Category 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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Updated AUTO3 Ph1/2 ALEXANDER Results; ESMO 2020 Investor Call Summary

On Friday, September 18, Autolus held an investor call (press release / presentation), highlighting updated clinical data from the AUTO3 (CD19/22 dual CAR-T) Ph1/2 ALEXANDER study in ≥3L DLBCL. The data was also presented at ESMO (E.Tholouli et al, Sep 2020). Below, Celltelligence provides thoughts on the significance of this data, and particularly how it compares to competitor autologous CD19 CAR-Ts from Novartis (Kymriah), Gilead (Yescarta), and BMS (liso-cel).

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Thoughts on Autolus’s CAR-T Program; Q2 2020 Earnings Call

On Thursday, August 6, Autolus held their Q2 2020 earnings call (press release/ presentation). The company announced that updated data from the AUTO3 Ph1/2 ALEXANDER study in ≥3L DLBCL will be presented at ESMO on September 18, 2020. In addition, management stated that they have experienced minimal interruption to their clinical program from COVID-19, except for the Ph1 AUTO4 trial (≥2L r/r TRBC1+ TCL) where data readout has been delayed from Q4 2020 to H1 2021. Below, Celltelligence provides key takeaways from the call, and thoughts on how Autolus’s CAR-T program, particularly in ALL (AUTO1) and DLBCL (AUTO3), may be able to compete with CAR-T leaders Novartis, Gilead, and BMS.

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Gilead Highlights No Impact of COVID-19 on Yescarta Sales; Two New LCM Initiatives for Yescarta; Q2 2020 Earnings Call Summary

On Thursday, July 30, Gilead held their Q2 2020 earnings call (press release / financial report / presentation). The company highlighted resilient Yescarta sales despite the COVID-19 pandemic, growing 11% QoQ and 37% YoY WW. Of note, Gilead highlighted the recent approval of Tecartus and ongoing LCM efforts for both approved CAR-T’s. Below Celltelligence highlights key LCM initiatives for 2021 and the significance of a synergistic authorized treatment center (ATC) onboarding protocol for Gilead.

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Thoughts on Allogene’s AlloCAR Program; Q2 2020 Earnings Call Summary

On Wednesday, August 5, Allogene held their Q2 2020 conference call (press release / company presentation). The company highlighted presented ASCO data from the ALLO-501 (CD19 allogeneic CAR-T) Ph1 ALPHA study in ≥3L NHL (DLBCL or FL) (Sattva Neelapu et al, May 2020). Management confirmed that the pivotal Ph1/2 ALPHA-2 study of ALLO-501A is underway, with no reported DLTs in the dose level 1 (DL1) cohort. Below, Celltelligence provides key takeaways about Allogene’s CAR-T clinical program, and thoughts on potential hurdles the company may face re-treating patients that have already received Gilead and Novartis’s CAR-Ts in earlier lines of therapy.

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BMS Highlights Ide-cel FDA Re-submission; Q2 2020 Earnings Call

On Thursday, August 6, BMS held their Q2 2020 results (press release / presentation). The company briefly discussed their CAR-T program, highlighting that the BLA for ide-cel in ≥4L RRMM has been re-submitted. In addition, management stated that they look forward to the November PDUFA date for liso-cel in ≥3L DLBCL. Below, Celltelligence provides thoughts on BMS’s two leading CAR-Ts, both of which have experienced delays to their FDA reviews.

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Thoughts on Gilead’s Recent FDA Approval for Tecartus (KTE-X19) in R/R Mantle Cell Lymphoma

On Friday, July 24, Gilead announced (press release) FDA approval of Tecartus (brexucabtagene autoleucel, formerly KTE-X19), the first and only CAR-T treatment for r/r mantle cell lymphoma (MCL). Priority review for Tecartus was based on results from the Ph2 ZUMA-2 trial; a single-arm, open-label study in which 87% of patients responded, with a 62% CR rate. Below, Celltelligence provides manufacturing insights between Yescarta/Tecartus, and how Gilead’s onboarding policy may influence competitors’ future roll-out of additional CAR-T products.

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Kymriah Sales Unaffected By COVID-19, but Ph3 Adult ALL Trial Withdrawn; Novartis Q2 2020 Earnings Update

On Tuesday, July 21, Novartis held their Q2 2020 earnings call (press release / financial report / presentation). Of note, Kymriah sales were resilient despite COVID-19, growing +103% WW QoQ and +27% WW versus Q1 2020. Interestingly, the Ph3 OBERON trial investigating Kymriah in adult ALL has been omitted from Novartis’s pipeline. Below, Celltelligence provides thoughts on Novartis’s cell therapy program, particularly surrounding the withdrawal of the Ph3 OBERON study and the ongoing risks posed by competitors, Gilead and Autolus, on Kymriah’s continued sales growth.

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Thoughts on Fate Therapeutics Updates to their CAR-T Programs in DLBCL and MM; Q1 2020 Call

On Monday, May 11, Fate Therapeutics held their Q1 2020 earnings call (press release), highlighting clinical and preclinical development updates to their pipeline, operational progress, and the recently established collaboration with Janssen for iPSC-derived CAR-NK and CAR-T assets. Below, FENIX provides thoughts on Fate’s cell therapy clinical strategy, particularly in the context of the current COVID-19 pandemic.

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