Tag Archives: Legend

Cilta-cel’s Submission on Track in the US, Europe, China, and Japan; Multiple Cilta-cel Clinical Updates Expected at ASCO and EHA 2021; Legend Q1 2021 Earnings Summary

On Tuesday, May 18, Legend released their Q1 2021 financial results (press release), highlighting that cilta-cel’s (BCMA CAR-T) US and EU regulatory approvals in r/r MM remain on track, with submissions in China and Japan anticipated in H2 2021. Furthermore, management confirmed that a number of cilta-cel clinical updates will be presented at ASCO and EHA 2021. Below, Celltelligence provides updated timelines for cilta-cel’s approval in the US and EU, while detailing cilta-cel’s upcoming clinical updates.

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No Mention of Abecma, Breyanzi, or Cilta-cel in May’s CHMP Agenda

On Monday, May 17, the CHMP agenda for May was released. Of note, no major updates were observed for Abecma (BMS), Breyanzi (BMS), or cilta-cel (JNJ / Legend). Below, Celltelligence provides an update on likely EU approval timelines for Abecma, Breyanzi, and cilta-cel.

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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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Humanigen Cancels Collaboration with Gilead (Kite) to Test Lenzilumab with Other Commercial CD19 CAR-Ts; FDA Accepts Allogene’s TurboCAR ALLO-605 (BCMA CAR-T) IND; First Patient Dosed with Ziopharm’s RPM CD19 CAR-T in Taiwan; No Regulatory Updates for Cilta-cel in JNJ’s Q1 2021 Earnings Call

A series of cell therapy-related news items have been observed:

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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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Gilead Files Tecartus’s sBLA in Adult R/R ALL; AUTO1 Receives PRIME Designation by the EMA; JNJ / Legend Complete Cilta-cel’s Rolling BLA in the US; BMS Files Abecma in Japan for R/R MM; Precision’s New CEO Transition Plan

Ahead of AACR, a series of cell therapy-related news items have been observed:

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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 Japanese BLA Submission Anticipated for H2 2021; CARTITUDE-1 and CARTITUDE-2 Clinical Updates Expected in 2021; No Major Updates for Precision BioSciences; Legend and Precision Q4 2020 Earnings Call Summaries

On Thursday, March 18, Legend held their Q4 2020 earnings presentation (press release / presentation), highlighting the anticipated BLA submission of cilta-cel in Japan, while providing further details on cilta-cel’s rolling submission in the US. Furthermore, Precision BioSciences released their Q4 2020 results (press release), however no major clinical or regulatory updates were provided. Below, Celltelligence provides insights on how cilta-cel’s expansion within Asia could become an important revenue source for JNJ / Legend in the long term.

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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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New Legend Ph1 Trial for CD4 CAR-T (LB1901) in R/R T-Cell Lymphoma Posted

On Friday, January 15, a new Legend-sponsored Ph1 trial was observed on CT.gov for a first-in-human study of LB1901 (CD4 CAR-T) in ≥3L r/r T cell Lymphoma (TCL). Below, Celltelligence provides details for this trial and how LB1901 compares to Autolus’s AUTO4 program.

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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 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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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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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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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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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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