Tag Archives: BMS

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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Breyanzi Approved in Japan; but What’s the Price?

On Monday, March 22, Japan’s Ministry of Health Labour and Welfare (MHLW) approved Breyanzi (CD19 CAR-T) for the treatment of diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL), transformed low-grade NHL, and high-grade B-cell lymphoma (press release). Below, Celltelligence provides insights on Breyanzi’s market access in Japan, while commenting on Breyanzi’s potential pricing and manufacturing strategies compared to key competitors Kymriah (Novartis) and Yescarta (Gilead).

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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 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 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 Breyanzi’s (liso-cel) Label, Price, Manufacturing, and TAT Compared to Kymriah and Yescarta

On Friday, February 5, BMS announced (press release) that the FDA approved Breyanzi (lisocabtagene maraleucel) for the treatment of r/r LBCL after ≥2L systemic therapy, which is essentially ≥3L r/r DLBCL. The application was based on data from the Ph1 TRANSCEND NHL 001 trial. Below, Celltelligence provides insights on Breyanzi’s approval, the higher DLBCL list price vs. Kymriah and Yescarta, how BMS may position Breyanzi in the CD19 CAR-T setting, why supplying Breyanzi in vials is strategically important, and a look at the Breyanzi mobile app.

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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 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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JPM 2021 Day 1: BMS, bluebird bio, Novartis, and JNJ

On the first day of JPM 2021, Celltelligence covered presentations by BMS, bluebird bio, Novartis, and JNJ. Below, Celltelligence provides a topline summary of key takeaways from each company followed by more in-depth coverage 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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Celgene’s CVR Payment Vanishes As Liso-cel Is Not Approved Before Dec 31, 2020

As of January 1, 2021, the FDA has not yet approved BMS’s CD19 CAR-T liso-cel, and BMS’s press release today confirmed the termination of the Celgene CVR. Below, Celltelligence provides insights on the potential for litigation following liso-cel’s missed approval deadline for Celgene’s CVR shareholders.

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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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ZUMA-12 Reports an 85% ORR in 1L DLBCL; Liso-cel’s Safety Profile vs Kymriah and Yescarta; Comparison of OOS Use of CD19 Commercial CAR-Ts; ASH Day 2

On the second day of ASH 2020, four key clinical updates were presented from Novartis, Gilead, and BMS / bluebird bio. Below, Celltelligence provides insights and context for each presentation.

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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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