Category Archives: Autologous

Carvykti Sales Flatten while Preparing for Launch in 2L MM; JNJ’s Q1 2024 Earnings Call Summary

On Tuesday, April 16, JNJ held its Q1 2024 earnings call (press release / presentation) mentioning Carvykti’s (BCMA CAR-T) revenue remained approximately flat. Additionally, management remarked on Carvykti approval by the FDA and the CHMP positive opinion for the treatment of 2L MM patients. Below, Celltelligence provides insights on Carvykti’s underperforming revenue during this quarter while discussing its upcoming launch in 2L MM.

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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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CRISPR Tx, AZ, and MiNK Tx Report Data in Solid Tumors; AACR 2024 Analysis 1

AACR 2024 Analysis 1: CRISPR Tx, AZ and MiNK Tx presented clinical and preclinical updates from their programs in solid tumors. Below, Celltelligence provides insights and key context for selected presentations. The following topics are covered: 

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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 and Abecma Receive FDA Approval for Early Lines of MM

On Friday, April 5, JNJ (press release) and Legend (press release) announced that the FDA approved Carvykti (BCMA CAR-T) for the treatment of adult patients with r/r MM who have received at least one prior LoT, including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), and are refractory to lenalidomide.

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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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You May Have Missed: New Breyanzi Ph3 Trial for R/R FL; Abecma Approved for 3L MM in the EU

In the past week, the Celltelligence team detected relevant news that was not discussed in individual blasts but worth highlighting. In this blast, Celltelligence will cover the following topics:

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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 the FDA ODAC Recommending Carvykti and Abecma in Earlier Lines of MM

On Friday, March 15, JNJ (press release) and Legend (press release) announced that the FDA’s Oncologic Drugs Advisory Committee (ODAC) recommended Carvykti (BCMA CAR-T) for the treatment of adult patients with r/r MM who have received at least one prior LoT including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD) and are refractory to lenalidomide.

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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 Receives FDA Accelerated Approval in ≥3L CLL/SLL

On Thursday, March 14, BMS announced (press release) that the FDA granted accelerated approval (AA) of Breyanzi (CD19 CAR-T) for the treatment of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) adult patients who have received at least 2 prior LoT including a BTK inhibitor and a BCL-2 inhibitor.

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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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Obe-cel MAA Submitted to the EMA; Nucleus Manufacturing Facility Ready for Obe-cel Launch; Obe-cel’s Trial in SLE and AUTO6NG’s Study in Pediatric Glioblastoma Initiated; Autolus Q4 2023 Earnings Call Summary

On Thursday, March 14, Autolus held its Q4 2023 earnings call (press release/ presentation) highlighting the recent submission of a Market Authorization Application (MAA) for obe-cel (CD19 CAR-T) in r/r ALL, while noting that its Nucleus manufacturing facility has successfully passed its first GMP inspection enabling the commercial product supply for obe-cel. Additionally, the Ph1 CARLYSLE confirmatory trial evaluating obe-cel in severe, refractory SLE, and the Ph1 MAGNETO trial studying AUTO6NG (GD2 CAR-T) in pediatric glioblastoma have been initiated.

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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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Poseida to Present Updated Clinical Results at AACR 2024; Legend Further Expands its Manufacturing Capacity; Poseida and Legend Q4 2023 Earnings Call Summary

On Thursday, March 7, Poseida released its Q4 and FY 2023 business updates (press release) highlighting clinical results from its lead asset P-BCMA-ALLO1’s (allogeneic BCMA CAR-T) Ph1 trial in r/r MM and an initial readout from its P-MUC1C-ALLO1’s Ph1 trial in advanced or metastatic solid tumors will be presented at AACR 2024.

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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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New BMS-986393 Ph2 Trial (QUINTESSENTIAL) for R/R Multiple Myeloma

On Thursday, March 7, a new BMS-sponsored Ph2 trial (QUINTESSENTIAL) evaluating BMS-986393 (CC-95266; GPRC5D CAR-T) in quadruple-class exposed [including: an immune modulatory drug (IMiD), a proteasome inhibitor (PI), an anti-CD38 mAb, and an anti-BCMA therapy] ≥4L MM was observed on CT.gov.

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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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Abecma US Revenue Continues to Decrease; 2seventy Bio’s Q4 2023 Earnings Call

On Tuesday, March 5, 2seventy bio held its Q4 and FY 2023 earnings call (press release / webcast) acknowledging the decline in Abecma (BMS / 2seventy bio’s BCMA CAR-T) sales in the US. Below, Celltelligence provides insights on the reasons behind the Abecma revenue decrease, while commenting on the future opportunities for the BCMA CAR-T upon its potential approval in ≥3L MM.

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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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