Tag Archives: Allogeneic

A New Ph1 Trial for Precision’s CD19 Allogeneic CAR-T PBCAR19B; Could PBCAR19B Knock Down B2M Expression to Enhance Persistence?

On Wednesday, December 2, a new Precision Biosciences-sponsored Ph1 trial has been detected on CT.gov for the allogeneic CD19 CAR-T, PBCAR19B, in ≥3L r/r NHL. Below, Celltelligence provides insights on this new trial and how PBCAR19B could use Precision’s B2M “stealth” vector to increase allogeneic CAR-T persistence, while avoiding NK cell activation.

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FDA Lifts Clinical Hold for Cellectis’s UCARTCS1 Ph1 MELANI-01 Trial; No Update on Protocol Changes

On Tuesday, November 17, Cellectis announced (press release) that the FDA has lifted the clinical hold on their UCARTCS1 (CS1 allogeneic CAR-T) Ph1 MELANI-01 trial in r/r MM. Below, Celltelligence provides insights on the trial’s FDA mandated clinical hold and possible protocol changes.

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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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UCART22 and UCART123 Clinical Updates to be Presented at ASH 2020; UCARTCS1 Remains on Clinical Hold; Cellectis Q3 2020 Earnings Call Summary

On Friday, November 6, Cellectis held their Q3 2020 earnings call (press release). No significant updates were provided about the FDA hold for the Ph1 MELANI-01 trial in r/r MM. Furthermore, management stated that preliminary data from the UCART22 Ph1 BALLI-01 study (in r/r ALL) and UCART123 Ph1 AMELI-01 (in r/r AML) trial will be presented at ASH 2020. Below, Celltelligence provides thoughts on Cellectis’s CAR-T programs and the possible impact of alemtuzumab lymphodepletion.

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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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Legend Appoints a New CEO and Chairperson; New Ph1 Pipeline Updates Including an Allogeneic BCMA CAR-T

On Monday, November 9, Legend announced (press release) the appointment of Ms. Ye (Sally) Wang as Chairwoman of the Board of Directors and Dr. Ying Huang (previous CFO) as Chief Executive Officer. Of note, Legend added three Ph1 trials to their clinical pipeline, including an allogeneic BCMA CAR-T. Below, Celltelligence provides additional context for the new leadership appointments and how Legend’s allogeneic BCMA CAR-T could impact the multiple myeloma landscape.

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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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Expanded Collaboration with Servier; PBCAR0191 Clinical Update Expected in Q4 2020; Precision’s Q3 2020 Earnings Call Summary

On Tuesday, November 10, Precision Biosciences released their Q3 2020 financial results and business update (press release), highlighting their allogeneic CD19 CAR-T PBCAR0191. Of note, management anticipate in Q4 2020 to present updated PBCAR0191 Ph1/2a data in a company-sponsored event. Furthermore, Precision provided guidance on their clinical development agreement evaluating PBCAR269A (allogeneic BCMA CAR-T) with nirogacestat (gamma-secretase inhibitor). Below, Celltelligence provides insights into Precision and Servier’s expanded agreement targeting solid tumors, pipeline updates, and upcoming data from their allogeneic CD19 CAR-T PBCAR0191.

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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 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 Ziopharm’s TCR-T Programs; Ziopharm at Jefferies Cell Therapy Summit Call Summary

On Monday, October 5, Ziopharm participated in the Jefferies Cell Therapy Summit (press release). Management highlighted advances to their library TCR-T and personalized TCR-T programs. Below, Celltelligence provides thoughts on the potential market opportunities for Ziopharm’s TCR-T and CD19 CAR-T therapies.

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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 and MD Anderson Announce a 5-Year Collaboration to Develop Allogeneic CAR-Ts

On Thursday, October 15, Allogene announced (press release) a five-year collaboration with the MD Anderson Cancer Center for the preclinical and clinical development of Allogene’s AlloCAR-T candidates. Below, Celltelligence provides insights on the significance of this collaboration for Allogene’s clinical pipeline.

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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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Ziopharm´s RPM Allogeneic CD19 CAR-T Trial Started Enrollment; Q2 2020 Earnings Summary

On Thursday, August 6, Ziopharm held their Q2 2020 earnings call (press release / presentation), highlighting the initiation of their allogeneic CD19 CAR-T Ph1 trial post allo-SCT. Management confirmed that the IND submission in Greater China (China and Taiwan) for autologous CD19 CAR-Ts is anticipated by YE 2020. In Q1 2021, Ziopharm expects to submit CMC data for their personalized and library TCR-T IND application. Below, Celltelligence provides thoughts on Ziopharm’s global CD19 CAR-T initiatives and the potential challenges and opportunities for their TCR-T 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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Precision Biosciences Highlights First Patient Dosed with BCMA CAR-T PBCAR269A; PBCAR0191 Clinical Updates Delayed to YE; Q2 2020 Earnings Summary

On Thursday, August 13, Precision Biosciences released their Q2 2020 financial results (press release). While no new data was presented, Precision highlighted that the first patient was dosed with PBCAR269A (an allogeneic BCMA CAR-T) for the Ph1/2 trial in r/r MM. Moreover, management confirmed that interim data from the PBCAR0191 (an allogeneic CD19 CAR-T) Ph1 study in ≥3L r/r NHL and r/r ALL will be delayed due to the COVID-19 pandemic. Below, Celltelligence provides thoughts on key competitors Precision and Allogene’s position within the allogeneic BCMA CAR-T setting and the possibility for a PBCAR0191 presentation at ASH 2020.

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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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