Category Archives: Autologous

Breyanzi Absent from February’s CHMP Highlights

On Friday, February 24, the CHMP meeting highlights were released following Monday’s CHMP agenda. Of note, Breyanzi (BMS’s CD19 CAR-T) was absent from the CHMP highlights implying that it has received a second RSI for its assessment in 2L LBCL. Below, Celltelligence provides updated EU approval timelines for Breyanzi.

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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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Christi Shaw to Depart Gilead and Kite Leadership

On Friday, February 17, Gilead / Kite announced (press release) that Christi Shaw (Kite’s CEO) decided to depart by the end of Q1 2023. Below, Celltelligence provides insights on Shaw’s tenure in Kite, while discussing the profile of her potential replacement.

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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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Type II Variation for Breyanzi Listed in February’s CHMP Agenda

On Monday, February 20, the CHMP agenda for February was released. For the second time, Breyanzi (BMS’s CD19 CAR-T) was listed under the ‘Type II Variations – Opinion or Requests for Supplementary Information’ section in 2L DLBCL Transplant Intended (TI) patients.

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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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Topline Results from Abecma’s KarMMa-3 in ≥3L MM; BMS, Gilead (Kite), and Novartis Present Clinical Updates from Leading CAR-T Assets; EBMT – EHA CAR-T Meeting 2023 Analysis 2

EBMT – EHA CAR-T Meeting 2023 Analysis 2: BMS, Kite (Gilead), and Novartis presented clinical data and follow-up outcomes from their leading CAR-T therapies. Below, Celltelligence provides insights and context for key selected presentations. 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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Cellpoint (Galapagos) and Takeda Present Novel CAR-Ts for Hematological Tumors; EBMT – EHA CAR-T Meeting 2023 Analysis 1

EBMT – EHA CAR-T Meeting 2023 Analysis 1: Cellpoint (Galapagos) and Takeda presented initial clinical and preclinical data from their CAR-T therapies. Below, Celltelligence provides insights and context for key selected presentations. 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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Gilead Reports Strong Cell Therapy Revenues; ZUMA-23 Delayed? New Galapagos Asset Added to the Pipeline; Gilead’s Q4 2022 Earnings Call Summary; Gracell Reports FDA IND Clearance for GC012F in R/R MM

On Thursday, February 2, Gilead (Kite) held its Q4 and FY 2022 earnings call (press release / presentation) highlighting WW FY 2022 cell therapy revenue of $1.5B, while noting a potential delay in the initiation of Yescarta’s (CD19 CAR-T) Ph3 ZUMA-23 trial for 1L HR LBCL. Moreover, Gilead included a new cell therapy asset in its pipeline and confirmed that Arcellx’s collaboration for CART-ddBCMA has been completed. On Friday, February 3, Gracell announced (press release) that the FDA cleared GC012F’s (autologous CD19xBCMA FastCAR-T) IND application for a Ph1b/2 trial in r/r MM. Below, Celltelligence provides insights on Gilead’s cell therapy revenue increase, while discussing Gracell’s major regulatory milestone.

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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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Increased Sales for Abecma and Breyanzi; BMS to Ramp Up Manufacturing Capacity in 2023; No Clinical or Regulatory Updates; BMS Q4 2022 Earnings Call Summary

On Thursday, February 2, BMS held its Q4 and FY 2022 earnings call (press release / presentation) highlighting significant revenue increases for both Abecma (BCMA CAR-T) and Breyanzi (CD19 CAR-T). Additionally, management commented on BMS’s strategy to ramp up cell therapy manufacturing production in 2023. Below, Celltelligence provides insights on how Breyanzi and Abecma revenues compare with key competitors Kymriah (Novartis’s CD19 CAR-T), Yescarta (Gilead / Kite’s CD19 CAR-T), and Carvykti (JNJ / Legend’s BCMA CAR-T), while discussing the impact that BMS’s manufacturing strategy could have in its cell therapy franchise’s revenue during 2023.

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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 Remain Flat; YTB323 to Be Evaluated in 1L HR LBCL; No Updates for PHE885; Novartis Q4 2022 Earnings Call Summary

On Wednesday, February 1, 2022, Novartis held their Q4 and FY 2022 earnings call (press release / presentation) reporting $139M in Kymriah’s (CD19 CAR-T) WW sales. Of note, the company highlighted their plan to evaluate YTB323 (rapcabtagene autoleucel; T-Charge CD19 CAR-T) in 1L HR LBCL. Below, Celltelligence provides insights on Kymriah’s Q4 revenue, while discussing YTB323’s potential in 1L HR LBCL and PHE885’s absence of updates.

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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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Thoughts on Carvykti’s CARTITUDE-4 Meeting Its Primary Endpoint in 2 – 4L MM

On Friday, January 27, JNJ and Legend reported (JNJ’s press release; Legend’s press release) positive topline results from Carvykti’s (BCMA CAR-T) Ph3 CARTITUDE-4 trial in 2 – 4L MM. Below, Celltelligence provides insights on how Carvykti’s potential approval timeline in r/r MM compares with key competitor Abecma (BMS / 2seventy’s BCMA CAR-T), while discussing JNJ / Legend’s difficulties in delivering Carvykti to patients.

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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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Breyanzi Meets Primary Endpoint in Pivotal Trial for R/R CLL

On Thursday, January 26, BMS announced (press release) that Breyanzi (CD19 CAR-T) has met its primary endpoint (CR) in the Ph1/2 TRANSCEND CLL 004 trial for patients with ≥3L CLL / SLL. Below, Celltelligence provides insights on Breyanzi’s market opportunity for CLL, while discussing potential approval timelines in the US.

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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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