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.
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