Category Archives: Autologous

Carvykti’s CARTITUDE-6 Trial to Initiate Ex-US Due to FDA Safety Concerns; LB2102 IND Clearance in SCLC; Legend H2 2022 Earnings Call Summary

On Thursday, March 30, Legend reported its H2 and FY 2022 clinical updates and financial results (press release) highlighting Carvykti’s (BCMA CAR-T) positive topline results from the Ph3 CARTITUDE-4 trial in 2-4L MM, as well as intentions to first proceed with the Ph3 CARTITUDE-6 trial for NDMM in ex-US countries after FDA safety concerns. Below, Celltelligence provides insights on Carvykti’s anticipated evaluation in NDMM as well as its potential FDA approval in 2-4L MM, while discussing Legend’s presence in the SCLC space.

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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 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 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 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 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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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 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 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 Merger of Adaptimmune and TCR2 Tx; Afami-cel’s BLA Filing Completion on Track for Mid-2023; Progress in ADP-A2M4CD8’s Clinical Development; Adaptimmune Q4 2022 Earnings Call Summary

On Monday, March 6, Adaptimmune held its Q4 and FY 2022 earnings call (press release / presentation) highlighting an agreement with TCR2 Tx for merging into a preeminent cell therapy company focused on treating solid tumors (press release). Additionally, management presented updates from afami-cel’s (autologous MAGE-A4 SPEAR-T) BLA filing in synovial sarcoma and ADP-A2M4CD8’s (autologous MAGE-A4 TCR-T) Ph2 SURPASS-3 trial in ovarian cancer. Below, Celltelligence provides insights on the decision of Adaptimmune to partner with TCR2 Tx while discussing the potential of their combined pipeline in the treatment of solid 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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