Category Archives: Topics

Thoughts on Gracell’s NMPA Accepted IND for GC019F a Rapidly Manufactured CD19 CAR-T

On Tuesday, January 19, Gracell Biotechnologies announced (press release) that the NMPA has accepted GC019F’s (FasTCAR-enabled autologous CD19 CAR-T) IND for treating patients with r/r adult B-ALL. Below, Celltelligence provides thoughts on Gracell’s recent IND approval and how the company’s focus on global GMP standards could allow Gracell to rapidly expand into the US and EU.

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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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NICE Recommends Tecartus in MCL; First Full Access Deal for Tecartus in Europe

On Tuesday, January 19, NICE announced (press release) that they have agreed to a managed access agreement with Gilead (Kite) for Tecartus (brexucabtagene autoleucel, formerly KTE-X19). Below, Celltelligence provides thoughts on Tecartus’s timely approval by NICE and which EU country could next approve Tecartus for reimbursement.

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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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FDA Accepts Precision’s PBCAR19B IND in R/R NHL; Francesco Marincola Joins Kite as Worldwide Head of Cell Therapy Research

On Tuesday, January 19, Precision BioSciences announced (press release) that the FDA has accepted the IND for PBCAR19B (an allogeneic CD19 CAR-T) in ≥3L r/r NHL. Additionally, Gilead announced (press release) that on February 1, 2021, Francesco Marincola will join Kite as Senior Vice President and Global Head of Cell Therapy Research. Below, Celltelligence provides insights into PBCAR19B’s dosing and anticipated clinical milestones, with thoughts on how Francesco Marincola’s vast healthcare experience could drive cell therapy innovation at Gilead (Kite).

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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 Legend Ph1 Trial for CD4 CAR-T (LB1901) in R/R T-Cell Lymphoma Posted

On Friday, January 15, a new Legend-sponsored Ph1 trial was observed on CT.gov for a first-in-human study of LB1901 (CD4 CAR-T) in ≥3L r/r T cell Lymphoma (TCL). Below, Celltelligence provides details for this trial and how LB1901 compares to Autolus’s AUTO4 program.

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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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JPM 2021 Day 4: Legend Biotech, Precision BioSciences, and Ziopharm

On the fourth day of JPM 2021, Celltelligence covered presentations by Legend Biotech (presentation), Precision BioSciences (presentation), and Ziopharm Oncology (presentation). Below, Celltelligence provides a topline summary of key takeaways from each company followed by more in-depth coverage 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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JPM 2021 Day 3: Allogene, Autolus, and Tmunity

On the third day of JPM 2021, Celltelligence covered presentations by Allogene (presentation), Autolus (presentation), and Tmunity (presentation). Below, Celltelligence provides a topline summary of key takeaways from each company followed by more in-depth coverage below.

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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JPM 2021 Day 2: Gilead and SpringWorks

On the second day of JPM 2021, Celltelligence covered presentations by Gilead (presentation) and SpringWorks (presentation). Below, Celltelligence provides a topline summary of key takeaways from each company followed by more in-depth coverage below.

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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JPM 2021 Day 1: BMS, bluebird bio, Novartis, and JNJ

On the first day of JPM 2021, Celltelligence covered presentations by BMS, bluebird bio, Novartis, and JNJ. Below, Celltelligence provides a topline summary of key takeaways from each company followed by more in-depth coverage below.

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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Celgene’s CVR Payment Vanishes As Liso-cel Is Not Approved Before Dec 31, 2020

As of January 1, 2021, the FDA has not yet approved BMS’s CD19 CAR-T liso-cel, and BMS’s press release today confirmed the termination of the Celgene CVR. Below, Celltelligence provides insights on the potential for litigation following liso-cel’s missed approval deadline for Celgene’s CVR shareholders.

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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Cilta-cel Submitted in US; Could Approval be Earlier than August 2021?

On Monday, December 21, JNJ announced (press release) the US rolling submission of cilta-cel’s (BCMA CAR-T) BLA in ≥4L r/r Multiple Myeloma (MM). Below, Celltelligence provides insights on cilta-cel’s potential approval date and how this could reduce ide-cel’s first-to-market advantage.

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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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