Category Archives: CAR-T

Could Novartis Deprioritize T-Charge? Novartis to Focus Exclusively on Innovative Medicines; Thoughts on Novartis Meet the Management Investor Event 2022

On Thursday, September 22, Novartis held its “Meet Novartis Management” investor event (press release / presentation), highlighting an organizational restructuring, while noting uncertainty regarding its rapid cell therapy manufacturing platform, T-Charge. Below, Celltelligence provides insights on the potential deprioritization of the T-Charge platform, while discussing what novel cell therapy technologies Novartis could leverage for its next wave of cell therapy assets.

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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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Servier Discontinues Partnership with Allogene

On Wednesday, September 21, Allogene reported (SEC Filing) that Servier has discontinued its involvement in the development of allogeneic CD19-directed assets, including Allogene’s most advanced candidates such as ALLO-501, ALLO-501A, and UCART19. Below, Celltelligence provides insights on how the lack of an ex-US licensing partner could affect Allogene’s pipeline development.

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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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Could JNJ Change the Treatment Paradigm in MM? Spotlight on JNJ’s MM Franchise

During 2022, JNJ’s (Janssen) MM franchise achieved major regulatory milestones that have positioned the company as a key player in the MM landscape. Carvykti’s (cilta-cel; BCMA CAR-T) US approval, EU approval, and Tecvayli’s (teclistamab; BCMA x CD3 bispecific antibody) recent conditional marketing authorization in the EU could potentially allow JNJ to change the treatment paradigm in MM. Below, Celltelligence provides insights on how JNJ could leverage its large MM portfolio and pipeline to disrupt the current SOC regimens for MM, as well as what may be going on with Tecvayli’s US regulatory delay.

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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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CHMP Adopts Positive Opinion for Yescarta; Breyanzi Absent from September’s CHMP Highlights

On Friday, September 16, the CHMP meeting highlights were released following Monday’s CHMP agenda. Of note, the CHMP adopted a positive opinion for Yescarta (Gilead / Kite’s CD19 CAR-T) in 2L LBCL. Additionally, Breyanzi (BMS’s CD19 CAR-T) was absent from the CHMP highlights. Below, Celltelligence provides insights on Yescarta’s positive opinion, while discussing updated EU timelines for Breyanzi.

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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 Messages on Solid Tumor Capabilities and Novel Manufacturing Methods; Gilead’s (Kite) ESMO 2022 Industry Symposium

On Friday, September 9, Gilead (Kite) hosted an industry satellite symposium at ESMO 2022 highlighting novel methods to increase cell therapy effectiveness both in solid and liquid tumors. Below, Celltelligence provides insights on Gilead’s potential strategy for solid tumors while discussing future manufacturing improvements.

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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 Tecartus Ph2 Trial (ZUMA-25) for R/R Rare B-cell Malignancies

On Tuesday, September 13, a new Gilead / Kite-sponsored Ph2 trial (ZUMA-25) evaluating Tecartus (autologous CD19 CAR-T) in rare B-cell malignancies was observed on CT.gov. Below, Celltelligence provides details for this trial while discussing how Gilead could leverage Tecartus’s indication expansion strategy to differentiate from its main competitors.

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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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Updated Results from BioNTech’s BNT211; Triumvira’s TAC01-HER2 Clinical Safety and Efficacy Data; Dosing Levels of ICT’s GCC19CART; ESMO 2022 Presentations Analysis

ESMO 2022 Presentations Analysis: BioNTech, Triumvira, and ICT presented clinical updates from their novel cell therapies in solid tumors. Below, Celltelligence provides insights and context for key selected presentations. The following topics are covered below:

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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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Type II Variations for Yescarta and Breyanzi Listed in September’s CHMP Agenda

On Monday, September 12, the CHMP agenda for September was released. Of note, Yescarta (Gilead / Kite’s CD19 CAR-T) and Breyanzi (BMS’s CD19 CAR-T) have been listed under the ‘Type II Variations – Opinion or Requests for Supplementary Information’ section for r/r DLBCL and high-grade B-cell lymphoma (HGBL), and 2L DLBCL Transplant Intended (TI) patients, respectively.

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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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UPDATED: Indications Table for BCMA and CD19 CAR-Ts US Approvals and Submissions

New content: The Celltelligence team has created a BCMA CAR-T indications table for estimated US approvals and submissions following key Q2 2022 earnings presentations and recent press releases (see below for download). Of note, no updates were observed in Celltelligence’s CD19 CAR-T indications table.

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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The EC Grants Tecartus Marketing Authorization for R/R Adult ALL

On Tuesday, September 6, Gilead (Kite) announced (press release) that the European Commission (EC) granted Marketing Authorization for Tecartus (CD19 CAR-T) in r/r adult (≥26 years) B-ALL. Below, Celltelligence provides insights on Tecartus’s approval in the EU, while comparing it with ARI-0001 (academic CD19 CAR-T) and obe-cel (Autolus’s CD19 CAR-T).

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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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