Saturday, January 14, 2023 4:14:22 PM
Some quick thoughts.
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).
Recent PGEN News
- Precigen to Announce First Quarter 2024 Financial Results on May 14th and Host a Conference Call on June 3rd following the Late-breaking Oral Presentation for PRGN-2012 at the 2024 ASCO Annual Meeting • PR Newswire (US) • 05/08/2024 08:05:00 PM
- Precigen to Present Late-breaking Abstract for Pivotal Phase 2 Study Data for PRGN-2012 AdenoVerse Immunotherapy for the Treatment of Patients with Recurrent Respiratory Papillomatosis at the 2024 ASCO Annual Meeting • PR Newswire (US) • 04/24/2024 02:20:00 PM
- Actym Therapeutics Appoints Thomas Smart as CEO • PR Newswire (US) • 04/24/2024 01:00:00 PM
- Precigen and Recurrent Respiratory Papillomatosis Foundation to Hold Inaugural International RRP Awareness Day on June 11th • PR Newswire (US) • 03/28/2024 08:05:00 PM
- Precigen Reports Full Year 2023 Financial Results and Business Updates • PR Newswire (US) • 03/19/2024 08:05:00 PM
- US Index Futures Decline Ahead of Federal Reserve Meeting, Oil Prices Retreat • IH Market News • 03/19/2024 11:27:29 AM
- Precigen to Participate in a Fireside Chat Hosted by Cantor Fitzgerald to Discuss PRGN-2012 AdenoVerse Immunotherapy for the Treatment of Recurrent Respiratory Papillomatosis • PR Newswire (US) • 03/12/2024 08:05:00 PM
- Precigen to Announce Fourth Quarter and Full Year 2023 Financial Results on March 19th • PR Newswire (US) • 03/05/2024 09:05:00 PM
- Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend] • Edgar (US Regulatory) • 02/27/2024 06:48:40 PM
- Form SC 13G - Statement of acquisition of beneficial ownership by individuals • Edgar (US Regulatory) • 02/14/2024 09:00:22 PM
- Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend] • Edgar (US Regulatory) • 02/14/2024 08:20:05 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/08/2024 09:25:09 PM
- Precigen to Participate in the Oppenheimer 34th Annual Healthcare Life Sciences Conference • PR Newswire (US) • 02/06/2024 09:05:00 PM
- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 01/18/2024 05:15:14 AM
- Precigen Receives Orphan Drug Designation for PRGN-2012 for the Treatment of Recurrent Respiratory Papillomatosis from the European Commission • PR Newswire (US) • 01/16/2024 01:05:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/08/2024 01:39:30 PM
- Precigen Highlights Pipeline Updates to be Presented at the 42nd Annual J.P. Morgan Healthcare Conference • PR Newswire (US) • 01/08/2024 01:30:00 PM
- Form S-3 - Registration statement under Securities Act of 1933 • Edgar (US Regulatory) • 12/29/2023 10:26:37 PM
- Precigen to Present at the 42nd Annual J.P. Morgan Healthcare Conference • PR Newswire (US) • 12/18/2023 09:05:00 PM
- Precigen to Participate in the JMP Securities Hematology and Oncology Summit • PR Newswire (US) • 11/29/2023 09:05:00 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 11/09/2023 10:08:34 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/09/2023 10:07:37 PM
- Precigen Reports Third Quarter 2023 Financial Results and Progress of Clinical Programs • PR Newswire (US) • 11/09/2023 09:55:00 PM
- Precigen to Participate in the Stifel 2023 Healthcare Conference • PR Newswire (US) • 11/07/2023 09:05:00 PM
- Precigen to Participate in Upcoming Leading Investor and Industry Conferences • PR Newswire (US) • 09/19/2023 08:05:00 PM
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