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Hi Celtic - from the Discussion section, "In our study, SRA737 exhibited significant single-agent activity in suppressing CRPC tumor growth and metastasis in a TRAMP mouse model. It was also well-tolerated in the 4-week treatment study, with no consequential body weight loss or gross toxicity. These preclinical data support the potential of SRA737 as a treatment for CRPC."
Hi SOG - the interesting thing is that although the AZ study you referred to was back in 2022, the 737/1775 study I posted made reference to data taken from the Cancer Genome Atlas in late May 2023 suggesting the scientists must've concluded that 1775 still has potential despite AZ stopping their own development.
I don't know if a drug's adverse effects would be universal irrespective of the type of cancer or if the patient is male or female. It may be that treating breast cancer with 1775 results in too many adverse events but it's excellent when used in men with prostate cancer.
Anyway, still all to play for, I think.
The paper below from Nov 2023 is still to be peer reviewed but it seems rather positive, "...both agents alone or in combination suppressed tumor growth, improved overall survival, and reduced the incidence of distant metastases, with SRA737 exhibiting remarkable single agent anticancer activity. Mechanistically, SRA737 synergized with AZD1775 by blocking AZD1775-induced feedback activation of CHK1 in prostate cancer cells, resulting in increased mitotic entry and accumulation of DNA damage. In summary, this preclinical study shows that CHK1 inhibitor SRA737 alone and its combination with AZD1775 offer potential effective treatments for castration-resistant (CRPC) and neuroendocrine prostate cancers (NEPC)"
and
"In our study, SRA737 exhibited significant single-agent activity in suppressing CRPC tumor growth and metastasis in a TRAMP mouse model. It was also well-tolerated in the 4-week treatment study, with no consequential body weight loss or gross toxicity. These preclinical data support the potential of SRA737 as a treatment for CRPC."
https://www.researchsquare.com/article/rs-3564450/v1
I wonder if there was a rep from AZ in the orderly queue that somebody once mentioned?
(And remember, as it's Hogmany if you're not in bed by 11pm you should probably just go home.)
Regards.
Hi Ben - scroll down to the 'outcomes' section for trial timings. What we don't know is if all recruits started at the same time as there is a 28-day screening window prior to the start of dosing.
https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=385663&isReview=true
Hi Krone - I wouldn't put too much faith in what the website says; admin doesn't appear to be a strong point with the Nucleus Network e.g. our food effects trial entry on the website says 'not yet recruiting' despite the fact that element of the trial has started.
Hi Blastoid - their compound is TYK2 only whereas ours is TYK2/JAK1 so without looking through whatever the patents say, it's maybe apples to oranges with enough delineation between things.
Hmmmm, I see we have some competition from the Chinese -
https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=384816&isReview=true
https://www.pharmaceutical-technology.com/data-insights/ua-021-usynova-pharmaceuticals-psoriasis-likelihood-of-approval/?cf-view
On a side note, a bit of digging shows AstraZeneca has entered into an exclusive licence agreement with the same Chinese biotech company for global rights to their preclinical(!!!) cancer drug candidate UA022 for almost $420m.
https://www.pmlive.com/pharma_news/astrazeneca_gains_rights_to_usynovas_kras_inhibitor_in_deal_worth_almost_$420m_1504188
I see the Nucleus Network are advertising for volunteers for a 6-night stay at their clinic which would tally with the SAD/MAD phase of the trial. However what I don't know is if this is our trial or maybe another company is starting one. If it is 1801 then at least it's not been halted.
https://www.nucleusnetwork.com/au/participate-in-a-trial/studies/the-regulating-study/
Indeed, Ajithoth. 737 shouldn't be written off by anyone (insert names of usual suspects here) though it may prove to be more effective when used in combination with other treatments rather than as a monotherapy.
From the study - "Colorectal cancer (CRC) is the 3rd most common cancer worldwide, with an estimated 1.93 million new cases diagnosed in 2020 causing 0.94 million deaths worldwide. TP53 mutation occurs in approximately 40–50% of sporadic CRC, with the mutation status being closely related to progression and outcome; patients with MUT TP53 appear more chemo-resistance and have poorer prognosis than those with WT TP53.
Lung cancer is the second commonest cancer worldwide, with more than 2.2 million cases and nearly 1.8 million deaths being estimated in 2020. For NSCLC, mutations of the TP53 gene occur in about 50% of cases."
So around half of all CRC and LC patients have a mutated TP53 gene and the study suggests 737 could be effective here. This is why we shouldn't write off a 737 deal just yet.
The link below explains why TP53 is so important.
https://www.verywellhealth.com/the-p53-gene-its-role-in-cancer-2249349
Anyhoo, enough from me as there may be another box of chocolates to open.....
The report below was partially funded by a “Specialist Unit Agreement” between Cancer Research UK and the University of Leicester. I hope they've also been poking CPF to get some sort of commercial deal sorted.
Latest paper published on 21st Dec: Investigations of the novel checkpoint kinase 1 inhibitor SRA737 in non-small cell lung cancer and colorectal cancer cells of differing tumour protein 53 gene status.
https://www.explorationpub.com/Journals/etat/Article/1002193
Regards all.
Last day for voting via Halifax was yesterday for some reason.
Just had a look at N4 Pharma (I'm not invested) and see they're up about 34% due to their latest RNS. I wonder if we'll see our BoD take a leaf out of N4P's book and hopefully announce good results from the food effects study.
Hi PCS - thank you for asking the question and what a disappointing answer if I heard it correctly! I appreciate those attending in person should take priority over written questions but it's a shame there wasn't enough time to address at least a few more of them.
The meeting was not helped by the poor sound quality but I got the gist of what the attendees were saying to the BoD. I thought JR in particular looked as if he'd rather have been anywhere else than at the meeting. A pity since his scientific contribution to the company appears top-notch and I don't think he has anything personally to feel bad about, afterall it's his name on all the patents.
Not being able to hear Mr. Smith's initial statement clearly enough, I thought SP looked as if he quickly switched off to some degree whilst Mr. Smith spoke. Either SP recognised what was being said and took it personally or he was thinking 'no, you're wrong but I can't refute the things you're saying without giving away inside info.' Just my take on what I saw.
Whether or not the BoD take on board what was said remains to be seen - perhaps one of the attendees could confirm if, after the meeting was over, they spoke directly to SP or TM to drill home the need for our IR people to engage more widely with the investment community.
If any attendee has any snippetts of post-meeting info they feel they can share, it would be appreciated.
Regards.
I quite agree, Potnak.
Re my first question, "Can you confirm if Mike Owen sits on the Scientific Advisory Board of the CRT Pioneer Fund and if so, when was his most recent involvement with the fund with respect to SRA737?", I tried to ask it in a way that they could answer without giving away anything covered by an NDA e.g. "yes, Mike's still very much involved there and he attended a meeting last month." Something like that could hint 737 is still in play even if they can't officially disclose details.
On the flipside, if they say 'nah, his last involvement was over a year ago before Sierra even handed all the data back' then at least it's an update of sorts and we perhaps shouldn't get our hopes up too much for an imminent deal.
Fingers crossed we get acceptable answers to reasonable questions.
Although the Nucleus Network haven't advertised yet for psoriasis patients I wonder if some people have already registered their interest in taking part. The sample size is just 12 so even if they've not got a pre-registration list it shouldn't take too long to rustle up enough volunteers.
I'll ask the question during tomorrow's meeting, 'Do you know if any psoriasis patients have already registered their interest in participating in the next stage of the 1801 trial or are Nucleus Network still to advertise for recruitment?'
Regards all.
Hi Potnak - the thing about the RF shares is that none of us know their current position. Shepherddollar recently posted, 'I know that a no. of large sells were not RF on a no. of days . Someone sold for personal reasons.'
So without concrete proof, perhaps RF haven't been dumping quite as many as has been mooted.
The thing we all have to remember is that there must be quite a few shareholders with huge holdings but they just don't post on any forum - the silent majority, and all that.
I blame the glaring typo in my reply on the root canal treatment I've just had. Add the demise of my washing machine and it's almost too much for any man to bear.
Hi LJ - I posted this at the end of November
"...the food effects trial could be completed just prior to the AGM. The first dosing was announced on the 9th Nov and the final follow-up visit is 29 days later. If all 16 participants started dosing that same week then we could see a pre-AGM RNS to say the safety committee now have all the data required to make a decision on whether the trial can proceed or not.
If there had been any nasty adverse events then the food effects trial wouldn't have been given the go-ahead. This suggests the safety committee just have to decide on the dose to be given to psoriasis patients and whether or not 1801 should be taken with food or on an empty stomach."
As no one probablys wants to be in hospital over Xmas/New Year, I'm guessing the food effects study was planned so that it'll be completed in the next week or two. The safety committee will have to review all data gathered as a whole before giving the green light to the final stage of the trial so I don't expect that to be until January....unless Christmas comes early!
Thought I'd post the questions I've submitted for the AGM.
Question 1:
Can you confirm if Mike Owen sits on the Scientific Advisory Board of the CRT Pioneer Fund and if so, when was his most recent involvement with the fund with respect to SRA737?
Question 2:
If the company were to receive income from the sale or on-licence of SRA737 will the Board buy back any shares still held by RiverFort with a view to cancelling them and therefore reduce share dilution?
Question 3:
The translational studies for SDC-1802 have been ongoing for quite some time. Are you any closer to an endpoint? Shareholders appreciate that there can always be another test or experiment that can be carried out but sometimes you do just have to call a halt and move to the next stage of development.
Question 4:
Assuming the Board has a strategy in place for the commercialisation of SDC-1801, could you outline some of the factors taken into consideration during the planning?
For those attending in person, it'd be interesting to hear your thoughts on the BoD's general demeanor when they're off-camera. Unless there's news prior to the AGM they won't be able to say too much but if any of you can read body language, it might prove helpful to gauge their own sentiment.
Further extract -
However, AbbVie’s Skyrizi and Rinvoq are well placed to be leading successors to Humira. The seven big pharma companies responsible for these 12 drugs are the main players in treatments for autoimmune diseases and just five of these firms have had top-50 drugs approved within the last eight years.
Promising pipelines
We now look at the new drug pipelines of the five biopharma groups mentioned above with approved autoimmune drugs to see what new late-stage drugs they are developing to treat autoimmune diseases.
The average probability of successfully completing a Phase-III clinical trial (the final stage of clinical trials) is 70%. But for Phase II this figure falls to 30%. So an early Phase II drug has only a 21% chance of successfully exiting Phase III. We will therefore concentrate on drugs for autoimmune diseases already in Phase-III trials, which are those most likely to gain regulatory approval.
AbbVie has five Phase-III trials in progress to expand the number of approved indications for Skyrizi and Rinvoq, along with three Phase-II trials of other drugs. Novartis has three Phase-III trials to expand the approved indications for Cosentyx, two new drugs in Phase-III trials and nine in Phase II. J&J has six PhaseIII trials to expand indications for Tremfya, three new drugs in Phase-III trials and four in Phase II. Lilly has two new drugs in Phase III and three in Phase II. Roche has three new drugs in Phase III and two in Phase II.
Oncology drugs form a large proportion of the pipelines for all five companies. Indeed, 14 of the bestselling drugs of 2022 were for various forms of cancer. Oncology is an important area where global sales of cancer drugs are expected to rise from $156bn in 2022 to $272bn in 2030 (representing a compound annual growth rate of 7.2%). AbbVie has 24 compounds for oncology in its pipeline, Novartis has 11, J&J 24, Lilly 12 and Roche more than 70. But pipeline drug numbers do not tell the whole story, since some drugs are likely to have much greater sales potential than others.