Category Archives: CAR-T

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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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 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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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 TCR-T Program at the NCI Continues to Face Delays; MD Anderson Hotspot TCR-T IND Filing on Track for 2021; Q3 2020 Earnings Call Summary

On Thursday, November 5, Ziopharm held their Q3 2020 earnings call (press release / presentation) highlighting that their TCR-T and RPM CAR-T programs remain on track. Of note, management commented that in Q1 2021 they anticipate filing an IND application for their MD Anderson, library TCR-T program. Below, Celltelligence provides insights on Ziopharm’s TCR-T and CAR-T programs, as well as the potential risk associated with further clinical delays.

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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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UCART22 and UCART123 Clinical Updates to be Presented at ASH 2020; UCARTCS1 Remains on Clinical Hold; Cellectis Q3 2020 Earnings Call Summary

On Friday, November 6, Cellectis held their Q3 2020 earnings call (press release). No significant updates were provided about the FDA hold for the Ph1 MELANI-01 trial in r/r MM. Furthermore, management stated that preliminary data from the UCART22 Ph1 BALLI-01 study (in r/r ALL) and UCART123 Ph1 AMELI-01 (in r/r AML) trial will be presented at ASH 2020. Below, Celltelligence provides thoughts on Cellectis’s CAR-T programs and the possible impact of alemtuzumab lymphodepletion.

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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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Expanded Collaboration with Servier; PBCAR0191 Clinical Update Expected in Q4 2020; Precision’s Q3 2020 Earnings Call Summary

On Tuesday, November 10, Precision Biosciences released their Q3 2020 financial results and business update (press release), highlighting their allogeneic CD19 CAR-T PBCAR0191. Of note, management anticipate in Q4 2020 to present updated PBCAR0191 Ph1/2a data in a company-sponsored event. Furthermore, Precision provided guidance on their clinical development agreement evaluating PBCAR269A (allogeneic BCMA CAR-T) with nirogacestat (gamma-secretase inhibitor). Below, Celltelligence provides insights into Precision and Servier’s expanded agreement targeting solid tumors, pipeline updates, and upcoming data from their allogeneic CD19 CAR-T PBCAR0191.

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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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AUTO1 and AUTO3 Clinical Updates to be Presented at ASH 2020; AUTO3 Pivotal Trial Likely in H1 2021; Autolus Q3 2020 Earnings Call Summary

On Thursday, November 5, Autolus held their Q3 2020 earnings call (press release/ presentation). Management highlighted that updated data from the AUTO1 Ph1 ALLCAR19 and AUTO3 Ph1/2 ALEXANDER studies will be presented at ASH 2020. Additionally, Autolus noted that AUTO3 may move to a pivotal trial in H1 2021. Below, Celltelligence provides insights into Autolus’s clinical updates at ASH 2020 and how AUTO3 could disrupt the increasingly crowded ≥3L DLBCL space.

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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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No FDA Updates for Liso-cel or Ide-cel; New GPRC5D CAR-T in MM; BMS Q3 2020 Earnings Call Summary

On Thursday, November 5, BMS held their Q3 2020 results (press release / presentation). No updates were provided for liso-cel’s or ide-cel’s regulatory approval. Of note, BMS added a new CAR-T targeting GPRC5D in ≥4L r/r multiple myeloma (MM) to their portfolio. Below, Celltelligence provides thoughts on liso-cel’s anticipated PDUFA November date and how a GPRC5D CAR-T could disrupt the MM space.

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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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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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