MAIA Biotechnology Reports Two‑Year Survival in Phase 2 NSCLC Trial at ELCC

MAIA
March 31, 2026

MAIA Biotechnology, Inc. (NYSE: MAIA) presented data at the European Lung Cancer Congress (ELCC) in Copenhagen on March 27, 2026, showing that eight patients treated with its telomere‑targeting agent ateganosine (THIO) in the Phase 2 THIO‑101 trial survived beyond two years. The company posted the poster on its website, marking the first new clinical data release since its June 2025 Phase 2 results.

The Phase 2 study enrolled 79 patients across Parts A and B, and a Part C expansion is currently enrolling up to 48 participants in Asia and Europe. In the eight patients who achieved the two‑year milestone, ateganosine was followed by the checkpoint inhibitor cemiplimab (Libtayo®) and no subsequent lines of therapy were administered.

The survival outcomes are striking when compared to the heavily pre‑treated population. One third‑line patient survived 33 months versus an expected 5.8 months, and four second‑line patients survived over 30 months versus an expected 10.5 months. These results reinforce MAIA’s claim that ateganosine, when sequenced with a PD‑(L)1 inhibitor, can induce durable tumor regression in advanced non‑small cell lung cancer.

CEO Vlad Vitoc said, "It's very encouraging to see such outstanding survival from these patients extending beyond our 24‑month trial protocol and without any subsequent treatment. OS surpassing two‑years bodes well as we continue to monitor patients in our ongoing Phase 3 pivotal trial and in THIO‑101 Part C." He added, "These results illuminate ateganosine's valuable role in targeting telomeres to eliminate NSCLC tumor cells and support this treatment—ateganosine sequenced by a CPI—as a potential breakthrough therapeutic option for NSCLC." Vitoc also noted that the company’s strategy targets the third‑line (3L) NSCLC population, where no established standard of care exists and chemotherapy remains the default, underscoring the unmet need that ateganosine seeks to address.

Financially, MAIA reported an earnings‑per‑share of –$0.08 for Q4 2025, beating consensus estimates. As a development‑stage company, a negative EPS is expected, but the beat indicates disciplined cost management amid continued investment in the pipeline. The company also holds FDA Fast Track designation for ateganosine and is advancing a Phase 3 pivotal trial (THIO‑104) that compares ateganosine plus a checkpoint inhibitor to chemotherapy.

The data strengthen MAIA’s pipeline and position the company within a >$50 billion global immunotherapy market. The positive survival signals may accelerate regulatory review and support future commercialization prospects, marking a significant milestone in the company’s trajectory toward a breakthrough therapy for NSCLC.

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