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:
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.
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).
Three key oral presentations for BCMA CAR-Ts were presented at ASCO 2020: ide-cel (Ph2 KarMMa) and orva-cel (Ph1/2 EVOLVE) from BMS, and JNJ-4528 (Ph1b/2 CARTITUDE-1) from Janssen. All three studies evaluated CAR-T cells in ≥4L RRMM patients. Below, FENIX provides key data highlights and analysis on the competitiveness of each CAR-T.
On Wednesday, May 6, Cellular Biomedicine Group (CBMG) held their Q1 2020 earnings call (press release). The company announced the successful IND application for their BCMA CAR-T (C-CAR088) in China as well as positive data from the ongoing investigator-initiated trial. Management also expressed optimism about the early data from their bi-specific CD19/CD20 CAR-T in DLBCL. Below, FENIX provides further highlights from the call and thoughts around how CBMG’s CAR-Ts could potentially differentiate themselves, despite their early stage of development, in the CAR-T space currently led by much larger players such as Novartis, Gilead, and BMS.
On Wednesday, May 6, Cellectis held their Q1 2020 earnings call (press release). The company stated that they have experienced limited disruption from COVID-19 and continue to progress with their CAR-T clinical trials and manufacturing expansion activities. Below, FENIX provides highlights and insights from the call, including how Cellectis’s ability to avoid delays to key strategic programs could help maintain its position as a leading cell therapy company developing allogeneic CAR-Ts for AML, ALL, and MM.
On Wednesday, May 6, Allogene held their Q1 2020 earnings call (webcast/press release/ slides), highlighting the off-the-shelf benefits allogeneic products have over autologous products, particularly during the COVID-19 pandemic. Below, FENIX provides thoughts on Allogene’s cell therapy program in the context of the ongoing health emergency.
On Thursday, April 30, Gilead held their Q1 2020 earnings call (press release / financial report / slides). Of note, Yescarta sales continued to grow versus the previous quarter (Q4 2019), seemingly with little initial impact from COVID-19, in contrast to Kymriah which saw a slight dip in Q1 2020 sales. Below, FENIX provides thoughts on Gilead’s cell therapy program, particularly in the context of the ongoing COVID-19 pandemic.
On Thursday, May 6, BMS held their Q1 2020 earnings call (press release / slides), providing an update on their CAR-T program. As announced on May 5 (press release), the company explained that the liso-cel PDUFA date has been pushed back three months to November 16, 2020 to allow the FDA time to review additional data considered to be a major amendment. Meanwhile, BMS provided brief commentary on their BCMA CAR-Ts ide-cel and orva-cel. Below, FENIX provides highlights and analysis from the call, particularly in the context of the liso-cel PDUFA setback in a field being led by Yescarta and Kymriah.