On August 9, 2021 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, reported that it has received Promising Innovative Medicine (PIM) designation from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for AUTO1 (obecabtagene autoleucel, obe-cel), the company’s CAR T cell therapy being investigated in the ongoing FELIX Phase 1b/2 study in relapsed/refractory (r/r) adult B-cell Acute Lymphocytic Leukemia (ALL) in patients 18 years and older (Press release, Autolus, AUG 9, 2021, View Source [SID1234586149]).
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"PIM designation is a recognition of obe-cel as a promising candidate for the Early Access to Medicines Scheme (EAMS) in the UK for the treatment of adult patients with r/r ALL, a life-threatening condition with high unmet need," said Dr. Christian Itin, chief executive officer of Autolus.
About PIM
PIM designations are given to medicinal products that are likely to offer a major advantage for patients. For the MHRA to grant a PIM Designation, the product must meet each of the following three criteria:*
Criterion 1: The conditions should be life-threatening or seriously debilitating with high unmet need, meaning there is no method of treatment, diagnosis or prevention available, or existing methods have serious limitations
Criterion 2: The medicinal product is likely to offer major advantage over methods currently used in the UK. Preliminary evidence should be submitted based on both non-clinical and clinical data
Criterion 3: The potential adverse effects of the medicinal product are likely to be outweighed by the benefits, allowing for the reasonable expectation of a positive benefit risk balance