Member Info for Krone

RMM - good afternoon.
Not doubting you for a second but to manage my own expectations could you please advise where you got the 7 day CTN 30 day CTA info from. Many thanks.

Better to have a series of individual RNSs which serve to build a sustained head is steam as opposed to massive dump which causes a spike and rapid retrace!

SRA737 gets a mention.
'There are two generations of CHK1 inhibitors. When combined with a cytotoxic agent, cancer cells showed sensitivity to the first generation of CHK1 inhibitors, but studies on this kind of inhibitor were limited due to its high toxicity. Second-generation CHK1 inhibitors have shown improvement compared to the first generation. LY2880070 and SRA737 are some of the CHK1 inhibitors that are currently under study. These drugs are being used in combination with other damaging agents, therapies, and antimetabolites [9].'
https://www.mdpi.com/2169072

https://endpts.com/theravance-cuts-17-of-staff-jak-inhibitor-program/

Seven months to the day since RNS confirming submission of CTA to MHRA. A status update would seem entirely reasonable.

Remembering that the Sierra/GSK deal, which was altogether more complex and on much larger scale was reportedly done and dusted in 2 months!

Potnak - given that CPF has reportedly already received a number of approaches/proposals re SRA737 and given that the data package was returned around a month ago, it must be reasonable to suppose that progression in the form of licence or full acquisition of SRA737 is imminent. It could well be that the absence of any update is because deals are being done.

"We are a global leader in strategic healthcare communications and investor relations. Experts across all sub-sectors of healthcare and financial markets, our specialist teams in Europe and the US enhance profile, reputation and perception with key audiences for a wide range of international healthcare companies."

Leggster - nicely balanced, sober and quietly optimistic post, thank you.

https://youtu.be/2ONbSnydrWo

I think the goal is to take a drug with some promise in the rare disease space for diseases that don’t have alternatives … and then take these products, maybe they have breakthrough or advanced therapy designation, they have promise and there is a product in development and not just a concept. And then give them the opportunity with not just chemistry, manufacturing and controls, which we have a pilot for, but allow the clinical development to happen in constant communication and sharing of potential results before a submission of an NDA or BLA. That’s the idea, is to move things as fast as possible.

https://endpts.com/operation-warp-speed-for-rare-diseases-cber-leader-says-pilot-is-coming-soon/

Dr Tim Mitchell, CEO of Sareum, commented:

"We close this financial year with growing excitement around the potential for our portfolio of differentiated TYK2/JAK1 inhibitors.

"Our lead programme, SDC-1801, is a TYK2/JAK1 inhibitor which we believe has significant potential for superior efficacy in autoimmune disease compared to oral therapies currently available and in development. We have submitted a Clinical Trial Authorisation (CTA) application to the UK Medicines and Healthcare products Regulatory Agency (MHRA) and, subject to the required approval, hope to begin clinical trials in healthy volunteers before the end of 2022, with a psoriasis trial planned for 2023. This comes against a background of increased recognition around the potential for the TYK2/JAK1 class, and we have been encouraged by the recent FDA approval of BMS's Sotyktu, the first approved TYK2 therapeutic, and the interest building around the space."

"Our expertise in kinase inhibition, alongside momentum in our translational work, also supports confidence in SDC-1802, our immunotherapy programme targeting cancer. We are working to further define an appropriate patient population for clinical work and look forward to continued progress with this and our other programmes.

"We are pleased to have clarity on SRA737 and to be able to plan the next steps for SRA 737 together with CPF. We continue to believe that SRA737 has great potential for the treatment of cancer, particularly in combination settings."

CHAIRMAN'S STATEMENT

Sareum is making exciting progress in advancing its programme of next generation kinase inhibitors for autoimmune disease and cancer into clinical development.

The Company has emerged strongly from the challenges of the COVID-19 pandemic with a new focus on autoimmune disease and particularly psoriasis, an area of high unmet need and one with significant commercial potential.

Management believes that dual inhibition of both TYK2 and JAK1 has the potential to offer superior efficacy, in comparison to other small molecule approaches, for the treatment of autoimmune diseases, and that the Company has a compelling and differentiated offering.

With this goal in mind, for much of the year, the Company has been focused on preparatory work to begin clinical development. All preliminary work, including toxicology studies, drug manufacture and formulation, and regulatory submission, is now complete and we look forward to advancing into the clinic soon, subject to approval from the MHRA.

Although SDC-1801 is the Company's primary focus, translational studies are also progressing in SDC-1802, an immunomodulating molecule that has demonstrated good efficacy in preclinical models of cancer.

Post-period, Sareum was advised that Sierra intends to return the rights for SRA737 to CPF. The Company and CPF will discuss the potential options for future development opportunities for SRA737 and evaluate its next steps accordingly.

Sareum continues to believe that, based on preclinical and early clinical data, SRA737 holds strong promise for the treatment of cancer, particularly in combination settings and are confident in the potential of this molecule.

Hi RMM,
Many thanks for taking the time out of your hols for your typically helpful response.
I’d agree that in an ideal world Sareum would buy out CPF’s share of 737 however I’m guessing that would take a level of funding which, in the current circumstances where even the CTA is a real challenge, investors simply wouldn’t have the confidence to stump up the required funds. I expect CPF to onlicence quickly given that there is no benefit in delaying further development any more than it has been already.
I’d agree also that CTA approval will come and that the MHRA delays may turn out to be a blessing in disguise in that whoever we eventually run with won’t be involved in the political game playing which is currently holding things up.
And yes, 2023 really should see some significant upturn.
Have a large G&T on me!
All the best.

Good evening RMM - it would be very helpful to hear your current thinking on where things stand.

It would seem that the promise of improved investor relations has turned out to be a very disappointing 'false dawn'. The buzzing optimism of the AGM was short lived and investors are once again left dangling. The appointment of a Head of Investor Relations appears to have had absolutely no impact! Tim just doesn't seem to get it!

Given that the GSK/Sierra deal reportedly took just over 2 months and would have involved due diligence on the Sierra drug assets as well as the entirety of the Sierra organisation, it would be reasonable to suppose that the on-licence of SRA737 by CPF, which would be an altogether simpler process, could be completed in significantly less time. This would be on the assumption that the data package is robust and complete. Sareum’s best interests will be very well protected by SP at the negotiating table given his impressive track record in Pharma deal making and his clear commitment to adding shareholder value. The next few weeks/months promise to be transformative for the company and investors alike, and as noted by the BoD at the AGM we are entering an increasingly exciting time!

Deals — and the lack thereof

Like many of its pharma brethren, Novartis said it continues to “actively evaluate” M&A deals, with the sweet spot still in the $4 to $5 billion range — and a sharp eye for high-quality data.

“Valuations, of course, have come down,” Narasimhan said on the media call. “But in and of itself, that’s not enough. We want attractive valuations, but more importantly, very compelling science.”

https://endpts.com/going-blockbuster-hunting-vas-narasimhan-outlines-vision-for-pure-play-novartis/