Poseida receives FDA orphan drug designation for lead candidate and FDA approval of fully outpatient dosing in Phase 2 clinical trial
Dublin-Ireland, 14 May 2019: Malin Corporation plc. (Euronext Growth Dublin:MLC) (“Malin”), a company investing in highly innovative life sciences companies, is pleased to note that Poseida Therapeutics Inc. (“Poseida”), one of Malin’s Priority Assets, has announced the US Food and Drug Administration (“FDA”) has granted orphan drug designation to P-BCMA-101 for the treatment of relapsed and/or refractory multiple myeloma.
Orphan drug designation is granted by the FDA Office of Orphan Products Development to drugs and biologics which are intended for the treatment, diagnosis or prevention of rare diseases/disorders. Under the Orphan Drug Act, the FDA may provide grant funding toward clinical trial costs, tax advantages, FDA user-fee benefits and seven years of market exclusivity in the US following marketing approval by the FDA.
“We are pleased with Poseida’s continued positive progress in the development of P-BCMA-101,” said Darragh Lyons, Chief Business and Financial Officer of Malin. “The receipt of orphan drug designation is an important regulatory milestone while the FDA approval of fully outpatient dosing in the Phase 2 study, due to commence in Q2 2019, is validation of the outstanding safety profile demonstrated by P-BCMA in the Phase 1 study.”
P-BCMA-101 is an autologous CAR-T therapy developed using Poseida’s piggyBac® platform technology. The programme is currently in an ongoing Phase 1 dose escalation clinical trial where it has displayed outstanding potency, with remarkably low rates of toxicity, and the FDA has approved fully outpatient dosing in the Phase 2 trial starting in the second quarter of 2019.
In April 2019, Poseida announced the closing of a Series C financing round, raising $142 million, led by a $75 million equity investment from Novartis Pharma AG. Having invested $4 million as part of this financing transaction, Malin retains approximately one-quarter of the issued share capital of Poseida.
A copy of Poseida’s press release is available to view here: