Tag Archives: RRMM

Gracell’s GC012F IND Submission Plans; Ph2 Portion of GC007 Trial to Start in Q3 2022; Gracell’s Q2 2022 Earnings Call Summary

On Monday, August 15, Gracell held their Q2 2022 earnings call (press release / presentation) highlighting GC012F’s (autologous BCMAxCD19 FasTCAR-T) IND filing plans both in the US and China, while updating clinical milestones for both TruUCAR and SMART CAR-T platforms. Below, Celltelligence provides insights on regulatory updates for GC012F in r/r MM and the potential delay in the GC027 trial (allogeneic CD7 TruUCAR-T) for r/r T-ALL patients.

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Thoughts on Carvykti’s EC Conditional Marketing Authorization in ≥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. Below, Celltelligence provides thoughts on Carvykti’s EC approval and its potential launch strategy within Europe.

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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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When Could Legend File Cilta-cel in 2L MM? Legend to Submit an NDA to Japan’s PMDA for Cilta-cel in R/R MM by YE 2021; Legend Develops a Novel Tri-Specific CAR-T; Legend Q3 2021 Earnings Summary

On Tuesday, November 16, Legend released their Q3 2021 financial updates (press release) highlighting that enrollment for cilta-cel’s (BCMA CAR-T) Ph3 CARTITUDE-4 study in 2-4L r/r MM has completed, while discussing cilta-cel’s FDA and PMDA regulatory updates. Additionally, management announced the development of LCAR-AIO, a novel tri-specific CD19 x CD20 x CD22 CAR-T for treating B-cell malignancies following CAR-T therapy relapse. Below, Celltelligence provides insights on when Legend / JNJ could potentially file cilta-cel’s sBLA in 2L r/r MM based on data from CARTITUDE-4, while discussing Legend’s novel tri-specific CAR-T and pipeline updates.

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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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BMS and bluebird bio Receive Priority Review for Ide-cel; PDUFA Projected Around March 27, 2021

On Tuesday, September 22, BMS and bluebird bio announced (press release, BMS / press release, bluebird bio) that the FDA has granted a Priority Review for ide-cel (BCMA CAR-T) in ≥4L RRMM with a projected PDUFA date around March 27, 2021. Below, Celltelligence provides additional thoughts on ide-cel’s anticipated approval and the potential impact on BMS’s CVR milestone if the FDA requests additional information.

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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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