Tag Archives: Abecma

No Cell Therapy-Related Updates in April’s CHMP Agenda

On Monday, April 24, the CHMP Agenda for April was released. Of note, no cell therapy-related updates were observed. Recall that Abecma’s (BMS’s BCMA CAR-T) indication extension to ≥3L MM patients could potentially be included in May’s CHMP agenda (see previous insight).

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Abecma’s Regulatory Applications for R/R MM Accepted in the US, Europe, and Japan

Abecma’s Regulatory Applications for R/R MM Accepted in the US, Europe, and Japan

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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 Breyanzi in 2L LBCL; When Could Abecma Receive a CHMP Positive Opinion for ≥3L MM? March CHMP Highlights

On Friday, March 31, the CHMP meeting highlights were released following Monday’s CHMP agenda. Of note, the CHMP adopted a positive opinion for Breyanzi (BMS’s CD19 CAR-T) in 2L LBCL. Below, Celltelligence provides insights on the March CHMP meeting with updated EU timelines for Breyanzi’s approval and Abecma’s (BMS’s BCMA CAR-T) regulatory pathway to gain an indication in ≥3L MM.

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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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Could Breyanzi Receive a CHMP Positive Opinion This Week? Abecma Starts EMA Assessment in ≥3L MM; March’s CHMP Agenda

On Monday, March 27, the CHMP agenda for March was released. Of note, Breyanzi (BMS’s CD19 CAR-T) was listed for the third time under the ‘Type II Variations – Opinion or Requests for Supplementary Information’ section in 2L DLBCL Transplant Intended (TI) patients. Additionally, Abecma (BMS’s BCMA CAR-T) was also listed as ‘Start of Procedure’ under ‘Type II Variations: Extension of Indications’ for ≥3L MM patients.

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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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Abecma’s sBLA Filing in ≥3L MM Remains on Track for Q1 2023; No Pipeline Updates; 2seventy bio Q4 2022 Earnings Summary; Gracell Acquires Patent Licenses from Seagen

On Thursday, March 16, 2seventy bio released its Q4 and FY 2022 financial results (press release) highlighting Abecma’s (BCMA CAR-T) increased US revenue. Additionally, management did not provide major milestone updates for 2023, with Abecma’s sBLA filing to the FDA for ≥3L MM still expected in Q1 2023. On the same day, Gracell reported (SEC Filing) a license agreement with Seagen, under which Gracell will have WW licenses to certain patents for clinical and preclinical research, as well as commercialization, of cell therapy products. Below, Celltelligence provides insights on Abecma’s potential market growth for 2023, while discussing the license agreement between Gracell and Seagen.

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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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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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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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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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JPM 2023 Analysis Day 1: BMS, Novartis, JNJ, and Gilead

On the first day of JPM 2023, Celltelligence covered presentations by BMS (presentation), Novartis (presentation), JNJ (webcast), and Gilead (presentation). 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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BMS and JNJ Report Clinical Updates from BCMA CAR-Ts in MM; ASH 2022 Analysis 2

ASH 2022 Analysis 2: BMS and JNJ presented updated results from their approved BCMA CAR-Ts in r/r MM. Below, Celltelligence provides insights and context for key selected presentations.

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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 Gilead’s Collaboration with Arcellx

On Friday, December 9, Gilead (Kite) and Arcellx announced (press release) a global strategic collaboration to co-develop and co-commercialize Arcellx’s CART-ddBCMA (autologous BCMA CAR-T) for the treatment of r/r MM. Additionally, Arcellx released (press release / presentation) clinical updates from CART-ddBCMA’s Ph1 trial in patients with r/r MM, ahead of its presentation at ASH 2022 (December 11; Abs#3313). Below, Celltelligence provides insights on Gilead’s strategic decision to enter the BCMA CAR-T space, while discussing potential FDA approval timelines for CART-ddBCMA and how it could compare with already approved BCMA CAR-Ts.

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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