 107 cells/kg to ≤3 × 107 cells/kg; or >3 × 107 to ≤10 × 107 cells/kg) after lympho-conditioning with fludarabine 25 mg/m2 IV and cyclophosphamide 300 mg/m2 IV on days −6 and −5. IP delivery of FATE-NK100 is safe, with clinical benefit in 3/9 patients treated. The allogeneic product cells persist and have enhanced function compared to patient NK cells for up to 21 days, even after retreatment. This phase I study in recurrent/refractory ovarian cancer shows promise for IP NK cell delivery."

P1 data • Cytomegalovirus Infection • Gynecologic Cancers • Immunology • Infectious Disease • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor • CD57 • IFNG • IL15

Open Label NK Cell Infusion (FATE-NK100) With Subq IL-2 in Adults With AML (clinicaltrials.gov) - P1; N=6; Completed; Sponsor: Masonic Cancer Center, University of Minnesota; Active, not recruiting ➔ Completed; Trial primary completion date: Jan 2021 ➔ Aug 2020

Clinical • Trial completion • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Intraperitoneal Delivery of Adaptive Natural Killer (NK) Cells (FATE-NK100) With Intraperitoneal Int (clinicaltrials.gov) - P1; N=10; Completed; Sponsor: Masonic Cancer Center, University of Minnesota; Active, not recruiting ➔ Completed; Trial completion date: Jan 2025 ➔ Mar 2021; Trial primary completion date: Jan 2025 ➔ Mar 2021

Clinical • Trial completion • Trial completion date • Trial primary completion date • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor

Intraperitoneal Delivery of Adaptive Natural Killer (NK) Cells (FATE-NK100) With Intraperitoneal Int (clinicaltrials.gov) - P1; N=10; Active, not recruiting; Sponsor: Masonic Cancer Center, University of Minnesota; Recruiting ➔ Active, not recruiting; N=16 ➔ 10

Clinical • Enrollment change • Enrollment closed • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor

Novel strategies to activate NK cells and make them antigen-specific (EBMT 2018) - "In addition, we have exploredIL-15/IL-15Ra-Fc (ALT-803), an IL-15 superagonistcomplex, which may be more optimal to present IL-15 to the immune system. Our data suggeststhat adaptive NK cells can be enriched from CMV+ donors after culture withIL-15 and a GSK3b inhibitor, a novelNK cell product in phase I clinical trials. Lastly, new strategies usingoff-the-shelf NK cells from induced pluripotent stem cells (iPSC) are beingdeveloped and will be in the clinic by the end of the year. This will allowmultiple dosing of cryopreserved “living drugs” to treat patients with cancer."

Acute Myelogenous Leukemia • Biosimilar • Cytomegalovirus Infection • Myelodysplastic Syndrome

Antibody-dependent NK cell control of Plasmodium falciparum infection (AAI 2017) - "This work indicates that protective antibodies may pair with the strong ADCC activity of adaptive NK cells to protect human subjects from malaria symptoms. These findings thus open a new avenue for vaccine development exploring antibody-dependent cell mediated killing of malaria parasites."

Biosimilar • Immunology • Oncology

Open Label NK Cell Infusion (FATE-NK100) With Subq IL-2 in Adults With AML (clinicaltrials.gov) - P1; N=6; Active, not recruiting; Sponsor: Masonic Cancer Center, University of Minnesota; Recruiting ➔ Active, not recruiting; N=20 ➔ 6

Clinical • Enrollment change • Enrollment closed

FATE-NK100 as Monotherapy and in Combination With Monoclonal Antibody in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=100; Active, not recruiting; Sponsor: Fate Therapeutics; Recruiting ➔ Active, not recruiting

Clinical • Combination therapy • Enrollment closed • Monotherapy • EGFR • HER-2

Intraperitoneal Delivery of Adaptive Natural Killer (NK) Cells (FATE-NK100) With Intraperitoneal Int (clinicaltrials.gov) - P1; N=16; Recruiting; Sponsor: Masonic Cancer Center, University of Minnesota; Trial completion date: Apr 2020 ➔ Jan 2025; Trial primary completion date: Nov 2019 ➔ Jan 2025

Clinical • Trial completion date • Trial primary completion date

Fate Therapeutics Reports Fourth Quarter and Full Year 2018 Financial Results and Highlights Operational Progress (GlobeNewswire, Fate Therapeutics, Inc.) - P1, N=20; NCT03081780; P1, N=16; NCT03213964; P1, N=100; NCT03319459; Sponsor: Fate Therapeutics; "Anti-Tumor Activity of FATE-NK100 Observed Across Three Phase 1 Studies. In November 2018, the Company reported initial dose-escalation clinical data of FATE-NK100 from fifteen subjects across three Phase 1 clinical trials for the treatment of relapsed / refractory acute myelogenous leukemia, recurrent ovarian cancer and advanced solid tumors. As of an October 22, 2018 data cutoff, no FATE-NK100-related dose limiting toxicities were reported, and anti-tumor activity was observed with a single dose of FATE-NK100 in seven of the fifteen subjects."

P1 data

In Vivo Persistence and Function of Adaptive NK Cell Infusions (FATE-NK100) from CMV Seropositive Haploidentical Related Donors (TCT-ASBMT-CIBMTR 2019) - P1, P2; "All patients at dose cohort 2 achieved clearance of their refractory AML at Day 14 (morphologic leukemia free state) and we await enrollment to the 3rd (maximum) dose cohort (3-10x107 NC/kg). In summary, adaptive FATE-NK100 cell infusions persist in vivo in both the peritoneum and peripheral blood and exhibit potent functional activity."

Preclinical

CMV-MVA Triplex Vac.Enhance Adap. NK Cell Recon. After Auto HSCT in pt Lymphoid Malig (clinicaltrials.gov) - P1; N=20; Recruiting; Sponsor: Masonic Cancer Center, University of Minnesota; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open