Category Archives: Topics

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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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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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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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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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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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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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.

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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 Partners with Sanofi for Anti-CD52 Antibody Alemtuzumab Over ALLO-647; Could Sanofi Apply Alemtuzumab Learnings to Kiadis’s Pipeline?

On Tuesday, May 11, Cellectis announced (press release) a partnership and supply agreement with Sanofi for alemtuzumab (anti-CD52 monoclonal antibody) as a lymphodepletion agent for allogeneic CAR-Ts. Below, Celltelligence provides insights on how Sanofi may leverage Cellectis’s collaboration to increase their presence within the cell therapy space while discussing Cellectis’s choice of alemtuzumab over Allogene’s ALLO-647 as a lymphodepleting agent in their clinical programs.

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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 Gilead-Sponsored Post-Marketing Trial for Tecartus (ZUMA-2 Cohort 3) in R/R MCL

On Monday, May 10, a new post-marketing Tecartus Ph2 ZUMA-2 Cohort 3 trial in r/r MCL was observed on CT.gov. Below, Celltelligence provides insights on the study’s design and how Gilead could leverage this trial to gain a full FDA approval for Tecartus.

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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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Will Next-Generation Modules be Enough to Differentiate Autolus’s Products? Ziopharm Deprioritizes Several Programs; What Targets and Indications Could Cellectis Pursue Next? Autolus, Ziopharm, and Cellectis Q1 2021 Earnings Call Summaries

On Thursday, May 6, Autolus held their Q1 2021 earnings call (press release / presentation) highlighting several anticipated AUTO1 data updates in 2021 while providing details on their next-generation programs and manufacturing strategy. On the same day, Ziopharm presented their Q1 2021 results (press release / presentation) announcing the deprioritization of their controllable IL-12 gene therapy and their allogeneic CD19 RPM programs. Furthermore, Cellectis reported their Q1 2021 financial results (press release) commenting on the progress of their clinical program and a series of R&D events to be held between May 24 — 28.

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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