On June 15, 2021 Autolus Therapeutics, a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, reported that it has received innovative licensing and access pathway (ILAP) 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, JUN 15, 2021, View Source [SID1234584088]).
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"The ILAP designation for obe-cel, alongside the recent PRIority MEdicines (PRIME) designation from the European Medicines Agency (EMA), is another step forward in accelerating the review process of this promising therapy," said Dr. Christian Itin, chief executive officer of Autolus. "Obe-cel continues to show the potential to be differentiated on efficacy, durability and safety from other CAR T cell products and could change standard of care by offering a potentially curative therapy for r/r ALL."
About ILAP
ILAP was announced in December 2020 and launched at the start of 2021 in order to accelerate the development and access to promising medicines and is geared toward medicines that are in the early stages of development. The pathway, part of the UK’s plan to attract life sciences development in the post-Brexit era, features enhanced input and interactions with MHRA and other stakeholders including the National Institute for Health and Care Excellence (NICE) and the Scottish Medicines Consortium (SMC). (RELATED: MHRA sheds light on pathway to accelerate R&D, Regulatory Focus 24 December 2020).
The innovation passport designation is the first step in the ILAP process and triggers the MHRA and its partner agencies to chart a roadmap for regulatory and development milestones with the goal of early patient access in the UK. Other benefits of ILAP include access to range of development tools, such as the potential for a 150-day accelerated Marketing Authorization Application (MAA) assessment, rolling review and a continuous benefit risk assessment.