Tag Archives: AUTO1

Obe-cel MAA Submitted to the EMA; Nucleus Manufacturing Facility Ready for Obe-cel Launch; Obe-cel’s Trial in SLE and AUTO6NG’s Study in Pediatric Glioblastoma Initiated; Autolus Q4 2023 Earnings Call Summary

On Thursday, March 14, Autolus held its Q4 2023 earnings call (press release/ presentation) highlighting the recent submission of a Market Authorization Application (MAA) for obe-cel (CD19 CAR-T) in r/r ALL, while noting that its Nucleus manufacturing facility has successfully passed its first GMP inspection enabling the commercial product supply for obe-cel. Additionally, the Ph1 CARLYSLE confirmatory trial evaluating obe-cel in severe, refractory SLE, and the Ph1 MAGNETO trial studying AUTO6NG (GD2 CAR-T) in pediatric glioblastoma have been initiated.

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Obe-cel’s BLA Submission on Track for YE 2023; New Obe-cel Ph1 Trial to Start for SLE; Two Assets Added to the Pipeline; Autolus’s Q2 2023 Earnings Call Summary

On Thursday, August 3, Autolus held its Q2 2023 earnings call (press release / presentation) highlighting that obe-cel’s (CD19 CAR-T) BLA submission in r/r ALL is still expected by YE 2023. Of note, the company plans to start a new obe-cel trial in SLE in 2024 and added two new assets to its pipeline, including an allogeneic version of obe-cel. Below, Celltelligence provides insights on obe-cel’s pathway towards commercialization, while discussing its entry into the autoimmune space.

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The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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Obe-cel’s BLA Submission on Track for YE 2023; Launch Preparedness Activities Underway; Cardinal Health to Serve as Autolus’s US Commercial Distribution Partner; Autolus’s Q1 2023 Earnings Call Summary

Autolus has had a series of updates recently, including a Capital Markets Day, an earnings call, and other related news items. On Thursday, May 4, Autolus held its Q1 2023 earnings call (press release / presentation) highlighting that obe-cel’s BLA submission to the FDA remains on track for YE 2023. Below, Celltelligence provides summary and insight on the recent updates from Autolus, including obe-cel’s launch approach and the company’s US distribution agreement with Cardinal Health.

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The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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JPM 2023 Analysis Day 4: Autolus and Caribou Biosciences

On the fourth and final day of JPM 2023, Celltelligence covered presentations from Autolus (webcast / presentation) and Caribou Biosciences (webcast / presentation). Below, Celltelligence provides insights and context for each presentation. The following topics are covered below.

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Obe-cel’s BLA Filing Anticipated by YE 2023; Multiple Clinical Updates Expected at ASH 2022; Autolus’s Q3 2022 Earnings Call Summary

On Thursday, November 3, Autolus held its Q3 2022 earnings call (press release / presentation) highlighting obe-cel’s (autologous CD19 CAR-T) anticipated BLA filing in r/r ALL by YE 2023. Additionally, initial results from obe-cel’s Ph2 FELIX trial are anticipated in Q4 2022, while other clinical updates from obe-cel, AUTO1/22 (autologous CD19 x CD22 CAR-T), and AUTO4 (autologous TRBC1 CAR-T) are expected at ASH 2022 (Dec 10 – 13). Below, Celltelligence provides insights on obe-cel’s potential approval timelines and competition in the r/r ALL setting, while discussing a delay in AUTO6NG’s (autologous GD2 CAR-T) Ph1 MCARGD2 trial initiation.

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The Celltelligence Team

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The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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The EC Grants Tecartus Marketing Authorization for R/R Adult ALL

On Tuesday, September 6, Gilead (Kite) announced (press release) that the European Commission (EC) granted Marketing Authorization for Tecartus (CD19 CAR-T) in r/r adult (≥26 years) B-ALL. Below, Celltelligence provides insights on Tecartus’s approval in the EU, while comparing it with ARI-0001 (academic CD19 CAR-T) and obe-cel (Autolus’s CD19 CAR-T).

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The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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Obe-cel’s Data Update Expected in Q4 2022; Afami-cel’s BLA Remains on Track for Q4 2022; Adaptimmune to Slow Down ADP-A2M4N7X19’s Development; Autolus and Adaptimmune Q2 2022 Earnings Summaries

On Thursday, August 4, Autolus held their Q2 2022 earnings call (press release / presentation) highlighting that initial data from obe-cel’s (CD19 CAR-T) Ph2 FELIX trial will be reported in Q4 2022. Additionally, multiple data updates from AUTO1/22 (CD19 x CD22 CAR-T) and AUTO4 (TRBC1 CAR-T) are expected at ASH 2022. On the same day, Adaptimmune reported their Q2 2022 financial results (press release) confirming afami-cel’s (MAGE-A4 SPEAR-T) anticipated BLA filing in Q4 2022, and a delayed IND submission for ADP-A2M4N7X19 (next-generation MAGE-A4 SPEAR-T). Below, Celltelligence provides insights on obe-cel’s potential approval, while discussing afami-cel’s BLA filing.

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The Celltelligence Team

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The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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Autolus Presents Updated Results for Obe-cel, AUTO1/22, and AUTO4; Autolus’s EHA 2022 Investor Event; Academic BCMA CAR-T ARI0002h Reports Encouraging Efficacy in R/R MM; EHA 2022 Final Analysis

EHA 2022 Final Analysis: Autolus presented clinical results for obe-cel, AUTO1/22, and AUTO4, while Hospital Clinic Barcelona reported data from ARI0002h. Moreover, Autolus held an investor call following updated clinical data presented at EHA 2022. Below, Celltelligence provides insights and context for key selected presentations and highlights from the call. The following topics are covered below:

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The Celltelligence Team

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The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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Autolus to Evaluate MRD Status in Obe-cel’s FELIX Trial; First Patient Dosed in AUTO8’s MCARTY Study; Autolus Q1 2022 Earnings Call Summary

On Thursday, May 5, Autolus held their Q1 2022 earning call (press release / presentation) highlighting obe-cel’s (CD19 CAR-T; formerly AUTO1) clinical progress, while confirming multiple clinical updates to be presented EHA 2022 (June 9 – 12). Of note, management confirmed the initiation of AUTO8’s (BCMA x CD19 CAR-T) Ph1 MCARTY trial in r/r MM. Below, Celltelligence provides insights on how Autolus may leverage MRD status to improve obe-cel’s efficacy and safety profile in r/r adult ALL, while discussing AUTO8’s trial initiation.

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The Celltelligence Team

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The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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Obe-cel’s US Filing Delayed to H2 2023; Stevenage Manufacturing Site to be Operational by Mid-2023; Autolus Q4 2021 Earnings Call Summary

On Thursday, March 10, Autolus held their Q4 2021 earnings call (press release / presentation) highlighting obe-cel’s (CD19 CAR-T; formerly AUTO1) regulatory delays, while confirming multiple clinical updates at EHA 2022. Furthermore, Autolus provided further manufacturing and executive updates. Below, Celltelligence provides insights on how Autolus may try to offset obe-cel’s delayed potential US approval, while discussing Autolus’s manufacturing strategy and AUTO1/22’s market opportunity.

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The Celltelligence Team

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The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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