Tag Archives: CD19 CAR-T

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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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.

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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 BLA in R/R B-ALL Accepted Although No Priority Review Was Granted

On Monday, January 22, Autolus announced (press release) that the FDA accepted its BLA for obe-cel (AUTO1, CD19 CAR-T) BLA for the treatment of adult r/r B-ALL. Notably, the regulatory agency did not grant Priority Review, setting a PDUFA date of November 16, 2024.

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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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JPM 2024 Analysis Day 4: Adaptimmune and Caribou

On the fourth and last day of JPM 2024, Celltelligence covered Adaptimmune (webcast / presentation) and Caribou (webcast / presentation). Below, Celltelligence provides insights and context to the presentation covering the following topics: 

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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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Novartis to Rapidly Advance YTB323 in Autoimmune Diseases; Cell Therapy Evaluation in MS Could Be Initiated Soon; Novartis’s R&D Day Summary

On Tuesday, November 28, Novartis held its R&D Day 2023 (press release / presentation) highlighting preparations for a Ph2b/3 study evaluating YTB323 (CD19 T-Charge CAR-T) in srSLE/LN while noting the data of 3 sentinel patients from the Ph1/2 trial in srSLE presented at ACR 2023. Additionally, the company disclosed it is preparing trials for other B-cell-driven indications and suggested it could evaluate the potential of cell therapies in MS. Below, Celltelligence provides insights on Novartis’s progress in autoimmune diseases while discussing the consequences that the FDA’s investigation into secondary T-cell malignancies after CAR-T infusion may have in the autoimmune disease space.

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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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Gilead’s Cell Therapy Revenue Continues to Grow; Promising Results from CART-ddBCMA Expected at ASH 2023; Gilead’s Q3 2023 Earnings Call Summary

On Tuesday, November 7, Gilead held its Q3 2023 earnings call (press release / presentation) highlighting increased sales for its cell therapy franchise. Additionally, the company underlined the presentation of a promising clinical update from CART-ddBCMA’s (KITE-772; BCMA CAR-T) Ph1 trial in ≥4L MM, co-developed with Arcellx, at ASH 2023. Below, Celltelligence provides insights on the barriers limiting Yescarta uptake in 2L LBCL in the US, while discussing the potential expansion of Gilead’s cell therapies outside of oncology.  

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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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Kymriah’s Revenue Continues to Decrease; No Updates on Cell Therapy Programs; Novartis’s Q3 2023 Earnings Call Summary

On Tuesday, October 24, Novartis held its Q3 earnings call (press release / presentation) reporting $124M in Kymriah (CD19 CAR-T) WW sales, while the company did not provide any update on its cell therapy programs. Below, Celltelligence provides insights on Kymriah’s Q3 2023 revenue while discussing changes observed in the company’s trial evaluating YTB323 in systemic lupus erythematosus (SLE).

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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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Precision and Imugene Agree on Terms for the Transfer of Azer-cel; Precision to Deprioritize its Cell Therapy Franchise

On Tuesday, August 15, Precision Biosciences announced (press release) a strategic transaction with Imugene for the exclusive WW licensing of azer-cel (PBCAR0191; allogeneic CD19 CAR-T) in oncology, which also included option to develop up to 3 other cancer programs. Additionally, Imugene disclosed (press release) its intention to continue azer-cel’s Ph1/2a trial in ≥3L NHL and r/r ALL, while planning the initiation of a potentially registrational trial in 2024. Below, Celltelligence provides insights on azer-cel’s transaction agreement, while analyzing the possible therapeutic potential of the combination of the licensed CD19 CAR-T with Imugene’s proprietary onCARlytics platform.

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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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Precision Receives Feedback from the FDA on Azer-cel’s Registrational Pathway

On Thursday, July 27, Precision Biosciences announced (press release) the receipt of final Type B meeting minutes from the FDA providing clarity on the potential registrational pathway of its lead asset azer-cel (PBCAR0191; allogeneic CD19 CAR-T). Moreover, the company disclosed discussions with multiple potential strategic partners for the development of its cell therapy assets. Below, Celltelligence provides insights on azer-cel’s potential in LBCL, while comparing the asset with its main allogeneic competitors.

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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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Azer-cel’s Potential Ph2 Trial in CAR-T-Relapsed DLBCL Patients; Clinical Updates for Azer-cel and PBCAR19B; Precision’s Mid-Year 2023 Event

On Wednesday, May 31, Precision Biosciences held its mid-year 2023 pipeline update event (press release / presentation), highlighting plans to hold a meeting with the FDA to discuss a potential Ph2 trial evaluating azer-cel (allogeneic CD19 CAR-T) in DLBCL patients who relapsed after autologous CAR-T therapy. Additionally, management presented clinical updates for both allogeneic CD19 CAR-Ts (azer-cel and PBCAR19B). Below, Celltelligence provides insights on azer-cel’s improved safety profile due to the company’s manufacturing optimization process while discussing its potential to be a first-in-class allogeneic CAR-T for CD19+ CAR-T-relapsed patients.

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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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