Member Info for Haywain

With all due respect TYK2 inhibitors are indicated for psoriasis not currently incurable life threatening rare cancers as is the case with Hemo. Therefore the body of clinical data required to prove the benefit/risk is on a different scale altogether. If we are making that comparison the TYK2 inhibitor would require much larger cohorts in each of the three phases of clinical trial reflective of the large number of people who suffer with the disease. The disease is not life threatening and therefore there are no expedited routes available to the innovator. The phase 1 would be conducted in healthy volunteers not in patients which is the case for Hemo- car-T. There would be an independent phase II prior to phase III study rather than a phase II/III. I agree it does take money to develop pharmaceuticals but you can not compare TYK2 (small molecule enzyme inhibitor) with Hemo car-T.

no words! The depth of the ignorance is quite astonishing.

nobody said it would be worth billions on the next trial - 100-200million for successful phase 1 and immediate phase 2/3 seems pretty reasonable but do you own research

yes but phase 1 will only be 10- 20 patients before phase 2/3 and they will get an efficacy read out from the phase 1 because it will be in AML patients. The bottle neck may be recruitment into the trial as AML is a rare disease that is why in my opinion it was so important to get Koen Van Besien on board with his own center and contacts at many others.

Well in my experience if the process development batches were successful then there is no reason the PQ batches won't be I work on biologic products and it does take a long time to manufacture and test batches- I agree with HT to some extent with respect to CAR-T manufacture it is very complicated but the vast majority of the manufacturing based risk is mitigated through the closed and automated processes of the Lonza cocoon system so I think the PQ batches will be successful if the PD batches were.

normally 3 engineering/ PPQ runs but I dont work with Car-T's

Still need to do process qualification runs - normally 3

the beauty of hemo's car-t is that they will get an efficacy read out in phase 1 which if all good on the safety front will but significant value on the product.

the way I read it is that they will need 3 PQ runs that are yet to start - possibly 1 before christmas and 2 in the new year prior to being able to finalise the IND which takes us to end of Q1 2023 for IND filing and end of April 2023 before no objection letter study may proceed May onwards if no objections from FDA. the length of the phase 1 will depend on how many patients were agreed and how many centers they are working with to recruit these patients. With professor Van Besien as chief Medical Officer - that may facilitate recruitment. I would think that Hemo could be a clinical company as of Q2 2023 but that Q1 2023 should be a news rich period.

thanks Hemotruth - Will the call be shared with the broader pool of investors as it was last time?

Hulver was all over this back in June : I must admit it had escaped me back then - hopefully now all done and dusted but it wouldnt surprise me if this shower were involved with Mint financing. https://www.lse.co.uk/profiles/hulver/

yeah both of them arrested for fraud - Bauer was arrested in the UK in april of this year and Auringer arrested in October hiding in Milan - Scumbags

makes this picture not a particularly good look : https://www.ilmattino.it/primopiano/cronaca/craig_auringer_truffatore_arrestato_milano-6997075.html?refresh_ce

makes sense - he was listed as a major shareholder but wouldnt his assets be frozen if he has just been arrested for fraud?

If the T-cells are from actual patients then I would agree with you it would seem unethical not to allow them the option of treatment with their own CAR-T modified cells but where did you read that it would be patient cells rather than just donor T-cells for proof of concept of the manufacturing process? Thanks

That makes sense : thanks

I thought it was minimum$100 M to list $40 M for IPO for NYSE exchange

I would take either or as patients would imply an approved IND

I hope that they have had good consultants advising about the building/equipment design to meet ISO 5 clean room requirements because they will need the regulatory stamp of approval for this as well before manufacturing any clinical material: https://www.cell.com/molecular-therapy-family/oncolytics/fulltext/S2372-7705(16)30039-0

It would be orphan designation and potentially fast tracked depending on the outcome of the clinical data : candidate for real time oncology review. You can apply for orphan designation at any point