Member Info for Krone

Yes Potnak, I got that wrong and on further reflection after a more thorough read it looks ok, particularly the timescales for notification of the go-ahead!

Poorly drafted and very unhelpful - totally missing the point that the issues are the fault of MHRA NOT Sareum. We actually pay these people!

https://www.edisongroup.com/research/2023-to-be-a-year-of-clinical-transition/32115/

SOG -
However, a company registered outside Australia does not need to register as a foreign company if they choose to incorporate an Australian company (subsidiary) to conduct business in Australia.
Sareum incorporated Pampisford Pty Ltd as a subsidiary.

RMM - thank you, that’s very helpful.

https://business.gov.au/Registrations/Register-a-company

How long it takes to register a company
A company application should take you around 15 minutes to complete online. If you have registered using the Business Registration Service and have provided all the required documents, and paid the fee, you should get confirmation within two business days.

SOG - more like 3 days.

RMM - thanks as always! I’m intrigued by the response to the question about the 1802 translational, toxicology and manufacturing studies and the confirmation by JR that the tox and manufacturing studies have not commenced. Given that the 1802 formulation has been determined, and the translational studies have been in train since Q4 2021, would it not be appropriate to run the tox and manufacturing studies in tandem? Is this simply a funding issue or something more strategic? If not, based on the time it has taken to get 1801 to the current position, we are a number of years away from getting 1902 even close to Phase 1 trials. Whilst appreciating that the focus has been on 1801 and that the MHRA debacle will have taken up a lot of JR and TMs time, one would think there would still be capacity to progress 1802.

This is actually extremely encouraging…in respect of a preclinical TYK2 JAK1.

Biohaven Ltd. (NYSE: BHVN) today announced that it acquired global rights, excluding China regions, for the development of an oral, brain-penetrant, dual inhibitor of Tyrosine Kinase 2 (TYK2) and Janus Kinase 1 (JAK1) for the treatment of brain disorders. BHV-8000 (previously TLL-041) was licensed from Hangzhou Highlightll Pharmaceutical Co. Ltd. (Highlightll) and Biohaven anticipates advancing the agent into a Phase 1 study in 2023.

https://twitter.com/bymadeleinea/status/1638512572289671169?s=46&t=f0alfz1F-88Q0eSeTZkxPA

Based on the procedure detailed below, the immediate question is whether there will be an initial RNS to confirm CTN approval followed by a further RNS to confirm approval by the 'Approving Authority'.

The CTN Scheme is a notification process involving the following:
The Australian clinical trial sponsor must notify us of the intent to sponsor a clinical trial involving an 'unapproved' therapeutic good. This must take place before starting to use the goods. The notification form must be submitted online and accompanied by the relevant fee.
We may give the sponsor of the trial written notice to provide specified information relating to goods notified in the CTN form.
We do not evaluate any data relating to the clinical trial at the time of submission. The Human Research Ethics Committee (HREC) reviews the scientific validity of the trial design, the balance of risk versus harm of the therapeutic good, the ethical acceptability of the trial process, and approves the trial protocol. The HREC is also responsible for monitoring the conduct of the trial.
The institution or organisation at which the trial will be conducted, referred to as the 'Approving Authority', gives the final approval for the conduct of the trial at the site, having due regard to advice from the HREC.
It is the responsibility of the sponsor to ensure that all relevant approvals are in place before supplying the 'unapproved' therapeutic goods in the clinical trial.
https://www.tga.gov.au/clinical-trials#ctn-scheme

Probably because it states ‘ SDC-1801’s CTA was turned down by the MHRA’. Totally misleading and inaccurate!!

https://twitter.com/hybridanllp/status/1637761982706139137?s=46&t=zUhZNEIH5IDRM4FGOA4K3A

It’s also considering mid-stage studies in lupus, Crohn’s disease and ulcerative colitis, and a team is looking into other diseases to target too, according to Plump.

“We’re looking at creative ways to understand activity in those additional indications and move rapidly,” he said.

Takeda, chasing Bristol Myers, unveils awaited TYK2 drug data

The anticipated study results show why the pharma paid $4 billion to buy the psoriasis drug from startup Nimbus Therapeutics.

These treatments have become highly coveted by drugmakers because of their potential to be oral alternatives to top-selling, injectable medicines like Humira.

https://www.biopharmadive.com/news/takeda-tyk2-psoriasis-study-results-aad-nimbus/645291/

Maybe SRA737 and/or SDC1802 will improve the cancer treatment journey.
https://www.theguardian.com/commentisfree/2023/mar/17/breast-cancer-treatment-life-health-chemotherapy-drugs-side-effects?CMP=Share_iOSApp_Other

Many thanks RMM that’s very helpful.

RMM, good morning, could you please advise where you got the 7 day CTN 30 day CTA info from. Many thanks.