MAIA Biotechnology Announces 100% Disease Control in Second-Line Non-Small Cell Lung Cancer Demonstrating Impressive Positive Preliminary Efficacy Data for Ongoing THIO-101 Phase 2 Trial

MAIA Biotechnology, Inc. (NYSE American: MAIA), a clinical stage company developing telomere-targeting immunotherapies for cancer, today reported positive preliminary efficacy data from its ongoing Phase 2 clinical trial, THIO-101, evaluating THIO in patients with advanced Non-Small Cell Lung Cancer (NSCLC) in sequential combination with Regeneron’s anti-PD-1 cemiplimab (Libtayo).

Key findings:

• 100% Preliminary DCR observed in second-line and 88% in third-line, in highly difficult-to-treat patients who already progressed through previous lines of treatment.
• DCRs across all dose levels met the pre-determined statistical requirements earlier than expected to proceed to next stage of the trial.

“In NSCLC patients who received at least one line of therapy, DCRs have shown to be excellent predictors of overall survival.¹ Observing 100% DCR to date in second-line treatment is unprecedented compared to DCRs for the SoC ranging from 53-64%,²” said Vlad Vitoc, M.D., MAIA’s Chief Executive Officer. “We have also observed unprecedented high DCRs in third-line, with an 88% control rate, with treatment of THIO followed by cemiplimab. The results are even more remarkable given patients in this population have previously failed treatment with a checkpoint inhibitor. Currently, there is no SoC for third-line, but previous studies have reported an approximate 30% DCR.³ These exceptional preliminary results underscore our confidence in advancing the trial to bring our novel treatment to advanced stage NSCLC patients.”

1 Matsumoto H et al. Transl Lung Cancer Res. 2021 May; 10(5): 2278–2289

2 REVEL https://www.cyramza.com/hcp/nsclc-treatment/revel-response-rate-effica ...

3 Journal of Thoracic Oncology (VOLUME 16, ISSUE 10, OCTOBER 2021), T. Beninato et al.

Study Disease Control Rates by Line of Treatment

Treatment Line	Standard of Care Treatment	DCR		Treatment Line	THIO + Libtayo (cemiplimab) DCR
NSCLC-1	pembrolizumab (KEYNOTE-024)	71%		NSCLC-1	TBD
NSCLC-2	ramucirumab + docetaxel (REVEL)	64%		NSCLC-2	100%
	docetaxel monotherapy (REVEL)	53%