Aug. 13 at 1:55 PM
$MDNAF Some people think ABILITY‑1 no longer matters due to NEO‑CYT-that’s not true. For now, ABILITY‑1 is MDNA’s core trial and the foundation for any future approval. The FDA does not approve neoadjuvant immunotherapies without prior metastatic approval, so ABILITY‑1 must come first before MDNA can earn a neoadjuvant label, a company‑sponsored trial with 300+ patients using EFS or FRS—the actual approval endpoints.
The current NEO‑CYT measures MPR, a strong biological signal, but MPR is not an Approval endpoint like FRS & EFS. And because NEO‑CYT is investigator‑led not company-led, regulators will not accept it as standalone approval data. Its purpose is to support, not replace, ABILITY‑1.
ABILITY‑1 shows that MDNA11 works.
NEO‑CYT shows how it works.
Together, they provide powerful clinical &mechanistic evidence that MDNA11 is not another me‑too IL‑2. NEO‑CYT is a strategic deal sweetener that de‑risks MDNA11, MDNA113, and the entire superkine platform.