This news from Dec. 30th! This is what happens when you have chemo brain. Missed opps, but, still not too late to enter.
By Jim Halley – Dec 30, 2022 at 1:25PM
KEY POINTS
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The clinical-stage biotech is going all-in on a promising lung cancer therapy.
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Summit now has two named therapies in its pipeline.
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The stock climbed more than 52% this past week.
I did a bit of peeking at this one. I wonder how long the clinical studies will take for this licensed drug. I’ll be checking it out on Summit’s site.
I would note that the other therapy is an antibiotic which failed to establish superiority to the established treatment. Doesn’t mean the product is dead, but it may not be worth much.
Rob
He is no fool who gives what he cannot keep to gain what he cannot lose.
Rob, gotta book mark for you:
Root around this site, which I give five-stars.
Discover what drugs are up for review publications this coming week, PDUFA dates, trial explanations, etc.
Give it a try.
Oh man, they must have started charging for ALL the dates. Hmmmm, will look that over later. Dinner and bed. Eating for the first time in 4 days. I’m famished. One tangerine a day doesn’t cut it.
On the SMMT site, it appears they will start clinical trials in the 2nd quarter of this year.
Two things:
- It isn’t clear to me how much Summit can use Chinese drug data. This is on the Summit site: "Ivonescimab is an investigational therapy that is not approved by any regulatory authority.
It is currently being investigated in Phase III clinical studies."
But it is designated as a breakthrough therapy in China. I haven’t tried to reconcile these statements.
- They presented at the JPM Healthcare Conference that wrapped up this week. I have not yet found their presentation… which I suspect would be pretty important.
Rob
He is no fool who gives what he cannot keep to gain what he cannot lose.
Here’s a SMT112 presentation of some sort, but doesn’t seem to be the one from JPM: https://www.smmttx.com/app/uploads/2023/01/Ivonescimab-SMT112-Fact-Sheet-010923.pdf
Rob
He is no fool who gives what he cannot keep to gain what he cannot lose.
Good eye. I’ll look at that with a clearer head Sunday. Like you already realize, it’s a very tricky sector to surf. But, Surf’s Up!
Just saw a video I want to share with new title. You will not believe what we are about to test out in the fields…
I’m a very experienced expert in losing money with biotech. I won many… and lost one big time (lost 1/3 of my portfolio value in minutes when the FDA delayed what seemed to be a “sure thing”). The net from winning many and losing that one has my past record at about… zero.
I’m quite a bit more cautious now. ARDX is my first biotech in years… and I’m very cautious with it despite a lot of good news.
Rob
He is no fool who gives what he cannot keep to gain what he cannot lose.
SMT112, the Summit proposed drug, is known as AK112 at the Chinese company that came up with it. It appears the study is probably underway with preliminary completion by the end of this year (Jan1 2024).
| Study Type : | Interventional (Clinical Trial) |
|---|---|
| Estimated Enrollment : | 320 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized, Double-blind, Multi-center, Phase III Study of AK112 or Placebo Combined With Pemetrexed and Carboplatin in Patients With EGFR-mutant Locally Advanced or Metastatic Non-squamous NSCLC Who Have Failed to EGFR-TKI Treatment |
|Actual Study Start Date :|January 1, 2022|
|Estimated Primary Completion Date :|January 1, 2024|
|Estimated Study Completion Date :|January 1, 2025|
Rob
He is no fool who gives what he cannot keep to gain what he cannot lose.
Really good finds, Rob. Need more analysis like this if you can find the time.