Tag Archives: JNJ

Carvykti’s CARTITUDE-4 Met its Primary Endpoint in r/r MM

On Friday, January 27, Legend Biotech announced (press release) that Carvykti’s (BCMA CAR-T) Ph3 CARTITUDE-4 trial in 2 – 4L MM met its primary endpoint (PFS), demonstrating a statistically significant improvement compared to the SOC (PVd or DPd). The Celltelligence team will be conducting an in-depth analysis in the coming days.

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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 Revenue Remains Flat; CARTITUDE-4 Readout Expected in 2023; JNJ Q4 2022 Earnings Call Summary

On Tuesday, January 24, JNJ held their Q4 and FY 2022 earnings call (press release / presentation) confirming that a data readout from Carvykti’s (BCMA CAR-T) Ph3 CARTITUDE-4 trial for 2 – 4L MM is expected in 2023. On the same day, Legend disclosed (SEC filing, Jan 2023) that Carvykti’s preliminary WW sales for Q4 2022 were $55M. Below, Celltelligence provides insights on Carvykti’s flat revenue, while discussing potential US regulatory timelines for Carvykti in 2L MM.

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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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JPM 2023 Analysis Day 1: BMS, Novartis, JNJ, and Gilead

On the first day of JPM 2023, Celltelligence covered presentations by BMS (presentation), Novartis (presentation), JNJ (webcast), and Gilead (presentation). Below, Celltelligence provides insights and context for each presentation. The following topics are covered below.

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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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Fate Tx, Adicet Bio, and Allogene Report Clinical Updates from Allogeneic Cell Therapies; ASH 2022 Analysis 1

ASH 2022 Analysis 1: Fate Tx, Adicet Bio, and Allogene presented clinical updates from their allogeneic cell therapies in hematological malignancies. Below, Celltelligence provides insights and context for key selected presentations. The following topics are covered below:

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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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UPDATED: Indications Table for BCMA and CD19 CAR-T US Approvals and Submissions (Q3 2022)

New content: The Celltelligence team has updated its BCMA CAR-T and CD19 CAR-T indications tables for estimated US approvals and submissions following key Q3 2022 earnings presentations and recent press releases (see below for download). Another update will be published in December after ASH.

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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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Carvykti Approved in Japan for ≥4L r/r MM

On Tuesday, September 27, Legend announced (press release) that Japan’s Ministry of Health, Labour, and Welfare (MHLW) approved Carvykti (BCMA CAR-T) for the treatment of ≥4L r/r MM. Below, Celltelligence provides insights on how Carvykti’s approval may challenge Abecma’s (BMS’s BCMA CAR-T) first-to-market advantage in Japan, while discussing Carvykti’s potential pricing.

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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 JNJ Change the Treatment Paradigm in MM? Spotlight on JNJ’s MM Franchise

During 2022, JNJ’s (Janssen) MM franchise achieved major regulatory milestones that have positioned the company as a key player in the MM landscape. Carvykti’s (cilta-cel; BCMA CAR-T) US approval, EU approval, and Tecvayli’s (teclistamab; BCMA x CD3 bispecific antibody) recent conditional marketing authorization in the EU could potentially allow JNJ to change the treatment paradigm in MM. Below, Celltelligence provides insights on how JNJ could leverage its large MM portfolio and pipeline to disrupt the current SOC regimens for MM, as well as what may be going on with Tecvayli’s US regulatory delay.

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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: Indications Table for BCMA and CD19 CAR-Ts US Approvals and Submissions

New content: The Celltelligence team has created a BCMA CAR-T indications table for estimated US approvals and submissions following key Q2 2022 earnings presentations and recent press releases (see below for download). Of note, no updates were observed in Celltelligence’s CD19 CAR-T indications table.

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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Abecma’s Ph3 KarMMa-3 Trial Meets Primary Endpoint; Potential Delays for bbT369 and SC-DARIC33; 2seventy bio Q2 2022 Earnings Call Summary

On Wednesday, August 10, 2seventy bio held their Q2 2022 earnings call (press release) highlighting positive topline results from Abecma’s (autologous BCMA CAR-T) Ph3 KarMMA-3 trial in ≥3L MM. Additionally, management provided updated data readouts for bbT369 (autologous CD20xCD79a dual CAR-T) and SC-DARIC33 (autologous CD33 CAR-T). Below, Celltelligence provides insights on Abecma’s LCM initiatives, while discussing potential clinical delays for bbT369 and SC-DARIC33.

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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