What's the Background?

Syntara released this afternoon interim 6 month data for the treatment of Myleofibrosis utilising its drug, SNT-5505. SNT-5505 is the most advanced and most valuable asset owned by SNT.  The company has around 25 staff and CEO Gary Phillips (GP) has been there for about 11 years. They have cash enough to take them through to mid 25.     SNT has a m/cap prior to the release of today’s data of around $90m.

This is significant for SNT and SNT director Hashan Desilva whom is also CIO of his recently launched biotech fund KP Rx.

Syntara and Curvebeam (ASX:CVB) are two of KP Rx fund’s major investments.  CVB has come off over 50% since floating, so KPRx had a lot riding on the success of SNT-5505.

I mention KP Rx and Hashan as he recently did a good buy-case write up on SNT on Livewire:

The ASX-listed Biotech set to unlock significant value - Hashan De Silva | Livewire

Results were?

Firstly it appears to be well tolerated. 

Secondly from this afternoon’s release:

“At 12 weeks of treatment, 46% of evaluable patients3 achieved a 50% improvement in Total Symptom Score (TSS50) which improved to 80% at 38 weeks of treatment. TSS50 is a standard efficacy endpoint used as the primary endpoint in MF clinical trials.”

As summarised by Professor Claire Harrison, Professor of myeloproliferative neoplasms at Guy's and St Thomas' NHS Foundation Trust:

“This interim data confirms the excellent safety profile of SNT-5505 and also suggests that the mechanism of SNT-5505 may exert a long-term effect on the disease, with both symptoms and spleen volume continuing to improve as we now see patients on drug for 9 months. This hasn’t been seen before with this class of drug and holds potential for real long-term benefits for MF patients. I look forward to seeing the data mature in the coming months to confirm these important early findings.”

Market summary release:

pdf

Presentation today at the 66th American Society of Hematology annual meeting (ASH).

ASH 2023

Did they have anything useful to say on the Conference Call?

Both CEO Gary Phillips and a lead clinician Prof Harrison were on the call. 

i)                        GP was a little dismissive (surprisingly) of the 12 wk data calling it a “honeymoon period” for patients. He placed much more store on the 38 wk data, (though only for five patients) where 80% TSS50 figure was reached.

ii)                      GP said the TSS50 was the FDA primary end point and he felt the secondary end point was up for negotiation though likely will be spleen size.

iii)                    Since 5505 is intended to stop fibrosis in the marrow GS was asked about Bone Marrow Failure Scores (BMF). GS said not all the results were back yet and all results would be looked at in the one lab when received.   Prof Harrison said this was difficult since the improvement in bone marrow took many years, then said later it took at least 12 to 18 months.

iv)                    Hematological improvements. Again Prof Harrison talked of this taking a long period of time. She indicated that the TSS50 and Spleen size were RUX benefits in any case. The inference appeared to be the need for 5505 to show this and more – ie BMF improvement and hematological improvements but both take long time frames. (Interesting)

v)                      Competition. GP spoke to 3: Pelabresib (Novartis) drug being stopped due to safety concerns. Navitclax – worked well on spleen reduction but faded in time. Navtemadlin going in Ph3 good results but not as well tolerated as 5505.  

What now?

In today’s release CEO Gary Phillips indicated:

“After receiving data from a subset of patients reaching 52 weeks of treatment by March 2025, the company intends to discuss with the FDA the trial design for a pivotal Phase 2c/3 study. Concurrently, the company will also engage with potential global and regional partners.”

By March we will have further readouts. Also by mid next year SNT will be in need of cash, so the last point is likely to be highly relevant.

(In SNT’s release to the market on the 28/11/24, SNT indicated an addressable market of $1b).

Your thoughts?

Like most everything in life FIIK. Prof Harrison called the data impressive and liked that it got better over time. In March 25 there will be further readouts and by mid 25 the important FDA feedback.  

GS in the Conference Call lead-in talked (again) about the sophistication of SNT’s register - over 50% institutional.  And emphasised how these investors have in the past made a lot of money out of myelofibrosis related drugs and by inference know what they are talking about.  So I guess when trade in SNT shares resumes tomorrow the worlds biotech investing elite will tell you what they think.