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Wednesday, 04/22/2020 9:10:20 PM

Wednesday, April 22, 2020 9:10:20 PM

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The FDA has accepted the IND application for AUTO1, for the treatment of adults with acute lymphoblastic leukemia. The active IND allows initiation of the US sites in the company's first pivotal trial (AUTO1-AL1). The AUTO1-AL1 trial application was approved by the MHRA in Jan and the first site opened in the UK in March. 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 trial will be minimal. The trial 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 trial.

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