Tag Archives: CD19

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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Novartis Ph1b PORTIA Results Presented at Virtual AACR II

On Monday, June 23, Novartis presented (Ulrich Jaeger et al, June 2020) updated clinical data from the Kymriah + pembrolizumab (pembro, a PD-1 inhibitor) Ph1 PORTIA study in ≥3L R/R DLBCL. Below, FENIX provides thoughts on the significance of this data, and particularly how it compares to recent CAR-T + checkpoint inhibitor data from Gilead (Yescarta), BMS (Liso-cel), and Autolus (AUTO3).

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Two New Gracell Early Ph1 Trials in MM and NHL Posted

Two new early Ph1 trials from Gracell have been observed on CT.gov: a BCMA/CD19 dual CAR-T in ≥4L R/R MM and another trial evaluating GC022F, a CD22 CAR-T rapidly manufactured <24 hours in ≥2L R/R NHL. Interestingly, both trials are being conducted at the same hospital. Below, FENIX provides insights on these new trials, particularly around how a BCMA/CD19 dual CAR-T could differentiate Gracell within the crowded BCMA MM space.

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Autolus Ph1/2 ALLCAR19 Results and EHA 2020 Investor Call Summary

On Friday, June 12, Autolus held an investor call (press release/ presentation), highlighting updated clinical data from the AUTO1 (CD19 CAR-T) Ph1/2 ALLCAR19 study in ≥2L adult ALL. The data was also presented at EHA (Claire Roddie et al, June 2020). Below, FENIX provides thoughts on the significance of this data, and particularly how it compares to competitor CD19 CAR-Ts from Novartis (Kymriah), Gilead (Yescarta), and Cellectis (UCART19).

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Thoughts on Ziopharm’s CAR-T And TCR-T Program Updates, Including Their Rapid Personalized Manufacturing Technology; Q1 2020 Call

On May 7, 2020, Ziopharm held their Q1 2020 earnings call (press release/slides), highlighting their clinical and regulatory milestones for both TCR-T and CAR-T programs. Below, FENIX provides thoughts on Ziopharm’s CD19 CAR-T and TCR-T pipeline, particularly within the context of COVID-19.

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Novartis Discusses Their Activated Rapid Manufacturing Program and Kymriah in the Community Setting

On Monday, June 15, Novartis held an investor call (presentation), highlighting advances to their activated rapid manufacturing (ARM) platform for cell therapy, and their assessment of the community setting for CD19 CAR-T therapies. Below, FENIX provides thoughts on the significance of the ARM platform compared to other rapid manufacturing methods, and the potential impact Kymriah could have outside Centers of Excellence (COE).

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Allogene ALLO-501 Ph1 ALPHA Results and ASCO 2020 Investor Call Summary

On Friday, May 29, Allogene held an investor call (press release/presentation), highlighting updated clinical data from the ALLO-501 (CD19 allogeneic CAR-T) Ph1 ALPHA study, in ≥3L NHL (DLBCL or FL). The data was also presented at ASCO (Sattva Neelapu et al, May 2020). Below, FENIX provides thoughts on the promising positive data from the ALPHA study, and particularly how ALLO-501 compares to equivalent autologous CD19 CAR-Ts from Novartis (Kymriah), Gilead (Yescarta), and BMS (liso-cel).

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