Tag Archives: JNJ

Could Abecma and Carvykti Be Approved in January 2024? Obe-cel MAA Could Happen in Q1 2024; December CHMP Highlights

On Friday, December 15, the CHMP meeting highlights were released. Of note, Carvykti (JNJ / Legend’s BCMA CAR-T) was absent from the CHMP highlights, implying that the Type II Variation (T2V) for its approval in ≥2L MM has received a second Request for Supplementary Information (RSI). Moreover, recall that the Abecma (BMS / 2seventy’s BCMA CAR-T) T2V in ≥3L MM was not included on Monday’s CHMP agenda. Below, Celltelligence provides insights on the December CHMP meeting with updated EU timelines for both cell therapies, while discussing the possible timeline for obe-cel accelerated assessment. 

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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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Uncertainty around OS Benefit Induced by Abecma in 3 – 5L MM; A MAIC Analysis Supports Carvykti’s Superiority versus Abecma in Early Line MM; ASH 2023 Analysis 7

ASH 2023 Analysis 7: BMS / 2seventy and JNJ / Legend presented analyses from their BCMA CAR-Ts in early line MM. 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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JNJ / AbelZeta and Mustang Bio Present Clinical Updates from their Assets Targeting CD20 in NHL; ASH 2023 Analysis 5

ASH 2023 Analysis 5: JNJ / AbelZeta and Mustang Bio presented clinical updates from assets targeting CD20 in NHL. 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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CARTITUDE-6 to Start Recruiting Soon in the US; Legend’s Facility in Belgium Set to Start Clinical Trial Manufacturing; Legend’s Q3 2023 Earnings Call Summary

On Monday, November 20, Legend held its Q3 2023 earnings call (press release) highlighting that the Ph3 CARTITUDE-6 trial evaluating Carvykti (BCMA CAR-T) versus ASCT in NDMM will start recruitment soon in the US while noting that its new production plant in Ghent, Belgium will be ready for clinical trial manufacturing by YE 2023. Below, Celltelligence provides insights on JNJ / Legend strategies to increase Carvykti manufacturing capacity, while discussing a slowdown of Carvykti’s sales in Q4 2023 and the initiation of CARTITUDE-6 trial in the US.

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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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Abecma T2V Receives a Second RSI; When Could Abecma and Carvykti Receive a Positive CHMP Opinion? November CHMP Highlights

On Friday, November 10, the CHMP meeting highlights were released. Of note, Abecma (BMS’s BCMA CAR-T) was absent from the CHMP highlights, implying that it has received a second Request for Supplementary Information (RSI) for its approval in ≥3L MM. Moreover, recall that the Carvykti (JNJ’s / Legend’s BCMA CAR-T) T2V in ≥2L MM was not included on Monday’s CHMP Agenda. Below, Celltelligence provides insights on the November CHMP meeting with updated EU timelines for both cell therapies.

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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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Carvykti’s Revenue Continues to Increase; CARTITUDE-6 Starts Recruitment; JNJ’s Q3 2023 Earnings Call Summary

On Tuesday, October 17, JNJ held its Q3 2023 earnings call (press release / presentation) highlighting Carvykti’s (BCMA CAR-T) revenue growth and reiterated the measures implemented to raise its manufacturing capacity. Moreover, on October 13, the status of the Ph3 CARTITUDE-6 trial was updated on CT.gov to report recruitment initiation. Below, Celltelligence provides insights on the increase in Carvykti sales and evaluates the potential of its revenue to further grow in the next quarters while discussing the initiation of the CARTITUDE-6 trial.

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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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Carvykti’s T2V Receives an RSI; When Could Abecma and Carvykti Receive a CHMP Positive Opinion? September CHMP Highlights

On Friday, September 15, the CHMP meeting highlights were released. Of note, Carvykti (JNJ / Legend’s BCMA CAR-T) was absent from the CHMP highlights implying that it has received a Request for Supplementary Information (RSI) for its assessment in ≥2L MM. Moreover, recall that Abecma (BMS / 2seventy’s BCMA CAR-T) was not included on Monday’s CHMP agenda. Below, Celltelligence provides insights on the September CHMP meeting with updated EU regulatory timelines for both cell therapies. 

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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Carvykti Appears in the CHMP Agenda; September’s CHMP Agenda

On Monday, September 11, the CHMP agenda for September was released. Of note, Carvykti (JNJ / Legend’s BCMA CAR-T) was included in the ‘Type II Variations – Opinions or Requests for Supplementary Information’ section for ≥2L MM, while Abecma’s (BMS’s BCMA CAR-T) Type II Variation for ≥3L MM was absent from the agenda.

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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Carvykti’s Revenue Increases Over +60% QoQ; JNJ Q2 2023 Earnings Call Summary

On Thursday, July 20, JNJ held its Q2 and H1 2023 earnings call (press release / presentation) highlighting Carvykti’s (BCMA CAR-T) remarkable revenue growth. Below, Celltelligence provides insights on the increase in Carvykti sales, while discussing JNJ / Legend’s ongoing strategies to improve CAR-T manufacturing capacity and analyzing Carvykti’s supply limitations ex-US.

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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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No Cell Therapy-Related Updates in July’s CHMP Agenda

On Monday, July 17, the CHMP Agenda for July was released. Of note, no cell therapy-related updates were observed and both Type II Variations applications (T2V) for Abecma (BMS’s BCMA CAR-T) and Carvykti (JNJ / Legend’s BCMA CAR-T) in r/r MM were absent from the agenda.

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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