Tag Archives: AUTO6NG

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 BLA Submission Remains on Track for YE 2023; YTB323 and Obe-cel to Compete on Safety in SLE; AUTO6NG’s Trial in Neuroblastoma to Be Initiated by YE 2023; Clinical Results of AUTO8 at ASH; Autolus’s Q3 2023 Earnings Call Summary

On Thursday, November 2, Autolus held its Q3 2023 earnings call (press release / presentation) highlighting that the obe-cel (CD19 CAR-T) BLA in r/r ALL remains on track to be submitted by YE 2023. The company also disclosed the initiation of an obe-cel Ph1 trial in pediatric ALL by YE 2023 to support its MAA with the EMA, while disclosing MHRA’s approval for the evaluation of AUTO6NG (GD2 CAR-T) in the Ph1 MAGNETO trial in pediatric r/r neuroblastoma. Additionally, Novartis will present initial safety data of YTB323’s (CD19 T-Charge CAR-T) Ph1/2 trial in SLE at ACR 2023. Below, Celltelligence provides insights on the regulatory pathway of Autolus’s leading cell therapy while discussing the potential of obe-cel and AUTO8 (BCMA x CD19 CAR-T) in the autoimmune disease space compared with Novartis’s YTB323.

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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 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 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 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 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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Gracell to Open an R&D Facility in the US; JPM 2022 Days 2 & 3: Legend, Allogene, and Autolus

A series of cell therapy-related news items have been observed:

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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 Confirms Obe-cel’s Ph1b/2 FELIX Trial Readout in 2022; Could Obe-cel be Approved by Early 2023? Yescarta Gains Reimbursement Approval in Australia and Gilead (Kite) Continues Expanding to Novel Cell Platforms with Appia Bio’s Collaboration; Autolus Q2 2021 Earnings Call Summary

On Thursday, August 5, Autolus held their Q2 2021 earnings call (press release / presentation) highlighting that obe-cel’s (CD19 CAR-T) Ph1b/2 FELIX study in r/r ALL readout is on track for 2022. On the same day, Gilead (Kite) announced Yescarta’s (CD19 CAR-T) reimbursement approval in Australia (press release) and a collaboration with Appia Bio for the development of CAR invariant natural killer T (CAR-iNKT) cells for hematological malignancies (press release).

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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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Will Next-Generation Modules be Enough to Differentiate Autolus’s Products? Ziopharm Deprioritizes Several Programs; What Targets and Indications Could Cellectis Pursue Next? Autolus, Ziopharm, and Cellectis Q1 2021 Earnings Call Summaries

On Thursday, May 6, Autolus held their Q1 2021 earnings call (press release / presentation) highlighting several anticipated AUTO1 data updates in 2021 while providing details on their next-generation programs and manufacturing strategy. On the same day, Ziopharm presented their Q1 2021 results (press release / presentation) announcing the deprioritization of their controllable IL-12 gene therapy and their allogeneic CD19 RPM programs. Furthermore, Cellectis reported their Q1 2021 financial results (press release) commenting on the progress of their clinical program and a series of R&D events to be held between May 24 — 28.

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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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