Tag Archives: Allogeneic

ALLO-501A Pivotal Trial on Track to Start by YE 2021; Allogene Prepares for Clinical Manufacturing; Allogene Q2 2021 Earnings Call Summary

On Wednesday, August 4, Allogene held their Q2 2021 earnings call (press release) highlighting clinical updates for their CD19 and BCMA CAR-T programs, and confirmed their plans to initiate cGMP manufacturing in their new Cell Forge 1 facility by YE 2021. Below, Celltelligence will discuss Allogene’s pipeline updates while providing thoughts on how the company may be preparing for ALLO-501A’s potential regulatory 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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First Patient Dosed With Precision’s Stealth Cell PBCAR19B

On Thursday, July 1, Precision BioSciences announced (press release) that the first patient has been dosed with PBCAR19B (stealth allogeneic CD19 CAR-T) in the Ph1 trial for r/r NHL. Below, Celltelligence discusses Precision’s stealth cell program while providing insights on how Precision could apply learnings from PBCAR19B’s dosing strategy to other programs.

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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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Spotlight on Bayer’s and Takeda’s Cell Therapy Strategy Part 2

In our part 1 Spotlight blast, Celltelligence discussed Bayer’s expanding position within the cell therapy space (see previous insight). Below, Celltelligence continues our analysis with an overview of Takeda’s approach while performing a head-to-head comparison of Bayer and Takeda in the cell therapy space.

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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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ALLO-501A Ph2 Trial Likely to Include a Consolidation Regimen and Outpatient Administration; CD52 LD Regimens May Require Educational Outreach to Increase ALLO-501A Adoption; Allogene’s CD19 Forum Summary

On Wednesday, May 19, Allogene held their CD19 forum (presentation / webcast) ahead of ASCO 2021 and presented updated clinical data from their ALLO-501 (CD19 CAR-T) program. Of note, Allogene discussed results from a survey assessing physicians’ CAR-T preferences in r/r LBCL. Below, Celltelligence provides insights on ALLO-501’s efficacy and safety profile and how it compares to currently approved CD19 CAR-Ts. Furthermore, Celltelligence comments on Allogene’s survey discussing the main factors that HCPs may consider when selecting allogeneic CAR-Ts over autologous therapies.

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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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CHMP Agenda Includes Hidden Request for Cilta-cel Accelerated Assessment; Precision Issued with a Notice of Allowance for PBCAR19B’s Patent

On Monday, January 25, the CHMP indirectly announced (CHMP agenda) that JNJ / Legend have requested an accelerated assessment for cilta-cel (BCMA CAR-T) in r/r MM, although the documentation only lists the code number for cilta-cel. Additionally, Precision BioSciences announced (press release) that the USPTO has issued a notice of allowance for PBCAR19B, a next-generation CD19 CAR-T. Below, Celltelligence provides insights on how a 1-month delay in filing cilta-cel could result in a 2-month delay for EC approval, an update on ide-cel’s estimated EU approval lead, and the significance of Precision’s latest patent milestone.

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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 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

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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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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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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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Kymriah Demonstrates a Favorable Safety Profile in FL; Updated Results for AUTO1’s Ph1 ALLCAR19 Trial in ALL and iNHL; Initial Data from Cellectis’s UCART22 Ph1 BALLI-01 Study; ASH Day 1 Encore

On the first day of ASH 2020, three key clinical updates were presented from Novartis, Autolus, and Cellectis. Below, Celltelligence provides insights and context for each presentation.

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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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Interim Results from PBCAR0191’s Ph1/2a Trial; Updated Clinical Strategies to Improve Response; New Details Disclosed for PBCAR19B Stealth CAR-T; Precision’s Pre-ASH Investor Call Summary

On Friday, December 4, Precision reported interim results from their PBCAR0191 Ph1/2a trial, an allogeneic CD19 CAR-T in r/r NHL and ALL, and held an investor webcast (press release / presentation). Management confirmed that PBCAR19B, a next generation CD19 “stealth cell” CAR-T, is expected to enroll patients in H1 2021. Below, Celltelligence provides insights into PBCAR0191’s lymphodepletion regimens and how their approach differs from key allogeneic competitor Allogene.

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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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