Category Archives: Uncategorized

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 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 Updates in October’s CHMP Highlights

On Friday, October 15, the CHMP meeting highlights were released following Monday’s CHMP agenda. As previously anticipated by the Celltelligence team, no cell therapy-related updates were observed in October’s CHMP Highlights. Recall that on Wednesday, October 13, 2021, the Celltelligence team prepared a full analysis on October’s CHMP agenda, discussing Breyanzi’s continued regulatory delay and in-depth scenarios for EC approvals of the following cell therapy products (see previous insight):

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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 Breyanzi’s Continuing EU Regulatory Delays; Will Kymriah Receive a Positive CHMP Opinion for R/R FL in December 2021? No Updates for Tecartus, Cilta-cel, and Yescarta in October’s CHMP Agenda

On Monday, October 11, the CHMP agenda for October was released. Of note, Breyanzi (BMS’s CD19 CAR-T) is listed under the ‘List of outstanding issues (LoOI)’ section, while Kymriah (Novartis’s CD19 CAR-T) has been listed under ‘Type II variations’ to include ≥3L r/r FL as a new indication. No updates were observed for Tecartus (Gilead’s CD19 CAR-T), cilta-cel (JNJ / Legend’s BCMA CAR-T), or Yescarta (Gilead’s CD19 CAR-T). Below, Celltelligence provides likely EU approval timelines for Breyanzi and Kymriah.

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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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T-Cure Partners With Atlas to Develop a KK-LC-1 Diagnostic Test

On Tuesday, October 5, T-Cure announced (press release) a collaborative agreement with Atlas Antibodies for the development, manufacture, and supply of CT83 (KK-LC-1-directed monoclonal antibody). Of note, CT83 will be used for the development of a diagnostic test to identify KK-LC-1-expressing tumors. Below, Celltelligence provides insights on how the use of a companion diagnostic test could improve clinical outcomes, while discussing T-Cure’s novel TCR-T 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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BMS Bets on Digital Health Coaching Following CAR-T Treatment to Improve Quality of Life Outcomes

On Friday, October 1, a new clinical study evaluating the feasibility of a Digital Health Coaching Program for individuals who have received CAR-T therapy was observed on CT.gov. Of note, Pack Health is the sponsor of the trial with BMS and the MD Anderson Cancer Center appearing as collaborators. Below, Celltelligence provides insights on BMS’s use of digital tools as a potential strategy to facilitate CAR-T reimbursement, while discussing BMS’s recently launched marketing campaign.

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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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Tecartus Receives FDA Approval for R/R Adult ALL

Late on Friday, October 1, Gilead (Kite) announced (press release) the US approval of Tecartus (CD19 CAR-T) in r/r adult ALL. Tecartus has become the first and only CAR-T therapy approved in r/r adult ALL. The Celltelligence team will be conducting a full analysis of Tecartus’s approval in the coming days.

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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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Carisma’s CT-0508 (HER2 CAR-Macrophage) Receives Fast Track Designation From the FDA

On Wednesday, September 22, Carisma announced (press release) that the FDA has granted Fast Track designation to CT-0508 (HER2-targeting CAR-Macrophage) for HER2-overexpressing solid tumors. Below, Celltelligence provides insights on how CT-0508 could benefit from Fast Track designation, while discussing the potential advantages of CAR-Macrophages (CAR-M).

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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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Two Novel CAR-Ts for Solid Tumors Demonstrate Promising Efficacy / Activity; Are CAR-Ts More Advantageous Than Bispecific Antibodies? ESMO 2021 Day 4 – 6

On the last three days of ESMO 2021, two key presentations highlighting clinical and pre-clinical data for CAR-T candidates treating solid tumors were presented. Additionally, a Controversy Session was held discussing the key benefits and challenges for bispecific antibodies and CAR-Ts.

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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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Autolus Announces Progress with New UK Manufacturing Site

On Thursday, September 16, Autolus announced (press release) planning approval for a new manufacturing facility in Stevenage, UK. Of note, the manufacturing facility will initially provide ~2,000 doses a year of obe-cel (CD19 CAR-T; formerly AUTO1). Below, Celltelligence provides insights into Autolus’s manufacturing strategy, while discussing whether the new facility could enhance Autolus’s potential to be acquired.

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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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Autolus Appoints John Johnson to Their Board of Directors

On Wednesday, September 15, Autolus announced (press release) John Johnson’s appointment as non-executive chairman of their Board of Directors. Additionally, Martin Murphy, who previously served as chairman, will continue to serve as a non-executive board member. Below, Celltelligence provides insights on Autolus’s leadership strategy to prepare for obe-cel’s (CD19 CAR-T, formerly AUTO1) commercial launch, while commenting on the potential acquisition of Autolus.

About The Author

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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