← Catalyst calendarMAIA biotech catalysts & pipeline
MAIA BIOTECHNOLOGY INC · Data as of 2026-09-08
Upcoming catalysts
ateganosine (THIO; 6-thio-2'-deoxyguanosine) — Interim data
2026
The targeted milestones include: (i) initial measures of efficacy from Phase 3 study, with interim disease control rates (DCR), overall response rates (ORR) and progression free survival (PFS) analysis of ateganosine compared to the control arm will support regulatory discussions; (ii) expected conclusion of Part C of Phase 2 study, which will provide additional clinical efficacy data to support regulatory review for commercial approval; (iii) Plan to engage in regulatory interactions with the FDA to expand ongoing FDA dialogue under the Fast Track designation, including discussions around trial enhancements and prospects for Accelerated Approval and Priority Review; (iv) clinical development of second-generation molecules planned to start in Phase 1 trials, with additional small molecules fully developed in-house with better expected efficacy compared to ateganosine.
Source filingateganosine (THIO; 6-thio-2'-deoxyguanosine) — FDA meeting
2026
Engage in regulatory interactions with the FDA .
Source filingateganosine (THIO; 6-thio-2'-deoxyguanosine) — NDA/BLA submission
2026
Based on the clinical data generated by our THIO-101 trial, we plan to seek filing for an accelerated approval of ateganosine in the United States for the treatment of patients with advanced NSCLC in 2026, but even if granted, accelerated approval status does not guarantee an accelerated review or marketing approval by the Food and Drug Administration (FDA).
Source filingateganosine (THIO; 6-thio-2'-deoxyguanosine) — Interim data
next year
Interim data from the Phase 3 trial, expected next year, may support a discussion with the FDA to present our case for early full commercial approval in third-line NSCLC.
Source filingateganosine (THIO; 6-thio-2'-deoxyguanosine) — NDA/BLA submission
2027
We initiated a Phase 3 pivotal trial in 2025, named THIO-104, to evaluate the efficacy of ateganosine administered in sequence with a checkpoint inhibitor (CPI) in third-line NSCLC patients who are resistant to checkpoint inhibitors and chemotherapy which could lead filing for early full commercial approval in 2027 and final analysis could lead to filing for full commercial approval in 2028.
Source filingateganosine (THIO; 6-thio-2'-deoxyguanosine) — NDA/BLA submission
2028
We initiated a Phase 3 pivotal trial in 2025, named THIO-104, to evaluate the efficacy of ateganosine administered in sequence with a checkpoint inhibitor (CPI) in third-line NSCLC patients who are resistant to checkpoint inhibitors and chemotherapy which could lead filing for early full commercial approval in 2027 and final analysis could lead to filing for full commercial approval in 2028.
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