– Designation is an important step toward bringing this potentially life-changing therapy to European patients – – EU Orphan Drug Designation is the first regulatory designation for a gorilla.
– FDA confirmed that the ongoing Phase 1/2 single arm study will serve as pivotal and no additional randomized, placebo-controlled trial will be required to support submission of a.
– First FDA Breakthrough Therapy Designation granted for AdenoVerse immunotherapy platform; designation prioritizes PRGN-2012 as a potential treatment for RRP –– . | June 20, 2023
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Share this article Share this article GERMANTOWN, Md., Jan. 13, 2021 /PRNewswire/ Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, today presented clinical and preclinical updates at the 39th Annual J.P. Morgan Healthcare Conference. Helen Sabzevari, PhD, President and CEO of Precigen, presented a summary of 2020 clinical achievements and set forth Precigen s clinical goals for 2021. In addition to reviewing the latest clinical updates for Precigen s PRGN-3005 UltraCAR-T, PRGN-3006 UltraCAR-T, AG019 ActoBiotics™, the presentation included the following additional announcements: UltraCAR-T Library Approach: Precigen introduced the Company s vision for a new UltraCAR-T library approach to transform the personalized cell therapy landscape for cancer patients. Precigen s goal is to develop and validate a library of non-viral plasmids to target tumor-associated antigens. Enabled by design and manufacturing advantages of UltraCAR-T, coupled with the capabilities of the UltraPorator