Category Archives: CAR-T

Thoughts on Bayer’s and Atara’s Collaboration to Develop Solid Tumor CAR-T Therapies

On Sunday, December 6, Bayer and Atara Biotherapeutics announced (Bayer press release / Atara press release) a collaboration and worldwide license agreement. The collaboration covers research, development, and manufacturing milestones for mesothelin-targeting CAR-T therapies in high mesothelin-expressing solid tumors. Of note, the agreement includes the development of ATA2271 (an autologous mesothelin-targeting CAR-T) and its allogeneic version ATA3271 to treat malignant pleural mesothelioma and non-small-cell lung cancer. Below, Celltelligence provides thoughts on Bayer’s growing cell therapy portfolio, a possible strategy for advancing cell therapies, and if they will license Atara’s allogeneic CD19 CAR-T.

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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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What is Behind Ide-cel’s mPFS and mOS Disparity? Thoughts on Ide-cel’s Launch Messaging and List Price; bb21217’s Manufacturing Updates; bluebird bio ASH Investor Event

On Monday, December 7, bluebird bio held an ASH-related investor event (press release / webcast) discussing recent advances to their BCMA CAR-Ts ide-cel (bb2121) and bb21217 in r/r MM. Below, Celltelligence provides thoughts on the significant differences in ide-cel’s mPFS and mOS data, how the data could influence launch messaging and list price, in addition to summarizing manufacturing updates for bb21217.

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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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Clinical Updates and Market Opportunities for AUTO1 and AUTO3; ASH Day 3 Autolus Investor Event

On Monday, December 7, 2020, Autolus held an investor event (presentation / webcast) discussing recent advances to their AUTO1 (CD19 CAR-T) in ALL and AUTO3 (CD19/CD22 CAR-T) in DLBCL programs. Below, Celltelligence provides insights into AUTO3’s potential use in the outpatient setting and AUTO1’s market opportunity in adult and pediatric ALL.

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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 Cilta-cel Become the BCMA CAR-T of Choice in 2021? ASH Day 3 Legend Investor Event

On the third day of ASH 2020, Legend held an investor event to discuss the recent data presented at ASH 2020 from the Ph1b/2 CARTITUDE-1 study. Below, Celltelligence provides a summary of the call, JNJ’s / Legend’s possible messaging for cilta-cel, and regulatory updates in the US and EU.

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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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ZUMA-12 Reports an 85% ORR in 1L DLBCL; Liso-cel’s Safety Profile vs Kymriah and Yescarta; Comparison of OOS Use of CD19 Commercial CAR-Ts; ASH Day 2

On the second day of ASH 2020, four key clinical updates were presented from Novartis, Gilead, and BMS / bluebird bio. Below, Celltelligence provides insights and context for each presentation.

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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 Results for ALLO-715 from ASH and Allogene’s Investor Call; CARsgen Fully Human BCMA CART CT053 Reports a 94% ORR in MM; Poseida Modifies Their P-BCMA-101 CAR-T Manufacturing Process; ASH Day 1 Encore

On the first day of ASH 2020, four key clinical updates were presented from Allogene, CARsgen and Poseida. Below, Celltelligence provides insights and context for each presentation.

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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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Interim Results from PBCAR0191’s Ph1/2a Trial; Updated Clinical Strategies to Improve Response; New Details Disclosed for PBCAR19B Stealth CAR-T; Precision’s Pre-ASH Investor Call Summary

On Friday, December 4, Precision reported interim results from their PBCAR0191 Ph1/2a trial, an allogeneic CD19 CAR-T in r/r NHL and ALL, and held an investor webcast (press release / presentation). Management confirmed that PBCAR19B, a next generation CD19 “stealth cell” CAR-T, is expected to enroll patients in H1 2021. Below, Celltelligence provides insights into PBCAR0191’s lymphodepletion regimens and how their approach differs from key allogeneic competitor Allogene.

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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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A New Ph1 Trial for Precision’s CD19 Allogeneic CAR-T PBCAR19B; Could PBCAR19B Knock Down B2M Expression to Enhance Persistence?

On Wednesday, December 2, a new Precision Biosciences-sponsored Ph1 trial has been detected on CT.gov for the allogeneic CD19 CAR-T, PBCAR19B, in ≥3L r/r NHL. Below, Celltelligence provides insights on this new trial and how PBCAR19B could use Precision’s B2M “stealth” vector to increase allogeneic CAR-T persistence, while avoiding NK cell activation.

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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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UPDATED: Novartis on Track to File Kymriah in R/R FL and 2L DLBCL in 2021; Meet the Management Investor Call Summary

New content: The Celltelligence team has included and updated its CAR-T indications table for estimated approvals and submissions (see below for download) and made a small clarification that BELINDA trial results for Kymriah are expected at ASH 2021.

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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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Will FDA Virtually Inspect for Liso-cel US Approval? Celgene CVR Hangs in the Balance

On Wednesday, November 18, 2020, BMS stated at the Wolfe Research Healthcare Conference (transcript available from Seeking Alpha) that they are open to the possibility of a FDA virtual inspection for liso-cel’s Texas facility. As a reminder, the FDA missed their anticipated PDUFA date for liso-cel (Nov 16, 2020), due to an incomplete site inspection. Below, Celltelligence provides thoughts on the possible scenarios for the Texas facility’s inspection and how this may impact BMS’s CVR milestone.

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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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