Sep. 9 at 7:14 PM
$MAIA I never cross post at all, but the moment an
$SLS buyout takes place (as I’ve told myself I won’t be selling a single share up until that point), a significant portion of my post-tax earnings will be unwinded into MAIA. I see the company as as an earlier stage SLS with growing legs that carry many similarities. I’m not here to pump anything as I do not have a sizeable position in MAIA for the time being, but for those who are looking for a company to invest in other than/after SLS, here are a few similarities to note for those who seek interest
Both are OS based, randomized 1:1, open label P3 studies
Both have shown efficacy signals that outperform control therapies relative to historical outcomes by multiples in P2 (largest factor)
Both dosing regimens are conceptually similar (relative to GPS’s ad infintrum dosing)
Both have strong, encouraging safety profiles
Both drugs have a platform-like potential to expand across multiple cancer types
Both are granted FDA fast track designation
Both have rationale for combination with checkpoint inhibitors
Both are attacking multi-billion dollar markets
Both Phase 3 OS studies are ≥90% powered relative to their respective control therapies - THIO is designed with 90% power to detect an HR of .62, while REGAL has been described as ≥90% powered under an assumed HR of .52, with ~.636 representing stat sig
GPS and Ateganosine work through different initial mechanisms but converge on a similar immune mediated process which is what got me so interested. As many in SLS know, GPS presents WT1 derived peptides to the immune system, stimulating WT1 specific CD4+ and CD8+ T cells that recognize and kill WT1 expressing cancer cells, whereas THIO is incorporated into the telomeres of telomerase positive cancer cells, causing telomere damage and cancer cell stress/death that activates pathways such as cGAS-STING, promotes antigen presentation, and ultimately recruits tumor-specific cytotoxic T cells. In short, GPS directly trains adaptive immunity against a defined tumor antigen, while THIO creates tumor damage that helps provoke adaptive antitumor immunity. Both aim to generate T-cell mediated recognition and destruction of cancer cells with durable immune memory, which is what I love about the two drugs.
My assumption on an assumed interim data analysis for THIO is anytime after summer of 2027, so it gives a nice gap of time between the two companies to ponder more on the science and data of MAIA. The design explicitly states 90% power to detect HR = 0.62, based on 9.4 months OS versus 5.8 months for chemotherapy, with FA at 186 deaths. Whats great for the mOS of this drug is the P2 efficacy showed 17.8 months in 22 third-line patients, 95% CI lower bound was 12.5 months and the 99% CI lower bound was 10.8 months relative to the published chemotherapy outcomes of roughly 5–6 months OS in similar later-line NSCLC populations. The P2 efficacy relative to control therapies + P3 trial design is what gets me locked onto the company.
This is similar to separate components of SLS’s company, giving lots of confidence that I’m investing in a mechanism that’s soon to be strongly proven. A boat load of shares will be docked into this company when the time comes that SLS is off the market. GLTA.