Category Archives: Autologous

Cilta-cel on Track to Gain FDA Approval in Q4 2021; JNJ Q3 2021 Earnings Call Summary

On Tuesday, October 19, JNJ held their Q3 2021 earnings presentation (press release / presentation) highlighting cilta-cel’s (BCMA CAR-T) anticipated FDA approval by YE 2021. Below, Celltelligence provides insights on cilta-cel’s potential US and EU regulatory timelines.

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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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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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CRISPR Tx’s CTX110 Reports a Comparable Efficacy and Safety Profile to Autologous CD19 CAR-Ts; 2seventy’s Launch Delayed to November 2021; bluebird and Poseida Appoint New Leadership Roles

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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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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Tecartus Website Analysis

On Wednesday, October 6, an update on Tecartus’s patient website was observed, with Gilead (Kite) now including Tecartus’s approval in r/r adult ALL. Below, Celltelligence provides an analysis on the updates included within the Tecartus website and insights into Tecartus’s messaging within the MCL and ALL setting.

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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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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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Gilead’s (Kite) Tecartus Receives FDA Approval for R/R Adult ALL

On Friday, October 1, Gilead (Kite) announced (press release) that the FDA has granted approval for Tecartus (CD19 CAR-T) in r/r adult ALL. Of note, Tecartus is the first approved CAR-T in the US for the treatment of adult ALL. Below, Celltelligence provides insights on how Tecartus’s approval in adult ALL compares with Kymriah’s pediatric and young adult ALL indication.

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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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Thoughts On the Evolution of the Cell Therapy Landscape; Will Traditional αβ CAR-T Cells be Replaced by Novel Cell Types?

Although cell therapy companies have traditionally used alpha beta (αβ) T cells to manufacture CAR-T therapies, the cell therapy field is rapidly evolving with an increasing number of companies developing novel and highly differentiated platforms. Below, Celltelligence discusses how CAR-derived therapies from natural killer (NK) cells, gamma delta (γδ) T cells, macrophages, and iPSCs could treat liquid or solid tumors and whether these novel cell types may overcome the challenges and limitations faced by conventional 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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