Category Archives: Topics

No Cell Therapy-Related Updates in March’s CHMP Agenda

On Monday, March 18, the CHMP Agenda for March was released. Of note, no cell therapy-related updates were observed. 

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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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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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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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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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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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New BMS-986393 Ph2 Trial (QUINTESSENTIAL) for R/R Multiple Myeloma

On Thursday, March 7, a new BMS-sponsored Ph2 trial (QUINTESSENTIAL) evaluating BMS-986393 (CC-95266; GPRC5D CAR-T) in quadruple-class exposed [including: an immune modulatory drug (IMiD), a proteasome inhibitor (PI), an anti-CD38 mAb, and an anti-BCMA therapy] ≥4L MM was observed on CT.gov.

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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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Afami-cel Potential US Launch in Q3 2024; Adaptimmune’s Q4 2023 Earnings Call Summary

On Wednesday, March 6, Adaptimmune held its Q4 2023 earnings call (press release / webcast) highlighting the company’s preparation for the potential launch of afami-cel (MAGE-A4 SPEAR-T) in Q3 2024 in the US. Below, Celltelligence provides insights on the launch preparation of afami-cel upon FDA approval, while commenting on the rest of the company’s pipeline updates.

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Abecma US Revenue Continues to Decrease; 2seventy Bio’s Q4 2023 Earnings Call

On Tuesday, March 5, 2seventy bio held its Q4 and FY 2023 earnings call (press release / webcast) acknowledging the decline in Abecma (BMS / 2seventy bio’s BCMA CAR-T) sales in the US. Below, Celltelligence provides insights on the reasons behind the Abecma revenue decrease, while commenting on the future opportunities for the BCMA CAR-T upon its potential approval in ≥3L MM.

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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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Arcellx / Gilead to Include BCMA-Relapsed Patients in Early Line MM Trials; Arcellx’s Q4 2023 Results Summary

On Thursday, February 28, Arcellx released its Q4 and FY 2023 results (press release) highlighting the recent expansion of the partnership agreement with Gilead (Kite). Moreover, as disclosed in a SEC filing, the companies are planning to include patients who have received prior BCMA-targeted treatments to support anito-cel’s label expansion into earlier MM lines while initiating additional clinical trials ex-US.

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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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CHMP Adopts Positive Opinion for Carvykti in ≥2L MM; February CHMP Highlights

On Friday, February 23, the CHMP meeting highlights were released, including the positive opinion of the CHMP for Carvykti (JNJ / Legend’s BCMA CAR-T) in ≥2L MM.

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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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