Category Archives: CD19

You May Have Missed: New Breyanzi Ph3 Trial for R/R FL; Abecma Approved for 3L MM in the EU

In the past week, the Celltelligence team detected relevant news that was not discussed in individual blasts but worth highlighting. In this blast, Celltelligence will cover the following topics:

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Allogene to Initiate Ph2 ALPHA3 Trial in Mid-2024; Updates from ALLO-316’s TRAVERSE Study Expected in 2024; ALLO-329’s Ph1 Trial in Autoimmune Diseases Set to Start in 2025; Allogene Q4 2023 Earnings Call

On Thursday, March 14, Allogene held its Q4 and FY 2023 earnings call (press release), noting that the start-up activities for the pivotal Ph2 ALPHA3 trial evaluating cema-cel (formerly ALLO-501A; allogeneic CD19 CAR-T) as consolidation therapy in 1L LBCL are ongoing, while the company expects to initiate ALLO-329’s (allogeneic CD19 x CD70 Dagger CAR-T) Ph1 trial in SLE in early 2025.

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The Celltelligence Team

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Content Leads & Contributors

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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Breyanzi Receives FDA Accelerated Approval in ≥3L CLL/SLL

On Thursday, March 14, BMS announced (press release) that the FDA granted accelerated approval (AA) of Breyanzi (CD19 CAR-T) for the treatment of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) adult patients who have received at least 2 prior LoT including a BTK inhibitor and a BCL-2 inhibitor.

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The Celltelligence Team

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Content Leads & Contributors

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 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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The Celltelligence Team

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Content Leads & Contributors

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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Caribou to Provide Updated Timeline for the Initiation of CB-010’s Trial in 2L LBCL in Q2 2024; First Patient Dosed in CB-012’s AmpLify Trial; Caribou Q4 and FY 2023 Earnings Summary

On Monday, March 11, Caribou released its Q4 and FY 2023 results (press release) highlighting that an updated timeline for the initiation of CB-010’s (allogeneic CD19 CAR-T) pivotal Ph3 trial in ≥2L LBCL is expected in Q2 2024 while noting that the first patient has been dosed in the Ph1 AMpLify trial evaluating CB-012 (allogeneic CLL-1 CAR-T) in ≥4L MM. Of note, the company has paused the development of CB-020 (allogeneic ROR-1 CAR-iNK) as part of a regular portfolio prioritization process.

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The Celltelligence Team

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Content Leads & Contributors

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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Poseida to Present Updated Clinical Results at AACR 2024; Legend Further Expands its Manufacturing Capacity; Poseida and Legend Q4 2023 Earnings Call Summary

On Thursday, March 7, Poseida released its Q4 and FY 2023 business updates (press release) highlighting clinical results from its lead asset P-BCMA-ALLO1’s (allogeneic BCMA CAR-T) Ph1 trial in r/r MM and an initial readout from its P-MUC1C-ALLO1’s Ph1 trial in advanced or metastatic solid tumors will be presented at AACR 2024.

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The Celltelligence Team

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Content Leads & Contributors

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 and BioNTech Enter into Strategic Alliance

On Thursday, February 8, Autolus and BioNtech announced (press release) a strategic CAR-T cell therapy collaboration to advance their pipelines and expand their late-stage programs. Below, Celltelligence provides insights on the partnership and how Autolus and BioNTech could benefit from it.

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The Celltelligence Team

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Content Leads & Contributors

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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Yescarta Revenue Decreases while Tecartus Sales Hold; ZUMA-24 Readout Delayed to H2 2024; Anito-cel’s Trial in Early Line MM to Initiate in H2 2024; Gilead’s Q4 2023 Earnings Call Summary

On Tuesday, February 6, Gilead held its Q4 2023 earnings call (press release / presentation) highlighting that the Yescarta (CD19 CAR-T) sales decreased Q0Q while Tecartus (CD19 CAR-T) revenue showed a slight increase. Additionally, the company delayed the readout from Yescarta’s Ph2 ZUMA-24 to H2 2024, with results from anito-cel’s (formerly CART-ddBCMA; BCMA CAR-T) Ph2 iMMagine-1 trial also anticipated in the second part of the year. Finally, Gilead disclosed that the enrollment of the first patient in anito-cel’s Ph3 trial in early-line MM is expected in H2 2024.

About The Author

The Celltelligence Team

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Content Leads & Contributors

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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Abecma and Breyanzi Revenues Increase; BMS-986353 to be Evaluated in MS; BMS’s Q4 2023 Earnings Call Summary

On Friday, February 2, BMS held its Q4 2023 earnings call (press release / presentation) highlighting the increase in global sales of Abecma (BMS / 2seventy bio’s BCMA CAR-T) and Breyanzi (CD19 CAR-T) while reporting plans to evaluate its BMS-986353 (CC-97540; CD19 NEX-T CAR-T) in multiple sclerosis (MS).

About The Author

The Celltelligence Team

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Content Leads & Contributors

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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Kymriah Sales Continue to Decline; No Updates on Cell Therapy Programs; Novartis’s Q4 2023 Earnings Call Summary

On Wednesday, January 31, Novartis held its Q4 2023 earnings call (press release / presentation) reporting $120M in Kymriah (CD19 CAR-T) WW sales, while the company did not provide any update on its cell therapy programs.

About The Author

The Celltelligence Team

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Content Leads & Contributors

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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