Tag Archives: ide-cel

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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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 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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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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First BCMA CAR-T Approved in the US for Multiple Myeloma; Will Abecma’s 33-day TAT and High Price Prevent Wide-Spread Adoption?

On Friday, March 26, BMS and bluebird bio announced (press release) that the FDA approved Abecma (idecabtagene vicleucel) for the treatment of ≥5L r/r MM (i.e. after completing at least 4 lines of prior therapy). Below, Celltelligence provides thoughts on Abecma’s higher list price and longer TAT vs. approved CD19 CAR-Ts, while discussing Abecma’s potential messaging strategy.

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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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Ide-cel Approved by FDA as Abecma in r/r MM After Four Lines of Previous Therapy

Late yesterday evening, BMS and bluebird bio announced US approval of ide-cel after completing at least 4 lines of prior therapy in r/r MM (BMS press release). The press release states that Abecma is a one-time infusion with a recommended dose range of 300 to 460 x 106 CAR-positive T cells. Of note, Abecma will be manufactured at BMS’s facility in Summit, New Jersey, with a median TAT of 33 days. The Celltelligence team will be conducting a full thoughts-on label review in the coming days (link to Abecma PI here).

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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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Cilta-cel’s MAA Not Submitted; No Regulatory Updates for Liso-cel and Ide-cel; CHMP March Agenda

On Monday, March 22, the CHMP agenda for March was released. Of note, JNJ / Legend’s BCMA CAR-T cilta-cel does not appear in either the agenda or the updated list of drugs under evaluation, suggesting that cilta-cel’s MAA has not yet been submitted to the EMA. Furthermore, no regulatory updates for BMS’s liso-cel (CD19 CAR-T) or ide-cel (BCMA CAR-T) were provided. Below, Celltelligence provides an update for cilta-cel’s likely EU approval timeline.

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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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Ide-cel Reverts to Standard Assessment; Liso-cel’s Potential Scenarios for Approval; CHMP February Agenda and Highlights

On Friday, February 26, CHMP meeting highlights were released following Monday’s CHMP agenda. Of note, regulatory updates for BMS’s liso-cel (CD19) and ide-cel (BCMA) CAR-T products were observed, including ide-cel’s start of standard review following its loss of accelerated assessment (AA) in December 2020. No updates for cilta-cel were provided. Below, Celltelligence provides insights on possible EC approval dates for liso-cel and ide-cel.

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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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BMS’s New US Cell Therapy Manufacturing Site; bluebird bio Quiet on Earnings; Former Kite Head of Development Joins Daiichi Sankyo

On Tuesday, February 23, BMS announced (press release) the construction of a new cell therapy manufacturing facility in Devens, Massachusetts. On the same day, bluebird bio released their Q4 and FY 2020 results (press release) without an investor call. Finally, Daiichi Sankyo announced (press release) Ken Takeshita, former Kite global head of development, will join the company as global head of R&D. Below, Celltelligence provides insights on BMS’s possible manufacturing footprint strategy, as well as thoughts on how Takeshita’s cell therapy experience could influence Daiichi Sankyo’s R&D strategy.

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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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No Regulatory Updates for Liso-cel; Orva-cel Discontinued; BMS Q4 2020 Earnings Call Summary

On Thursday, February 4, BMS held their Q4 2020 results (press release / presentation). Management discussed liso-cel’s possible imminent approval and their strategy for rapid ATC onboarding. Of note, BMS’s humanized BCMA CAR-T orva-cel has been discontinued. Below, Celltelligence provides insights on BMS’s potential strategy for liso-cel and thoughts on orva-cel’s discontinuation.

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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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CHMP Agenda Includes Hidden Request for Cilta-cel Accelerated Assessment; Precision Issued with a Notice of Allowance for PBCAR19B’s Patent

On Monday, January 25, the CHMP indirectly announced (CHMP agenda) that JNJ / Legend have requested an accelerated assessment for cilta-cel (BCMA CAR-T) in r/r MM, although the documentation only lists the code number for cilta-cel. Additionally, Precision BioSciences announced (press release) that the USPTO has issued a notice of allowance for PBCAR19B, a next-generation CD19 CAR-T. Below, Celltelligence provides insights on how a 1-month delay in filing cilta-cel could result in a 2-month delay for EC approval, an update on ide-cel’s estimated EU approval lead, and the significance of Precision’s latest patent milestone.

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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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