On Friday, May 15, Precision Biosciences held their Q1 2020 earnings call (press release/presentation), highlighting the current clinical progress for their three Ph1/2 allogeneic CAR-T candidates:
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).
On Monday, June 15, Ziopharm announced (press release) the appointment of Carl June as chairman to the company’s newly formed scientific advisory board (SAB). Below, FENIX provides thoughts on this appointment, particularly around June’s experience pioneering the initial CAR-T studies leading to the commercialization of Kymriah.
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).
On Friday, June 12, Gilead announced (press release) that the European Medicine Agency (EMA) has approved the company’s Amsterdam facility for end-to-end manufacturing of Yescarta. Below, FENIX highlights the potential impact on Yescarta’s EU turn-around-time (TAT), and the effect this may have on Kymriah sales.
A new Allogene-sponsored ALLO-501A Ph1/2 ALPHA-2 trial has been observed on CT.gov. Below, FENIX provides insights on this new trial and how ALLO-501A could disrupt the autologous CD19 CAR-T market, currently being led by Novartis, Gilead, and BMS.
On Monday, June 1, 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 ASCO (Wendy Osborne et al, May 2020). Below, FENIX 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).
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).
A new Autolus-sponsored AUTO1 Ph1b/2 AUTO1-AL1 trial in R/R adult ALL has been observed on CT.gov. Of note, the trial uses a split dosing regimen. Below, FENIX provides insights on this new pivotal trial and how a split dose could differentiate Autolus’s position compared to CAR-T leaders Novartis and Gilead in R/R adult ALL.