Tag Archives: Legend

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 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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FDA Accepts Legend’s LB2102 (DLL-3 CAR-T) IND in SCLC

On Monday, November 21, Legend announced (press release) that the FDA has accepted the IND for LB2102 (autologous DLL-3 CAR-T) in extensive stage small cell lung cancer (SCLC). Below, Celltelligence provides insights on LB2102’s IND clearance, discusses potential competition, and highlights how CAR-T therapies could succeed where AbbVie previously failed when targeting DLL-3.

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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 Carvykti be Approved in 2L MM by 2023? Legend Introduces New γδ CAR-T Program; Updates to Solid Tumor Programs; Thoughts on Legend’s R&D Day 2022

On Monday, October 3, Legend Biotech held their R&D Day (webcast), highlighting Carvykti’s (BCMA CAR-T) LCM initiatives, while providing updates on Legend’s pipeline platforms and programs. Below, Celltelligence provides insights on Carvykti’s ongoing competition with Abecma (BMS’s BCMA CAR-T), while evaluating the strength of Legend’s pipeline compared to its competitors.

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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 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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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.

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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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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.

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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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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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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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UPDATE: Legend Discloses Carvykti’s Q2 2022 Revenue of $24M

On Thursday, July 21, Legend Biotech reported (6-K SEC) that Carvykti (JNJ / Legend’s BCMA CAR-T) generated approximately $24M in “net trade sales” in Q2 2022. Of note, during JNJ’s Q2 2022 earnings call, management highlighted that the first Carvykti sales had been recorded, but did not disclose its Q2 2022 revenue (see previous insight). The Celltelligence team will analyze how Carvykti’s revenue compares with key competitor Abecma (BMS’s BCMA CAR-T) after BMS releases its Q2 2022 financial results on July 27, 2022.

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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No Carvykti Revenue Disclosed; JNJ Q2 2022 Earnings Call Summary

On Tuesday, July 19, JNJ held their Q2 2022 earnings call (press release / presentation) highlighting Carvykti’s (JNJ / Legend’s BCMA CAR-T) US launch in April 2022, and subsequent EC conditional approval for ≥4L MM in May 2022. Below, Celltelligence provides insights on Carvykti’s potential US and EU launch strategy, while comparing it with key competitor Abecma (BMS’s BCMA CAR-T).

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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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CARTITUDE-1 and CARTITUDE-2 Study Updates; Carvykti Demonstrates Durable Responses at 2-Year Follow-Up; Legend Reports Delayed Cases of Parkinsonism; ASCO 2022 Legend Investor Event

On Sunday, June 5, Legend held their ASCO investor event highlighting updated clinical results from Carvykti’s (BCMA CAR-T; cilta-cel) Ph1b/2 CARTITUDE-1 and Ph2 CARTITUDE-2 studies in r/r MM. Below, Celltelligence provides insights on Carvykti’s durable responses in comparison with Abecma (BMS’s BCMA CAR-T), while discussing whether parkinsonism could require a novel mitigation strategy.

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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