Tag Archives: JNJ

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.

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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 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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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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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 to Present Multiple Updates at ASCO and EHA 2023; Legend to Use Raised Funding for Carvykti’s Development; Legend’s Q1 2023 Earnings Summary

On Thursday, May 18, Legend reported its Q1 2023 clinical updates and financial results (press release) highlighting Carvykti’s (BCMA CAR-T) upcoming clinical presentations at ASCO and EHA 2023, and its WW revenue during this period. Below, Celltelligence provides insights on CARTITUDE-4 data to be presented in the upcoming conferences and Carvykti’s future development.

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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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JNJ to Invest in CAR-T Therapies for Lymphoma

On Tuesday, May 2, JNJ announced (press release) a WW agreement with Cellular Biomedicine Group (CBMG) for the development, manufacturing, and commercialization of two novel cell therapies, C-CAR039 (prizloncabtagene autoleucel; CD20 x CD19 CAR-T) and C-CAR066 (CD20 CAR-T) for the treatment of B-cell malignancies. Below, Celltelligence provides insights on JNJ’s cell therapy pipeline extension and new interest in the lymphoma space while discussing its potential direct competitors in the space.

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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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Thoughts on CARTITUDE-4’s EHA Abstract Being Prematurely Posted; Carvykti Demonstrates an Impressive Efficacy Profile in 2-4L MM

On Tuesday, April 18, Carvykti’s (JNJ / Legend’s BCMA CAR-T) topline results of its Ph3 CARTITUDE-4 trial were reported after its abstract was unintentionally posted on EHA’s website. The results suggest a superior efficacy profile of Carvykti over SOC therapy (news, Endpoints News, Apr 2023). Below, Celltelligence provides insights on Carvykti’s outstanding performance compared to SOC while discussing its potential to become the new SOC therapy in the 2L MM setting.

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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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UPDATED: Carvykti’s CARTITUDE-6 Trial to Initiate Ex-US Due to FDA Safety Requirements; LB2102 IND Clearance in SCLC; Legend H2 2022 Earnings Call Summary

UPDATED: On April 3, 2023, Celltelligence published a blast entitled “Carvykti’s CARTITUDE-6 Trial to Initiate Ex-US Due to FDA Safety Concerns; LB2102 IND Clearance in SCLC; Legend H2 2022 Earnings Call Summary”. Since then, Janssen reached out to Celltelligence to clarify that FDA’s safety “concern” is really more about meeting a “requirement” for re-filing the IND than anything else. The team has updated the April 3 blast to reflect the clarity provided by Janssen.

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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 +31% QoQ; Novartis to Manufacture Carvykti; JNJ Q1 2023 Earnings Call Summary

(Celltelligence is aware of the CARTITUDE-4 abstract leak and will have a thoughts-on analysis after the team returns from AACR.)

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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.

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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