Precision Bio receives Fast Track Designation from FDA for PBCAR269A in r/rMM

PBCAR269A is being evaluated in a Phase 1/2a multi-center, non-randomized, open-label, parallel assignment, single-dose, dose-escalation, and dose-expansion study to evaluate the safety and clinical activity of PBCAR269A in adults with relapsed/refractory multiple myeloma. The starting dose of PBCAR269A is 6 x 105 CAR T cells/kg body weight with subsequent cohorts treated with escalating doses to a maximum dose of 6 x 106 CAR T cells/kg body weight. The trial is being conducted at multiple U.S. sites with clinical trial material generated in-house at the Manufacturing Center for Advanced Therapeutics (MCAT) in Durham, North Carolina. 

Precision is advancing a pipeline of cell-phenotype optimized allogeneic CAR T therapies, leveraging fully scaled, proprietary manufacturing processes. The platform is designed to maximize the number of patients who can potentially benefit from CAR T therapy. Precision carefully selects high-quality T cells derived from healthy donors as starting material, then utilizes its unique ARCUS genome editing technology to modify the cells via a single-step engineering process. By inserting the CAR gene at the T cell receptor (TCR) locus, this process knocks in the CAR while knocking out the TCR, creating a consistent product that can be reliably and rapidly manufactured that is designed to prevent graft-versus-host disease. Precision optimizes its CAR T therapy candidates for immune cell expansion in the body by maintaining a high proportion of naive and central memory CAR T cells throughout the manufacturing process and in the final product. 

TherapeuticsMD gets another patent for ANNOVERA female contraceptive

In addition, based on recent communications from the USPTO, a third ANNOVERA patent (U.S. Patent No. 10,780,047) is scheduled to be issued on 9/22/2020. These Orange Book eligible patents, which provide patent protection through 2039, cover ANNOVERA and its use for the labeled indication of preventing pregnancy in females of reproductive potential.

Before the issuance of the first Orange Book listable patent for ANNOVERA, the product was protected by FDA regulatory exclusivity through 2023 as a new chemical entity. These additional patents, which cover different aspects of ANNOVERA, provide independent layers of patent protection.

ANNOVERA is a critical component of the company’s drive towards EBITDA breakeven in 2021.