Tag Archives: ALLO-501A

Allogene Plans to Evaluate ALLO-501A in 2L DLBCL; No Updates for Allogene’s BCMA Programs; ALLO-316’s Initial Data Likely Delayed to 2023; CF1 to Produce ~20,000 Doses Annually; Allogene Q1 2022 Earnings Call Summary

On Wednesday, May 4, Allogene held their Q1 2022 earnings call (press release) highlighting their plans to evaluate ALLO-501A (allogeneic CD19 CAR-T) in 2 DLBCL, while noting that ALLO-316’s (allogeneic CD70 CAR-T) initial clinical data may be delayed until 2023. Of note, no major updates were provided for ALLO-501A’s pivotal study or Allogene’s BCMA programs. Below, Celltelligence provides insights on how ALLO-501A could compete with autologous CAR-Ts in the 2L setting, while discussing Allogene’s upcoming clinical updates and manufacturing capabilities.

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ALLO-501A Pivotal Trial on Track to Initiate in Mid-2022; Which BCMA Program Will Be Prioritized? New Registrational ALLO-647 Trial Anticipated for Mid-2022; Allogene Q4 2021 Earnings Call Summary

On Wednesday, February 23, Allogene held their Q4 2021 earnings call (press release) highlighting that their AlloCAR-T studies have resumed enrollment following the removal of the clinical hold in January 2022. Furthermore, Allogene confirmed that ALLO-501A’s pivotal trial is anticipated to start by mid-2022, and the company is preparing CMC data for the BLA submission. Below, Celltelligence provides insights on Allogene’s upcoming clinical updates while discussing how Allogene’s preparation of CMC data could position the company for a successful regulatory review.

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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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Gracell to Open an R&D Facility in the US; JPM 2022 Days 2 & 3: Legend, Allogene, and Autolus

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

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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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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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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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Thoughts on Heidi Hagen’s Appointment as Interim Ziopharm CEO; Allogene Anticipates Two New Clinical Trials in 2021; Ziopharm and Allogene Q4 2020 Earnings Call Summaries

On Thursday, February 25, Ziopharm (press release / slides) and Allogene (press release) held their Q4 2020 earnings presentations. Ziopharm announced that Heidi Hagen will act as Interim CEO replacing Laurence Cooper, while Allogene presented several clinical and regulatory updates. Below, Celltelligence provides insights into Allogene’s pipeline strategy and their efforts to target the solid tumor setting in the mid- to long-term, while providing thoughts on the appointment of Heidi Hagen as Ziopharm’s Interim CEO.

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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-715 Ph1 UNIVERSAL Initial Data to be Presented at ASH 2020; Redosing Strategy Confirmed for ALLO-501 Ph1 ALPHA Trial; Allogene Q3 2020 Earnings Call Summary

On Wednesday, November 4, Allogene held their Q3 2020 earnings call (press release). Allogene highlighted data from their ALLO-715 Ph1 UNIVERSAL trial in ≥4L r/r multiple myeloma (MM) due to be presented at ASH 2020. Moreover, management confirmed the redosing strategy for their ALLO-501 (CD19 CAR-T) Ph1 ALPHA trial study. Below, Celltelligence provides insights into the significance of the UNIVERSAL data and how Allogene may approach redosing for their other clinical 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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