Benzinga | Nov 29, 2021 08:04AM EST

Celularity Announces FDA Clearance Of Investigational New Drug Application For Natural Killer Cell Therapy CYNK-101 In First-line Advanced Her2/Neu Positive Gastric And Gastroesophageal Junction Cancer

Celularity Inc. (NASDAQ:CELU) ("Celularity"), a clinical-stage biotechnology company developing placental-derived allogeneic cell therapies, today announced the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for the use of CYNK-101 in combination with standard chemotherapy, trastuzumab and pembrolizumab in patients with first-line locally advanced unresectable or metastatic HER2/neu positive gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. CYNK-101 is an investigational genetically engineered natural killer (NK) cell therapy designed to enhance antibody-dependent cellular cytotoxicity (ADCC) with approved and novel antibody therapeutics.

"Gastric cancer represents the fifth most common cancer worldwide, and in advanced stages of the disease, continues to be associated with less than desirable survival outcomes despite recent advances," said Robert Hariri, M.D., Ph.D., Founder, Chairperson and Chief Executive Officer of Celularity. "By enhancing the innate ADCC activity of our placental-derived NK cells, we have developed a cellular therapy platform that holds promise to complement and synergize with a range of antibody treatment strategies across a variety of tumor types. Our goal is to combine the potential advantages of placental-derived cellular therapies, including enhanced persistence, proliferation and resistance to cell exhaustion, with approved treatment strategies," Hariri said.

Andrew Pecora, M.D., President of Celularity, said, "Among patients with locally advanced unresectable or metastatic HER2/neu positive gastric or gastroesophageal junction adenocarcinoma, advances in patient outcomes have been achieved with the addition of trastuzumab, and more recently, pembrolizumab, to standard chemotherapy, leading to regulatory approval of this combination. We are now excited to begin assessing if our off-the-shelf allogeneic placental-derived NK cells that have been genetically modified to enhance ADCC and resist cleavage of CD16 can improve clinical outcomes when added to the current combination in this patient population."

The Phase 1/2a open-label, non-randomized clinical trial is designed to evaluate the safety and preliminary efficacy of the combination treatment strategy.