Category Archives: BCMA

CHMP Adopts Positive Opinion for Breyanzi in 2L LBCL; When Could Abecma Receive a CHMP Positive Opinion for ≥3L MM? March CHMP Highlights

On Friday, March 31, the CHMP meeting highlights were released following Monday’s CHMP agenda. Of note, the CHMP adopted a positive opinion for Breyanzi (BMS’s CD19 CAR-T) in 2L LBCL. Below, Celltelligence provides insights on the March CHMP meeting with updated EU timelines for Breyanzi’s approval and Abecma’s (BMS’s BCMA CAR-T) regulatory pathway to gain an indication in ≥3L MM.

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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 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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Could Breyanzi Receive a CHMP Positive Opinion This Week? Abecma Starts EMA Assessment in ≥3L MM; March’s CHMP Agenda

On Monday, March 27, the CHMP agenda for March was released. Of note, Breyanzi (BMS’s CD19 CAR-T) was listed for the third time under the ‘Type II Variations – Opinion or Requests for Supplementary Information’ section in 2L DLBCL Transplant Intended (TI) patients. Additionally, Abecma (BMS’s BCMA CAR-T) was also listed as ‘Start of Procedure’ under ‘Type II Variations: Extension of Indications’ for ≥3L MM patients.

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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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Abecma’s sBLA Filing in ≥3L MM Remains on Track for Q1 2023; No Pipeline Updates; 2seventy bio Q4 2022 Earnings Summary; Gracell Acquires Patent Licenses from Seagen

On Thursday, March 16, 2seventy bio released its Q4 and FY 2022 financial results (press release) highlighting Abecma’s (BCMA CAR-T) increased US revenue. Additionally, management did not provide major milestone updates for 2023, with Abecma’s sBLA filing to the FDA for ≥3L MM still expected in Q1 2023. On the same day, Gracell reported (SEC Filing) a license agreement with Seagen, under which Gracell will have WW licenses to certain patents for clinical and preclinical research, as well as commercialization, of cell therapy products. Below, Celltelligence provides insights on Abecma’s potential market growth for 2023, while discussing the license agreement between Gracell and Seagen.

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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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GC012F’s Ph1/2 Trials in the US and China to Initiate in 2023; Will FasTCAR-Ts be as Fast as Initially Thought? Gracell’s Q4 2022 Earnings Call Summary

On Monday, March 13, Gracell held their Q4 and FY 2022 earnings call (press release / presentation) highlighting the upcoming initiation of GC012F’s (autologous BCMA x CD19 FasTCAR-T) Ph1/2 trials for r/r MM in the US and China. Additionally, management reported clinical updates for GC007g (allogeneic CD19 CAR-T) and GC506 (CLDN18.2 SMART CAR-T). Below, Celltelligence provides insights on Gracell’s potential partnership for advancing the clinical development of GC012F in the US, while discussing if fast manufacturing platforms will ultimately be able to differentiate themselves from traditional autologous 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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Cellectis’s UCART20x22 Trial in NHL Starts Enrollment; Precision’s Azer-cel and PBCAR19B Programs Delayed; Poseida to Provide Further Clinical Updates in 2023; Cellectis, Precision, and Poseida Q4 2022 Earnings Calls Summary

On Thursday, March 9, the following companies released their Q4 and FY 2022 earnings providing clinical updates and financial results:

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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 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

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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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ALLO-501A’s Pivotal Trial in ≥3L DLBCL Top Priority for 2023; Clinical Development of BCMA CAR-Ts Postponed Until 2024; Allogene’s Q4 2022 Earnings Call Summary

On Tuesday, February 28, Allogene held its Q4 and FY 2022 (press release) highlighting that their top priority for 2023 is ALLO-501A’s (allogeneic CD19 CAR-T) Ph2 ALPHA2 trial in ≥3L DLBCL, while the clinical development for ALLO-715 (allogeneic BCMA CAR-T) and ALLO-605 (allogeneic BCMA TurboCAR-T) is paused until 2024. Additionally, the company will focus on ALLO-316’s (allogeneic CD70 CAR-T) development in solid tumors with the possibility to expand into liquid tumors. Below, Celltelligence provides insights on Allogene’s decision to focus on ALLO-501A, while discussing ALLO-316’s combination with checkpoint inhibitors in solid tumors and its expansion in hematological tumors.

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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 P-MUC1C-ALLO1 and P-BCMA-ALLO1; Novel Allogeneic CAR-T (P-ckit-ALLO1) for AML; Upcoming Milestones for Poseida; Poseida’s R&D Day Summary

On Wednesday, February 22, Poseida held its R&D day (press release / presentation) highlighting clinical results from P-MUC1C-ALLO1 (allogeneic MUC1-C CAR-T) in solid tumors and P-BCMA-ALLO1 (allogeneic BCMA CAR-T) for r/r MM. Additionally, management noted that P-CD19CD20-ALLO1’s (allogeneic CD19 x CD20 CAR-T) IND filing is expected in mid-2023 and presented a novel allogeneic CAR-T (P-ckit-ALLO1) for AML. Below, Celltelligence provides insights on Poseida’s clinical results, while discussing the potential of its more novel allogeneic assets.

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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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Topline Results from Abecma’s KarMMa-3 in ≥3L MM; BMS, Gilead (Kite), and Novartis Present Clinical Updates from Leading CAR-T Assets; EBMT – EHA CAR-T Meeting 2023 Analysis 2

EBMT – EHA CAR-T Meeting 2023 Analysis 2: BMS, Kite (Gilead), and Novartis presented clinical data and follow-up outcomes from their leading CAR-T therapies. 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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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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