Member Info for B2HS2L

Estura - If the company needs money, wouldn't it make sense to sell Dx first, or do they need a lot more money than Dx proceeds would fetch?

I don't think you know anything about a raise.

It makes sense to you, that's why you post, but you don't know anything about a raise.

13.12.23 Q/A after presentation:

Q5 – The patient with the 65% tumour reduction, is that a good result? – Would you have expected to see that sort of response in this patient if treated with Doxorubicin?

CC – So it is possible that we would see a response like this with Doxorubicin, as it is active in soft tissue sarcoma. Across the board, if we look at the different subsets and then in sarcoma in general we can see response rates of as low as 6.4%, but it can get up into the 20’s depending on the particular subtype of sarcoma ...

Research isn't everyone's forte, but it is clear when it's missing.

Touk -

HENCE p1 continues? - No choice but to continue now they have stopped Arm 1 and created Arm 2 for all the right reasons.

Yes it's only phase 1 data, (with already some evidence of efficacy), but safety is proven for me.

PS.

Re that 'lucky' patient - Turns out he has multiple STS cancer various organs:

CC Slide 17 - "What we’ve seen in this particular patient is a deepening tumour response whereby the lesions or the tumours in the various organs in this patient have shrunk by 65% from their baseline"

CC slipped up stating this I think. -

What percentage shrinkage will we see after his next scan results, - and will that feature

in the new data in the AACR conference come April.

Remember the 13.12.23 presentation LDA.

Data Cutoff 27 November 2023, so they could release data collected after that date, not necessarily full 1a data

Cj62 -

https://www.trinitydelta.org/research-notes/building-on-therapeutic-and-diagnostic-foundations/

Doxorubicin efficacy (PFS, OS, ORR values)

"...Doxorubicin efficacy (progression-free survival, PFS, of four to six months;

overall survival, OS, of 12 to 15 months;

and a typical objective response rate, ORR, of 10-15%) leaves considerable room for improvement."

AVA6000 is well on the way to improving these values, and FDA are certainly aware.

This is the wording of statements concerning Arm 2 recruitment (both 13.12.13) from two sources:

Source - transcript of 13.12.23 Investor Meet video presentation:

CC "This is a recent development in the trial where the enrolment criteria for the last cohort, and the every two week dosing regimen has been modified to a select set of high FAP disease settings, as well as to allow patients without prior therapy in the metastatic setting". - (Not just STS only patients)

CC - " The two week dose arm is currently screening patients in the US".

AS - "just to remind you that we are now as Chris mentioned screening patients in the United States on the two-weekly study and that leaves us on track for beginning the phase two study in 2024"

13.12.23 - RNS - "A fortnightly dosing study to optimise the selection of the Phase 2 dose is now screening patients in the United States"

Transcript of 13.12.23 Investor Meet video presentation (CC - Slide 12)

"This is a recent development in the trial where the enrolment criteria for the last cohort, and the every two week dosing regimen has been modified to a select set of high FAP disease settings, as well as to allow patients without prior therapy in the metastatic setting."

+++

Searched on the word Recruit, but nothing found.

😀

The company provided many more Q/A to Investor Meet after the 13.12.23 presentation.

One of them was this:

This is a question for Fiona : You have mentioned a few times now that you are gaining new insights into FAP, potential active and non active forms for example. Can you elaborate on this and explain how, if at all, these findings affect the potential use of the platform? Thanks.

Fiona: This is an important question. We are exploring this but these insights potentially constitute new IP which we need to protect before we can discuss them publicly. We look forward to discussing this in the future.

Thorno - you stated - "The trial results have to be applicable to Real World conditions so patients wont be selected by tumour FAP levels in my opinion."

You could always ask Alastair whether he feels it appropriate now to drop this RNS quote. Please advise if that's the case.

Thornog -

RNS 13.12 2023 - ALS-6000-101 Phase 1a Study Data

"4. The next steps with AVA6000 involve optimising the patient population, dose and schedule in order to increase efficacy and tolerability of doxorubicin treatment via pre|CISIONTM targeting. Given the favourable safety data from the three-weekly dosing study, a fortnightly dosing study, which is now screening patients *with high FAP levels* in the United States, will assist in optimising the schedule and dose for a potentially pivotal Phase 2 study in 2024."

8 Feb - new Senior R&D Scientist post announced

"The Senior R&D Scientist will lead a scientific team researching and developing novel technologies to assess commercial viability, as well as assessing external technological collaborative partnerships".

Also recently-

1 It is announced that Paul Eros, ex-Chief Business Officer of Novacyt, has become CEO of Amicon Bio UK

https://www.aqsens.com/news-and-blog/mr-paul-eros-brings-over-25-years-of-executive-experience-in-diagnostics-to-aqsens

2 Linkedin - Timo Teimonen CEO - Aqsens Health Ltd, - Helsinki and Turku Finland, - "I am happy announce that Paul Eros will join us as a Senior Advisor.

His experience within diagnostic industry will bring much wanted domain knowledge to our operations and business strategy. Welcome Paul!"

3 https://www.aqsens.com/products

From the above - Aqsens developing Biosensors.

