On April 16, 2020 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies for the treatment of cancer, reported that the U.S. Food and Drug Administration (FDA) has accepted the Investigational New Drug (IND) application for AUTO1, its lead CAR T product candidate for the treatment of adults with acute lymphoblastic leukemia (ALL) (Press release, Autolus, APR 16, 2020, View Source [SID1234556399]). The active IND allows initiation of the US sites in the company’s first pivotal study, AUTO1-AL1. The AUTO1-AL1 study clinical trial application was approved by the MHRA in January 2020 and the first site opened in the UK in March of this year.
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The COVID-19 situation has had varying degrees of impact on the ability of clinical sites to operate normally; however, based on current expectations, the company anticipates that the impact on the AUTO1-AL1 clinical study will be minimal. The AUTO1-AL1 study has a run in phase, with a small number of patients scheduled to be enrolled into the study in Q2, limiting the impact from the COVID-19 situation at this stage. The company has continued to manufacture, without interruption, from its operations at the Cell and Gene Therapy Catapult located in Stevenage, UK, including supply to the US of clinical products for the treatment of DLBCL patients in its AUTO3-ALEXANDER study.
"We are looking forward to starting the treatment of patients at US clinical study sites in an indication where currently no CAR T therapy is approved," said Dr. Christian Itin, chairman and chief executive officer of Autolus. "Our AL1 clinical trial is already open in the UK and this milestone enables us to build on the encouraging data published to date, which suggests AUTO1 has a high level of clinical activity combined with a manageable safety profile."