Tag Archives: ALL

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; Full FELIX Trial Data to be Presented at ASCO 2023; LCM Initiatives for Obe-cel Detailed; Partnering Opportunity for AUTO8 in MM; Autolus Q4 2022 Earnings Call Summary

On Tuesday, March 7, Autolus held its Q4 and FY 2022 earnings call (press release / presentation) highlighting that obe-cel’s (autologous CD19 CAR-T) BLA submission in r/r ALL continues to be expected by YE 2023. Additionally, management detailed future LCM plans for obe-cel and AUTO1/22 (autologous CD19 x CD22 CAR-T) and disclosed an interest in partnering AUTO8 (BCMA x CD19 dual CAR-T) for MM. Below, Celltelligence provides insights on obe-cel’s potential US and EU approval timelines, while discussing obe-cel’s potential in other indications and Autolus’s chances of finding a partner for AUTO8.

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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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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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Clinical Results from Autolus, Cellectis, and Precigen; ASH 2022 Analysis 7

ASH 2022 Analysis 7: Autolus, Cellectis, and Precigen presented updated data in ALL, PTCL, and AML. Below, Celltelligence provides insights and context for key selected presentations. 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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Positive Interim Analysis from Obe-cel’s Pivotal Ph2 FELIX Trial for r/r ALL; BLA Submission Still Anticipated by YE 2023; Autolus Receives $70M in Milestone Payments

On Thursday, December 8, 2022, Autolus announced that obe-cel’s (autologous CD19 CAR-T) Ph1/2 FELIX trial in r/r ALL has met its primary endpoint (press release). Moreover, management highlighted that they will receive $70M from Blackstone in milestone payments (press release). Below, Celltelligence provides insights on how obe-cel’s best-in-class profile could compete with Tecartus (Gilead / Kite’s CD19 CAR-T), while discussing obe-cel’s potential FDA regulatory timelines.

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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 Submit GC012F’s IND for R/R MM in the US and China; GC012F Demonstrates 100% ORR in NDMM; Clinical Progress from GC007g, GC503, and GC506; Gracell’s Q3 2022 Earnings Call Summary

On Monday, November 14, Gracell held their Q3 2022 earnings call (press release / presentation), highlighting results from GC012F’s (autologous BCMAxCD19 FasTCAR-T) Ph1/2 IIT in NDMM, and planned IND submissions in the US and China for r/r MM. Additionally, management provided clinical updates for GC007g (allogeneic CD19 CAR-T), GC503 (mesothelin SMART CAR-T), and GC506 (CLDN18.2 SMART CAR-T). Below, Celltelligence provides insights on GC012F’s potential as a first-line treatment in MM, while discussing a possible partnership strategy in the US.

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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

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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

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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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Type II Variations for Yescarta and Tecartus Listed in July’s CHMP Agenda

On Monday, July 18, the CHMP agenda for July was released. Of note, Yescarta and Tecartus (Gilead / Kite’s autologous CD19 CAR-Ts) have been listed as ‘For adoption’ under the ‘Type II Variations – Opinion or Requests for Supplementary Information’ section for 2L LBCL and r/r adult B-ALL, respectively.

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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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