Tag Archives: PBCAR0191

Precision Receives Feedback from the FDA on Azer-cel’s Registrational Pathway

On Thursday, July 27, Precision Biosciences announced (press release) the receipt of final Type B meeting minutes from the FDA providing clarity on the potential registrational pathway of its lead asset azer-cel (PBCAR0191; allogeneic CD19 CAR-T). Moreover, the company disclosed discussions with multiple potential strategic partners for the development of its cell therapy assets. Below, Celltelligence provides insights on azer-cel’s potential in LBCL, while comparing the asset with its main allogeneic 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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Arcellx’s CART-ddBCMA Program to Be Expanded; Precision to Provide Clinical Updates on Azer-cel and PBCAR19B Programs in May 2023; Arcellx’s and Precision’s Q1 2023 Results Summary

On Monday, May 8, Arcellx released its Q1 2023 results (press release) highlighting the progress made in the clinical development of its lead asset CART-ddBCMA (autologous BCMA CAR-T) for ≥4L MM. A day later, Precision reported a business update (press release) confirming that clinical updates for its allogeneic CD19 CAR-Ts (azer-cel and PBCAR19B) in NHL patients are still anticipated in May 2023. Below, Celltelligence provides insights on the potential expansion of the CART-ddBCMA’s iMMagine program with a future iMMagine-3 trial while commenting on the expected clinical updates of Precision’s cell therapy assets.

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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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Cellectis’s UCART20x22 Trial in NHL Starts Enrollment; Precision’s Azer-cel and PBCAR19B Programs Delayed; Poseida to Provide Further Clinical Updates in 2023; Cellectis, Precision, and Poseida Q4 2022 Earnings Calls Summary

On Thursday, March 9, the following companies released their Q4 and FY 2022 earnings providing clinical updates and financial results:

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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 BioSciences and 2seventy bio Provide Business Updates for 2023; JPM 2023 Analysis Day 2: Allogene and GSK

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

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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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KarMMa-2 Results to be Presented at ASH 2022; No Updates for bbT369 and SC-DARIC33; PBCAR269A Discontinued; 2seventy bio and Precision BioSciences Q3 2022 Earnings Summaries

On Monday, November 7, 2seventy bio released their Q3 2022 earnings results (press release) highlighting Abecma’s (BMS / 2seventy’s BCMA CAR-T) increased revenue. Moreover, preliminary clinical results from Cohorts 2A and 2C of the Ph2 KarMMa-2 in ≥2L HR MM will be presented at ASH 2022 (Dec 10-13). On Tuesday, November 8, Precision BioSciences reported their Q3 2022 financials and business updates (press release) highlighting the discontinuation of PBCAR269A (allogeneic BCMA CAR-T). Below, Celltelligence provides insights on Abecma’s improved efficacy in the KarMMa-2 study, while discussing Precision’s decision to deprioritize its BCMA franchise.

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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’s Cash Runway Extended to YE 2024; No Major Clinical Updates; Precision BioSciences Q2 2022 Earnings Call Summary

On Monday, August 8, Precision BioSciences released their Q2 2022 earnings results (press release) highlighting PBCAR0191’s (allogeneic CD19 CAR-T) data readout in June 2022. Of note, no major updates were reported for PBCAR19B (allogeneic stealth CD19 CAR-T) or PBCAR269A (allogeneic BCMA CAR-T). Below, Celltelligence provides insights on PBCAR0191’s potential approval pathway, while discussing potential clinical delays for Precision’s MM 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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PBCAR0191 Reports Improved Efficacy in CAR-T Relapse Patients; Precision to Evaluate PBCAR0191 with sLD; Updated Milestones for PBCAR19B and PBCAR269A; Precision Mid-Year 2022 Event

On Wednesday, June 8, Precision BioSciences held their mid-year 2022 pipeline update event (press release / presentation), highlighting updated clinical results from PBCAR0191’s (allogeneic CD19 CAR-T) Ph1/2a study in CAR-T relapse patients. Additionally, management provided updated milestones for PBCAR19B (stealth CD19 CAR-T) and PBCAR269A (allogeneic BCMA CAR-T). Below, Celltelligence provides insights on Precision’s lymphodepleting strategy for PBCAR0191 in CAR-T relapse patients, while discussing PBCAR0191’s potential regulatory pathway.

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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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Afami-cel’s BLA Filing Remains On Track for Q4 2022; ADP-A2M4N7X19’s IND Submission Planned by YE 2022; Precision’s Clinical Updates Expected in June 2022; Adaptimmune and Precision Q1 2022 Earnings Summaries

On Monday, May 9, Adaptimmune held their Q1 2022 earnings call (press release / webcast) highlighting afami-cel’s (autologous MAGE-A4 SPEAR-T; formerly ADP-A2M4) anticipated BLA filing in Q4 2022, while discussing anticipated milestones for their MAGE-A4 franchise. On the same day, Precision BioSciences reported their Q1 2022 financial results (press release) confirming multiple planned clinical updates for June 2022. Below, Celltelligence provides insights on Adaptimmune’s vector supply strategy, while discussing at which conference Precision may present their 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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Afami-cel’s BLA Filing Anticipated During Q4 2022; MAGE-A4 Allogeneic Platform On Track for IND Submission in 2023; No Major Updates for Precision BioSciences; Adaptimmune and Precision Q4 2021 Earnings Summaries

On Monday, March 14, Adaptimmune held their Q4 2021 earnings call (press release / webcast) highlighting afami-cel’s (autologous MAGE-A4 SPEAR-T; formerly ADP-A2M4) anticipated BLA filing in Q4 2022, while discussing anticipated milestones for their MAGE-A4 franchise. On Tuesday, March 15, Precision BioSciences reported their Q4 2021 financial results (press release), however, no major clinical or regulatory updates were provided. Below, Celltelligence provides insights on potential approval timelines for afami-cel.

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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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JPM 2022 Day 3 & 4: Precision and TCR2 Tx

On the third and fourth (final) day of JPM 2022, Celltelligence covered presentations by Precision BioSciences (presentation) and TCR2 Tx (press release / corporate presentation). Below, Celltelligence provides insights and context for each presentation. The following topics are covered below:

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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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