Tag Archives: BCMA

Could Kymriah Have Become the CAR-T Market Leader in Q4 2020? PORTIA Deprioritized; No Updates on Cilta-cel’s Regulatory Submissions; Novartis and JNJ Q4 2020 Earnings Call Summaries

On Tuesday, January 26, Novartis (press release / presentation) and JNJ (press release / presentation) held their Q4 2020 earnings calls. Novartis highlighted Kymriah’s FY 2020 WW growth of 68% YoY, while JNJ confirmed the rolling submission of cilta-cel’s BLA in December 2020. Below, Celltelligence provides insights on how Kymriah could become the CAR-T market leader, Novartis’s reprioritization of the Ph1b PORTIA trial (Kymriah + pembrolizumab), and the possibility of an August US approval for cilta-cel.

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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 3: Allogene, Autolus, and Tmunity

On the third day of JPM 2021, Celltelligence covered presentations by Allogene (presentation), Autolus (presentation), and Tmunity (presentation). 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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JPM 2021 Day 2: Gilead and SpringWorks

On the second day of JPM 2021, Celltelligence covered presentations by Gilead (presentation) and SpringWorks (presentation). 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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Cilta-cel Submitted in US; Could Approval be Earlier than August 2021?

On Monday, December 21, JNJ announced (press release) the US rolling submission of cilta-cel’s (BCMA CAR-T) BLA in ≥4L r/r Multiple Myeloma (MM). Below, Celltelligence provides insights on cilta-cel’s potential approval date and how this could reduce ide-cel’s first-to-market advantage.

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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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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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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 Cilta-cel Become the BCMA CAR-T of Choice in 2021? ASH Day 3 Legend Investor Event

On the third day of ASH 2020, Legend held an investor event to discuss the recent data presented at ASH 2020 from the Ph1b/2 CARTITUDE-1 study. Below, Celltelligence provides a summary of the call, JNJ’s / Legend’s possible messaging for cilta-cel, and regulatory updates 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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Cilta-cel’s ASH 2020 Clinical Updates; Global Regulatory Filings Remain on Track; Allogeneic BCMA CAR-T Enters into Ph1 Trial; Legend’s Q3 2020 Earnings Call Summary

On Monday, November 16, Legend Biotech released their Q3 2020 earnings and financial results (press release), highlighting upcoming ASH 2020 presentations for their BCMA CAR-T cilta-cel (Ph1b/2 CARTITUDE-1 and Ph2 LEGEND-2 trials). Furthermore, management confirmed that cilta-cel’s submission to the FDA and EMA are anticipated by YE 2020 and early 2021, respectively. Finally, Legend commented that in 2021 they anticipate to file cilta-cel with the Chinese NMPA. Below, Celltelligence provides insights on cilta-cel’s global regulatory updates and the potential impact to BMS’s BCMA CAR-T 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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Legend Appoints a New CEO and Chairperson; New Ph1 Pipeline Updates Including an Allogeneic BCMA CAR-T

On Monday, November 9, Legend announced (press release) the appointment of Ms. Ye (Sally) Wang as Chairwoman of the Board of Directors and Dr. Ying Huang (previous CFO) as Chief Executive Officer. Of note, Legend added three Ph1 trials to their clinical pipeline, including an allogeneic BCMA CAR-T. Below, Celltelligence provides additional context for the new leadership appointments and how Legend’s allogeneic BCMA CAR-T could impact the multiple myeloma landscape.

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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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ALLO-715 Ph1 UNIVERSAL Initial Data to be Presented at ASH 2020; Redosing Strategy Confirmed for ALLO-501 Ph1 ALPHA Trial; Allogene Q3 2020 Earnings Call Summary

On Wednesday, November 4, Allogene held their Q3 2020 earnings call (press release). Allogene highlighted data from their ALLO-715 Ph1 UNIVERSAL trial in ≥4L r/r multiple myeloma (MM) due to be presented at ASH 2020. Moreover, management confirmed the redosing strategy for their ALLO-501 (CD19 CAR-T) Ph1 ALPHA trial study. Below, Celltelligence provides insights into the significance of the UNIVERSAL data and how Allogene may approach redosing for their other clinical products.

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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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