Category Archives: Topics

Mark Gergen Appointed as Poseida’s New CEO; Poseida and 2seventy Provide Business Updates for 2022; Allogene’s Collaboration with Antion Bio for miCAR Technology; JPM 2022 Day 2 Part 1: GSK and SpringWorks

A series of cell therapy-related news items have been observed:

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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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Allogene’s FDA Clinical Hold Lifted; JPM 2022 Day 1: BMS, Novartis, JNJ, and Gilead

On Monday, January 10, Allogene (press release) announced that the FDA has lifted the clinical hold on their AlloCAR-T programs. Moreover, on the first day of JPM 2022, Celltelligence covered presentations by BMS (press release / presentation), Novartis (presentation), JNJ (press release), and Gilead (presentation). Below, Celltelligence provides insights and context for each presentation. 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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Kymriah Absent From December’s CHMP Highlights

On Friday, December 17, the CHMP meeting highlights were released following Monday’s CHMP agenda. Of note, no updates from Kymriah’s Type II variation in r/r FL were observed. Below, Celltelligence provides updated likely EU approval timelines for Kymriah, Yescarta, Tecartus, Breyanzi, and Carvykti (cilta-cel).

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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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Daiichi Sankyo Authorizes Yescarta’s First Treatment Center in Japan 11 Months After Approval

On Thursday, December 16, Gilead (Kite) announced (press release) that Daiichi Sankyo has authorized Yescarta’s (Gilead’s CD19 CAR-T) first treatment center in Japan. Below, Celltelligence provides insights on how Yescarta’s footprint in Japan may potentially increase Gilead’s (Kite) WW market revenue, while discussing differences in ATC onboarding rates between the US and Japan.

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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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Novartis May Apply Learnings from BELINDA’s Failure to YTB323 in 2L DLBCL; How Could Novartis Position Their Novel T-Charge Manufacturing Platform in 2L DLBCL and MM Settings? Yescarta’s ZUMA-12 Demonstrates an 89% ORR in 1L DLBCL; ASH 2021 Day 3

On the last day of ASH 2021, 6 clinical updates were presented by Novartis and Gilead (Kite). Below, Celltelligence provides insights and context for each presentation. 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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CARTITUDE-1 and CARTITUDE-2 Study Updates; Carvykti Improves Clinical Outcomes Compared to Real-World Clinical Practice in R/R MM; ASH 2021 Day 3 Legend Investor Event

On Monday, December 13, Legend held their investor event highlighting updated clinical results from Carvykti’s (BCMA CAR-T; cilta-cel) Ph1b/2 CARTITUDE-1 and Ph2 CARTITUDE-2 studies in r/r MM. Below, Celltelligence provides insights on Carvykti’s improved efficacy profile compared to real-world clinical practice (RWCP) in r/r MM, while discussing whether a GSI combination is necessary to improve a BCMA CAR-T’s efficacy.

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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Could ALLO-715 Compete or Complement Carvykti / Abecma? ASH 2021 Day 3 Allogene Investor Event

On Monday, December 13, Allogene held their ASH 2021 investor event (presentation) providing updated clinical results from their BCMA (ALLO-715) and CD19 (ALLO-501 and ALLO-501A) allogeneic CAR-T programs. Bellow, Celltelligence provides insights on how ALLO-715 may be able to compete with autologous BCMA CAR-Ts.

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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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Autolus’s Industrialized Manufacturing Process for Obe-cel; Updated Results From Autolus’s Ph1 ALLCAR19 and Ph1 CARPALL Trials; ASH 2021 Day 3 Autolus Investor Event

On Monday, December 13, Autolus held their investor event (press release / presentation) comparing obe-cel’s (CD19 CAR-T; formerly AUTO1) Ph1 ALLCAR19 study and Ph1b/2 FELIX trial in r/r B-ALL. Moreover, management provided updated preclinical and clinical data for obe-cel’s ALLCAR19 iNHL cohort and AUTO1/22 (CD19 x CD22 CAR-T) in r/r pediatric ALL. Below, Celltelligence provides insights on obe-cel’s industrialized manufacturing process, while discussing Autolus’s AUTO1/22 indication 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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Will Kymriah Receive a CHMP Positive Opinion in R/R FL This Week? Carvykti’s CHMP Opinion Likely to Occur by February 2022; Tecartus and Breyanzi Continue to Experience Delays; December’s CHMP Agenda

On Monday, December 13, the CHMP agenda for December was released. Of note, Kymriah’s (Novartis’s CD19 CAR-T) Type II variation for r/r FL is listed as ‘For Adoption’, while Carvykti (JNJ / Legend’s BCMA CAR-T; cilta-cel) is displayed under the ‘List of outstanding issues (LoOI)’ section. Moreover, Tecartus (Gilead’s / Kite’s CD19 CAR-T) and Breyanzi (BMS’s CD19 CAR-T) were absent from December’s CHMP agenda. Below, Celltelligence provides insights on potential EU approval timelines for Kymriah and Carvykti, while discussing possible causes for Tecartus’s and Breyanzi’s regulatory delays.

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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Will a KarMMa Data Cut Help Abecma’s Successor Products? Safety and Efficacy Updates From bb21217’s Ph1 CRB-402 Study; Carvykti’s CARTITUDE-1 Continues Demonstrating Positive Clinical Results; ASH 2021 Day 2 Part 1

On the second day of ASH 2021, 3 clinical updates were presented by BMS, 2seventy, and Legend. Below, Celltelligence provides insights and context for each presentation.

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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