Tag Archives: LEADING COMPANIES

FDA Places Clinical Hold on Arcellx’s Pivotal Ph2 iMMagine-1 Trial in ≥4L MM; How Could the Hold Affect CART-ddBCMA’s Development Plans?

On Monday, June 19, Arcellx announced (press release) that the FDA has placed a clinical hold on CART-ddBCMA’s (autologous BCMA CAR-T) Ph2 iMMagine-1 trial in ≥4L MM. Below, Celltelligence provides insights on possible causes of the clinical hold while discussing how this may affect Arcellx’s development plans for its leading asset.

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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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Impressive Results for Breyanzi in ≥3L FL and ≥3L MCL; MB-106 Demonstrates Excellent Efficacy and Safety in R/R FL

On Saturday, June 17, BMS presented results from Breyanzi’s (CD19 CAR-T) Ph2 TRANSCEND FL trial in r/r FL patients and a primary analysis from the MCL cohort of the Ph1 TRANSCEND NHL 001 trial at ICML 2023. Moreover, Mustang Bio presented data from the FL cohort dosed with MB-106 (CD20 CAR-T) in the single-center Ph1/2 trial that led to the initiation of a registrational Ph1/2 trial for the treatment of r/r B-NHL or CLL in the same conference. Below, Celltelligence provides insights on how Breyanzi’s results compare to its key competitor CD19 CAR-Ts in ≥3L FL and ≥3L MCL, and discusses potential approval timelines for both indications in the US while analyzing which assets could rival MB-106 to become the first approved CD20 CAR-T.

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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 Abecma Receive a CHMP Positive Opinion This Week? Carvykti Starts EMA Assessment in ≥2L MM; June’s CHMP Agenda

On Monday, June 19, the CHMP agenda for June was released. Of note, Abecma (BMS’s BCMA CAR-T) was included in the ‘Type II Variations – Opinions or Requests for Supplementary Information’ section for ≥3L MM, while Carvykti (JNJ / Legend’s BCMA CAR-T) was listed as ‘Start of Procedure’ under ‘Type II Variations: Extension of Indications’ to expand its label to ≥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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GC012F Demonstrates a Promising Profile in ≥3L DLBCL Patients; ALYCANTE Trial Confirms Yescarta’s Excellent Efficacy in TI 2L LBCL Patients; NKX019 Shows Potential in NHL Patients; EHA 2023 Analysis 3

EHA 2023 Analysis 3: Gracell and Nkarta presented clinical updates from their programs in B-cell malignancies. Moreover, the French Lymphoma Academic Research Organisation (LYSARC) provided the final results of Yescarta’s (Gilead’s (Kite) CD19 CAR-T) ALYCANTE trial. Below, Celltelligence provides insights and context for key selected presentations. The following topics are covered:

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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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Promising Efficacy Data from BMS’s GPRC5D CAR-T in ≥4L MM; Abecma Demonstrates Superiority Vs SOC in ≥3L MM Across All High-Risk Subgroups; Preliminary Clinical Data from Innovent’s P329G-CAR-T in ≥4L MM; EHA 2023 Analysis 2

EHA 2023 Analysis 2: BMS / 2seventy bio and Innovent / Roche presented clinical updates from their programs in MM. Below, Celltelligence provides insights and context for key selected presentations, where the first topic also includes an evidence roundup of the PDUFA date for Janssen’s talquetamab. The following topics are covered:

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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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Promising Preliminary GC007g Efficacy Data in B-ALL Patients that Relapsed Post-Allo-HSCT; Prior CD19-Targeting Treatments Could Affect Tecartus Efficacy in R/R ALL; UCART22 Shows 50% CR in r/r B-ALL Patients Failing Previous CD19 CAR-T Therapy; EHA 2023 Analysis 1

EHA 2023 Analysis 1: Gracell, Gilead (Kite), and Cellectis presented clinical updates from their programs in B-ALL. Below, Celltelligence provides insights and context for key selected presentations. The following topics are covered:

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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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Analysis of Breyanzi in CLL/SLL Demonstrates Long Survival in Patients Achieving CR; Yescarta Reduces Risk of Death in 2L LBCL; Tecartus’s RW Study Shows Improved Results when Compared with ZUMA-2; ASCO 2023 Analysis 5

ASCO 2023 Analysis 5: BMS and Gilead (Kite) presented clinical outcomes from their autologous CD19 CAR-Ts in hematological malignancies. Below, Celltelligence provides insights and context for key selected presentations. The following topics are covered:

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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Carvykti’s sBLA Application Submitted to the FDA after Outperforming the SOC on CARTITUDE-4 Trial in ≥2L MM; Longer-term Follow-up Data for CARTITUDE-1 and LEGEND-2 Trials; ASCO 2023 Analysis 4

ASCO 2023 Analysis 4: JNJ and Legend presented results for Carvykti’s (BCMA CAR-T) Ph3 CARTITUDE-4 trial in 2-4L MM, which are the base of its sBLA submission to the FDA, announced by Legend on June 6, 2023 (press release). Additionally, 3-year and 5-year follow-up analyses for Carvykti’s Ph1b/2 CARTITUDE-1 and LEGEND-2 trials in ≥4L MM, respectively, were presented during ASCO 2023. Below, Celltelligence provides insights on Carvykti’s outstanding performance compared to SOC and the timeline of its potential FDA approval while discussing its curative potential for a wide range of MM 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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Rapid CAR-T Manufacturing Platforms Show Promise in R/R MM; Novartis and Gracell Present New Ph1 Data for PHE885 and GC012F; ASCO 2023 Analysis 2

ASCO 2023 Analysis 2: Novartis and Gracell presented clinical updates on CAR-T assets in r/r MM developed using next-generation platforms designed to reduce manufacturing time. Below, Celltelligence provides insights and context for key selected presentations. The following topics are covered:

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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Carvykti’s Type II Variation Application Submitted to the EMA; Carvykti’s Submission to the FDA Planned; Could Carvykti be First Approved for ≥2L MM in Europe Ahead of the US?

On Thursday, May 25, Legend announced (press release) that a Type II Variation (T2V) application was submitted to the EMA for Carvykti’s (BCMA CAR-T) use in ≥2L MM patients. Below, Celltelligence provides insights on Carvykti’s regulatory timelines to gain a label extension for this setting in Europe, while discussing its to-date absent filing with the FDA.

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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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