Category Archives: Topics

Breyanzi Absent from November’s CHMP Agenda

On Monday, November 7, the CHMP agenda for November was released. Of note, Breyanzi’s (BMS’s CD19 CAR-T) Type II Variation for 2L LBCL transplant-intended patients was absent from the agenda, and no other cell therapy-related updates were observed. On Friday, November 11, when the CHMP highlights are released, the Celltelligence team will provide updated timelines for Breyanzi’s potential EU approval.

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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 UCART123 and UCARTCS1 at ASH 2022; UCART20x22 and UCART22 Manufactured In-House; Cellectis’s Q3 2022 Earnings Call Summary

On Friday, November 4, Cellectis held its Q3 2022 earnings call (press release) highlighting that preliminary clinical data from UCART123’s (allogeneic CD123 CAR-T) Ph1 AMELI-01 study in r/r AML and preclinical results from UCARTCS1 (allogeneic CS1 CAR-T) will be presented at ASH 2022 (Dec 10 – 13). Of note, no major clinical updates were provided from UCART20x22 (allogeneic CD20 x CD22 CAR-T) or UCART22 (allogeneic CD22 CAR-T). Below, Celltelligence provides insights on UCART123’s anticipated clinical results, while discussing the progress of other pipeline 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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New Yescarta Ph3 Trial (ZUMA-23) for 1L LBCL Posted

On Friday, November 4, a new Kite-sponsored Ph3 trial (ZUMA-23) evaluating Yescarta (Gilead / Kite’s CD19 CAR-T) in 1L high-risk LBCL was observed on CT.gov. Below, Celltelligence provides details for the trial while discussing Yescarta’s potential to displace the current SOC in 1L LBCL.

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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 Filing Anticipated by YE 2023; Multiple Clinical Updates Expected at ASH 2022; Autolus’s Q3 2022 Earnings Call Summary

On Thursday, November 3, Autolus held its Q3 2022 earnings call (press release / presentation) highlighting obe-cel’s (autologous CD19 CAR-T) anticipated BLA filing in r/r ALL by YE 2023. Additionally, initial results from obe-cel’s Ph2 FELIX trial are anticipated in Q4 2022, while other clinical updates from obe-cel, AUTO1/22 (autologous CD19 x CD22 CAR-T), and AUTO4 (autologous TRBC1 CAR-T) are expected at ASH 2022 (Dec 10 – 13). Below, Celltelligence provides insights on obe-cel’s potential approval timelines and competition in the r/r ALL setting, while discussing a delay in AUTO6NG’s (autologous GD2 CAR-T) Ph1 MCARGD2 trial initiation.

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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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Allogene Plans to Expand ALLO-501A’s Pivotal Trial to Europe; Clinical Updates Ahead of ASH 2022; New Manufacturing Facility in China; Allogene’s Q3 2022 Earnings Call Summary

On Wednesday, November 2, Allogene held its Q3 2022 earnings call (press release) highlighting the initiation of ALLO-501A’s (allogeneic CD19 CAR-T) Ph2 ALPHA2 trial in r/r LBCL and its potential expansion into the EU. Furthermore, management announced an R&D showcase on November 29, 2022, to provide updates on the ALLO-501A and ALLO-715 (allogeneic BCMA CAR-T) programs, while results from ALLO-715’s Ph1 UNIVERSAL study will also be presented at ASH 2022. Below, Celltelligence provides insights on Allogene’s potential involvement in ALLO-501A’s ex-US development, while discussing its allogeneic BCMA CAR-T strategy.

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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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GSK Deprioritizes Cell Therapy Franchise; GSK’s Q3 2022 Earnings Summary

On Wednesday, November 2, GSK held its Q3 2022 earnings call (press release / presentation), highlighting the removal of three clinical TCR-T programs from its pipeline. Below, Celltelligence provides insights on GSK’s pipeline update, while discussing the company’s future in cell therapy.

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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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Gilead Reports Increased Cell Therapy Revenue; Yescarta and Tecartus Approved in the EU; New Galapagos Asset Added to Gilead’s Pipeline; Viral Vector Manufacturing Plant Receives FDA Approval; Gilead’s Q3 2022 Earnings Call Summary

On Thursday, October 27, Gilead (Kite) held their Q3 2022 earnings call (press release / presentation) highlighting an increase in revenue for their cell therapy franchise, while discussing recent EC approvals for Yescarta and Tecartus (CD19 CAR-Ts). Moreover, Gilead included a new cell therapy asset in its pipeline and confirmed the FDA approval of its new vector manufacturing facility in Oceanside, CA. Below, Celltelligence provides insights on Gilead’s cell therapy revenue increase, while discussing how recently gained approvals in several geographies could increase the ex-US sales for Yescarta and Tecartus.

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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Thoughts on GSK’s Decision to Transfer Cell Therapy Programs to Adaptimmune and Terminate Collaboration with Lyell; Is GSK Giving Up on Cell Therapy?

On Tuesday, October 25, Adaptimmune announced (press release / SEC Form 8-K) the transfer of GSK’s NY-ESO and PRAME cell therapy programs to Adaptimmune. Additionally, on Monday, October 24, Lyell Immunopharma reported (SEC Form 8-K) that GSK has terminated its agreement with Lyell for the research and development of T-cell therapies, including LYL132 and LYL331. Below, Celltelligence provides insights on how GSK’s decision could affect the strategy from Adaptimmune and Lyell, while discussing GSK’s uncertain future in cell therapy.

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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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Abecma’s Revenue Increases +20% QoQ Driven by ex-US Sales; KarMMa-2 Results to be Presented at ASH 2022; NEX-T Programs Deprioritized; BMS Q3 2022 Earnings Call Summary

On Wednesday, October 26, BMS held its Q3 2022 earnings call (press release / presentation) highlighting an increase in revenue for Abecma (BCMA CAR-T) and Breyanzi (CD19 CAR-T). Additionally, management provided clinical updates for Abecma and noted the discontinuation of their NEX-T CAR-T programs. Below, Celltelligence provides insights on how Breyanzi and Abecma revenues compare with key competitors Kymriah (Novartis’s CD19 CAR-T), Yescarta (Gilead / Kite’s CD19 CAR-T), and Carvykti (JNJ / Legend’s BCMA CAR-T), while discussing the impact of BMS’s clinical updates in its strategy.

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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Kymriah Sales Remain Flat Despite Japan Approval in ≥3L FL; Kymriah’s LCM Initiatives Deprioritized; YTB323’s Plans Under Review; Novartis Q3 2022 Earnings Call Summary

On Tuesday, October 25, 2022, Novartis held their Q3 2022 earnings call (press release / presentation) reporting $134M in Kymriah’s WW sales. Of note, Kymriah’s pivotal Ph2 CASSIOPEIA trial in 1L HR ALL was removed from Novartis’s pipeline and YTB323’s (T-Charge CD19 CAR-T) Ph3 trial initiation has been delayed. Below, Celltelligence provides insights on Kymriah’s Q3 2022 revenue, while discussing Kymriah’s LCM initiative deprioritization and YTB323’s delayed development strategy.

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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