Category Archives: Autologous

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 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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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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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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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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Clinical Updates from ADP-A2M4CD8’s SURPASS Study; Adaptimmune to Evaluate Multiple Combinations in the SURPASS Program; Adaptimmune’s ESMO 2022 Investor Event

On Friday, September 9, Adaptimmune held their ESMO 2022 Investor Event (press release / presentation) highlighting the clinical results from ADP-A2M4CD8’s (next-gen MAGE-A4 SPEAR-T) Ph1 SURPASS trial presented at ESMO 2022. Moreover, management disclosed future plans for the SURPASS family of trials. Below, Celltelligence provides insights on ADP-A2M4CD8’s updated clinical results, while discussing Adaptimmune’s new strategy to combine ADP-A2M4CD8 with checkpoint inhibitors.

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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.

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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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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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New Abecma KarMMa-9 Trial for Newly Diagnosed MM Patients

On Wednesday, September 7, 2seventy bio announced (press release) plans to initiate the KarMMa-9 study evaluating Abecma (BMS / 2seventy’s BCMA CAR-T) in newly diagnosed MM patients who have suboptimal response to transplant. The Celltelligence team will conduct an in-depth analysis of the KarMMa-9 trial as more details are released on CT.gov.

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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Gilead / Kite Expands Cell Therapy Operations in Brazil, Singapore, and Saudi Arabia

On Wednesday, August 31, Gilead (Kite) announced the expansion of their cell therapy operations to Brazil, Singapore, and Saudi Arabia (press release). Below, Celltelligence provides insights on how Yescarta (Kite’s CD19 CAR-T) could quickly challenge Kymriah’s (Novartis’s CD19 CAR-T) market exclusivity in these geographies, while discussing Kite’s potential manufacturing expansion 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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