Category Archives: Uncategorized

Could Autolus’s AUTO1/22 Novel CD22 Binder Avoid Antigen-Related Relapse in ALL? Updated Results from Cellectis’s UCART22 Ph1 BALLI-01 Trial; Yescarta’s Ph2 ZUMA-5 Trial Continues to Demonstrate Positive Long-Term Results; ASH 2021 Day 1 Part 1

On the first day of ASH 2021, 3 clinical updates were presented by Autolus, Cellectis, and Gilead. Below, Celltelligence provides insights and context for each presentation. In a subsequent blast, the Celltelligence team will provide insights from Precision’s PBCAR0191 (allogeneic CD19 CAR-T) clinical update and results from both Ph3 2L DLBCL studies from BMS (Breyanzi; CD19 CAR-T) and Gilead (Yescarta; CD19 CAR-T).

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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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Novartis’s T-Charge Platform Reduces CAR-T Manufacturing to 2 Days; Novartis’s R&D Day Summary

On Thursday, December 2, Novartis held their R&D day (press release / presentation) highlighting T-Charge, a next-generation CAR-T manufacturing platform that reduces manufacturing time to ~2 days. Moreover, management discussed two novel assets YTB323 (CD19 CAR-T) and PHE885 (BCMA CAR-T) manufactured using the T-Charge platform. Below, Celltelligence provides insights on how Novartis could leverage T-Charge’s rapid manufacturing and potentially lower COGS to position their novel assets within the already crowded DLBCL and MM settings.

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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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Cilta-cel to be Commercialized as Carvykti Upon FDA Approval; JNJ Highlights Innovative Manufacturing and Supply System for Carvykti; How Quickly Could Carvykti Move Into Earlier Lines? JNJ’s Business Review Event 2021

On Thursday, November 18, JNJ held their Pharmaceutical Business Review 2021 Event (website) revealing cilta-cel’s (BCMA CAR-T) brand name as Carvykti, while commenting on their manufacturing and supply strategy to ensure a strong launch for Carvykti. Additionally, management emphasized their plan to quickly advance Carvykti into earlier lines of treatment. Below, Celltelligence provides insights on how JNJ’s manufacturing strategy may ensure a successful launch for Carvykti, while comparing JNJ’s digital platform with key competitors Gilead (Kite) and BMS. Moreover, Celltelligence will comment on the potential challenges JNJ may encounter advancing Carvykti into earlier lines for MM.

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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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William Young Appointed as a Non-Executive Director of Autolus’s Board of Directors

On Monday, November 15, Autolus announced (press release) that William Young, Senior Advisor to Blackstone Life Sciences, has been appointed as a non-executive director to their Board of Directors, effective immediately. Of note, Young’s appointment follows Autolus’s recent collaboration with Blackstone. Below, Celltelligence provides insights on how Autolus could leverage Young’s operational experience to facilitate obe-cel’s (CD19 CAR-T, formerly AUTO1) launch.

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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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Precision’s PBCAR20A Deprioritized; TCR2 Tx Focuses on Building up Their Manufacturing Capacity in the US; Precision and TCR2 Tx Q3 2021 Earnings Summaries

On Wednesday, November 10, Precision BioSciences reported their Q3 2021 financial results (press release) highlighting the deprioritization of PBCAR20A (CD20 CAR-T) in NHL. On the same day, TCR2 Tx released their Q3 2021 financial results (press release) highlighting gavo-cel’s (TC-210; mesothelin TRuC-T) anticipated Ph2 trial initiation in early 2022 and their manufacturing capacity expansion at ElevateBio BaseCamp in Cambridge, MA.

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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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Poseida to Prioritize P-BCMA-ALLO1 Over P-BCMA-101; Program Updates for P-PSMA-101 and P-MUC1C-ALLO1; Poseida Q3 2021 Earnings Summary

On Tuesday, November 9, Poseida Therapeutics released their Q3 2021 financial results (press release) highlighting their strategic shift towards allogeneic CAR-Ts for their BCMA program. Additionally, management provided further updates on their PSMA and MUC1 candidates. Below, Celltelligence provides insights on Poseida’s overarching strategy to prioritize their allogeneic BCMA and PSMA therapies while discussing their MUC1-targeting approach.

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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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NICE Suspends Breyanzi’s Appraisal for R/R NHL

On Tuesday, November 9, NICE reported that Breyanzi’s (BMS’s CD19 CAR-T) clinical and cost-effectiveness appraisal was ‘suspended’ (website). Below, Celltelligence provides insights on the importance and potential causes for Breyanzi’s suspended appraisal in the UK.

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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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Will Ziopharm Ever be Able to Commercialize Their Cell Therapy Products? Continuing Delays for Ziopharm’s TCR-T Programs; TriArm’s Joint Venture Eden BioCell Dissolved; Ziopharm Q3 2021 Earnings Call Summary

On Monday, November 8, Ziopharm held their Q3 2021 earnings call (press release) highlighting that during H1 2022 they anticipate manufacturing therapies at their Houston, TX, clinical production unit (CPU), as well as dosing the first patient in their TCR-T Library program. Moreover, management announced that they have developed four additional TCRs and plan submitting an amended IND protocol within the next few months. Below, Celltelligence provides insights on Ziopharm’s continued program delays and collaboration failures, while discussing the company’s likelihood of successfully bringing a cell therapy product to market.

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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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Precision Appoints Sam Wadsworth and Shari Lisa Piré to Their Board of Directors

On Monday, November 8, Precision BioSciences announced (press release) that Sam Wadsworth and Shari Lisa Piré have been appointed to the Company’s Board of Directors. Below, Celltelligence provides insights on Precision’s latest additions to their leadership team and Board of Directors.

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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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Cellectis Remains Confident on TALEN Editing Safety; UCART22 Clinical Updates Anticipated at ASH 2021; UCARTMESO on Track to Enter the Clinic in 2022; 2seventy Provides Further Insights on Their Business Separation; Cellectis Q3 2021 Earnings Call Summary

On Friday, November 5, Cellectis held their Q3 2021 earnings call (press release) highlighting UCART22’s (allogeneic CD22 CAR-T) Ph1 BALLI-01 trial update at ASH 2021 and a preclinical data presentation for UCARTMESO (allogeneic mesothelin CAR-T) at SITC 2021. Furthermore, Cellectis discussed Allogene’s recent clinical hold, and provided an update on their manufacturing facilities in Paris, France, and Raleigh, NC. On the same day, bluebird bio announced their Q3 2021 earnings (press release) highlighting 2seventy’s successful business separation. Moreover, on Thursday, November 4, 2seventy bio (press release) provided additional guidance covering clinical updates and manufacturing capabilities.

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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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