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.

The biotech industry is flourishing, yet most traders lack the tools and guidance to profit and profit consistently. Lucky for you, Kyle Dennis can be your mentor. He’s made millions after starting with just $15,000 years ago. Here, sign up for his free training and he’ll walk you through the 3 step process he uses to extract profits from the biotech sector.