U.S. FDA Grants Fast Track Designation to Artiva Biotherapeutics' Lead Program AB-101

Jul 21 2025

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U.S. FDA Grants Fast Track Designation to Artiva Biotherapeutics’ Lead Program AB-101

Artiva Biotherapeutics, Inc., a clinical-stage company whose mission is to provide highly effective, off-the-shelf, allogeneic natural killer (NK) cell-based therapies, announces that the U.S. FDA has granted Fast Track designation to Artiva’s lead program AB-101. AB-101 is a non-genetically modified, allogeneic, cryopreserved, ADCC-enhancing NK cell therapy candidate for use in the outpatient setting in combination with monoclonal antibodies or innate-cell engagers.

Publish Date: 31-01-2023 Source: Artiva Biotherapeutics, Inc.

Diffuse intrinsic pontine glioma (DIPG) is a lethal malignant pediatric tumour that spreads throughout the pons. Pediatric gliomas with a K27M mutation in histone H3 with a diffuse growth pattern in a midline location are referred to as diffuse midline glioma, H3 K27M mutant; this designation is inclusive of DIPG cases bearing the K27M mutation. This devastating disease has a median age of 6-7 years at diagnosis and is rarely detected in adults. Given its eloquent location, current treatment options are limited, and the prognosis is dismal—with less than 10% of patients surviving beyond two years from the time of diagnosis. DIPGs account for 80% of all paediatric brain tumours in the brainstem. These tumours share histological characteristics with anaplastic astrocytomas (grade III) or glioblastomas (GBM) (grade IV. Brainstem gliomas affect approximately 350 to 450 children in the United States annually and are the major cause of death in children with brain tumours. The most common of these is DIPG comprising 80% of the cases.

  • DIGP incidence is 1 to 2 cases per 100,000 population, with a peak incidence of 6-9 years and slightly higher among males.

However, the current Relapsed or Refractory B-cell Non-Hodgkin’s lymphoma treatment market share, market uptake, and attribute analysis concerning the most potential emerging therapies (Mosunetuzumab, TAK-007, Pralatrexate, etc..) has been provided under the market outlook section of the study covering 8 MM countries; The United States, EU5 (Germany, Spain, France, Italy, UK) Japan and China.

In terms of pharmacologic therapies, several pharmaceutical products are being approved and under different phases of development for the Relapsed or Refractory B-cell Non-Hodgkin’s lymphoma treatment. The key companies in the advanced development stage are Hoffmann-La Roche, Takeda, Spectrum Pharmaceuticals, Inc, etc.

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