Category Archives: Uncategorized

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 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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Fate Tx and Carisma Present Clinical Updates in Liquid and Solid Tumors; SITC 2022 Analysis 2

SITC 2022 Analysis 2: Fate Tx and Carisma presented clinical updates from their novel cell therapies in liquid and 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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Poseida, CRISPR Tx, and Cellectis Present Novel Allogeneic CAR-T for Solid Tumors; SITC 2022 Analysis 1

SITC 2022 Analysis 1: Poseida, CRISPR Tx, and Cellectis presented preclinical and clinical updates from their allogeneic 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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New Yescarta Ph3 Trial (ZUMA-23) for 1L LBCL Posted

On Friday, November 4, a new Kite-sponsored Ph3 trial (ZUMA-23) evaluating Yescarta (Gilead / Kite’s CD19 CAR-T) in 1L high-risk LBCL was observed on CT.gov. Below, Celltelligence provides details for the trial while discussing Yescarta’s potential to displace the current SOC in 1L LBCL.

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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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GSK Deprioritizes Cell Therapy Franchise; GSK’s Q3 2022 Earnings Summary

On Wednesday, November 2, GSK held its Q3 2022 earnings call (press release / presentation), highlighting the removal of three clinical TCR-T programs from its pipeline. Below, Celltelligence provides insights on GSK’s pipeline update, while discussing the company’s future in cell therapy.

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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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No Cell Therapy-Related Updates in October’s CHMP Highlights

On Friday, October 14, the CHMP meeting highlights were released. In line with Monday’s CHMP agenda (see previous insight), no cell therapy-related updates were observed in October’s CHMP highlights.

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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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Allogene Initiates ALLO-501A’s Pivotal Ph2 Trial

On Thursday, October 6, Allogene announced (press release) the initiation of ALLO-501A’s (allogeneic CD19 CAR-T) potentially pivotal Ph2 ALPHA2 trial in patients with r/r LBCL. Additionally, management confirmed that they are in the process of initiating ALLO-647’s (anti-CD52 monoclonal antibody) EXPAND study. Below, Celltelligence provides insights on both trials, while discussing potential approval timelines for ALLO-501A.

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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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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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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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TCR2 Tx Completes Gavo-Cel’s Ph1 Trial; Dosing Started in Gavo-cel’s Pivotal Ph2 Study; Gilead’s KITE-222 Receives Orphan Drug Designation

On Wednesday, September 28, 2022, TCR2 Tx held an investor event highlighting positive topline results from gavo-cel’s (TC-210; autologous mesothelin TRuC-T) Ph1 portion of the Ph1/2 trial (press release / presentation). On Tuesday, September 27, Gilead’s (Kite) KITE-222 (autologous CLL-1 CAR-T) was granted Orphan Drug Designation (ODD) by the FDA (FDA Designation). Below, Celltelligence provides insights on gavo-cel’s positive clinical results and future pivotal development as well as discusses KITE-222’s ODD in AML.

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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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Carvykti Approved in Japan for ≥4L r/r MM

On Tuesday, September 27, Legend announced (press release) that Japan’s Ministry of Health, Labour, and Welfare (MHLW) approved Carvykti (BCMA CAR-T) for the treatment of ≥4L r/r MM. Below, Celltelligence provides insights on how Carvykti’s approval may challenge Abecma’s (BMS’s BCMA CAR-T) first-to-market advantage in Japan, while discussing Carvykti’s potential pricing.

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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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