CYNK-101 Receives Fast Track Designation for HER2-Positive Gastric/GEJ Cancers

The FDA has granted fast track designation to a natural killer (NK) cell therapy (CYNK-101) being developed in combination with standard chemotherapy, trastuzumab, and pembrolizumab for patients in first-line locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma.

CYNK-101 is a genetically modified cryopreserved human placental hematopoietic stem cell–derived NK cell therapy developed by Celularity Inc. The company received approval for an investigational new drug (IND) application for the allogeneic NK cell therapy in November 2021.

A phase 1/2a study is currently being planned to test the safety and preliminary efficacy of the combination.

“We are extremely excited to receive this fast track designation and the support from the FDA for our investigational genetically modified NK cell therapy in the first-line setting of [gastric]/GEJ cancers,” Robert Hariri, MD, PhD, founder, chair, and CEO of Celularity, said in a statement. “Using novel genetic engineering, we have enhanced the ability of CYNK-101 cells to synergize with approved antibodies and provide a novel and potentially non–cross resistant therapy to improve the lives of patients with [gastric]/GEJ cancers as well as a broad range of other indications.”

For gastric/GEJ cancer treatment, the addition of pembrolizumab to chemotherapy and trastuzumab significantly increased overall response rates, explained Andrew Pecora, MD, president of Celularity. In gastric cancer, the median overall survival (OS) is 10 to 12 months and the 5-year OS is approximately 5% to 20%.

“Our recently accepted IND enables the assessment to possibly further improve outcomes in [gastric]/GEJ treated with triple combination therapy by adding CYNK-101 cells, a potentially non–cross resistant therapy (enhanced [antibody-dependent cellular cytotoxicity], direct NK cell tumor killing and help of T-cell function and memory) after initially cytoreducing the tumor mass and potentially diminishing resistance in the tumor microenvironment with combined chemotherapy, traztuzumab and pembrolizumab ‘induction’ followed by reinduction and maintenance with CYNK-101 cells in combination with trastuzumab and pembrolizumab,” Pecora said.

Celularity presented preclinical data on CYNK-101 at the 2021 Society for Immunotherapy of Cancer Annual Meeting.

This is the third fast track designation that Celularity has received within the last 12 months, following fast track designations for CYNK-001 for acute myeloid leukemia and for recurrent glioblastoma multiforme. The purpose of a fast track designation is to expedite the review of drugs that treat serious conditions and fill an unmet medical need for the purpose of getting treatments to patients faster.