FDA Lifts Clinical Hold On Gamida's Cryopreserved Formulation Of GDA-201

(RTTNews) - Gamida Cell Ltd. (GMDA), a clinical-stage biopharmaceutical company, on Tuesday announced that it has received FDA clearance to initiate a phase I/II trial of a cryopreserved formulation of GDA-201 in patients with diffuse large B cell lymphoma and follicular lymphoma.

Last October, the FDA had placed the company's application for the cryopreserved formulation of GDA-201 on clinical hold, pending modifications to donor eligibility procedures and sterility assay qualification.

Now that the clinical hold has been lifted, the company plans to initiate a phase I/II study with cryopreserved formulation of GDA-201 in patients with follicular and diffuse large B-cell lymphomas this year.

An earlier investigator-sponsored study evaluating the fresh formulation of GDA-201 had demonstrated durable complete responses in heavily pre-treated patients with relapsed or refractory lymphoma.

GDA-201 is an off-the-shelf cell therapy candidate for the treatment of follicular and diffuse large B cell lymphomas. It leverages the company's proprietary NAM technology platform to expand the number and functionality of NK cells to direct tumor cell killing properties and antibody-dependent cellular cytotoxicity.

The unique properties of Nicotinamide is expected to expand and metabolically modulate multiple cell types - including stem cells and natural killer cells - with appropriate growth factors to maintain the cells' active phenotype and enhance potency.

Shares of Gamida Cell are currently trading in pre-market at $3.42, up $0.60 or 21.28 percent from the previous close.