Category Archives: Topics

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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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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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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Yescarta Sales Impacted by COVID-19; ZUMA-7 Data Delayed to H1 2021; Q3 2020 Gilead Earnings Call Summary

On Wednesday, October 28, Gilead held their Q3 2020 earnings call (press release / presentation). Management highlighted the recent launch of Tecartus and the reduction in Yescarta sales. Of note, Gilead confirmed that ZUMA-7’s data readout has been delayed to H1 2021. Furthermore, updated Yescarta data is anticipated for ASH 2020. Below, Celltelligence provides thoughts on Gilead’s launch strategy for Tecartus and implications for Yescarta sales in an ongoing COVID-19 environment.

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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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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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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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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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Gilead Appoints Anthony Welters to Their Science Board of Directors

On Thursday, October 22, Gilead announced (press release) that Anthony Welters was selected to join their Science Board of Directors. Below, Celltelligence provides thoughts on this appointment, particularly around Welters’s experience in the healthcare industry.

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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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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.

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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