Category Archives: BCMA

No Cell Therapy-Related Updates in July’s CHMP Agenda

On Monday, July 17, the CHMP Agenda for July 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) and Carvykti (JNJ / Legend’s BCMA CAR-T) in r/r MM were absent from the agenda.

About The Author

The Celltelligence Team

|
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.

If you receive our email blasts, you already have an account.

Sign UpFREE

You’ll be able to access the full article from your Celltelligence Library after signing up.

Abecma’s T2V Receives an RSI; When Could Abecma and Carvykti Receive a CHMP Positive Opinion? June CHMP Highlights

On Friday, June 23, the CHMP meeting highlights were released. Of note, Abecma (BMS’s BCMA CAR-T) was absent from the CHMP highlights implying that it has received a Request for Supplementary Information (RSI) for its assessment in ≥3L MM. Moreover, recall that 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 on Monday’s CHMP agenda. Below, Celltelligence provides insights on the June CHMP meeting with updated EU regulatory timelines for both cell therapies.

About The Author

The Celltelligence Team

|
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.

If you receive our email blasts, you already have an account.

Sign UpFREE

You’ll be able to access the full article from your Celltelligence Library after signing up.

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.

About The Author

The Celltelligence Team

|
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.

If you receive our email blasts, you already have an account.

Sign UpFREE

You’ll be able to access the full article from your Celltelligence Library after signing up.

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.

About The Author

The Celltelligence Team

|
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.

If you receive our email blasts, you already have an account.

Sign UpFREE

You’ll be able to access the full article from your Celltelligence Library after signing up.

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:

About The Author

The Celltelligence Team

|
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.

If you receive our email blasts, you already have an account.

Sign UpFREE

You’ll be able to access the full article from your Celltelligence Library after signing up.

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:

About The Author

The Celltelligence Team

|
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.

If you receive our email blasts, you already have an account.

Sign UpFREE

You’ll be able to access the full article from your Celltelligence Library after signing up.

IASO, AbClon, Parasol and Affyimmune Present Promising Results of Their New Cell Therapies in Hematological and Solid Tumor Indications; ASCO 2023 Analysis 6

ASCO 2023 Analysis 6: IASO Biotherapeutics, AbClon, Parasol Biotech, and Affyimmune presented clinical updates from their novel CAR-T assets. Below, Celltelligence provides insights and context for key selected presentations. The following topics are covered:

About The Author

The Celltelligence Team

|
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.

If you receive our email blasts, you already have an account.

Sign UpFREE

You’ll be able to access the full article from your Celltelligence Library after signing up.

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.

About The Author

The Celltelligence Team

|
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.

If you receive our email blasts, you already have an account.

Sign UpFREE

You’ll be able to access the full article from your Celltelligence Library after signing up.

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

|
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.

If you receive our email blasts, you already have an account.

Sign UpFREE

You’ll be able to access the full article from your Celltelligence Library after signing up.

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.

About The Author

The Celltelligence Team

|
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.

If you receive our email blasts, you already have an account.

Sign UpFREE

You’ll be able to access the full article from your Celltelligence Library after signing up.