Precigen, Inc., a subsidiary unit of Intrexon Corp (NASDAQ:XON) reported that the U.S. FDA has approved the Investigational New Drug application for PRGN-3006. It is a first-in-class investigational treatment using Precigen’s UltraCAR-T™.

The buzz

PRGN-3006 UltraCAR-T marks as an autologous CAR-T therapy for cure of patients with refractory or relapsed higher risk myelodysplastic syndrome and acute myeloid leukemia. PRGN-3006 uses Precigen’s advanced UltraCAR-T platform, which lowers manufacturing period to less than two days post non-viral gene transfer.

David Sallman, MD, the main investigator for the PRGN-3006 trial at the Moffitt Cancer Center, expressed that they are eager to assess the PRGN-3006 UltraCAR-T in these subject populations as existing treatment alternatives are limited. The PRGN-3006 UltraCAR-T exhibits the prospect of precision drug to offer targeted treatment alternatives for this underserved patient group.

PRGN-3006 UltraCAR-T can be stated as a multigenic CAR-T cell therapy using Precigen’s clinically-supported Sleeping Beauty setup to co-express chimeric antigen receptor, mbIL15, and a kill switch for improved control and precision in targeting refractory or relapsed AML and increased risk MDS. The study to assess the maximal tolerated dose and safety of PRGN‐3006 UltraCAR-T will be performed together with Moffitt Cancer Center.

Helen Sabzevari, PhD, the President of Precigen, expressed that with their introductory in-human UltraCAR-T IND approval from the FDA in around a year since their establishment, they have achieved another major milestone for Precigen and patients. They are dedicated to advancing the PRGN-3006 UltraCAR-T as efficiently and as quickly as possible with the objective of offering an effective treatment alternative for these people with high unmet need.

UltraCAR-T platform showcases the prospective to unsettle the CAR-T treatment setting by improving patient access via reducing manufacturing period from weeks to days, lowering manufacturing-linked costs, and improving results using developed methods for specific tumor targeting and management of the immune system. This platform offers numerous major advancements. Precigen has scheduled a conference call on December 26, 2018.

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