Category Archives: CAR-T

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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Breyanzi Included in the NCCN Guidelines for the Treatment of 2L DLBCL

On Tuesday, July 12, the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for B-Cell Lymphomas were updated (NCCN Guidelines in B-Cell Lymphoma) to include Breyanzi’s (BMS’s CD19 CAR-T) treatment in 2L DLBCL. Of note, Breyanzi is now recommended as a 2L therapy for patients who have primary refractory disease or have relapsed within 12 months, as well as patients who are non-candidates for transplant. Below, Celltelligence provides insights on Breyanzi’s inclusion in the NCCN Guidelines, while discussing how Yescarta’s (Gilead / Kite’s CD19 CAR-T) NCCN recommendation.

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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Are Cell Therapy Leaders Losing Their Innovative Edge? Spotlight on Novartis (Blast 2/6)

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. Below, Celltelligence provides part 2 of its analysis on Novartis’s pipeline, manufacturing technology, CDMO potential, and collaborative strategy to remain a leader in the space. In subsequent blasts, Celltelligence will provide a similar overview for BMS and 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).

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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Are Cell Therapy Leaders Losing Their Innovative Edge? Spotlight on Novartis (Blast 1/6)

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. Below, Celltelligence provides a two-part analysis on Novartis’s pipeline, manufacturing technology, CDMO potential, and collaborative strategy to remain a leader in the space. In subsequent blasts, Celltelligence will provide a similar overview for BMS and Gilead (Kite). At the end of the six-part series, Celltelligence will present a semi-qualitative analysis comparing the innovative strategies from Novartis, BMS, and Gilead (Kite).

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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Are Cell Therapy Leaders Losing Their Innovative Edge? Spotlight Series on Novartis, BMS, and Gilead (Kite)

Since the first US CAR-T approval in 2017, the cell therapy field has rapidly evolved with 5 additional CAR-Ts receiving FDA approval. Nevertheless, challenges surrounding TATs, cost, and patient access still remain. As such, companies are developing innovative strategies to overcome the challenges that the field is currently facing. In the upcoming six-part series, the Celltelligence team will analyze different innovative strategies which the cell therapy leaders (Novartis, BMS, and Gilead) are utilizing to remain competitive in this dynamic space. At the end of the series, Celltelligence will present a semi-qualitative analysis comparing the innovative strategies from Novartis, BMS, and Gilead (Kite).

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

New content: The Celltelligence team has updated its CD19 CAR-T indications table for estimated US approvals and submissions following key Q1 2022 earnings presentations and recent press releases (see below for download).

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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Thoughts on Breyanzi’s FDA Approval in 2L LBCL

On Friday, June 24, BMS announced (press release) that the FDA approved Breyanzi (CD19 CAR-T) in 2L LBCL. Of note, Breyanzi’s approval in 2L LBCL is based on results from the Ph3 TRANSFORM study and Ph2 PILOT trial. Below, Celltelligence provides insights on how Breyanzi’s broad label in 2L LBCL compares with key competitor Yescarta (Gilead / Kite’s CD19 CAR-T), while discussing how BMS may position Breyanzi in the 2L setting.

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 Yescarta Marketing Authorization for ≥4L R/R FL

On Tuesday, June 28, Gilead (Kite) announced (press release) that the European Commission (EC) granted Marketing Authorization for Yescarta (CD19 CAR-T) in ≥4L r/r FL. Below, Celltelligence provides insights on Yescarta’s approval in the EU, while comparing it with key competitor Kymriah (Novartis’s CD19 CAR-T).

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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Breyanzi Receives FDA Approval for 2L LBCL

Late on Friday, June 24, BMS announced (press release) that the FDA approved Breyanzi (CD19 CAR-T) in 2L LBCL based on results from the Ph3 TRANSFORM trial and Ph2 PILOT study. Of note, Breyanzi is the second CD19 CAR-T to move into an earlier line of therapy for LBCL. The Celltelligence team will be conducting a full thoughts-on analysis and label review in the coming days.

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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Breyanzi Could Receive a CHMP Opinion for 2L LBCL (TI) as Early as September 2022; Yescarta in 2L LBCL and Tecartus in R/R ALL Absent from June’s CHMP Highlights

On Friday, June 24, the CHMP meeting highlights were released following Monday’s CHMP agenda. As previously anticipated by the Celltelligence team, no cell therapy-related updates were observed in June’s CHMP Highlights. Below, the Celltelligence team provides a full analysis of June’s CHMP meeting with updated EU timelines for Breyanzi in 2L LBCL (TI) and Tecartus in r/r ALL.

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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