Slide 4: Despite AG019 being listed they did not provide an update.
Slide 8: The internal assessment leaves a lot to be desired. Focusing on iPSC-derived, it allows for a company to create multiplexed engineered, clonal master cell lines, which are a renewable source that enables routine, mass production of immune cells that are off-the-shelf (on-demand availability). Also, allows for broad patient access as it can scale. For example, FATE created over 300 doses of FT500 for around $3,000 per dose. PGEN on the other hand has never disclosed any (projected) COGM.
As for auto, GILD's Kite has a median manufacturing time (from apheresis to finished product) of 16 days in the US, but are hoping to reduce this to just a few days. BMY and others are following suit. For COGM (one paper puts it in the $160-170,000 range), it could be cut in at least half with automation alone.
Slide 11: Talk about apples to oranges! Not only do they compare auto to allo (both iPSC- and donor-derived), but CAR-T to CAR-NK as well! Typically, NK do not expand upon encounter with antigen and have (very) limited persistence.
Slide 12: If the depth and duration of response (from the dose expansion) is as poor as it has been no more time and money should be wasted on it.
Slide 15: Again, they have switched to giving the therapy via IV (plus LD chemo), so there is no known safety (on target, off tumour toxicities, CRS and/or ICANS) or efficacy profile. Also, the ORR (when given via IP) was zero. In addition, those treated at DL3 did worse (despite better expansion and persistence) than those treated at DL1 and DL2.
Slide 17: True, gene therapies have the potential to revolutionise medicine, but I very much doubt any company will be using the AdenoVerse platform to deliver them.
Slide 24: Totality of the data is what matters, not a single patient. I hope the update for PRGN-2012 isn't like the last time!
Slide 27: The ORR for the vaccine alone was zero. As for the combo, 30%, but just three out of ten. Based on that, they shouldn't have continued with the current trial.
Slide 29: Major milestones? The only updates for this year will be PRGN-2012 and PRGN-2009 (+/- M7824).
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