Category Archives: CAR-T

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 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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When Could Legend File Cilta-cel in 2L MM? Legend to Submit an NDA to Japan’s PMDA for Cilta-cel in R/R MM by YE 2021; Legend Develops a Novel Tri-Specific CAR-T; Legend Q3 2021 Earnings Summary

On Tuesday, November 16, Legend released their Q3 2021 financial updates (press release) highlighting that enrollment for cilta-cel’s (BCMA CAR-T) Ph3 CARTITUDE-4 study in 2-4L r/r MM has completed, while discussing cilta-cel’s FDA and PMDA regulatory updates. Additionally, management announced the development of LCAR-AIO, a novel tri-specific CD19 x CD20 x CD22 CAR-T for treating B-cell malignancies following CAR-T therapy relapse. Below, Celltelligence provides insights on when Legend / JNJ could potentially file cilta-cel’s sBLA in 2L r/r MM based on data from CARTITUDE-4, while discussing Legend’s novel tri-specific CAR-T and pipeline updates.

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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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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 Significant Cell Therapy Updates in November’s CHMP Highlights; Celltelligence Reducing Ziopharm’s Coverage; UPDATED: Indications Table for CD19 CAR-T US Approvals and Submissions

On Friday, November 12, the CHMP meeting highlights were released following Monday’s CHMP agenda, with no cell therapy-related updates observed. Recall that on Monday, November 8, 2021, the Celltelligence team prepared a full analysis on November’s CHMP agenda, discussing the potential timelines for Yescarta’s Type II variation in r/r FL and Tecartus’s Type II variation in r/r adult ALL, while providing an updated projected approval date for cilta-cel (see previous insight).

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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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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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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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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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Will Yescarta Receive a Positive CHMP Opinion for R/R FL This Week? No Mention of Tecartus or Cilta-cel in November’s CHMP Agenda

On Monday, November 8, the CHMP agenda for November was released. Of note, Yescarta’s (Gilead’s CD19 CAR-T) Type II variation for ≥4L r/r FL is listed as ‘For Adoption’, while no updates were observed for Tecartus (Gilead’s CD19 CAR-T) in r/r adult ALL and cilta-cel (JNJ / Legend’s BCMA CAR-T) in r/r MM. Below, Celltelligence provides likely EU approval timelines for Yescarta, Tecartus, and cilta-cel.

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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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Why Blackstone’s $250M Investment in Autolus Is Necessary for Obe-cel’s Clinical Development

On Monday, November 8, Autolus announced (press release) that they have entered into a collaboration and financing agreement with Blackstone Life Sciences for the development of obe-cel (CD19 CAR-T, formerly AUTO1) and obe-cel’s next-generation therapies in B cell malignancies. Below, Celltelligence provides insights on how Autolus’s collaboration with Blackstone could secure obe-cel’s clinical development while giving the company flexibility to develop other assets within their pipeline.

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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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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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