Tag Archives: cilta-cel

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 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 4: Legend Biotech, Precision BioSciences, and Ziopharm

On the fourth day of JPM 2021, Celltelligence covered presentations by Legend Biotech (presentation), Precision BioSciences (presentation), and Ziopharm Oncology (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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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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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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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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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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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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Thoughts on Cilta-cel’s Global Market Opportunities; Legend and JNJ’s Strategy to Position Cilta-cel in Earlier Lines of Therapy; Legend at Jefferies Cell Therapy Summit Call Summary

On Tuesday, October 6, Legend Biotech presented at the Jefferies Cell Therapy Virtual Summit (press release). Legend highlighted their clinical strategy and market opportunity for the BCMA CAR-T cilta-cel (JNJ-4528). Below, Celltelligence provides thoughts on Legend’s strategy for moving cilta-cel into earlier lines of therapy and the potential market opportunity compared to other BCMA CAR-Ts in development.

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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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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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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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