Tag Archives: ALLO-715

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 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

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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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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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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 in Allogene’s ALLO-715 + Nirogacestat Cohort in the Ph1 UNIVERSAL Trial

On Monday, April 12, Allogene and SpringWorks announced (press release) that the first patient has been dosed with ALLO-715 (BCMA CAR-T) + nirogacestat (GSI) in the Ph1 UNIVERSAL trial (r/r MM). Below, Celltelligence provides insights into Allogene’s and key competitor Precision Biosciences’s clinical progress combining a GSI with their lead BCMA CAR-T assets, while discussing other strategies currently under evaluation to improve BCMA-targeting CAR-T efficacy.

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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 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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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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Updated Results for ALLO-715 from ASH and Allogene’s Investor Call; CARsgen Fully Human BCMA CART CT053 Reports a 94% ORR in MM; Poseida Modifies Their P-BCMA-101 CAR-T Manufacturing Process; ASH Day 1 Encore

On the first day of ASH 2020, four key clinical updates were presented from Allogene, CARsgen and Poseida. Below, Celltelligence provides insights and context for each presentation.

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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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