Tag Archives: Legend

Carvykti Meets Another Regulatory Milestone; LB1901’s FDA Clinical Hold Lifted; Legend Q1 2022 Earnings Summary

On Wednesday, June 1, Legend released their Q1 2022 results (press release) highlighting Carvykti’s (cilta-cel; BCMA CAR-T) recent European Commission (EC) conditional marketing authorization in ≥4L r/r MM. Additionally, management confirmed that the FDA lifted the clinical hold on LB1901’s (LCAR-T2C; autologous CD4 CAR-T) Ph1 trial in r/r TCL. Below, Celltelligence provides insights on Carvykti’s EC approval, while discussing LB1901’s FDA clinical hold lift.

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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 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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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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Legend Achieves Another Milestone Payment from Janssen for Carvykti

On Thursday, April 21, Legend announced (press release) that they have achieved a 50M USD milestone under their collaboration agreement with JNJ for Carvykti (cilta-cel; BCMA CAR-T). Recall that Legend received an upfront payment of 350M USD, with additional milestone payments covering development, production performance, regulatory and sales.

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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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Yescarta and Kymriah Product Attributes; Early Results from Gracell’s GC502 Ph1 Study in r/r B-ALL; Legend’s LB1901 Ph1 Study Design in r/r TCL; AACR 2022 Analysis 3

AACR 2022 Analysis 3: Several clinical updates were presented by Gilead, Novartis, Gracell, and Legend. Below, Celltelligence provides insights and context for each presentation. The following topics are covered below:

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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 Continues to Expand the CARTITUDE Program; Will Carvykti Receive Approval in Japan by September 2022? Legend Receives Official FDA Clinical Hold Letter for LB1901; Legend Q4 2021 Earnings Summary

On Friday, March 18, Legend released their Q4 2021 results (press release) highlighting Carvykti’s (cilta-cel; BCMA CAR-T) recent FDA approval in ≥5L r/r MM and several clinical program updates. Additionally, management confirmed that they received an official FDA clinical hold letter for LB1901’s (LCAR-T2C; autologous CD4 CAR-T) Ph1 trial in r/r TCL. Below, Celltelligence provides insights on Legend’s LCM initiatives for Carvykti, while discussing LB1901’s FDA clinical hold.

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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’s CD4 CAR-T Trial in TCL is Placed on Clinical Hold by the FDA

On Tuesday, February 15, Legend announced (press release) that the FDA has placed a clinical hold on LB1901’s (LCAR-T2C; autologous CD4 CAR-T) Ph1 trial in r/r TCL. Below, Celltelligence provides insights on plausible causes of the clinical hold and how competitors may achieve a better safety profile.

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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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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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