Tag Archives: JNJ

BMS Reports Positive Topline Results From Abecma’s Ph3 KarMMa-3 Trial for ≥3L MM vs SoC: Will Abecma be the First Approved CAR-T in ≥3L MM?

On Wednesday, August 10, BMS and 2seventy bio reported positive topline results from Abecma’s (BCMA CAR-T) Ph3 KarMMa-3 trial in ≥3L MM (press release). Below, Celltelligence provides insights on how Abecma’s potential approval timeline in ≥3L MM compares with key competitor Carvykti (JNJ / Legend’s BCMA CAR-T).

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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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UPDATE: Legend Discloses Carvykti’s Q2 2022 Revenue of $24M

On Thursday, July 21, Legend Biotech reported (6-K SEC) that Carvykti (JNJ / Legend’s BCMA CAR-T) generated approximately $24M in “net trade sales” in Q2 2022. Of note, during JNJ’s Q2 2022 earnings call, management highlighted that the first Carvykti sales had been recorded, but did not disclose its Q2 2022 revenue (see previous insight). The Celltelligence team will analyze how Carvykti’s revenue compares with key competitor Abecma (BMS’s BCMA CAR-T) after BMS releases its Q2 2022 financial results on July 27, 2022.

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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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No Carvykti Revenue Disclosed; JNJ Q2 2022 Earnings Call Summary

On Tuesday, July 19, JNJ held their Q2 2022 earnings call (press release / presentation) highlighting Carvykti’s (JNJ / Legend’s BCMA CAR-T) US launch in April 2022, and subsequent EC conditional approval for ≥4L MM in May 2022. Below, Celltelligence provides insights on Carvykti’s potential US and EU launch strategy, while comparing it with key competitor Abecma (BMS’s BCMA 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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The EC Grants Carvykti (BCMA CAR-T) Conditional Marketing Authorization for ≥4L R/R MM

On Thursday, May 26, JNJ announced (press release) that the European Commission (EC) granted Conditional Marketing Authorization for Carvykti (cilta-cel; BCMA CAR-T) in ≥4L r/r MM. Of note, Carvykti’s EC approval was based on results from the Ph1b/2 CARTITUDE-1 trial. The Celltelligence team will be conducting a full thoughts-on analysis in the coming days.

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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 Obe-cel Receives FDA RMAT Designation; JNJ / Legend Update Carvykti’s HCP Website

On Monday, April 25, 2022, Autolus announced (press release) that the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to obe-cel (AUTO1; autologous CD19 CAR-T) for adult r/r B-ALL. On the same day, Carvykti’s (JNJ / Legend’s autologous BCMA CAR-T) HCP website was updated to include onboarded treatment centers and additional product messaging (Carvykti HCP website). Below, Celltelligence provides insights on how RMAT designation may accelerate obe-cel’s regulatory pathway, while analyzing Carvykti’s updated HCP website.

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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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Is Carvykti’s Launch Constrained by JNJ’s Manufacturing Capacity? JNJ Q1 2022 Earnings Call Summary

On Tuesday, April 19, JNJ held their Q1 2022 earnings call (press release / presentation) highlighting Carvykti’s (cilta-cel; JNJ / Legend’s BCMA CAR-T) FDA approval and launch strategy for r/r MM. Below, Celltelligence provides highlights and insights on Carvykti from the call.

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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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Thoughts on Carvykti’s Label, Price, Manufacturing, and TAT Compared to Abecma

On Monday, February 28, 2022, JNJ / Legend announced (JNJ press release / Legend press release) that the FDA approved Carvykti (cilta-cel; autologous BCMA CAR-T) for the treatment of r/r MM after ≥4 prior lines of therapy based on results from the Ph1b/2 CARTITUDE-1 trial. Below, Celltelligence provides insights on Carvykti’s reported higher manufacturing failure rate compared with Abecma, while discussing Carvykti’s potential messaging strategy.

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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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Carvykti Approved by FDA in R/R MM After Four Lines of Previous Therapy

Following JNJ’s press release, Celltelligence has updated Carvykti’s FDA approval for r/r MM patients having received at least 4 lines of prior therapy. 

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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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Legend Achieves Two Major Milestone Payments for Carvykti

On Friday, February 11, Legend announced that they have achieved two milestones under their collaboration with JNJ for the development of Carvykti (cilta-cel; BCMA CAR-T), resulting in an aggregate payment of $50M to Legend. Below, Celltelligence guesses which milestones the payments could be related to.

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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 FDA Approval Anticipated Around February 28, 2022; JNJ Q4 2021 Earnings Call Summary

On Tuesday, January 25, JNJ held their Q4 and FY 2021 earnings call (press release / presentation) highlighting Carvykti’s (BCMA CAR-T; cilta-cel) anticipated FDA approval around February 28, 2022. Below, Celltelligence provides insights on how JNJ may leverage Carvykti’s best-in-class profile to quickly gain market share following launch.

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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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