Category Archives: Topics

Autolus’s Obe-cel Receives FDA RMAT Designation; JNJ / Legend Update Carvykti’s HCP Website

On Monday, April 25, 2022, Autolus announced (press release) that the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to obe-cel (AUTO1; autologous CD19 CAR-T) for adult r/r B-ALL. On the same day, Carvykti’s (JNJ / Legend’s autologous BCMA CAR-T) HCP website was updated to include onboarded treatment centers and additional product messaging (Carvykti HCP website). Below, Celltelligence provides insights on how RMAT designation may accelerate obe-cel’s regulatory pathway, while analyzing Carvykti’s updated HCP website.

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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 Yescarta in ≥4L FL; Yescarta in 2L DLBCL Absent from April’s CHMP Meeting

On Friday, April 22, the CHMP meeting highlights were released following Tuesday’s CHMP agenda. Of note, the CHMP adopted a positive opinion for Yescarta (Gilead / Kite’s CD19 CAR-T) in ≥4L r/r FL. Additionally, Yescarta’s Type II variation for 2L DLBCL was absent from April’s CHMP meeting. Below, the Celltelligence team provides thoughts on Yescarta’s positive opinion in r/r FL, while providing updated EU timelines for Yescarta in 2L DLBCL.

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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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Legend Achieves Another Milestone Payment from Janssen for Carvykti

On Thursday, April 21, Legend announced (press release) that they have achieved a 50M USD milestone under their collaboration agreement with JNJ for Carvykti (cilta-cel; BCMA CAR-T). Recall that Legend received an upfront payment of 350M USD, with additional milestone payments covering development, production performance, regulatory and sales.

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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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Is Carvykti’s Launch Constrained by JNJ’s Manufacturing Capacity? JNJ Q1 2022 Earnings Call Summary

On Tuesday, April 19, JNJ held their Q1 2022 earnings call (press release / presentation) highlighting Carvykti’s (cilta-cel; JNJ / Legend’s BCMA CAR-T) FDA approval and launch strategy for r/r MM. Below, Celltelligence provides highlights and insights on Carvykti from the call.

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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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Could Yescarta in r/r FL Receive a CHMP Positive Opinion This Week?

On Tuesday, April 19, the CHMP agenda for April was released. Of note, Yescarta in r/r FL after three or more lines of systemic therapy has been listed as for adoption under ‘Type II variations – variation of therapeutic indication’.

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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’s Oncology Deep Dive 2022: Celltelligence Analysis – Part 1

On Thursday, April 14, Gilead / Kite held their Oncology Deep Dive event, highlighting their differentiated pipeline, with key updates to their cell therapy platforms, including several new clinical trials (Presentation). Below, Celltelligence provides insights on Gilead / Kite’s expansion of Yescarta and Tecartus (CD19 CAR-Ts) into earlier lines of therapy / additional indications.

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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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Fate’s Novel FT573 Pan-Tumor Targeting Asset and Tri-Modal CAR-TCR Platform; Shoreline’s iPSC-derived Screening Platform; BMS’s Abecma to be Reimbursed in Japan on April 20; AACR 2022 Final Analysis

AACR 2022 Final Analysis: Several preclinical results were presented from Fate Tx, and Shoreline. Additionally, a cell therapy-related piece of news was observed, with Abecma set to become reimbursed in Japan after joining the NHI’s reimbursement price list on April 20, 2022. Below, Celltelligence provides insights and context for each presentation. The following topics are covered below:

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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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Different Strategies for Enhancing CAR-Ts to Treat Solid Tumors; Preclinical Results from Allogene’s ALLO-316; TCR2 Tx’s Allogeneic TRuC-T Platform; AACR 2022 Analysis 4

AACR 2022 Analysis 4: Several key cell therapy-related topics were discussed to overcome the challenges associated with utilizing CAR-Ts for solid tumors. Additionally, preclinical results were presented from Allogene and TCR2 Tx. Below, Celltelligence provides insights and context for each presentation. The following topics are covered below:

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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Yescarta and Kymriah Product Attributes; Early Results from Gracell’s GC502 Ph1 Study in r/r B-ALL; Legend’s LB1901 Ph1 Study Design in r/r TCL; AACR 2022 Analysis 3

AACR 2022 Analysis 3: Several clinical updates were presented by Gilead, Novartis, Gracell, and Legend. Below, Celltelligence provides insights and context for each presentation. The following topics are covered below:

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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Preclinical Results from 2seventy’s bbT369 and Cellectis’s UCART20x22 for r/r NHL; Switchable CAR-T Updates from Arcellx and Roche; AACR 2022 Analysis 2

AACR 2022 Analysis 2: Several preclinical updates were presented describing two different dual-targeting strategies for r/r NHL and two approaches for developing switchable CAR-Ts. Below, Celltelligence provides insights and context for each presentation. The following topics are covered below:

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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