Category Archives: Autologous

Breyanzi Absent from December’s CHMP Agenda

On Monday, December 12, the CHMP agenda for December was released. Of note, Breyanzi’s (BMS’s CD19 CAR-T) Type II Variation for 2L LBCL transplant-intended patients was absent from the agenda, and no other cell therapy-related updates were observed. On Friday, December 16, when the CHMP highlights are released, the Celltelligence team will provide updated timelines for Breyanzi’s potential EU approval.

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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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Positive Interim Analysis from Obe-cel’s Pivotal Ph2 FELIX Trial for r/r ALL; BLA Submission Still Anticipated by YE 2023; Autolus Receives $70M in Milestone Payments

On Thursday, December 8, 2022, Autolus announced that obe-cel’s (autologous CD19 CAR-T) Ph1/2 FELIX trial in r/r ALL has met its primary endpoint (press release). Moreover, management highlighted that they will receive $70M from Blackstone in milestone payments (press release). Below, Celltelligence provides insights on how obe-cel’s best-in-class profile could compete with Tecartus (Gilead / Kite’s CD19 CAR-T), while discussing obe-cel’s potential FDA regulatory timelines.

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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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Allogene’s R&D Showcase 2022: Celltelligence Analysis – Part 1

On Tuesday, November 29, Allogene held an R&D showcase (press release / presentation) providing updated clinical milestones and results from ALLO-501A (allogeneic CD19 CAR-T) and ALLO-715 (allogeneic BCMA CAR-T). Below, Celltelligence provides insights on the new data presented by Allogene from its hematology franchise, while discussing potential regulatory timelines for ALLO-501A and how it could compete with approved autologous 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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Thoughts on AstraZeneca’s Acquisition of Neogene

On Tuesday, November 29, AstraZeneca announced (press release) an agreement to acquire Neogene Therapeutics for the development of TCR-T therapies in solid tumors. Below, Celltelligence provides insights on AstraZeneca’s increasing interest in the cell therapy space, while discussing Neogene’s potential 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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UPDATED: Indications Table for BCMA and CD19 CAR-T US Approvals and Submissions (Q3 2022)

New content: The Celltelligence team has updated its BCMA CAR-T and CD19 CAR-T indications tables for estimated US approvals and submissions following key Q3 2022 earnings presentations and recent press releases (see below for download). Another update will be published in December after ASH.

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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 GSK’s Decision to Terminate its Collaboration with Immatics

On Thursday, November 17, Immatics held its Q3 2022 earnings call (press release / presentation) disclosing GSK’s decision to terminate their collaboration to develop novel adoptive cell therapies. Below, Celltelligence provides insights on how GSK’s decision to deprioritize its cell therapy programs could affect Immatics’s strategy, while discussing how BMS could benefit from it.

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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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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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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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Gracell to Submit GC012F’s IND for R/R MM in the US and China; GC012F Demonstrates 100% ORR in NDMM; Clinical Progress from GC007g, GC503, and GC506; Gracell’s Q3 2022 Earnings Call Summary

On Monday, November 14, Gracell held their Q3 2022 earnings call (press release / presentation), highlighting results from GC012F’s (autologous BCMAxCD19 FasTCAR-T) Ph1/2 IIT in NDMM, and planned IND submissions in the US and China for r/r MM. Additionally, management provided clinical updates for GC007g (allogeneic CD19 CAR-T), GC503 (mesothelin SMART CAR-T), and GC506 (CLDN18.2 SMART CAR-T). Below, Celltelligence provides insights on GC012F’s potential as a first-line treatment in MM, while discussing a possible partnership strategy in the US.

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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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ICT, Takeda, and PACT Pharma Report Clinical Data in Solid Tumors; SITC 2022 Final Analysis

SITC 2022 Final Analysis: Innovative Cellular Therapeutics (ICT), Takeda, and PACT Pharma presented clinical results from their T cell therapies in solid tumors. 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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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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