Tag Archives: Autologous

Kymriah’s First Asian Commercial Manufacturing Facility is Approved; Novartis Increases Manufacturing Footprint to Five Global Centers

On Friday, October 30, Novartis announced (press release) that they have received marketing authorization from Japan’s MHLW (Ministry of Health, Labor and Welfare) for the FBRI (Foundation for Biomedical Research and Innovation) to commercially manufacture Kymriah. Below, Celltelligence provides thoughts on the impact of Novartis’s Japanese manufacturing site and anticipated approvals in other locations.

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Continued Kymriah Sales Growth Despite COVID-19; Kymriah’s LCM Initiatives Remain on Track; Q3 2020 Earnings Call Summary

On Tuesday, October 27, Novartis held their Q3 2020 earnings call (press release / financial report / presentation). Of note, Kymriah sales grew +51% WW YoY, and +3% WW QoQ. Below, Celltelligence provides thoughts on Kymriah’s reduced growth rate and potential implications for Yescarta’s Q3 2020 results.

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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 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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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 Ziopharm’s TCR-T Programs; Ziopharm at Jefferies Cell Therapy Summit Call Summary

On Monday, October 5, Ziopharm participated in the Jefferies Cell Therapy Summit (press release). Management highlighted advances to their library TCR-T and personalized TCR-T programs. Below, Celltelligence provides thoughts on the potential market opportunities for Ziopharm’s TCR-T and CD19 CAR-T therapies.

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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 Adopts Positive Opinion for Gilead’s Tecartus in r/r Mantle Cell Lymphoma

On Friday, October 16, Gilead announced (press release) that the CHMP has adopted a positive opinion for Tecartus (brexucabtagene autoleucel, formerly KTE-X19) in ≥3L r/r mantle cell lymphoma (MCL). If approved by the EC, Tecartus would become the first and only CAR-T treatment approved for r/r MCL in Europe. Below, Celltelligence provides thoughts on Tecartus’s positive CHMP opinion and the likelihood of Gilead onboarding EU centers within 30 days of EC approval.

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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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Ziopharm´s RPM Allogeneic CD19 CAR-T Trial Started Enrollment; Q2 2020 Earnings Summary

On Thursday, August 6, Ziopharm held their Q2 2020 earnings call (press release / presentation), highlighting the initiation of their allogeneic CD19 CAR-T Ph1 trial post allo-SCT. Management confirmed that the IND submission in Greater China (China and Taiwan) for autologous CD19 CAR-Ts is anticipated by YE 2020. In Q1 2021, Ziopharm expects to submit CMC data for their personalized and library TCR-T IND application. Below, Celltelligence provides thoughts on Ziopharm’s global CD19 CAR-T initiatives and the potential challenges and opportunities for their TCR-T programs.

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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 Gilead’s sBLA Submission for Yescarta in r/r iNHL (ZUMA-5)

On Friday, September 4, Gilead announced (press release) the submission of an sBLA to the FDA for Yescarta in r/r ≥3L iNHL (follicular lymphoma and marginal zone lymphoma). The sBLA application is based upon positive results from the Ph2 ZUMA-5 trial. Below, Celltelligence provides insights on Yescarta’s sBLA timeline and the potential impact from competitors Novartis (Kymriah) and BMS (liso-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 Biotech Highlights FDA Filing of Cilta-Cel by YE 2020; Q2 2020 Earnings Summary

On Friday, August 28, Legend Biotech published their Q2 2020 results (press release). Management confirmed that their BCMA CAR-T, cilta-cel (JNJ-4528), co-developed with Janssen, is expected to be filed with the FDA by YE 2020, the EMA in early 2021, and with China’s NMPA in 2021. Furthermore, by YE 2020, Legend anticipates filing an IND application for LB1901 (a CD4 CAR-T) in r/r T cell lymphoma (TCL). Below, Celltelligence provides thoughts on cilta-cel’s commercial opportunity following the anticipated approval of ide-cel (BMS) around March 2021, and Legend’s market opportunity for LB1901 in the TCL setting.

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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 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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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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