4 Aqsens Health Chief Scientific Officer Dr. Janne Kulpakko and Brigham and Women's Hospital at Harvard Medical School research fellow Dr. Mohd Moin Khan has started a project to research organ transplantation rejection in patients with the use of biosensors developed at Aqsens.

https://www.aqsens.com/news-and-blog/could-biosensors-enable-better-prediction-for-organ-transplantation-rejection-a-research-project-with-the-department-of-medicine-harvard-medical-school-lung-transplantation-teamnbsp

5 https://www.aqsens.com/technology

Non-invasive screening test for preventive healthcare, - See Biosensor video at bottom of page.

++++

There may be not a lot in the above for Novacyt, and an Eluceda and Aqsens search produces nothing.

Whether Paul Eros is to partner with Novacyt on Biosensor collaboration remains to be seen.

Aqsens are certainly keen on biosensor technology.

The intention to do the fortnightly study was announced FIVE MONTHS AGO. Screening was already ongoing TWO MONTHS AGO. Something is seriously wrong somewhere in this process.

For all those concerned about the start of the 2 week trial.

Screening started 2 months ago.

Cancer patients need to know they are either on a trial or it hasn't started yet.

Any trial team announcing a trial and nor starting a trial to schedule is guaranteed to wind up everybody.

Fred Hutchinson and Memorial Sloan I'm sure are not in the habit of winding anyone up like this,

so I think those who are signed up to the fortnightly trial, are receiving AVA6000 twice weekly.

😉😊😉

Looks useful thanks LLP.

Thanks for the link CTSFO.

Does anyone recall a histogram showing levels of FAP versus differing types of cancer / sarcoma,

possibly sourced from FDA please?

Soft-tissue sarcomas are more common than bone sarcomas.

The 50 different types of soft-tissue sarcomas differ in terms of their tissue of origin, clinical behaviour, age of occurrence, aggressiveness, the way they spread, genetic alterations, and their sensitivity to certain therapies.

https://sarctrials.org/education/soft-tissue-sarcoma/#:~:text=Extrarenal%20Rhabdoid%20Tumor,%2C%20lung%2C%20and%20other%20sites.

As stated - https://www.youtube.com/watch?v=eqj0hhgmX6U&t=1239s

Christina Coghlin Slide 17 (32:34)

"What we’ve seen in this particular patient is a deepening tumour response whereby the lesions or the tumours in the various organs in this patient have shrunk by 65% from their baseline"

I stand to be corrected but I think CC has been the only official to confirm multiple cancerous organs.

Prior discussion has surrounded a patient with a 65% tumour reduction.

Icecool - I recently created a transcript of the 13.12.23 Investor meet presentation.

I wanted searchable text that tracked the proceedings.

What follows highlights discussion concerning a 59-year-old male patient, which amplifies some of the extra Q/A provided by the company:

https://www.youtube.com/watch?v=eqj0hhgmX6U&t=1239s

Christina Coghlin Slide 17 (32:34) "The first case to discuss is the young 59 yo gentleman with a soft tissue sarcoma, this is called an Undifferentiated Pleomorphic Sarcoma (UPS). Based on the evidence in the literature this subset of sarcoma is anticipated to have high FAP expression and has a limited response to standard dose Doxorubicin.

What we’ve seen in this particular patient is a deepening tumour response whereby the lesions or the tumours in the various organs in this patient have shrunk by 65% from their baseline, - we do this with CAT scans. [A computerized tomography (CT) scan combines a series of X-ray images taken from different angles around the body and uses computer processing to create cross-sectional images (slices) of the bones, blood vessels and soft tissues inside the body. CT scan images provide more-detailed information than plain X-rays].

What’s critically important here is not just the deepness of the response also the deepening meaning over time the response has continued to increase. We’re actually seeing now a duration of the response that is more than six months and this gentleman is now approaching ten months on the trial. He continues to receive AVA 6000 and is doing well. You’ll recall I mentioned at the beginning that standard dose Doxorubicin is only administered for six cycles or eighteen weeks, so four and a half months. However, given the limited exposure that we’ve seen in the bloodstream in this patient and others at this dose level of 160 migs, we are going to be able to dose this patient a further seven additional cycles if his tumour doesn’t progress and this represents up to another five months of therapy which would bring him up to a total of fifteen months on AVA 6000. This represents three times the length of time that this patient could be treated if he was receiving standard dose Doxorubicin. Correlative studies also indicate that tumour biopsy in this patient has high FAP expression, and again speaking to that mechanism of action and completely recapitulating what Fiona described for us in the preclinical setting that patients with high FAP disease or high FAP expression in their disease would be susceptible to the mechanism of action of AVA 6000."

+++

This definitely amplifies your 08:38 statement

Perhaps revving up the "Exclusive agreement with Eluceda to develop biosensor technology"?

Just as likely to be a new collaboration.

Based at Southampton, it seems unlikely to do with Yourgene.

1) R&D Scientist (12 Month Full Time Contract)

2) Senior R&D Scientist

Role Purpose

The Novacyt Group is looking for an enthusiastic and talented Senior R&D Scientist for an opportunity to join the R&D department within a fast-growing and friendly biotech business.

*The Senior R&D Scientist will lead a scientific team researching and developing novel technologies to assess commercial viability, as well as assessing external technological collaborative partnerships. *

As Senior R&D Scientist you will lead on supporting software validation and new product development.

Novacyt are experts in the development, manufacture, and distribution of high-quality molecular diagnostic products. We have customers in many different industries including academia, research, diagnostics, food industry and the veterinary industry selling to over 100 countries worldwide.

I like the sound of * *

With so much territorial interest from China, investment in Taiwanese companies may be scuppered until the situation pans out.