Category Archives: Uncategorized

Breyanzi’s Sales Increase While Abecma’s Remain Flat; BMS Prepares for an Increase in Cell Therapy Demand; No Clinical Milestone Updates for Breyanzi or Abecma; BMS’s Q1 2022 Earnings Call Summary

On Friday, April 29, BMS held their Q1 2022 earnings call (press release / presentation) highlighting Breyanzi’s (CD19 CAR-T) revenue increase and anticipated US approval in 2L LBCL. Of note, no updated clinical milestones for Breyanzi and Abecma (BCMA CAR-T) were observed. Below, Celltelligence provides insights on how Breyanzi’s revenue increase compares with Kymriah (Novartis’s CD19 CAR-T) and Yescarta (Gilead/Kite’s 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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Gilead’s Oncology Deep Dive 2022: Celltelligence Analysis – Part 2

On Thursday, April 14, Gilead / Kite held their Oncology Deep Dive event (presentation) highlighting a rapid manufacturing process, while discussing strategies to remain innovative in the cell therapy space via robust collaborations and novel technologies. Below, Celltelligence provides a second round of insights on Gilead / Kite’s rapid manufacturing and off-the-shelf cell therapy candidates.

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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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Kymriah’s Sales Decline; PHE885 Pivotal Study Initiated; YTB323’s Anticipated Submission Delayed to 2025; Novartis’s Q1 2022 Earnings Call Summary

On Tuesday, April 26, 2022, Novartis held their Q1 2022 earnings call (press release / presentation) highlighting a decline in Kymriah’s (CD19 CAR-T) sales. Additionally, management noted Kymriah’s positive CHMP opinion in ≥3L FL, PHE885’s (T-Charge BCMA CAR-T) Ph2 trial initiation in 4L MM, and YTB323’s (T-Charge CD19 CAR-T) delayed regulatory filing in 2L DLBCL. Below, Celltelligence provides insights on Kymriah’s Q1 2022 revenue, while discussing YTB323’s delayed submission.

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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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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

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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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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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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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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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Thoughts on Yescarta’s FDA Approval in 2L LBCL

On Friday, April 1, Gilead (Kite) announced (press release) that the FDA has approved Yescarta (CD19 CAR-T) in 2L LBCL. Of note, Yescarta is now approved for adult patients with LBCL that are refractory or have relapsed within 12 months of 1L chemoimmunotherapy, independent of their eligibility for ASCT. Below, Celltelligence provides insights on how Yescarta could become the CAR-T of choice for 2L LBCL while discussing Gilead’s (Kite) potential strategy to increase patient referrals for Yescarta over ASCT.

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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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Yescarta Becomes the First Approved CAR-T for 2L LBCL in the US

On Friday, April 1, Gilead (Kite) announced (press release) that the FDA approved Yescarta (CD19 CAR-T) in 2L LBCL based on results from the Ph3 ZUMA-7 trial. Of note, Yescarta has become the first CD19 CAR-T to move into an earlier line of therapy for LBCL. The Celltelligence team will be conducting a full thoughts-on analysis and label review in the coming days.   

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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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