Tag Archives: CD19

Kymriah Demonstrates a Favorable Safety Profile in FL; Updated Results for AUTO1’s Ph1 ALLCAR19 Trial in ALL and iNHL; Initial Data from Cellectis’s UCART22 Ph1 BALLI-01 Study; ASH Day 1 Encore

On the first day of ASH 2020, three key clinical updates were presented from Novartis, Autolus, and Cellectis. Below, Celltelligence provides insights and context for each presentation.

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Interim Results from PBCAR0191’s Ph1/2a Trial; Updated Clinical Strategies to Improve Response; New Details Disclosed for PBCAR19B Stealth CAR-T; Precision’s Pre-ASH Investor Call Summary

On Friday, December 4, Precision reported interim results from their PBCAR0191 Ph1/2a trial, an allogeneic CD19 CAR-T in r/r NHL and ALL, and held an investor webcast (press release / presentation). Management confirmed that PBCAR19B, a next generation CD19 “stealth cell” CAR-T, is expected to enroll patients in H1 2021. Below, Celltelligence provides insights into PBCAR0191’s lymphodepletion regimens and how their approach differs from key allogeneic competitor Allogene.

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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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A New Ph1 Trial for Precision’s CD19 Allogeneic CAR-T PBCAR19B; Could PBCAR19B Knock Down B2M Expression to Enhance Persistence?

On Wednesday, December 2, a new Precision Biosciences-sponsored Ph1 trial has been detected on CT.gov for the allogeneic CD19 CAR-T, PBCAR19B, in ≥3L r/r NHL. Below, Celltelligence provides insights on this new trial and how PBCAR19B could use Precision’s B2M “stealth” vector to increase allogeneic CAR-T persistence, while avoiding NK cell activation.

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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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FDA Lifts Clinical Hold for Cellectis’s UCARTCS1 Ph1 MELANI-01 Trial; No Update on Protocol Changes

On Tuesday, November 17, Cellectis announced (press release) that the FDA has lifted the clinical hold on their UCARTCS1 (CS1 allogeneic CAR-T) Ph1 MELANI-01 trial in r/r MM. Below, Celltelligence provides insights on the trial’s FDA mandated clinical hold and possible protocol changes.

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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 Liso-cel’s Incomplete FDA Review; PDUFA Analysis may have Possible Implications for CAR-T CMOs and Manufacturing Partnerships

Yesterday, November 16, 2020, BMS announced (press release) that the FDA informed the company that its BLA review for liso-cel (CD19 CAR-T) in ≥3L r/r LBCL will not be completed by the PDUFA action date of November 16, 2020. Management confirmed that the FDA was unable to conduct an inspection of a third-party manufacturing facility in Texas during the current review cycle due to travel restrictions related to the COVID-19 pandemic. Below, Celltelligence provides thoughts on the missed PDUFA action date, how liso-cel’s progress compares with other CAR-T PDUFA dates, and the risk associated with using a CMO (clinical manufacturing organization) for commercially manufacturing CAR-T products.

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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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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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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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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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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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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

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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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