Member Info for B2HS2L

Https://www.bbc.com/news/uk-england-bristol-67296381

The £225m supercomputer using artificial intelligence (AI) to develop new drugs and vaccines will be

fully operational this summer.

Isambard-AI will be based at the National Composites Centre, in collaboration with the Universities of Bath, Bristol, Cardiff and Exeter.

Biden must have been slow not to introduce AI.

As we built ours quite quickly, I hope they do the same.

Https://www.bbc.com/news/articles/cy5kley15pyo

Sarah Turnnidge

BBC News, Bristol

Published

20 January 2025

A £225m supercomputer is using artificial intelligence (AI) to develop new drugs and vaccines.

When it is fully operational this summer, the Isambard-AI computer in Bristol will be the most powerful supercomputer in the UK.

Last week, Prime Minister Sir Keir Starmer unveiled plans to "unleash AI" across the UK in an effort to boost growth.

Simon McIntosh-Smith, a professor in high-performance computing at Bristol University, said the Isambard-AI meant the UK "genuinely can be competitive with the world".

Speaking to BBC Radio Bristol, Prof McIntosh-Smith said: "We've actually got a little bit of the system already up and running, we already have people using it to do things like look for new drugs and new vaccines to treat people."

He added that the team are using the computer to develop vaccines for Alzheimer's and other forms of dementia, as well as treatments for heart disease, emphysema and different types of cancers.

The technology is even being used by one group of researchers to greatly improve the detection of a type of skin cancer called melanoma in a huge range of skin tones.

"It can do a lot of the grunt work, a lot of the things that would just be beyond humans because they have so much thinking power and so much computing power," he added.

But how exactly can artificial intelligence be used to create new vaccines and drugs?

As Prof McKintosh-Smith explained, AI models are now capable of "simulating the way that drugs actually work inside the body, at the molecular level right down to atoms and molecules".

"Many drugs work by targeting certain proteins in the human body and deactivating them or changing the way they behave," he explained.

In the past, scientists would have had to work out themselves how potential treatments could interact with these proteins - a process based on "lots of experience and intelligence", but also "educated guessing".

"You can only make so many [guesses] Prof McKintosh-Smith added, "and physically making things takes time and costs money and all sorts of things like that, so how that sort of physical experimentation is quite limited."

++++

This is around half the article.

I have previously requested that CC update us with Avacta's use of AI in new product development; - no response.

However, let's hope it has not stopped her buying into parts of the technology to benefit Avacta. Speed of development, and not 'barking up the wrong tree' at project start, should have become easier now.

'PM plans to 'unleash AI' across UK to boost growth'

https://www.bbc.com/news/articles/crr05jykzkxo for more.

...ie those who know the price of everything (sp) and the value of nothing (IP)

Chris said the basement has power.

Shmoozing of potential partners done in the tree house for privacy, - lucky guys.

A request please:

perplexity.ai was selected because I stated I wanted to use an AI platform to search medical criteria, and perplexity was one of those short listed.

If you have the time, and for those using Chat GPT, please put exactly the same search queery into both AI platforms and advise satisfaction with result and advise.

I performed about 3 hours of research trying to establish which subtypes of Salivary Gland Cancers had been awarded an ODD in USA, Europe and Britain, before testing perplexity.ai, and I'm pleased with it's comprehensive response.

There are also these points

Question

Does MHRA issue Orphan Drug Designations

Response

No, the MHRA does not issue separate Orphan Drug Designations prior to marketing authorization applications.

Instead, the MHRA reviews applications for orphan designation at the time of a marketing authorization application (MAA)12.

Key points about this process include:

There is no pre-marketing authorization orphan designation step in the UK system.

Applicants must submit their request for orphan designation with their MAA in module 1.2 of the eCTD, indicating their intention to seek orphan designation in the cover letter.

The MHRA's advisory committee, the Commission on Human Medicines (CHM), examines applications for orphan designation.

A decision on fulfilment of the orphan criteria runs parallel with the assessment of the marketing authorization procedure.

The decision on orphan status is made at the same time as the decision on approval of the marketing authorization.

This approach differs from the European Medicines Agency (EMA) process, where orphan designation can be obtained separately and prior to a marketing authorization application.

