On Tuesday, MAIA Biotechnology Inc (NASDAQ:MAIA) announced treatment updates from its Phase 2 THIO-101 trial of THIO sequenced with Regeneron Pharmaceuticals Inc's (NASDAQ:REGN) cemiplimab (Libtayo) for advanced non-small-cell-lung-cancer patients who failed two or more standard-of-care therapy regimens.
The trial's therapeutic regimen is cycled every three weeks, with THIO 180mg administered in 60mg incremental doses on days 1, 2 and 3, followed by immune activation on day 4 (no dosing), and cemiplimab 350mg administered on day 5.
As of the latest clinical cutoff date, June 12, 2024:
- Six patients remain on treatment following at least 12 months of therapy.
- Treatment with THIO followed by cemiplimab has been well tolerated throughout the trial, with much lower toxicity than standard-of-care treatments.
- Continuing treatment past 12 months demonstrates safety, efficacy and ongoing benefit from MAIA's novel telomere targeting NSCLC therapy.
"Our longest treated patient so far has completed 21 cycles of THIO sequenced with a CPI, and six patients who have crossed the 12-month survival follow-up are continuing the treatment," said Vlad Vitoc, chairman and chief executive officer of MAIA.
In June, MAIA Biotechnology shared new efficacy data from its Phase 2 THIO-101 study of THIO.
Updated results show a favorable overall response rate (ORR) of 38% and a disease control rate (DCR) of 85% from THIO + CPI in third-line treatment:
- The disease control rate (DCR) was 85% for THIO vs. standard of care DCR of 25–35% for chemotherapy.
- 65% of patients crossed the 5.8-month overall survival (OS) threshold.
- 85% of patients crossed the 2.5-month progression-free survival (PFS) threshold.
- Median survival follow-up time is currently 9.1 months (n=20)
Price Action: MAIA stock is down 14.25% at $3.31 at last check Tuesday.
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Image created using artificial intelligence via Midjourney.