Category Archives: CAR-T

Autolus to Evaluate MRD Status in Obe-cel’s FELIX Trial; First Patient Dosed in AUTO8’s MCARTY Study; Autolus Q1 2022 Earnings Call Summary

On Thursday, May 5, Autolus held their Q1 2022 earning call (press release / presentation) highlighting obe-cel’s (CD19 CAR-T; formerly AUTO1) clinical progress, while confirming multiple clinical updates to be presented EHA 2022 (June 9 – 12). Of note, management confirmed the initiation of AUTO8’s (BCMA x CD19 CAR-T) Ph1 MCARTY trial in r/r MM. Below, Celltelligence provides insights on how Autolus may leverage MRD status to improve obe-cel’s efficacy and safety profile in r/r adult ALL, while discussing AUTO8’s trial initiation.

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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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Allogene Plans to Evaluate ALLO-501A in 2L DLBCL; No Updates for Allogene’s BCMA Programs; ALLO-316’s Initial Data Likely Delayed to 2023; CF1 to Produce ~20,000 Doses Annually; Allogene Q1 2022 Earnings Call Summary

On Wednesday, May 4, Allogene held their Q1 2022 earnings call (press release) highlighting their plans to evaluate ALLO-501A (allogeneic CD19 CAR-T) in 2 DLBCL, while noting that ALLO-316’s (allogeneic CD70 CAR-T) initial clinical data may be delayed until 2023. Of note, no major updates were provided for ALLO-501A’s pivotal study or Allogene’s BCMA programs. Below, Celltelligence provides insights on how ALLO-501A could compete with autologous CAR-Ts in the 2L setting, while discussing Allogene’s upcoming clinical updates and manufacturing capabilities.

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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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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

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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 Cell Therapy Sales Continue to Grow; Gilead’s New Manufacturing Facility Could Accelerate Yescarta’s Launch in 2L LBCL; Gilead’s Q1 2022 Earnings Call Summary

On Thursday, April 28, Gilead (Kite) held their Q1 2022 earnings call (press release / presentation) highlighting an increase in revenue for their cell therapy franchise, while discussing new clinical developments for Yescarta (CD19 CAR-T). Additionally, management noted the FDA approval of their state-of-the-art manufacturing site in Frederick, MD. Below, Celltelligence provides insights on how Gilead’s new cell therapy facility could assist Yescarta’s expected increase in demand, while discussing Yescarta’s expansion into 2L LBCL.

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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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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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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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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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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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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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