Therapy Areas: Infectious Diseases
NantKwest Releases Phase 1 Results for First-in-Human PD-L1 Tumor-Targeted Natural Killer Cells (PD-L1.t-haNK) in Patients with Locally Advanced or Metastatic Solid Cancers
4 December 2019 - - US-based immunotherapy company NantKwest, Inc. (NASDAQ: NK) is touting promising safety data generated from the first six patients in its QUILT-3.064 trial, the company said.

The first-in-human study evaluated the safety and preliminary efficacy of the company's first-in-class, tumor-targeted PD-L1.t-haNK cell therapy in patients with locally advanced or metastatic solid tumors.

On December 2, 2019 at the NantKwest Key Opinion Leader and Investors conference, Dr. Soon-Shiong described the clinical development plans for two of NantKwest's first-in-class NK products: haNK, which was developed to target binding to approved monoclonal therapies such as Trastuzumab, Rituximab and Cetuximab; and PD-L1.t-haNK, which was also designed to target these approved therapies plus directly target PD-L1-expressing tumor cells.

PD-L1.t-haNK cells are a human-derived, allogeneic, natural killer cell line engineered to express a chimeric antigen receptor targeting PD-L1, whose origins arise from NantKwest's proprietary NK-92 master cell bank.

In addition to targeting PD-L1, PD-L1.t-haNK is engineered to produce intracellular IL-2 for enhanced CD16-targeted antibody-dependent cellular cytotoxicity capabilities.

The QUILT-3.064 study is an open-label, Phase 1 study of PD-L1.t-haNK in subjects with locally advanced or metastatic solid cancers to evaluate safety, preliminary efficacy, determine maximum tolerated dose or highest tolerated dose and designate the recommended Phase 2 dose.

The study is being conducted in two parts: the first is evaluating dose escalation using a 3 + 3 design and the second part will evaluate the expansion of the recommended Phase 2 dose to further assess the safety and efficacy of PD-L1.t-haNK therapy.

In part one, six subjects were sequentially enrolled, starting at dose level 1 and assessed for dose-limiting toxicities.

The primary study objectives are to determine the MTD or HTD, RP2D (recommended phase 2 dose), and safety. The secondary endpoints include objective response rate, progression free survival and overall survival. More information can be found at, Identifier: NCT04050709.

NantKwest (NASDAQ: NK) is an immunotherapy company focused on harnessing the power of the innate immune system to treat cancer and virally induced infectious diseases.

We are the leading producer of clinical dose forms of off-the-shelf Natural Killer cell therapies. Our activated NK cell platform is designed to destroy cancer and virally infected cells from the body.

The safety of our optimised, activated NK cells, as well as their activity against a broad range of cancers, have been tested in phase I clinical trials in Canada and Europe, as well as in multiple phase I and II clinical trials in the United States.

By leveraging an integrated and extensive genomics and transcriptomics discovery and development engine, together with a pipeline of multiple, clinical-stage, immuno-oncology programmes, NantKwest's goal is to transform medicine by delivering living drugs in a bag and bringing novel NK cell-based therapies to routine clinical care. NantKwest is a member of the NantWorks ecosystem of companies.