Tag Archives: 2seventy bio

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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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 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 Abecma and Carvykti Be Approved in January 2024? Obe-cel MAA Could Happen in Q1 2024; December CHMP Highlights

On Friday, December 15, the CHMP meeting highlights were released. Of note, Carvykti (JNJ / Legend’s BCMA CAR-T) was absent from the CHMP highlights, implying that the Type II Variation (T2V) for its approval in ≥2L MM has received a second Request for Supplementary Information (RSI). Moreover, recall that the Abecma (BMS / 2seventy’s BCMA CAR-T) T2V in ≥3L MM was not included on Monday’s CHMP agenda. Below, Celltelligence provides insights on the December CHMP meeting with updated EU timelines for both cell therapies, while discussing the possible timeline for obe-cel accelerated assessment. 

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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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Uncertainty around OS Benefit Induced by Abecma in 3 – 5L MM; A MAIC Analysis Supports Carvykti’s Superiority versus Abecma in Early Line MM; ASH 2023 Analysis 7

ASH 2023 Analysis 7: BMS / 2seventy and JNJ / Legend presented analyses from their BCMA CAR-Ts in early line MM. 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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Abecma sBLA to Face FDA AdCom; PDUFA Date Delayed; Could Carvykti Be Approved Before Abecma in Earlier Lines of MM?

On Monday, November 20, BMS / 2seventy bio announced (press release) that the FDA Oncologic Drugs Advisory Committee (ODAC) will meet to review data supporting the sBLA for Abecma (BCMA CAR-T) in triple-class exposed MM. Importantly, the companies disclosed the FDA will not meet the PDUFA date originally set for December 16, 2023. Below, Celltelligence provides insights on the possible reasons behind the FDA’s decision, while discussing potential timelines for the ODAC meeting and the new PDUFA date.

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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 Revenue Decreases Significantly; bbT4015 IND on Track for YE 2023; JW Tx to Initiate JWTCR001’s IIT by YE 2023; 2seventy Bio’s Q3 2023 Earnings Call

On Tuesday, November 14, 2seventy bio held its Q3 2023 earnings call (press release / webcast) acknowledging Abecma’s (BMS / 2seventy’s BCMA CAR-T) decline in US sales while confirming milestones for its preclinical cell therapy programs in solid tumors. Below, Celltelligence provides insights on the causes behind Abecma’s revenue decrease while discussing the company’s preclinical solid tumor pipeline.

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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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2seventy bio Announces Strategic Restructuring and Pipeline Reprioritization; Abecma’s US Revenue Guidance Lowered; Nick Leschly to Resign as CEO; Company to Expand Strategic Partnership with JW Tx

On September 12, 2023, 2seventy bio held a conference call (webcast / press release) announcing the strategic restructuring of the company’s business operations and R&D model. Measures include a 40% workforce reduction and a pipeline reprioritization and are driven by a projected decrease in Abecma’s (BMS / 2seventy BCMA CAR-T) revenue for 2023. Additionally, the company disclosed Nick Leschly’s decision to step down as CEO. On the same day, 2seventy announced the expansion of its collaboration with JW Tx adding 2 new assets from its pipeline: a solid tumor targeting TCR-T and a CAR-T for autoimmune diseases (press release). Below, Celltelligence provides insights on 2seventy’s new Abecma revenue projections for 2023 and the collaborative R&D model that the company aims to implement for its pipeline.

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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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Promising Efficacy Data from BMS’s GPRC5D CAR-T in ≥4L MM; Abecma Demonstrates Superiority Vs SOC in ≥3L MM Across All High-Risk Subgroups; Preliminary Clinical Data from Innovent’s P329G-CAR-T in ≥4L MM; EHA 2023 Analysis 2

EHA 2023 Analysis 2: BMS / 2seventy bio and Innovent / Roche presented clinical updates from their programs in MM. Below, Celltelligence provides insights and context for key selected presentations, where the first topic also includes an evidence roundup of the PDUFA date for Janssen’s talquetamab. The following topics are covered:

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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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SC-DARIC33 Shows Promising Preliminary Clinical Results; 2seventy Bio Reveals Next-Generation AML Program; ASGCT 2023 Analysis 2

ASGCT 2023 Analysis 2: 2seventy bio presented preliminary clinical results of SC-DARIC33’s (autologous drug-regulated CD33 CAR-T) Ph1 PLAT-08 trial and several updates on preclinical assets at ASGCT. Moreover, on Friday, May 19, the company held a virtual R&D Deep Dive event further detailing the data presented at ASGCT 2023, disclosing the main features of its new AML asset 27T32 (next-generation autologous drug-regulated CD33 x CLL1 dual CAR-T) and confirming anticipated milestones for the rest of their pipeline assets (presentation). Below, Celltelligence provides insights on the potential advantage that drug-regulated activation could confer to SC-DARIC33 over other cell therapies in the AML space while commenting on the novel asset, 27T32, disclosed by the company.

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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 US Revenue Continues to Increase; DARIC33’s Data to Be Presented at ASGCT 2023; Manufacturing Capacity Ramping Up; 2seventy bio’s Q1 2023 Earnings Call Summary

On Wednesday, May 3, 2seventy bio held its Q1 2023 earnings call (press release) highlighting Abecma’s (BMS / 2seventy’s BCMA CAR-T) significant revenue increase. Moreover, management confirmed that early clinical data from DARIC33’s Ph1 PLAT-08 trial in r/r AML will be presented at ASGCT 2023 (May 16-20). Below, Celltelligence provides insights on 2seventy bio’s strategy to improve manufacturing capacity with a newly FDA-approved viral vector manufacturing suite, while discussing the main clinical milestones achieved by the assets in the pipeline.

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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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