Category Archives: BCMA

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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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 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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CHMP Adopts Positive Opinions for Kymriah and Carvykti; Tecartus Absent From March’s CHMP Highlights

On Friday, March 25, the CHMP meeting highlights were released following Monday’s CHMP agenda. Of note, the CHMP adopted a positive opinion for Kymriah (Novartis’s CD19 CAR-T) in ≥3L r/r FL and a positive conditional marketing authorization for Carvykti (JNJ / Legend’s BCMA CAR-T) in ≥4L r/r MM. Additionally, Tecartus (Gilead / Kite’s CD19 CAR-T) was absent from the CHMP highlights. Below, the Celltelligence team provides thoughts on Kymriah’s and Carvykti’s positive opinion, while providing updated EU timelines for Tecartus.

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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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Could Carvykti Receive a CHMP Positive Opinion This Week? Type II Variations for Tecartus and Kymriah Listed in March’s CHMP Agenda

On Monday, March 21, the CHMP agenda for March was released. Of note, Carvykti (JNJ / Legend’s BCMA CAR-T) has been listed under ‘Initial applications; Opinions’. Additionally, Tecartus (Gilead / Kite’s CD19 CAR-T) and Kymriah (Novartis’s CD19 CAR-T) have been listed under the ‘Type II Variations – Opinion or Requests for Supplementary Information’ section for r/r adult B-ALL and r/r FL, respectively. Below, Celltelligence provides insights on the potential EU approval timeline for Carvykti in r/r MM.

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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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Gracell’s GC012F US IND Submission Delayed to H2 2022; Assets Targeting Solid Tumors to Enter the Clinic in 2022; Gracell Expands Operations in the US; Gracell Q4 2021 Earnings Call Summary

On Monday, March 14, Gracell held their Q4 2021 earnings call (press release / presentation) highlighting GC012F’s delayed US IND filing while confirming multiple clinical updates for both TruUCAR and SMART CAR platforms in 2022. Furthermore, management confirmed the opening of their first R&D site in the US. Below, Celltelligence provides insights on possible reasons why GC012F’s IND submission may have been delayed, while discussing Gracell’s potential pipeline reprioritization.

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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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Poseida’s Upcoming Clinical Updates for 2022; Poseida Seeks Further Partners to Develop Their Novel Platforms; Poseida Q4 2021 Earnings Summary

On Thursday, March 10, Poseida released their Q4 2021 results (press release) highlighting their anticipated clinical updates for 2022, while expressing their interest in partnering their emerging technologies. Below, Celltelligence provides insights on Poseida’s potential strategy to prioritize allogeneic PSMA therapies while discussing their possible partnering strategy for their emerging technologies.

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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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Yescarta Absent From February’s CHMP Highlights

On Friday, February 25, the CHMP meeting highlights were released following Monday’s CHMP agenda. Of note, Yescarta (Gilead / Kite’s CD19 CAR-T) was absent from the CHMP highlights. Below, Celltelligence provides thoughts on Yescarta’s absence from the CHMP highlights, while providing updated EU timelines:

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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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