Tag Archives: MM

BMS Reports Positive Topline Results From Abecma’s Ph3 KarMMa-3 Trial for ≥3L MM vs SoC: Will Abecma be the First Approved CAR-T in ≥3L MM?

On Wednesday, August 10, BMS and 2seventy bio reported positive topline results from Abecma’s (BCMA CAR-T) Ph3 KarMMa-3 trial in ≥3L MM (press release). Below, Celltelligence provides insights on how Abecma’s potential approval timeline in ≥3L MM compares with key competitor Carvykti (JNJ / Legend’s BCMA 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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Are Cell Therapy Leaders Losing Their Innovative Edge? Spotlight on BMS (Blast 3/6)

As the cell therapy field continues to grow and evolve, companies are developing innovative strategies to overcome the current challenges that the field is facing. In our Spotlight blasts 1 and 2, Celltelligence discussed Novartis’s pipeline, novel cell types, manufacturing platform, and potential strategy in the solid tumor space (see previous insight part 1 here; see previous insight part 2 here). Below, Celltelligence provides its analysis on BMS’s pipeline, novel cell types, platforms, and solid tumor strategy. In subsequent blasts, Celltelligence will provide a similar overview for Gilead (Kite). At the end of the series, Celltelligence will present a semi-qualitative analysis comparing the innovative strategies from Novartis, BMS, and Gilead (Kite).

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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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Autolus Presents Updated Results for Obe-cel, AUTO1/22, and AUTO4; Autolus’s EHA 2022 Investor Event; Academic BCMA CAR-T ARI0002h Reports Encouraging Efficacy in R/R MM; EHA 2022 Final Analysis

EHA 2022 Final Analysis: Autolus presented clinical results for obe-cel, AUTO1/22, and AUTO4, while Hospital Clinic Barcelona reported data from ARI0002h. Moreover, Autolus held an investor call following updated clinical data presented at EHA 2022. Below, Celltelligence provides insights and context for key selected presentations and highlights from the call. The following topics are covered below:

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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Gracell Presents Updated Results for GC012F and GC502; Gracell’s EHA 2022 Investor Event; EHA 2022 Analysis 2

EHA 2022 Analysis 2: Gracell presented clinical results for GC012F’s dual FasTCAR-T in r/r B-NHL + r/r MM, and GC502’s TruUCAR in r/r B-ALL. Additionally, Gracell held an investor call following updated clinical data presented at EHA 2022. Below, Celltelligence provides insights and context for key selected presentations and highlights from the call. The following topics are covered below:

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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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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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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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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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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Preliminary Results from Poseida’s P-PSMA-101 (PSMA CAR-T) Ph1 Trial in mCRPC; FDA Accepts Poseida’s P-BCMA-ALLO1 (Allogeneic BCMA CAR-T) IND in R/R MM

On Tuesday, August 31, Poseida presented (press release / webcast) preliminary results from P-PSMA-101’s (PSMA CAR-T) Ph1 trial in metastatic castration-resistant prostate cancer (mCRPC). Additionally, on Monday, August 30, Poseida announced (press release) that the FDA has accepted an IND application for P-BCMA-ALLO1 (allogeneic BCMA CAR-T) in r/r MM. Below, Celltelligence provides insights on how Poseida’s novel technology may be a key differentiating factor for the successful development of P-PSMA-101, while discussing Poseida’s position in the race to develop an allogeneic BCMA CAR-T for r/r 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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Legend Biotech Highlights FDA Filing of Cilta-Cel by YE 2020; Q2 2020 Earnings Summary

On Friday, August 28, Legend Biotech published their Q2 2020 results (press release). Management confirmed that their BCMA CAR-T, cilta-cel (JNJ-4528), co-developed with Janssen, is expected to be filed with the FDA by YE 2020, the EMA in early 2021, and with China’s NMPA in 2021. Furthermore, by YE 2020, Legend anticipates filing an IND application for LB1901 (a CD4 CAR-T) in r/r T cell lymphoma (TCL). Below, Celltelligence provides thoughts on cilta-cel’s commercial opportunity following the anticipated approval of ide-cel (BMS) around March 2021, and Legend’s market opportunity for LB1901 in the TCL setting.

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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