Tag Archives: BCMA CAR-T

UPDATED: Carvykti’s CARTITUDE-6 Trial to Initiate Ex-US Due to FDA Safety Requirements; LB2102 IND Clearance in SCLC; Legend H2 2022 Earnings Call Summary

UPDATED: On April 3, 2023, Celltelligence published a blast entitled “Carvykti’s CARTITUDE-6 Trial to Initiate Ex-US Due to FDA Safety Concerns; LB2102 IND Clearance in SCLC; Legend H2 2022 Earnings Call Summary”. Since then, Janssen reached out to Celltelligence to clarify that FDA’s safety “concern” is really more about meeting a “requirement” for re-filing the IND than anything else. The team has updated the April 3 blast to reflect the clarity provided by Janssen.

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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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Carvykti’s CARTITUDE-6 Trial to Initiate Ex-US Due to FDA Safety Concerns; LB2102 IND Clearance in SCLC; Legend H2 2022 Earnings Call Summary

On Thursday, March 30, Legend reported its H2 and FY 2022 clinical updates and financial results (press release) highlighting Carvykti’s (BCMA CAR-T) positive topline results from the Ph3 CARTITUDE-4 trial in 2-4L MM, as well as intentions to first proceed with the Ph3 CARTITUDE-6 trial for NDMM in ex-US countries after FDA safety concerns. Below, Celltelligence provides insights on Carvykti’s anticipated evaluation in NDMM as well as its potential FDA approval in 2-4L MM, while discussing Legend’s presence in the SCLC space.

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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 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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Arcellx and Gilead Focus on Accelerating CART-ddBCMA Clinical Development, Initiation of ACLX-002’s Ph1 trial in AML; Arcellx Q4 2022 Earnings Summary

On Wednesday, March 29, Arcellx provided its Q4 and FY 2022 financial results and business updates (press release) highlighting its strategic collaboration with Gilead (Kite) to co-develop and co-commercialize CART-ddBCMA (autologous BCMA CAR-T) for the treatment of ≥4L MM announced on December 9, 2022. Additionally, the company noted the initiation of ACLX-002’s (Universal ARC-T cells + CD123 targeting SparX protein) Ph1 trial in r/r AML and HR-MDS in December 2022. Below, Celltelligence provides insights on Arcellx’s strategic decision to partner with Gilead (Kite), while discussing ARC-SparX platform.

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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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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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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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Carvykti’s Revenue Remains Flat; CARTITUDE-4 Readout Expected in 2023; JNJ Q4 2022 Earnings Call Summary

On Tuesday, January 24, JNJ held their Q4 and FY 2022 earnings call (press release / presentation) confirming that a data readout from Carvykti’s (BCMA CAR-T) Ph3 CARTITUDE-4 trial for 2 – 4L MM is expected in 2023. On the same day, Legend disclosed (SEC filing, Jan 2023) that Carvykti’s preliminary WW sales for Q4 2022 were $55M. Below, Celltelligence provides insights on Carvykti’s flat revenue, while discussing potential US regulatory timelines for Carvykti in 2L 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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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.

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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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KarMMa-2 Results to be Presented at ASH 2022; No Updates for bbT369 and SC-DARIC33; PBCAR269A Discontinued; 2seventy bio and Precision BioSciences Q3 2022 Earnings Summaries

On Monday, November 7, 2seventy bio released their Q3 2022 earnings results (press release) highlighting Abecma’s (BMS / 2seventy’s BCMA CAR-T) increased revenue. Moreover, preliminary clinical results from Cohorts 2A and 2C of the Ph2 KarMMa-2 in ≥2L HR MM will be presented at ASH 2022 (Dec 10-13). On Tuesday, November 8, Precision BioSciences reported their Q3 2022 financials and business updates (press release) highlighting the discontinuation of PBCAR269A (allogeneic BCMA CAR-T). Below, Celltelligence provides insights on Abecma’s improved efficacy in the KarMMa-2 study, while discussing Precision’s decision to deprioritize its BCMA franchise.

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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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