Category Archives: Uncategorized

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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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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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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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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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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Strategic Combination of TCR2 Tx and Adaptimmune; Upcoming Clinical Updates for Gavo-cel and TC-510; TCR2 Tx Q4 2022 Earnings Summary

On Thursday, March 23, 2023, TCR2 Tx released its Q4 2022 financial results and corporate updates (press release) highlighting the agreement with Adaptimmune for merging into a preeminent cell therapy company focused on treating solid tumors announced on March 6, 2023. Additionally, management reported upcoming clinical updates for gavo-cel (autologous MSLN TRuC-T) and TC-510 (autologous MSLN TRuC-T with PD-1:CD28 switch). Below, Celltelligence provides insights on the benefits of TCR2 Tx’s merger with Adaptimmune, while discussing the company’s pipeline reprioritization.

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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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Francesco Marincola Departs Kite as Head of Cell Therapy Research; Yescarta Significantly Improved OS in 2L LBCL

On Tuesday, March 21, Sonata Therapeutics announced (press release) the CSO appointment of Francesco Marincola, former SVP and Global Head of Cell Therapy Research at Gilead (Kite). On the same day, Gilead (Kite) reported (press release) the primary overall survival (OS) data analysis of Yescarta’s (autologous CD19 CAR-T) Ph3 ZUMA-7 trial in 2L DLBCL demonstrating a significant OS improvement for Yescarta versus SOC. Below, Celltelligence provides insights on Marincola’s departure from Kite, while discussing how OS data could further support Yescarta’s leading position in the market.

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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

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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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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’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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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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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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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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Christi Shaw to Depart Gilead and Kite Leadership

On Friday, February 17, Gilead / Kite announced (press release) that Christi Shaw (Kite’s CEO) decided to depart by the end of Q1 2023. Below, Celltelligence provides insights on Shaw’s tenure in Kite, while discussing the profile of her potential replacement.

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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