Category Archives: CAR-T

Spotlight on Bayer’s and Takeda’s Cell Therapy Strategy Part 2

In our part 1 Spotlight blast, Celltelligence discussed Bayer’s expanding position within the cell therapy space (see previous insight). Below, Celltelligence continues our analysis with an overview of Takeda’s approach while performing a head-to-head comparison of Bayer and Takeda in the cell therapy space.

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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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Canada Approves BMS’s Abecma (BCMA CAR-T) in ≥4L R/R MM; Will the Earliest Reimbursement Occur in 2022?

On Monday, May 31, BMS announced (press release) that Health Canada has granted conditional approval for Abecma (BCMA CAR-T) in ≥4L r/r MM, based on results from the Ph2 KarMMa trial. Below, Celltelligence provides insights on Abecma’s conditional approval in an earlier line of therapy compared to the US, while discussing when an earliest possible decision on reimbursement in Canada could occur.

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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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Spotlight on Bayer’s and Takeda’s Cell Therapy Strategy Part I

As Bayer continues to invest and expand into the cell therapy space, the Celltelligence team provides an analysis below on Bayer’s possible strategy, manufacturing technology, and partnerships. In a subsequent part 2 blast, the Celltelligence team will provide a similar overview for Takeda, who appears to be pursuing a similar cell therapy approach.

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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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JNJ / Legend Receive Priority Review for Cilta-cel in MM; Approval Before Thanksgiving?

On Wednesday, May 26, Legend announced (press release) that the FDA has granted cilta-cel (BCMA CAR-T) Priority Review in r/r MM, with a projected PDUFA date around November 29, 2021. Furthermore, management confirmed that updated results from the Ph1b/2 CARTITUDE-1 trial will be presented at ASCO 2021. Below, Celltelligence provides additional thoughts on cilta-cel’s anticipated US approval and its potential best-in-class efficacy profile, while discussing JNJ’s / Legend’s possible US ATC onboarding 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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Cellectis Adds 4 Novel Cell Therapy Assets to Their Pipeline; Could UCARTFAP Become a Standard Backbone Therapy in Solid Tumors? Cellectis’s Innovation Series Day 2 Summary

On Tuesday, May 25, Cellectis held the second session from their Innovation Series highlighting the addition of 4 novel UCART assets to their pipeline. Below, Celltelligence provides insights on Cellectis’s novel assets and their innovative strategies to overcome the solid tumor microenvironment.

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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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ALLO-501A Ph2 Trial Likely to Include a Consolidation Regimen and Outpatient Administration; CD52 LD Regimens May Require Educational Outreach to Increase ALLO-501A Adoption; Allogene’s CD19 Forum Summary

On Wednesday, May 19, Allogene held their CD19 forum (presentation / webcast) ahead of ASCO 2021 and presented updated clinical data from their ALLO-501 (CD19 CAR-T) program. Of note, Allogene discussed results from a survey assessing physicians’ CAR-T preferences in r/r LBCL. Below, Celltelligence provides insights on ALLO-501’s efficacy and safety profile and how it compares to currently approved CD19 CAR-Ts. Furthermore, Celltelligence comments on Allogene’s survey discussing the main factors that HCPs may consider when selecting allogeneic CAR-Ts over autologous therapies.

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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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Breyanzi’s Reimbursement in Japan Matched to Kymriah’s and Yescarta’s

On Wednesday, May 19, Japan’s Ministry of Health, Labor, and Welfare (MHLW) listed Breyanzi (BMS) in the NHI’s reimbursement price list (publication, Nichiyaku, May 2021). Below, Celltelligence provides thoughts on Breyanzi’s lower price in Japan while discussing the potential impact on pricing for upcoming cell therapies.

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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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Cilta-cel’s Submission on Track in the US, Europe, China, and Japan; Multiple Cilta-cel Clinical Updates Expected at ASCO and EHA 2021; Legend Q1 2021 Earnings Summary

On Tuesday, May 18, Legend released their Q1 2021 financial results (press release), highlighting that cilta-cel’s (BCMA CAR-T) US and EU regulatory approvals in r/r MM remain on track, with submissions in China and Japan anticipated in H2 2021. Furthermore, management confirmed that a number of cilta-cel clinical updates will be presented at ASCO and EHA 2021. Below, Celltelligence provides updated timelines for cilta-cel’s approval in the US and EU, while detailing cilta-cel’s upcoming clinical updates.

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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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No Mention of Abecma, Breyanzi, or Cilta-cel in May’s CHMP Agenda

On Monday, May 17, the CHMP agenda for May was released. Of note, no major updates were observed for Abecma (BMS), Breyanzi (BMS), or cilta-cel (JNJ / Legend). Below, Celltelligence provides an update on likely EU approval timelines for Abecma, Breyanzi, and cilta-cel.

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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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Precision BioSciences Provides No Major Clinical Updates; Q1 2021 Earnings Call Summary

On Thursday, May 13, Precision BioSciences released their Q1 2021 results (press release) highlighting their recent reacquisition of all global rights for their allogeneic CAR-T program from Servier. No major clinical, regulatory, or corporate updates were provided. Below, Celltelligence provides details on Precision’s upcoming milestones.

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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