Question

What are the benefits to sponsors of a successful British Orphan drug designation application

Response

Based on the search results, sponsors of a successful British Orphan Drug Designation application can benefit from the following incentives:

Market Exclusivity: Orphan designated medicines receive up to 10 years of market exclusivity in Great Britain for the particular indication.

This exclusivity can be extended to 12 years if an approved paediatric investigation plan is carried out.

Fee Reductions: Companies applying for regulatory approval of a designated orphan medicine may be entitled to reduced fees for Marketing Authorization (MA) applications.

Protocol Assistance: While not explicitly stated for the British system, it's likely that sponsors receive scientific advice specific to designated orphan medicines, similar to the European system.

Competitive Advantage: The orphan designation creates a barrier to entry for competitors, as no other marketing authorization will be issued for the same therapeutic indication in respect of a "similar medicinal product" during the exclusivity period, with some exceptions.

Extended Protection: The orphan rewards run in parallel to patent and Supplementary Protection Certificate (SPC) protection, as well as standard data exclusivity and market protection.

This can be particularly valuable for products that take a long time to develop.

It's important to note that as of January 1, 2025, the criteria for UK orphan designation are considered in relation to the entire UK, rather than just Great Britain.

The Medicines and Healthcare products Regulatory Agency (MHRA) automatically reviews applications for orphan designation at the time of submitting the marketing authorization application.

Based on research using AI facility - perplexity.AI

https://www.perplexity.ai/search/which-salivary-gland-cancers-h-HWppYaTzT3a4B5LnKEbN8A

Two salivary gland cancers have been awarded FDA Orphan Drug Designation:

1 Anatomically accessible oral cancers, including salivary gland cancer: Cisplatin ChemoThin Wafer was granted ODD for the treatment of anatomically accessible oral cancers, which specifically includes salivary gland cancer.

2 Adenoid Cystic Carcinoma (ACC): Rivoceranib (apatinib) received ODD for the treatment of ACC, a rare cancer that commonly develops in the salivary glands.

Adenoid cystic carcinoma (ACC) is the most common malignancy arising in the minor salivary glands and second most common overall.

Its clinical course is slow but relentless, marked by perineural invasion, with 40–50% of the patients experiencing disease recurrence after curative intent therapy.

Aside from site of origin and stage, the presence of “any solid” component and/or high-grade transformation/dedifferentiation on histology has been linked with prognosis, with high reproducibility, low interobserver variability, and high negative predictive value, thus establishing high unmet need.

From https://link.springer.com/chapter/10.1007/978-3-031-23175-9_20 New Systemic Therapies in Salivary Gland Cancer

Open Access, First Online: 28 March 2023

Among the more common subtypes of SGC, but still rare:

Adenoid Cystic Carcinoma

Mucoepidermoid Carcinoma

Salivary Duct Carcinoma

Mammary Analogue Secretory Carcinoma

Acinic Cell Carcinoma

Polymorphous Adenocarcinoma

Adenocarcinoma not Otherwise Specified

Carcinoma ex Pleomorphic Adenoma

Very rare SGC subtypes:

Carcinoma ex pleomorphic adenoma

Epithelial-myoepithelial carcinoma

Myoepithelia carcinoma

Intraductal carcinoma

Poorly differentiated carcinoma

"Feels like we should be close to an FDA accelerated approval for an unmet need". Agreed, - mighty close perhaps:

21.03.2023 - https://link.springer.com/content/pdf/10.1007/978-3-031-23175-9_20.pdf?pdf=inline%20link

Salivary gland cancer (SGC) is a rare malignancy that accounts for less than 5% of all cases of head and neck cancer .

The annual age-standardized rate of SGC is 0.57 per 100,000 people worldwide, and is expected to increase by 50% by 2040.

Although the causes remain largely unknown, several factors have been associated with the development of

malignant salivary gland tumors, including radiation exposure, history of prior malignancy,

viral infections (i.e., Epstein Barr virus [EBV], human immunodeficiency virus [HIV]), industrial chemicals (rubber manufacturing), and nickel compounds.

Malignant tumors arising from the major or minor salivary glands are also characterized by considerable diversity.

+++

ODD awards, UK, USA, Europe:

https://www.perplexity.ai/search/which-salivary-gland-cancers-h-HWppYaTzT3a4B5LnKEbN8A :

Based on the search results, one salivary gland cancer treatment has been awarded by

European Orphan Drug Designation:

Larotrectinib (EU/3/18/1995) was granted orphan designation by the European Commission on March 21, 2018,

for the treatment of salivary gland cancer.

