Biologics

Allogene Gets 3 Fast Tracks for Cell Therapy

FDA has granted Allogene Therapeutics three fast track designations for ALLO-329, an investigational dual-targeted CD19/CD70 allogeneic CAR T cell therapy. The designations are for treating adults with:

active refractory moderate-to-severe systemic lupus erythematous (SLE);
active severe/refractory idiopathic inflammatory myopathy (IIM), specifically dermatomyositis, immune mediated necrotizing myopathy and anti-synthetase syndrome; and
active refractory diffuse systemic sclerosis (SSc).

The company says it expects to initiate a Phase 1 RESOLUTION “basket” trial later this year. A basket trial evaluates a single drug in patients with different types of disease that often share a common biomarker or genetic alteration, according to NIH. The trial design will leverage “clinically validated Dagger technology to drive CAR T cell expansion and prevent rejection, includes two distinct lymphodepletion arms: one using a dose of cyclophosphamide alone, which is used by rheumatologists, and another that eliminates lymphodepletion entirely,” the company says.

ALLO-329 uses CRISPR-based site-specific integration for dual CAR expression, according to Allogene, adding that the approach targets both CD19+ B cells and CD70+ T cells, which play a role in autoimmune disease pathogenesis.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome