The latest Investing Matters Podcast episode featuring Jeremy Skillington, CEO of Poolbeg Pharma has just been released. Listen here.
Oh and Richard Branson joined the party this year too, he knows a good thing when he sees one......
https://www.cnbc.com/2021/06/17/gene-testing-firm-23andme-trades-higher-after-branson-spac-merger-.html
GLA
Hi SOG
Thanks for your valued interpretation of the patent. As you say there are hours of reading and further research to be done with it.
As I posted on Sunday, one of the key factors for me is the gene connections and screening for bio markers that can be used to identify susceptibility of a treatment for individuals based either on overexpression or inactive Tyk2 in the patients. This really is next generation medicine and the advent of ‘tailor made’ treatment. I believe this could also apply to SDC-1802 in blood cancers.
This is the work that GSK got into with 23andMe in 2018 (a 4 year collaboration)
https://www.gsk.com/en-gb/media/press-releases/gsk-and-23andme-sign-agreement-to-leverage-genetic-insights-for-the-development-of-novel-medicines/
An extract - which almost matches what is said in the SAR patent:
“Improve target selection to allow safer, more effective ‘precision’ medicines to be discovered. Genetic data can significantly improve our understanding of diseases, their pathways and mechanisms, supporting the design and development of more targeted medicines. Use of genetic data in selecting drug targets can increase both the probability of success in a particular indication and avoid unwanted safety risks”.
And:
“Support identification of patient subgroups that are more likely to respond to targeted treatments. Scale is critical for the detection of genetic effects in smaller subsets of diseases and patients. With over 80% of 23andMe’s customer base consenting to participate in research, their aggregate and de-identified data could help enable the discovery of a significant number of novel associations from a diverse range of people, which would not otherwise be possible”.
GLA
Hi All
Some more information directly from the patent submission for methods of diagnosis relating to the specific bio markers
* Methods of Diagnosis
Prior to administration of a compound of the invention, a patient may be screened to determine whether a disease or condition from which the patient is or may be suffering is one which would be susceptible to treatment with a compound having activity against TYK2.
Accordingly, in further embodiments the invention provides:
A crystalline form of the compound of formula (1) as defined in any one of Embodiments 1.0 to 5.2 for use in the treatment or prophylaxis of a disease state or condition in a patient who has been screened and has been determined as suffering from, or being at risk of suffering from, a disease or condition which would be susceptible to treatment with a compound having activity against a TYK2 kinase. (This IMHO is what GSK and 23andMe have been working on in their TYK2 research)
A method for the diagnosis and treatment of a disease state or condition mediated by TYK2 kinase, which method comprises (i) screening a patient to determine whether a disease or condition from which the patient is or may be suffering is one which would be susceptible to treatment with a compound having activity against the kinase; and (ii) where it is indicated that the disease or condition from which the patient is thus susceptible, thereafter administering to the patient an effective TYK2 inhibiting amount of a crystalline form of the compound of formula (1) as defined in any one of Embodiments 1.0 to 5.2.
A subject (e.g. patient) may be subjected to a diagnostic test to detect a marker indicative of the presence of a disease or condition in which TYK2 is implicated, or a marker indicative of susceptibility to the said disease or condition. For example, subjects may be screened for genetic markers indicative of a susceptibility to develop an autoimmune or inflammatory disease.
The genetic marker can comprise a particular allele or single nucleotide polymorphism of the TYK2 gene which is indicative of susceptibility to an autoimmune disease such as multiple sclerosis.......or an inflammatory bowel disease such as Crohn’s disease. The genetic marker can, for example, be a single nucleotide polymorphism in the TYK2 gene, or it can be a haplotype comprising a single nucleotide polymorphism in the TYK2 gene and a polymorphism in another gene.
The diagnostic tests are typically conducted on a biological sample selected from blood samples, biopsy samples, stool biopsies, sputum, chromosome analysis, pleural fluid, peritoneal fluid, or urine*.
The links with GSK and 23andMe research are strong. As others have suggested, the split of GSK, its dwindling pipeline, patents ending and Elliot shareholders revolt we could well be in their sights already with this connection to the work they have been doing and our available for license SDC-1801. Could even be a direct buyout.
GLA
Hi All - been doing some more reading around the submission. It is clear that the inhibition of Tyk2 is the on/off switch for treating autoimmune conditions (as mentioned in the description).
What is really interesting are the sections from the patent publication that has stark similarities and links to the genetic work that both GSK and 23andMe have been doing with Tyk2 to identify bio markers that indicate which patients are likely to respond best to ‘tailored’ or ‘targeted personal’ treatment.
Directly from the patent description (text between *’s)
*Emerging evidence from genome-wide association studies suggests that single nucleotide polymorphisms (SNPs) in the TYK2 gene significantly influence autoimmune disease susceptibility*.
*Less efficient TYK2 variants are associated with protection against systemic lupus erythematosus (SLE)*.
*It has been reported (see WO2014074661 and references cited therein) that in humans, individuals expressing an inactive variant of TYK2 are protected from multiple sclerosis and possibly other autoimmune disorders, and that genome-wide association studies have shown other variants of TYK2 to be associated with autoimmune disorders such as Crohn's Disease, psoriasis, systemic lupus erythematosus, and rheumatoid arthritis, further demonstrating the importance of TYK2 in autoimmunity*.
*Overexpression of TYK2 kinase has been implicated in the development of some disease states. For example, elevated levels of TYK2 were found in patients suffering from progressive pulmonary sarcoidosis*.
*Thus, the available evidence strongly indicates that TYK2 plays essential roles in both innate and adaptive immunity. A lack of TYK2 expression manifests in the attenuated signalling of multiple proinflammatory cytokines and a profound imbalance in T helper cell differentiation. Furthermore, evidence from genetic association studies supports that TYK2 is a shared autoimmune disease susceptibility gene. Taken together, these reasons suggest TYK2 as a target for the treatment of inflammatory and auto-immune diseases*.
IMHO and as Thoth has been indicating for sometime, there is a distinct correlation with this patent and the work GSK has been doing with 23andMe. Furthermore, the patent refers to the requirements to test patients for the bio markers to provide the best outcomes of treatment based on either their over-expression or inactive measure of Tyk2.
This could truly be our ‘penicillin’ moment.
GLA
Re the submarine patent, from further reading this can best be described as a literal ‘surfacing’ of the invention.
This is classed as ‘publication type A1’ which is its first publication. Yes, the world now knows (well the biotech and pharmaceutical world does - and that’s all that matters at this stage).
I believe the novelty of the invention is not in question as the citing documents in the publication both relate to our existing patents for our TYK2s (SDC series) from 2018 and 2020 respectively.
It looks as though the readers/examiner have queried the nomination of ‘forms’ (ie form A, form B, form C and form D) and states that the description as defined cannot be an invention. I believe that Sareum have amended this issue with supplemental information.
It is clear that the invention is lodged and registered and therefore afforded protection worldwide. This in and of itself as added millions to the value.
I’m with Zylo, I don’t think we will see an RNS but would be happy to be proven wrong.
GLA
Hi All - some great posts (overnight for me as being in NZ) just catching up again.
Re the publication date (Thursday 14 Oct) and an RNS. I’m sure the company has 3 business days to release. So expecting a nice juicy ‘red’ button on Monday. It must have been drafted already, maybe approved Friday for release Monday.
Will read some more later but on the face of it, this now fixes all our solubility issues across all compounds (even FLT3) which could see this being ‘dusted off’ again and rolled into the whole portfolio.
GLA
The initial publication is 109 pages and is specifically for the cyrstalline formulation of TYK2 compounds.
I got up to page 31 and will continue reading but this, for me is the icing on the cake.
Fascinating reading.
Yes looks like we have surfaced and SAR have indeed played a blinder. Thus worldwide patent was granted on the 14 October.
Expecting a RNS on Monday and this certainly looks like the final piece of the preclinical data packs.
GLA
Hi SOG
I was referring to the HMUBEC tie up from 2013 when they took our FLT3 to work up the preclinical to commercialisation.
The RNS I was thinking of was 31 May 2018 when we took it back. See below re formulation.
Sareum Holdings plc (AIM: SAR), the specialist cancer drug discovery and development business, announced that it has regained worldwide rights to preclinical-stage small molecule inhibitors of Aurora and FLT3 kinases that have shown potential in acute myeloid leukaemia (AML) and other haematological cancers. The rights have been returned by Hebei Medical University Biomedical Engineering Center (HMUBEC), a pharmaceutical research and development group based in China that has been conducting preclinical development activities.
As part of the reversion package, Sareum will receive all preclinical data generated by HMUBEC and full control over the future preclinical development programme for both intravenous (IV) and oral formulations of candidates. HMUBEC will retain a low-mid single digit percentage of net revenues that Sareum may receive from any future licence agreement or sales of Aurora+FLT3 inhibitors. In regaining the worldwide rights, there is no immediate or material financial impact to Sareum. The company will review the full preclinical data package over the coming months and consider the best way forward with these assets.
The termination of the 2013 agreement with HMUBEC is a result of several factors, including ongoing issues relating to the intravenous (IV) formulation, which are preventing higher doses from being explored to establish maximum-tolerated dose, thereby delaying the completion of toxicity studies, coupled with organisational changes at HMUBEC.
Sareum has been funding formulation specialists in the UK to try and resolve the IV formulation issue to enable preclinical studies to complete. In parallel, Sareum is beginning to explore the potential of orally available formulations of the lead Aurora+FLT3 inhibitor candidate.
IMHO - this was the start of were we are now with the crystalline formulation patent.
The £50k gig with the unnamed Chinese pharma was also particularly bizarre but not the issue I was linking back to.
ATB
Hi SOG - I believe you are spot on.
We had noted issues with solubility with our FLT3 years ago when it came back from the Chinese University. I recall at that time SAR saying they would be working on solving this. I feel the UK IPO lodgement is as JR stated ‘crystalline formulation’. With this now looking sorted and as you state patented the value of the compounds will be significantly increased.
Cant be long to wait now before all is revealed.
ATB
Hi All - the other issue that is being overlooked is that the recent 1802 grant announcement was by the US Patent Office and the submarine patent had been lodged in Apr 2020 with the UK Intellectual Protection Office.
The 1802 grant is peculiar as I can’t recall another application going in following the grant that was awarded in January (check the RNS) and this new 1802 grant was referenced as ‘associated with’
IMHO the two are not linked but a good muse Steady.
GLA
I think the UK IPO can also accept other applications for similar inventions from the 18 months deadline.....so SAR should have been getting on with the application requirements ready for granting of full protection. I’m sure with added pressure from HNWI investors they won’t be so tardy on published timelines to complete the CTA. The pending patent may also be linked to the same CTA (preclinical data package). Still loads of news due in the pipeline.
GLA
Agree Mafuta - especially considering it’s Friday and with so much more news due. We know SAR have a habit of ‘news out of the blue’ but in this case they have signalled our timeframe to CTA for 1801. I posted a couple weeks back predicting this will need to be in by w/c 18 Oct if it is to be approved before Christmas with a start Q1 2022.
We then have:
the usual year end results/update,
the submarine patent which could be announced, any news on covid trials
SRA737
1801 license deal
1802 license deal
AGM
Takeover/buy out
Would you want to be out over any of the forthcoming weekends
GLA
This one is another booming sector
Colorectal Cancer Market size is forecast to reach $31,237m by 2025 from $26,269m in 2019, growing at a CAGR of 3.0% during the forecast period 2020-2025.
https://www.industryarc.com/Report/15559/colorectal-cancer-market.html
GLA
Says it all.......
The Global Pancreatic Cancer Market is expected to exceed more than US$ 13 billion by 2024.
https://www.marketwatch.com/press-release/pancreatic-cancer-market-size-forecast-2021-2025-with-impact-analysis-of-covid-19-marketresearchenginecom-2021-07-27