The investigational adaptive memory natural killer (NK) therapy FATE-NK100 has been administered with success to the first acute myelogenous leukemia (AML) patient enrolled in the VOYAGE Phase 1 trial (NCT03081780), the therapy’s developer, Fate Therapeutics, announced in the company’s second quarter financial report for 2017.
The open-label, dose-escalation Phase 1 study, which is currently recruiting participants, was designed to assess the effects of a single infusion of FATE-NK100 in patients with relapsed or refractory AML.
Its primary goal is to determine the therapy’s safety and persistence in the body seven and 14 days after a single injection. Additionally, researchers will assess FATE-NK100’s anti-tumor activity by measuring the rates of complete responses 42 days post-infusion, as well as clearance of minimal residual disease.
FATE-NK100 is a first-in-class immunotherapy containing NK cells primed to attack a patient’s cancer cells.
In previous preclinical studies, FATE-NK100 showed enhanced anti-tumor activity against different types of tumor cells. The investigational therapy was more resistant to immune checkpoint proteins, which dampen the immune responses against tumors cells, than currently available NK cell therapies.
VOYAGE is underway at the Masonic Cancer Center, University of Minnesota, and its results will allow researchers to determine the maximum tolerated dose of a single intravenous infusion of FATE-NK100. They also will determine the best dose to be tested in a Phase 2 trial. Final data collection to measure the primary outcome is expected in January 2021.
“Clinical momentum across our first-in-class cellular immunotherapy programs continues to accelerate. The first subject was treated with FATE-NK100 in VOYAGE for AML, and we look forward to opening two additional clinical trials of FATE-NK100 for the treatment of multiple advanced solid tumor types including in combination with monoclonal antibody therapy,” Scott Wolchko, president and chief executive officer of Fate Therapeutics, said in a press release.
The company also is planning to test FATE-NK100 in patients with solid tumors both as a stand-alone treatment and in combination with FDA-approved therapies. The DIMENSION trial will test FATE-NK100 as a monotherapy in patients with small cell lung cancer and liver cancer; in combination with Herceptin (trastuzumab) for advanced HER2-positive cancers, including breast and gastric cancers; and in combination with Erbitux (cetuximab) for advanced EGFR1-positive cancers, including colorectal and head and neck cancers.
The APOLLO Phase 1 trial (NCT03213964) will assess the safety and effectiveness of FATE-NK100 administered intraperitoneally to women with advanced ovarian, fallopian tube, or primary peritoneal cancer who relapsed after platinum-based chemotherapy or failed to respond to it.