I am a new investor and have found information on the various PTX threads really helpful. There is a lot to understand so I have worked on a summary as a starting point for correction and input/discussion amongst us all. I really have not seen a company like PTX before.PRESCIENT THERAPEUTICS (ASX Code = PTX)
22/8/22 WEBINAR plus insights mainly from Shell Bell
FDA = USA regulatory body.
TGA = Australian regulatory body.
Cell Pryme A announcement soon. ? involved in automated non viral activation in the process of changing genetics of T cells in the manufacturing process of Omnicar CAR T cells.
PTX 100 (PTCL)
- Orphan status means 7 years exclusivity with FDA
- All other drugs available for PTCL are 25-80% toxic to the patient BUT PTX 100 zero toxicity. Patients are ill and medically fragile so this is really important.
- Expansion study data soon
- Steve said that this product is especially likely to be a company maker defined as drug on market and associated financial success that means PTX will not be forced to partner early. PTX wants to go all the way without a partner. Used the example of another biotech company that I didn’t get the name of as well as Radiopharmaceuticals. ( Australasian Radiopharmaceutical Trials Network or ARTnet)
PTX 200 (AML)
- 4 complete remissions so far, ? how many partial I missed that bit.
- Results this year
TFS Deal = 1st Commercial Deal for PTX
- Steve limited to what he can say because of conditions of deal
- TFS globally is a huge company with US $40 billion pa in revenue, and market cap of US $236B
- PTX could never itself afford this. No cost to PTX. Must be worth millions of $’s to PTX.
- TFS must see Omnicar and CellPryme as promising to deliver the universalfix for immunotherapy that the world has been looking for, for decades. (refer Shell Bell post 23/8/22)
- PTX combines it’s IP with TFS’s IP to design a universal platform that is scalable, reproducible, economical, closed and fully automated. Current CAR T production takes weeks, costs US $500,000 for one treatment. Uses viral activation to modify genes of T cells, is not reproducible, errors occur, labour intensive adding hugely to the cost, and requires patient’s own T cells to be harvested. Is not effective against solid tumours. Cannot be stopped or restarted. Unable to change if cancer cell mutates.
- PTX also working on gene editing with TFS
- TFS = sales of equipment, reagents, consumables, software etc to labs to manufacture.
- Automated, closed end so no variability. Current CAR T production relies on virus
- How it happened: very fast. Rebecca Lim helped develop products with TFS team in past and has remained in contact. When TFS heard through that mutual group what Rebecca/PTX were working on they approached PTX and deal done quickly.
- Commercialisation of PTX products will be fully automated closed end production multicentre treatments across the world.
- Steve said that biggest hold up with 1st generation CAR T is supply
- TFS goal is to position themselves to sell more of their products and ? develop extensions (see below).
- Also would have huge financial gains for being the first mover advantage
- Platform Extensions by TFS could be 1. unexplored anti-viral benefits of Omnicar, and 2. allogeneic cell manufacturing ie patient could receive cells that are not derived from their own T cells but another human’s).
- One ? was what do TFS get out of deal. Steve was very careful in how he worded his answer and flagged his need to be careful with what he said. His response was if he was TFS he would want to align himself with techs that were very experienced and have products/treatments that would grow his business (worldwide business concept).
- Prototype Runs they expect to take 12 months work to work through to develop the Omnicar superior product with CP M and A
- Steve said that they are hoping to incorporate all PTX programs apart from AML/PTX 200 which will be ready earlier so will run without.
Q GEN
- Are delighted to be working with PTX
- Cell Pryme in Omnicar production M and ? A
- More detail in coming months
- Steve said that Immune cells are the hardest cell to manufacture in the universe
- Extremely difficult for a Biotech to get a manufacturing slot for production once trials completed. Q Gen specialty is cell manufacturing.
- Will supply our manufacturing requirements, Omnicar with CP M (and no doubt A when revealed, ? “A” is speculated as being for Activation) This would be once TFS completed development of ultimate superior CAR T version with TFS, ? by late next year at the latest.
- More detail in coming months
- Cell Pryme M and ? A to 3rd party : Much lower hurdle for adoption by 3rd party. Would still need to do their due diligence. Steve said to think of CP M as a high value reagent and so is much easier to incorporate. Would not require much for regulator approval, just a minor amendment.
- Omnicar/PTX is 1st customer of CPM and ? CPA. PTX will be validating CP with it’s own clinical data.
- Steve said tech transfer and optimisation all being done each step of the process, not at the end.
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- PTX Summary week ending 26/8/22
PTX Summary week ending 26/8/22
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