Tag Archives: Allogene

Mark Gergen Appointed as Poseida’s New CEO; Poseida and 2seventy Provide Business Updates for 2022; Allogene’s Collaboration with Antion Bio for miCAR Technology; JPM 2022 Day 2 Part 1: GSK and SpringWorks

A series of cell therapy-related news items have been observed:

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Allogene’s FDA Clinical Hold Lifted; JPM 2022 Day 1: BMS, Novartis, JNJ, and Gilead

On Monday, January 10, Allogene (press release) announced that the FDA has lifted the clinical hold on their AlloCAR-T programs. Moreover, on the first day of JPM 2022, Celltelligence covered presentations by BMS (press release / presentation), Novartis (presentation), JNJ (press release), and Gilead (presentation). Below, Celltelligence provides insights and context for each presentation. The following topics are covered below.

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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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Could ALLO-715 Compete or Complement Carvykti / Abecma? ASH 2021 Day 3 Allogene Investor Event

On Monday, December 13, Allogene held their ASH 2021 investor event (presentation) providing updated clinical results from their BCMA (ALLO-715) and CD19 (ALLO-501 and ALLO-501A) allogeneic CAR-T programs. Bellow, Celltelligence provides insights on how ALLO-715 may be able to compete with autologous BCMA CAR-Ts.

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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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When Will the FDA Lift Allogene’s Clinical Hold on AlloCAR-T Programs? Allogene to Present Major Clinical Updates at ASH 2021; Could ALLO-501A’s Pivotal Trial Include Consolidation Dosing? Allogene Q3 2021 Earnings Call Summary

On Thursday, November 4, Allogene held their Q3 2021 earnings call (press release) highlighting their interactions with the FDA to resolve the clinical hold on their AlloCAR-T clinical programs and preparation for ALLO-501A’s (allogeneic CD19 CAR-T) pivotal trial. Moreover, management outlined the clinical data expected from their CD19 and BCMA CAR-T programs at ASH 2021. Below, Celltelligence will discuss Allogene’s clinical hold and the potential impact to their joint venture with Overland Pharma, while providing insights on the likelihood of ALLO-501A’s pivotal trial, including consolidation dosing.

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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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Allogene’s AlloCAR-T Programs Placed on Clinical Hold by the FDA

On Thursday, October 7, Allogene announced (press release) that the FDA has placed a clinical hold on all of Allogene’s AlloCAR-T trials, with the company providing additional insights via a webcast. Of note, the FDA ordered the clinical hold following a reported chromosomal abnormality event from a patient treated with ALLO-501A (allogeneic CD19 CAR-T) in the Ph1/2 ALPHA-2 study for r/r LBCL. Additionally, on Friday, October 8, Precision BioSciences released a statement (press release) highlighting the safety of their allogeneic CAR-T approach. Below, Celltelligence provides insights on the potential impact of the clinical hold, while discussing how other companies developing gene-edited allogeneic therapies could be affected.

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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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Allogene Appoints Jae Park to Their Scientific Advisory Board

On Monday, September 20, Allogene announced (press release) that Jae Park has been appointed to their Scientific Advisory Board (SAB). Below, Celltelligence provides insights on how Allogene could leverage Park’s clinical experience to advance novel pipeline products.

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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 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

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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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Allogene’s TurboCAR ALLO-605 Receives Fast Track Designation From the FDA

On Wednesday, June 30, Allogene announced (press release) that the FDA has granted Fast Track designation to ALLO-605 (allogeneic BCMA TurboCAR) for r/r MM. Furthermore, management noted that ALLO-605’s Ph1 IGNITE trial was initiated in Q2 2021. Below, Celltelligence provides insights on how ALLO-605 could benefit from Fast Track designation while discussing Allogene’s TurboCAR program.

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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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Precision Improves Response Rates With an Enhanced LD; Is ALLO-501A’s Efficacy Good Enough? How Will CRISPR Tx Compare to Precision and Allogene in the CD19 CAR-T Space? ASCO 2021 Day 2

On the second day of ASCO 2021, two key clinical updates were presented from Precision BioSciences and Allogene, while CRISPR Therapeutics discussed their clinical trial design for CTX110. 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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BMS Announces New EU Manufacturing Site in the Netherlands; AUTO4 (TRBC1 CAR-T) Receives Innovation Passport and ILAP Designation; Allogene’s ALLO-715 Receives RMAT Designation by the FDA; No Major Updates in April’s CHMP Agenda

On Thursday, April 22, BMS announced (press release) that they plan to build a new cell therapy manufacturing site in Europe. Furthermore, Autolus confirmed (press release) that the UK Medicines and Healthcare products Regulatory Agency (MHRA) granted AUTO4 an Innovation Passport and entry into the Innovative Licensing and Access Pathway (ILAP) evaluating the TRBC1-targeting CAR-T in a Ph1/2 trial for peripheral T cell lymphoma (PTCL). Allogene announced (press release) that the FDA granted a Regenerative Medicine Advanced Therapy (RMAT) designation to ALLO-715 (BCMA CAR-T) for the Ph1 UNIVERSAL trial in r/r MM. Finally, no major regulatory updates were observed for Abecma, Breyanzi, or cilta-cel from this week’s April CHMP Agenda (publication). Below, Celltelligence provides insights into BMS’s potential manufacturing strategy in Europe. Moreover, Celltelligence will provide thoughts on AUTO4’s ILAP designation and how this may accelerate approvals compared to the EMA’s PRIME designation, while discussing ALLO-715’s RMAT designation.

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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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