This designation was given to Loxo Oncology Limited, United Kingdom, and later transferred to

Bayer AG, Germany.

It's important to note that:

This orphan designation was withdrawn in July 2019 at the request of the marketing authorization holder

when the product (marketed as Vitrakvi) was granted marketing authorization.

Larotrectinib targets salivary gland cancers with NTRK-fusion mutations, which result in the production

of altered TRK proteins that can cause cancer.

At the time of designation, salivary gland cancer affected approximately 0.5 in 10,000 people in the European Union, which met the criteria for orphan designation (less than 5 in 10,000 people).

While the orphan designation for larotrectinib has been withdrawn, it remains the only salivary gland cancer

treatment explicitly mentioned in the search results as having received European orphan drug designation.

A patient cured is a customer lost. 😕

A deceased patient is also a customer lost.

jm2c

Bigears

Simon Bennett operates differently to other Avacta leaders.

SB would be replaced by now if results were unsatisfactory to CC, but the nature of his work means no news is announced before all his efforts are revealed at once in a deal announcement, (example Dx)

An all or nothing existence, when all investors want is news of commercial successes.

Dx sale news will be ready when it's ready, but SB will at last have something to show for his efforts.

It's the cloak and dagger way any CBO operates.

I posted this prior to this mornings RNS.

I'm sure you would agree this video contains sound advice for Shaun Chilton, Christina Coughlin and Simon Bennett.

https://www.youtube.com/shorts/QZCLIPMrXik

I often think fair value would be hard to negotiate but there are no choices, and preCISION comes complete with full IP.

21.03.2023

https://link.springer.com/content/pdf/10.1007/978-3-031-23175-9_20.pdf?pdf=inline%20link

Salivary gland cancer (SGC) is a rare malignancy that accounts for less than 5% of

all cases of head and neck cancer . The annual age-standardized rate of SGC is

0.57 per 100,000 people worldwide, and is expected to increase by 50% by 2040.

Although the causes remain largely unknown, several factors have been associated with the development of malignant salivary gland tumors, including radiation

exposure, history of prior malignancy, viral infections (i.e., Epstein Barr virus [EBV],

human immunodeficiency virus [HIV]), industrial chemicals (rubber manufacturing),

and nickel compounds. Malignant tumors arising from the major or minor salivary glands are also characterized by considerable diversity. The 5th edition of the

World Health Organization (WHO) classification of head and neck tumors identifies

24 distinct histologic subtypes of SGC, with implications to disease biology and

clinical features.

28.03.2023 https://link.springer.com/chapter/10.1007/978-3-031-23175-9_20

Subtypes of Salivary Gland Cancers

1

Adenoid Cystic Carcinoma

Adenoid cystic carcinoma (ACC) is the most common malignancy arising in the minor salivary glands and second most common overall. Its clinical course is slow but relentless, marked by perineural invasion, with 40–50% of the patients experiencing disease recurrence after curative intent therapy. Aside from site of origin and stage, the presence of “any solid” component and/or high-grade transformation/dedifferentiation on histology has been linked with prognosis, with high reproducibility, low interobserver variability, and high negative predictive value.

2

Patients on apatinib had an ORR and DCR of 46% and 99%, respectively; at a median follow-up of 25.8 months, the median PFS was not reached. As a result, in February 2021, apatinib gained Orphan Drug Designation by the FDA for patients with ACC.

+++

At least one subtype of Salivary Gland Cancer (ACC) has FDA Orphan Drug Designation.

Next bond payment is due on 22.01.25 I think.

Sorry I meant to add

🚀

Not nearly enough rockets on these posts guys.

Are you all disappointed no buyout announced today?

There's always the last day of San Francisco for more deals to be announced tomorrow..

I'm on investing.com live prices.

Nope, 55p at open.

A reminder from the JP Morgan website -

"The 43rd Annual Healthcare Conference will take place on January 13-16, 2025 in San Francisco, CA.

This premier conference is the largest and most informative health care investment symposium in the industry which connects global industry leaders, emerging fast-growth companies, innovative technology creators and members of the investment community."

+++

Reserved the news for maximum impact on the last day?

Bh - that probably means FDA already provided with results so far, ha ha.

Timster, if accelerated approval is granted that will do wonders for the sp.

rocket emoji's missing here.