tw0122
4 months ago
...Appr. oximately $25,000,000. Item 4 of the Original Schedule 13D is hereby amended and supplemented as follows: The information set forth in Items 3 and 6 is incorporated herein by reference. In the Offering, the Company issued 79,000 shares of Preferred Stock of the Company and 52,666,669 warrants to purchase Common Stock of the Company (the "Warrants") to certain new and existing investors, including RJ DOT, on the terms and conditions set forth in that certain SPA. The Preferred Stock is convertible into shares of common stock of the issuer (i) at the option of the holder at any time on or after the later of the six-month anniversary of the issue date and the date on which the issuer has, among other things, obtained shareholder approval, and (ii) at an initial conversion price of approximately $1.125 per share, which is 150% of the exercise price of the Warrants. The conversion price is subject to upward adjustment based on the valuation of the common stock from time to time. The Preferred Stock is redeemable, in whole or in part, for cash at the issuer's option at any time on or after the issue date for an amount equal to the liquidation preference at such time, plus accumulated and unpaid dividends. Dividends on the Preferred Stock will be paid annu
jondoeuk
10 months ago
(OT) BlueSphere Bio, a T-cell receptor (TCR) T-cell therapy company utilizing a powerful TCR discovery platform to identify novel therapeutic candidates for patients with hematologic malignancies and solid tumors, today announced a strategic collaboration with the National Cancer Institute (NCI), part of the National Institutes of Health. The collaboration will seek to advance a novel TCR T-cell therapy targeting recurrent respiratory papillomatosis (RRP), a rare orphan disease.
Under the terms of a Cooperative Research and Development Agreement (CRADA), BlueSphere will collaborate with the Center for Cancer Research (CCR) at the NCI. The clinical studies contemplated under the CRADA will be conducted under the leadership of Clint Allen, M.D. and Scott Norberg, D.O. at the CCR, NCI. An earlier Material Transfer Agreement had granted BlueSphere access to HPV+ tumor samples collected by the NCI, with which BlueSphere leveraged its proprietary high-throughput TCR discovery platform, TCXpress™, to identify multiple TCRs with a high affinity for human papilloma virus (HPV) 6 and 11, strains of the virus intricately linked to RRP.'' https://finance.yahoo.com/news/bluesphere-bio-establishes-strategic-collaboration-140000958.html
jondoeuk
2 years ago
More preclinical data! https://www.abstractsonline.com/pp8/#!/10828/presentation/3388
Considering the other (preclinical) data for PRGN-3005, 3006 and 3007, I wouldn't read much, if anything into it. Also, by now, you would think that the company would have translational data from the two ongoing trials, which could help inform them as to why genes they might silence next, using (from memory) miRNA.
jondoeuk
2 years ago
JPM presentation https://investors.precigen.com/static-files/bd82c7b7-e8b9-4b19-be44-6a9de4165ae6
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).
jondoeuk
2 years ago
PRGN-3005: They moved forward with testing DL3 plus LD chemo prior to IV infusion. Also, are able to incorporate repeat dosing. Based on the previous data, as well as this, I don't hold out much hope.
PRGN-3006: Another year has passed and only nine additional patients have been treated. Worse still, none have responded.
PRGN-3007: Not only haven't they dosed the first patient, but the trial isn't even listed on the clinicaltrials website.