Tag Archives: LB2102

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 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 2024 Analysis Day 2: Legend, AstraZeneca, and BioNTech

On the second day of JPM 2024, Celltelligence covered presentations by Legend (presentation / webcast), AstraZeneca (presentation / webcast), and BioNTech (presentation / webcast). Below, Celltelligence provides insights and context for each presentation. 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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Thoughts on Novartis’s Agreement with Legend

On Monday, November 13, Legend announced (press release) that it entered into an exclusive WW license agreement with Novartis. Of note, Novartis will gain exclusive rights to Legend’s DLL3 cell therapies, including LB2102 (DLL3 CAR-T), and may apply its T-Charge platform to their manufacturing. Below, Celltelligence provides insights on Novartis’s decision to enter the solid tumor cell therapy space while discussing the competitive landscape of DLL3-targeting SCLC.

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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 sBLA in 2L MM Did Not Receive Priority Review; JNJ / Legend Continue To Improve Manufacturing Capacity; Updates on Solid Tumor Programs; Legend’s Q2 2023 Earnings Call Summary

On Tuesday, August 15, Legend held its Q2 2023 earnings call (press release) highlighting that the FDA set a PDUFA date for Carvykti’s (BCMA CAR-T) sBLA in ≥2L MM on April 5, 2024. Moreover, management listed measures that the company is taking to improve its manufacturing capacity and reported updates on its solid tumor programs. Below, Celltelligence provides insights on the FDA’s standard review of Carvykti’s sBLA while discussing future development for Carvykti and the company’s solid tumor programs.

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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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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

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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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FDA Accepts Legend’s LB2102 (DLL-3 CAR-T) IND in SCLC

On Monday, November 21, Legend announced (press release) that the FDA has accepted the IND for LB2102 (autologous DLL-3 CAR-T) in extensive stage small cell lung cancer (SCLC). Below, Celltelligence provides insights on LB2102’s IND clearance, discusses potential competition, and highlights how CAR-T therapies could succeed where AbbVie previously failed when targeting DLL-3.

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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 Carvykti be Approved in 2L MM by 2023? Legend Introduces New γδ CAR-T Program; Updates to Solid Tumor Programs; Thoughts on Legend’s R&D Day 2022

On Monday, October 3, Legend Biotech held their R&D Day (webcast), highlighting Carvykti’s (BCMA CAR-T) LCM initiatives, while providing updates on Legend’s pipeline platforms and programs. Below, Celltelligence provides insights on Carvykti’s ongoing competition with Abecma (BMS’s BCMA CAR-T), while evaluating the strength of Legend’s pipeline compared to its competitors.

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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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Gracell to Open an R&D Facility in the US; JPM 2022 Days 2 & 3: Legend, Allogene, and Autolus

A series of cell therapy-related news items have been observed:

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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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Cilta-cel’s Potential Off-Label Use in the US; Could BMS’s KarMMa-3 Trial Design Limit Abecma’s Targetable Population? Legend / JNJ Pivot to Earlier Lines; Legend Explores Allogeneics, CAR-NKs, and Novel Solid Tumor Targets; Legend’s R&D Day

On Monday, October 18, Legend held an R&D day (presentation) detailing preclinical and clinical assets across their BCMA, allogeneic, and solid tumors programs. Below, Celltelligence provides insights on Legend’s LCM strategy for cilta-cel (BCMA CAR-T) and possible ‘off-label’ usage in the US, while discussing the company’s allogeneic and solid tumors platforms.

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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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