Tag Archives: multiple myeloma

Gracell’s GC012F Receives IND Clearance in Early Line MM

On Monday, January 29, Gracell announced (press release) that the FDA cleared the IND application to start a Ph1 trial to evaluate GC012F (BCMA x CD19 FasTCAR-T) in early line MM. Below, Celltelligence provides insights on Gracell’s major regulatory milestone, while discussing the importance of this trial for AstraZeneca’s cell therapy franchise.

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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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We’re Back! Holiday Recap Ahead of JPM 2024 (Blast 1/2): Thoughts on AstraZeneca’s Acquisition of Gracell

Happy New Year! It’s great to be back in 2024 serving our growing audience!

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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 October’s CHMP Agenda

On Monday, October 9, the CHMP Agenda for October 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) in ≥3L MM and Carvykti (JNJ / Legend’s BCMA CAR-T) in ≥2L MM were absent from the agenda.

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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’s Regulatory Applications for R/R MM Accepted in the US, Europe, and Japan

Abecma’s Regulatory Applications for R/R MM Accepted in the US, Europe, and Japan

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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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Thoughts on Carvykti’s CARTITUDE-4 Meeting Its Primary Endpoint in 2 – 4L MM

On Friday, January 27, JNJ and Legend reported (JNJ’s press release; Legend’s press release) positive topline results from Carvykti’s (BCMA CAR-T) Ph3 CARTITUDE-4 trial in 2 – 4L MM. Below, Celltelligence provides insights on how Carvykti’s potential approval timeline in r/r MM compares with key competitor Abecma (BMS / 2seventy’s BCMA CAR-T), while discussing JNJ / Legend’s difficulties in delivering Carvykti to patients.

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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 JNJ Report Clinical Updates from BCMA CAR-Ts in MM; ASH 2022 Analysis 2

ASH 2022 Analysis 2: BMS and JNJ presented updated results from their approved BCMA CAR-Ts in r/r MM. Below, Celltelligence provides insights and context for key selected presentations.

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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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Allogene’s R&D Showcase 2022: Celltelligence Analysis – Part 1

On Tuesday, November 29, Allogene held an R&D showcase (press release / presentation) providing updated clinical milestones and results from ALLO-501A (allogeneic CD19 CAR-T) and ALLO-715 (allogeneic BCMA CAR-T). Below, Celltelligence provides insights on the new data presented by Allogene from its hematology franchise, while discussing potential regulatory timelines for ALLO-501A and how it could compete with approved autologous CAR-Ts.

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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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Gracell to Submit GC012F’s IND for R/R MM in the US and China; GC012F Demonstrates 100% ORR in NDMM; Clinical Progress from GC007g, GC503, and GC506; Gracell’s Q3 2022 Earnings Call Summary

On Monday, November 14, Gracell held their Q3 2022 earnings call (press release / presentation), highlighting results from GC012F’s (autologous BCMAxCD19 FasTCAR-T) Ph1/2 IIT in NDMM, and planned IND submissions in the US and China for r/r MM. Additionally, management provided clinical updates for GC007g (allogeneic CD19 CAR-T), GC503 (mesothelin SMART CAR-T), and GC506 (CLDN18.2 SMART CAR-T). Below, Celltelligence provides insights on GC012F’s potential as a first-line treatment in MM, while discussing a possible partnership strategy 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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Carvykti’s Revenue Increases to $55M; JNJ Expects Franchise to Generate $5B by 2025; Will Carvykti be Approved in 2L MM by Q3 2023? JNJ Q3 2022 Earnings Call Summary

On Tuesday, October 18, JNJ held their Q3 2022 earnings call (press release / presentation) highlighting Carvykti’s (JNJ / Legend’s BCMA CAR-T) potential to generate $5B by 2025. Additionally, management confirmed that a data readout from Carvykti’s Ph3 CARTITUDE-4 trial in 2-4L MM is expected by YE 2022. On the same day, Legend disclosed (SEC filing, Oct 2022) that Carvykti’s preliminary WW sales for Q3 2022 were $55M. Below, Celltelligence provides insights on Carvykti’s revenue increase, while discussing potential US regulatory timelines for Carvykti in 2L MM.

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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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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.

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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