Tag Archives: CD19 CAR-T

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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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.

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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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The EC Grants Yescarta Marketing Authorization in 2L LBCL

On Monday, October 17, Gilead (Kite) announced (press release) that the European Commission (EC) has granted Yescarta approval (CD19 CAR-T) for the treatment of DLBCL and high-grade B-cell lymphoma (HGBL) refractory patients or that have relapsed within 12 months of 1L chemoimmunotherapy (2L LBCL). Below, Celltelligence provides insights on Yescarta’s approval in the EU, while comparing it with key competitor Breyanzi (BMS’s CD19 CAR-T).

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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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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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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 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 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 Sales Increase While Breyanzi’s Revenue is Affected by Manufacturing Issues; No Clinical Milestone Updates for Breyanzi or Abecma; Oxford Biomedica’s Expanded LSA Agreement; BMS’s Q2 2022 Earnings Call Summary

On Wednesday, July 27, BMS held their Q2 2022 earnings call (press release / presentation) highlighting Breyanzi’s (CD19 CAR-T) sales decrease and US approval in 2L LBCL. Moreover, management reported a revenue increase for Abecma (BCMA CAR-T). Of note, no updated clinical milestones for Breyanzi and Abecma were observed. Below, Celltelligence provides insights on how Breyanzi and Abecma revenue compares with key competitors Kymriah (CD19 CAR-T; Novartis), Yescarta (CD19 CAR-T; Gilead / Kite), and Carvykti (BCMA CAR-T; JnJ / Legend). Additionally, Celltelligence discusses BMS’s LSA expansion agreement with Oxford Biomedica.

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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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Type II Variations for Yescarta and Tecartus Listed in July’s CHMP Agenda

On Monday, July 18, the CHMP agenda for July was released. Of note, Yescarta and Tecartus (Gilead / Kite’s autologous CD19 CAR-Ts) have been listed as ‘For adoption’ under the ‘Type II Variations – Opinion or Requests for Supplementary Information’ section for 2L LBCL and r/r adult B-ALL, respectively.

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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 Yescarta Ph2 Trial (ZUMA-24) for 2L LBCL in the Outpatient Setting Posted

On Friday, July 15, a new Kite-sponsored Ph2 trial (ZUMA-24) evaluating the outpatient administration of Yescarta (CD19 CAR-T) in 2L LBCL was observed on CT.gov. Below, Celltelligence provides details for this trial while discussing how Yescarta’s outpatient treatment strategy compares with key competitor Breyanzi (BMS’s CD19 CAR-T).

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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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Are Cell Therapy Leaders Losing Their Innovative Edge? Spotlight on BMS (Blast 3/6)

As the cell therapy field continues to grow and evolve, companies are developing innovative strategies to overcome the current challenges that the field is facing. In our Spotlight blasts 1 and 2, Celltelligence discussed Novartis’s pipeline, novel cell types, manufacturing platform, and potential strategy in the solid tumor space (see previous insight part 1 here; see previous insight part 2 here). Below, Celltelligence provides its analysis on BMS’s pipeline, novel cell types, platforms, and solid tumor strategy. In subsequent blasts, Celltelligence will provide a similar overview for Gilead (Kite). At the end of the series, Celltelligence will present a semi-qualitative analysis comparing the innovative strategies from Novartis, BMS, and Gilead (Kite).

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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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