Category Archives: Allogeneic

Allogene Plans to Expand ALLO-501A’s Pivotal Trial to Europe; Clinical Updates Ahead of ASH 2022; New Manufacturing Facility in China; Allogene’s Q3 2022 Earnings Call Summary

On Wednesday, November 2, Allogene held its Q3 2022 earnings call (press release) highlighting the initiation of ALLO-501A’s (allogeneic CD19 CAR-T) Ph2 ALPHA2 trial in r/r LBCL and its potential expansion into the EU. Furthermore, management announced an R&D showcase on November 29, 2022, to provide updates on the ALLO-501A and ALLO-715 (allogeneic BCMA CAR-T) programs, while results from ALLO-715’s Ph1 UNIVERSAL study will also be presented at ASH 2022. Below, Celltelligence provides insights on Allogene’s potential involvement in ALLO-501A’s ex-US development, while discussing its allogeneic BCMA CAR-T strategy.

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Allogene Initiates ALLO-501A’s Pivotal Ph2 Trial

On Thursday, October 6, Allogene announced (press release) the initiation of ALLO-501A’s (allogeneic CD19 CAR-T) potentially pivotal Ph2 ALPHA2 trial in patients with r/r LBCL. Additionally, management confirmed that they are in the process of initiating ALLO-647’s (anti-CD52 monoclonal antibody) EXPAND study. Below, Celltelligence provides insights on both trials, while discussing potential approval timelines for ALLO-501A.

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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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Could Carvykti be Approved in 2L MM by 2023? Legend Introduces New γδ CAR-T Program; Updates to Solid Tumor Programs; Thoughts on Legend’s R&D Day 2022

On Monday, October 3, Legend Biotech held their R&D Day (webcast), highlighting Carvykti’s (BCMA CAR-T) LCM initiatives, while providing updates on Legend’s pipeline platforms and programs. Below, Celltelligence provides insights on Carvykti’s ongoing competition with Abecma (BMS’s BCMA CAR-T), while evaluating the strength of Legend’s pipeline compared to its competitors.

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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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Servier Discontinues Partnership with Allogene

On Wednesday, September 21, Allogene reported (SEC Filing) that Servier has discontinued its involvement in the development of allogeneic CD19-directed assets, including Allogene’s most advanced candidates such as ALLO-501, ALLO-501A, and UCART19. Below, Celltelligence provides insights on how the lack of an ex-US licensing partner could affect Allogene’s pipeline development.

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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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Gilead Messages on Solid Tumor Capabilities and Novel Manufacturing Methods; Gilead’s (Kite) ESMO 2022 Industry Symposium

On Friday, September 9, Gilead (Kite) hosted an industry satellite symposium at ESMO 2022 highlighting novel methods to increase cell therapy effectiveness both in solid and liquid tumors. Below, Celltelligence provides insights on Gilead’s potential strategy for solid tumors while discussing future manufacturing improvements.

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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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Updated Results from BioNTech’s BNT211; Triumvira’s TAC01-HER2 Clinical Safety and Efficacy Data; Dosing Levels of ICT’s GCC19CART; ESMO 2022 Presentations Analysis

ESMO 2022 Presentations Analysis: BioNTech, Triumvira, and ICT presented clinical updates from their novel cell therapies in solid tumors. Below, Celltelligence provides insights and context for key selected presentations. 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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Precision Appoints Cindy Atwell as CBO and Jeff Smith as CRO; Derek Jantz to Act as CEO’s Partner

On Friday, September 2, Precision BioSciences announced (press release) several senior leadership organizational changes. Below, Celltelligence provides insights on Precision’s latest additions to their leadership team.

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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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Gracell’s GC012F IND Submission Plans; Ph2 Portion of GC007 Trial to Start in Q3 2022; Gracell’s Q2 2022 Earnings Call Summary

On Monday, August 15, Gracell held their Q2 2022 earnings call (press release / presentation) highlighting GC012F’s (autologous BCMAxCD19 FasTCAR-T) IND filing plans both in the US and China, while updating clinical milestones for both TruUCAR and SMART CAR-T platforms. Below, Celltelligence provides insights on regulatory updates for GC012F in r/r MM and the potential delay in the GC027 trial (allogeneic CD7 TruUCAR-T) for r/r T-ALL patients.

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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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P-PSMA-101 Clinical Program Delayed; Poseida’s Global Collaboration with Roche; Poseida Q2 2022 Earnings Summary

On Thursday, August 11, 2022, Poseida released their Q2 2022 results (press release) highlighting anticipated clinical updates for H2 2022 and the recent partnership with Roche. Below, Celltelligence provides insights on a potential delay for Poseida’s P-PSMA-101 (autologous PSMA CAR-T) program, while discussing Poseida’s partnering strategy.

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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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FDA to Potentially Clear ALLO-501A’s Pivotal Study in Q3 2022; Nirogacestat Combo Deprioritized; Data from ALLO-316 Delayed to 2023; Allogene Q2 2022 Earnings Call Summary

On Tuesday, August 9, Allogene held their Q2 2022 earnings call (press release) highlighting an anticipated FDA clearance of ALLO-501A’s (allogeneic CD19 CAR-T) pivotal trial in ≥3L DLBCL, while announcing the deprioritization of ALLO-715’s (allogeneic BCMA CAR-T) combination with nirogacestat. Of note, no major updates were presented from ALLO-316’s (allogeneic CD70 CAR-T) clinical development. Below, Celltelligence provides insights on how Allogene could accelerate ALLO-501A’s regulatory pathway, while discussing Allogene’s upcoming clinical updates.

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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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