Tag Archives: BLA

Adaptimmune Completes Afami-cel Rolling BLA Submission in Advanced SS

On Wednesday, December 6, Adaptimmune announced (press release) the completion of the afami-cel (MAGE-A4 SPEAR T-cell) rolling BLA submission for the treatment of advanced synovial sarcoma (SS). Of note, the submission is supported by results from Cohort 1 of the pivotal Ph2 SPEARHEAD-1 trial. Below, Celltelligence provides insights on afami-cel’s results in r/r SS, while discussing the potential path of lete-cel (NY-ESO-1 TCR-T) in the same indication.

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Obe-cel’s BLA Submission on Track for YE 2023; Full FELIX Trial Data to be Presented at ASCO 2023; LCM Initiatives for Obe-cel Detailed; Partnering Opportunity for AUTO8 in MM; Autolus Q4 2022 Earnings Call Summary

On Tuesday, March 7, Autolus held its Q4 and FY 2022 earnings call (press release / presentation) highlighting that obe-cel’s (autologous CD19 CAR-T) BLA submission in r/r ALL continues to be expected by YE 2023. Additionally, management detailed future LCM plans for obe-cel and AUTO1/22 (autologous CD19 x CD22 CAR-T) and disclosed an interest in partnering AUTO8 (BCMA x CD19 dual CAR-T) for MM. Below, Celltelligence provides insights on obe-cel’s potential US and EU approval timelines, while discussing obe-cel’s potential in other indications and Autolus’s chances of finding a partner for AUTO8.

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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’s Review Progresses in the US and EU; Legend Continues Expanding their CARTITUDE Program; Legend Q2 2021 Earnings Call Summary

On Monday, August 23, Legend released their Q2 2021 results (press release) highlighting the initiation of cilta-cel’s (BCMA CAR-T) review processes for r/r MM in the US and Europe. Furthermore, management noted the expansion of the CARTITUDE program with the initiation of a Ph3 CARTITUDE-5 trial for newly diagnosed MM (NNMM) patients. Below, Celltelligence provides insights on likely US and EU approvals for cilta-cel, while commenting on Legend’s aggressive strategy to move cilta-cel into earlier lines of therapy.

About The Author

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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