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Celularity Garners IND Clearance for NK-Cell Therapy, Immunotherapy Combo Trial

NEW YORK – Celularity on Monday said it has received permission from the US Food and Drug Administration to begin studying its genetically engineered natural killer (NK)-cell therapy CYNK-101 in combination with immunotherapy in patients with advanced HER2/neu-positive gastric or gastroesophageal junction cancer.

According to the Florham Park, New Jersey-based cell therapy company, CYNK-101 comprises off-the-shelf allogeneic placental-derived NK cells that it has modified to enhance antibody-dependent cellular cytotoxicity and resist cleavage of CD16. The company believes its cell therapy will work synergistically with other antibody drugs.

With the FDA's clearance of its investigational new drug application for CYNK-101, Celularity will now test out this hypothesis in a Phase I/IIa open label, non-randomized trial of its NK-cell therapy with the anti-HER2 monoclonal antibody trastuzumab (Genentech's Herceptin) and the anti-PD-1 immunotherapy pembrolizumab (Merck's Keytruda). Celularity will explore the safety and preliminary efficacy of the combination as a first-line treatment for patients with local advanced, unresectable, or metastatic HER2/neu-positive gastric or gastroesophageal junction cancer.

Earlier this year, the FDA granted accelerated approval to pembrolizumab with trastuzumab and chemotherapy for this same indication.

"By enhancing the innate [antibody-dependent cellular cytotoxicity] 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," Robert Hariri, Celularity's chairperson and CEO, said in a statement. "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."