MAIA Biotechnology Announces New Updates from Phase 2 Trial of Novel Cancer Treatment Agent THIO followed by cemiplimab shown to be well tolerated throughout trial, with far lower toxicity compared to standard of care tr

Biotechnology Announces New Updates from Phase 2 Trial of Novel Cancer Treatment Agent

- July 23, 2024 - MAIA Biotechnology, Inc., (NYSE American: MAIA) ("MAIA", the "Company"), a clinical-stage

biopharmaceutical company developing targeted immunotherapies for cancer, today announces positive treatment updates from its Phase 2

clinical trial, THIO-101, evaluating THIO sequenced with the immune checkpoint inhibitor (CPI) cemiplimab (Libtayo ) in patients

with advanced non-small cell lung cancer (NSCLC) who failed two or more standard-of-care therapy regimens.

trial's therapeutic regimen is cycled every 3 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,

longest treated patient so far has completed 21 cycles of THIO sequenced with a CPI, and 6 patients who have crossed the 12-month survival

follow-up are continuing the treatment," said Vlad Vitoc, M.D., Chairman and Chief Executive Officer of MAIA. "With current

therapies, second-line patients' treatment duration is usually around 3-4 months1 and third-line is even lower than

that. It is very encouraging to see that our patients can remain on treatment for much longer. The ongoing benefits of THIO in longer-term

patients are particularly notable, signifying THIO's potential as a durable and efficacious treatment for advanced NSCLC patients

faced with limited options."

(6-thio-dG or 6-thio-2'-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development

to evaluate its activity in Non-Small Cell Lung Cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role

in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2'-deoxyguanosine (THIO)

induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. THIO-damaged telomeric

fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential

treatment with THIO followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models

by induction of cancer type-specific immune memory. THIO is presently developed as a second or later line of treatment for NSCLC

for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

THIO-101, a Phase 2 Clinical Trial

is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate THIO's anti-tumor

activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of THIO administered prior to cemiplimab

(Libtayo ) will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance

and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives:

(1) to evaluate the safety and tolerability of THIO administered as an anticancer compound and a priming immune activator (2) to assess

the clinical efficacy of THIO using Overall Response Rate (ORR) as the primary clinical endpoint. Treatment with cemiplimab (Libtayo )

followed by THIO has been generally well-tolerated to date in a heavily pre-treated population. For more information on this Phase II

trial, please visit ClinicalTrials.gov using the identifier NCT05208944.

MAIA Biotechnology, Inc.

is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with

novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is

THIO, a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive

cancer cells. For more information, please visit www.maiabiotech.com.

cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements.

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