Tag Archives: ide-cel

What is Behind Ide-cel’s mPFS and mOS Disparity? Thoughts on Ide-cel’s Launch Messaging and List Price; bb21217’s Manufacturing Updates; bluebird bio ASH Investor Event

On Monday, December 7, bluebird bio held an ASH-related investor event (press release / webcast) discussing recent advances to their BCMA CAR-Ts ide-cel (bb2121) and bb21217 in r/r MM. Below, Celltelligence provides thoughts on the significant differences in ide-cel’s mPFS and mOS data, how the data could influence launch messaging and list price, in addition to summarizing manufacturing updates for bb21217.

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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 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 FDA Updates for Liso-cel or Ide-cel; New GPRC5D CAR-T in MM; BMS Q3 2020 Earnings Call Summary

On Thursday, November 5, BMS held their Q3 2020 results (press release / presentation). No updates were provided for liso-cel’s or ide-cel’s regulatory approval. Of note, BMS added a new CAR-T targeting GPRC5D in ≥4L r/r multiple myeloma (MM) to their portfolio. Below, Celltelligence provides thoughts on liso-cel’s anticipated PDUFA November date and how a GPRC5D CAR-T could disrupt the MM 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 Ide-cel Data Presentation at ASH 2020; FDA Unlikely to Hold an Ide-cel Advisory Committee Meeting; Summary of bluebird at Jefferies Cell Therapy Summit

On Tuesday, October 6, bluebird bio at the Jefferies Cell Therapy Virtual Summit (press release) highlighted upcoming clinical results for ide-cel at ASH 2020. Of note, bluebird discussed ide-cel’s projected approval timeline and the possibility of an FDA Advisory Committee Meeting. Furthermore, management outlined their position on ide-cel combinations with gamma-secretase inhibitors. Below, Celltelligence provides thoughts on ide-cel’s anticipated clinical update and bluebird’s possible messaging strategy for autologous CAR-Ts vs allogeneics.

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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-4528 US Filing Anticipated in Q4 2020; JNJ Q3 2020 Earnings Summary

On Tuesday, October 13, JNJ held their Q3 2020 earnings call (press release / presentation). Management reported a +13.3% WW sales growth for their oncology division, driven by their multiple myeloma product Darzalex (US +46%; WW +43.8%). Of note, JNJ confirmed that JNJ-4528 (BCMA CAR-T) is anticipated to be filed with the FDA in Q4 2020. Below, Celltelligence provides insights on a JNJ-4528 approval in 2021 and the potential impact on ide-cel (BMS) sales in the US and EU.

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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 and bluebird bio Receive Priority Review for Ide-cel; PDUFA Projected Around March 27, 2021

On Tuesday, September 22, BMS and bluebird bio announced (press release, BMS / press release, bluebird bio) that the FDA has granted a Priority Review for ide-cel (BCMA CAR-T) in ≥4L RRMM with a projected PDUFA date around March 27, 2021. Below, Celltelligence provides additional thoughts on ide-cel’s anticipated approval and the potential impact on BMS’s CVR milestone if the FDA requests additional information.

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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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bluebird bio Highlights Ide-cel Resubmission; Q2 2020 Earnings Call

On Wednesday, August 5, bluebird bio released their Q2 2020 financial results (press release). No new data was reported; however, the company highlighted the successful resubmission of their ide-cel BLA application. Below, Celltelligence provides insights on ide-cel’s potential approval date in the EU and a possible alternative messaging strategy for the CAR-T in earlier lines of therapy.

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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 and bluebird bio Resubmit Ide-cel to FDA; Dynamic H1 2021 BCMA Launch Environment Expected with Janssen

On Wednesday, July 29, BMS and bluebird bio announced (press release) the resubmission of their BLA application for ide-cel (bb2121) to the FDA. According to the press release, the submission provides further details on the CMC module, addressing the additional regulatory information requested by the FDA in May 2020 (see previous insight). Below, Celltelligence provides additional thoughts on ide-cel’s potential approval, and the possible benefit a delayed ide-cel launch could have for 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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