Gami­da Cell gets IND cleared and clin­i­cal hold lift­ed, paving the way for PhI/II clin­i­cal tri­als

The small Boston-based cell ther­a­py out­fit Gami­da Cell re­cent­ly axed 10% of its work­force in or­der to slow the burn rate. But now it’s got some more up­beat news for in­vestors: The FDA cleared the com­pa­ny’s IND for a B cell lym­phoma treat­ment and re­leased a clin­i­cal hold for the drug can­di­date.

The treat­ment is a cry­op­re­served for­mu­la­tion of a drug called GDA-201, an off-the-shelf, en­gi­neered nat­ur­al killer cell pro­gram de­signed to treat fol­lic­u­lar and dif­fuse large B cell lym­phomas. The FDA had placed the com­pa­ny’s ap­pli­ca­tion for the cry­op­re­served for­mu­la­tion of GDA-201 on clin­i­cal hold back in Oc­to­ber af­ter the agency re­quest­ed that Gami­da Cell mod­i­fy its donor el­i­gi­bil­i­ty pro­ce­dures and steril­i­ty as­say qual­i­fi­ca­tion.

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