In an update on its business outlook for 2021 and 2022, Autolus, which is focused on developing next-generation programmed T-cell therapies, said it is prioritising its AUTO1 treatment for adult acute lymphoblastic leukaemia.
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Autolus, which expects full data from its AUTO1-AL1 study in 2022, said it also intends to seek a partner for AUTO3, a programmed T cell investigational therapy designed to help treat large B cell lymphoma, ahead of progressing into the next phase of development.
Meanwhile, the portfolio firm also said it is cutting its workforce by 20% and infrastructure footprint to align with its prioritisation of AUTO1, which is expected to result in annual cash savings of US$15mln once fully implemented.
The company added that it is continuing to develop its pipeline of next-generation programmes which are specifically tailored for oncology indications with high unmet need.
“We are very excited about the unique characteristics of AUTO1 that we reported at ASH in December 2020, with some patients continuing in molecular complete remission at 24 months without a subsequent transplant, an event-free survival of 52% at 12 months and a well-tolerated safety profile”, Autolus chairman and chief executive Christian Itin said in a statement.
“Taking into consideration the high unmet need in adult ALL and the commercial opportunity this represents, we are prioritizing this program with potential pivotal data expected in 2022. We also plan to capitalise on the differentiated profile of AUTO1 by exploring activity in additional B-cell malignancies, including Primary CNS Lymphoma (PCNSL) where no adequate standard of care currently exists. We expect to see first data from these additional indications in 2021.
“Building on its differentiated clinical profile, we believe AUTO1 is well positioned to deliver fundamental value for patients and shareholders. Our organisational focus will position us well to realize the potential of AUTO1 and lay the foundation for the next opportunities in our pipeline with several clinical proof of concepts targeted during 2021 and 2022.”
Broker Peel Hunt said: “We always knew that Q122E would see a ‘go/no go’ decision for AUTO3 in clinical development, and the company is now seeking partnership opportunities to fund additional clinical development for AUTO3 in relapsed/refractory diffuse large B cell lymphoma (DLBCL) – currently in a Phase 1/2 trial – before progressing the programme.”
Analysts noted that data in AUTO3 had “not been unfavourable (with a promising safety and efficacy profile), but Autolus has been very clear about this decision point, and though the shares will likely see weakness from this today, much of the risk-adjusted impact of this decision should have been recognised in the EV”.
Imara trial update
Imara, meanwhile, reported results from its Phase 2a clinical trial of its IMR-687 treatment in adult patients with sickle cell disease (SCD).
The trial showed promising reductions in the rate of vaso-occlusive crises/sickle cell-related pain crises (VOCs/SCPCs) for patients treated with IMR-687 as a monotherapy compared to placebo.
Biomarker data from both monotherapy IMR-687 and in combination with hydroxyurea (HUP) groups showed improvement in markers of hemolysis, with variable fetal hemoglobin (HbF) results.
Reductions in high sensitivity C-reactive protein (hsCRP) and amino-terminal pro-brain type natriuretic peptide (NTproBNP) in patients treated with IMR-687 as a monotherapy suggest its potential for lowering inflammation and cardiac stress in SCD.
IMR-687 was well tolerated as a monotherapy and in combination with HUP.
Additional data from Phase 2a open label extension trial and interim results from Ardent and Forte Phase 2b clinical trials is expected later in 2021.
“I am encouraged by the incremental data from this readout, especially in light of the COVID-19 pandemic challenges,” said Biree Andemariam, MD, associate professor at UConn School of Medicine, director of the New England Sickle Cell Institute at UConn Health and lead investigator for the trial.
“This includes a favorable safety profile of IMR-687, lower rate of VOCs/SCPCs and VOC-related hospitalizations in the population A1 monotherapy arm and improvements in several biomarker results across both the monotherapy and combination groups.
“I am also pleased by the reductions in hsCRP and NT-proBNP in the Population A1 monotherapy arm. Both are clinically utilized biomarkers of inflammation and cardiac stress, respectively, and suggest that higher doses of IMR-687 may have novel anti-inflammatory and cardiovascular benefits in sickle cell disease.”