Tag Archives: CART-ddBCMA

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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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 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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Thoughts on the Expansion of Arcellx and Gilead Partnership; Gilead to Expand Scope of CART-ddBCMA to Lymphomas and Exercise Option to ACLX-001

On Wednesday, November 15, Arcellx and Gilead announced (press release) an expansion of their existing partnership, whereby Gilead includes lymphomas in the scope of the collaboration for CART-ddBCMA (BCMA CAR-T) and exercises its option to license ACLX-001 (universal ARC-T cell + BCMA-targeting SparX protein) in MM. Additionally, on Monday, November 13, Arcellx released its Q3 2023 business updates (press release) highlighting the presentation of promising clinical data from CART-ddBCMA’s Ph1 trial in ≥4L MM at ASH 2023. Below, Celltelligence provides insights on the potential of using a BCMA CAR-T in lymphomas, while discussing CART-ddBCMA’s excellent profile in MM and ACLX-001’s main characteristics and competitive advantages.

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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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FDA Lifts Clinical Hold on CART-ddBCMA’s Ph2 iMMagine-1 Trial; How Did the Hold Impact CART-ddBCMA Development Timelines? Arcellx’s Q2 2023 Results Summary

On Monday, August 14, Arcellx released its Q2 2023 results (press release) disclosing that the FDA has lifted the partial clinical hold placed on CART-ddBCMA’s (BCMA CAR-T) Ph2 iMMagine-1 trial in ≥4L MM. Below, Celltelligence provides insights on the protocol changes done in the trial while discussing how this may affect Arcellx’s development timelines for its leading asset.

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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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FDA Places Clinical Hold on Arcellx’s Pivotal Ph2 iMMagine-1 Trial in ≥4L MM; How Could the Hold Affect CART-ddBCMA’s Development Plans?

On Monday, June 19, Arcellx announced (press release) that the FDA has placed a clinical hold on CART-ddBCMA’s (autologous BCMA CAR-T) Ph2 iMMagine-1 trial in ≥4L MM. Below, Celltelligence provides insights on possible causes of the clinical hold while discussing how this may affect Arcellx’s development plans for its leading asset.

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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’s CART-ddBCMA Program to Be Expanded; Precision to Provide Clinical Updates on Azer-cel and PBCAR19B Programs in May 2023; Arcellx’s and Precision’s Q1 2023 Results Summary

On Monday, May 8, Arcellx released its Q1 2023 results (press release) highlighting the progress made in the clinical development of its lead asset CART-ddBCMA (autologous BCMA CAR-T) for ≥4L MM. A day later, Precision reported a business update (press release) confirming that clinical updates for its allogeneic CD19 CAR-Ts (azer-cel and PBCAR19B) in NHL patients are still anticipated in May 2023. Below, Celltelligence provides insights on the potential expansion of the CART-ddBCMA’s iMMagine program with a future iMMagine-3 trial while commenting on the expected clinical updates of Precision’s cell therapy assets.

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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 and Gilead Focus on Accelerating CART-ddBCMA Clinical Development, Initiation of ACLX-002’s Ph1 trial in AML; Arcellx Q4 2022 Earnings Summary

On Wednesday, March 29, Arcellx provided its Q4 and FY 2022 financial results and business updates (press release) highlighting its strategic collaboration with Gilead (Kite) to co-develop and co-commercialize CART-ddBCMA (autologous BCMA CAR-T) for the treatment of ≥4L MM announced on December 9, 2022. Additionally, the company noted the initiation of ACLX-002’s (Universal ARC-T cells + CD123 targeting SparX protein) Ph1 trial in r/r AML and HR-MDS in December 2022. Below, Celltelligence provides insights on Arcellx’s strategic decision to partner with Gilead (Kite), while discussing ARC-SparX 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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Updated Results from CART-ddBCMA in R/R MM; Could Gilead Take an Interest in the ARC-SparX Platform? Arcellx Meets Clinical Milestones; ASH 2022 Arcellx Investor Event

On Sunday, December 11, Arcellx held an ASH investor event (presentation) highlighting updated clinical data from CART-ddBCMA’s (autologous BCMA CAR-T) Ph1 trial in patients with r/r MM. Moreover, management provided further details on their recently signed collaboration with Gilead (Kite). Below, Celltelligence provides insights on CART-ddBCMA’s potential best-in-class profile while discussing how Gilead’s collaboration could impact the MM space in the long-term.

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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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Thoughts on Gilead’s Collaboration with Arcellx

On Friday, December 9, Gilead (Kite) and Arcellx announced (press release) a global strategic collaboration to co-develop and co-commercialize Arcellx’s CART-ddBCMA (autologous BCMA CAR-T) for the treatment of r/r MM. Additionally, Arcellx released (press release / presentation) clinical updates from CART-ddBCMA’s Ph1 trial in patients with r/r MM, ahead of its presentation at ASH 2022 (December 11; Abs#3313). Below, Celltelligence provides insights on Gilead’s strategic decision to enter the BCMA CAR-T space, while discussing potential FDA approval timelines for CART-ddBCMA and how it could compare with already approved BCMA CAR-Ts.

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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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Novel CAR-T Assets in MM; Arcellx, Gracell, and OriCell Present Updated Clinical Results in R/R MM; ASCO 2022 Analysis 4

ASCO 2022 Analysis 4: Arcellx, Gracell, and OriCell presented clinical updates from their novel CAR-Ts in r/r MM. Additionally, Arcellx held an ASCO 2022 Investor Event. 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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