On April 20, 2023 MAIA Biotechnology, Inc. (NYSE American: MAIA) reported preliminary survival data in the Part A safety lead-in of its ongoing phase 2 trial, THIO-101 evaluating THIO in patients with advanced Non-Small Cell Lung Cancer (NSCLC) (Press release, MAIA Biotechnology, APR 20, 2023, View Source [SID1234630375]).

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The first 2 patients enrolled in Part A of the study continue to be alive, approximately 10 and 9 months respectively, from treatment initiation. Both patients have advanced Stage IV metastatic disease and are heavily pretreated, receiving third and fourth line of therapy respectively after previously failing treatment with an immune checkpoint inhibitor.

As previously reported, the first 6 evaluable patients in Part A of THIO-101 cleared the THIO high dose (THIO 360 mg per cycle (120 mg on Days 1-3 Q3W) followed by the standard 350 mg dose of cemiplimab on Day 5) with no dose limiting toxicities. Treatment has been generally well tolerated and enrollment is underway in Part B. As of now, the first 2 patients continue to be progression free following their last dose, 7 and 6 months respectively, with no new treatment.

"The current treatment options in patients with advanced relapsed or refractory NSCLC who failed two or more therapy regimens are limited and show minimal benefit. Furthermore, discontinuation of treatment is rapidly followed by physical decline and death, therefore seeing patients with such survival and no disease progression in this clinical setting, is noteworthy," says MAIA’s Chief Medical Officer Mihail Obrocea.

"This observation may correlate well with the evidence of induction of innate and adaptive immune responses seen in the preclinical models of lung cancer, where only three doses of THIO followed by an immune checkpoint inhibitor resulted in long-lasting complete tumor regression with no recurrence," says MAIA’s Chief Scientific Officer, Sergei Gryaznov.

"In real-world clinical practice, observed survival in such heavily pretreated patients is 3-4 months. These preliminary survival results are very encouraging for patients with lung cancer," added Vlad Vitoc, MAIA’s Chief Executive Officer.

About THIO-101, a Phase 2 Clinical Trial

THIO-101 is a multicenter, open-label, dosing finding Phase 2 clinical trial. It is the first trial designed to evaluate THIO’s potential immune system activation effects in NSCLC patients by administering THIO in advance of administration of an immune checkpoint inhibitor allowing for immune activation and PD-1 sensitivity to take effect. The trial will test the hypothesis that low doses of THIO administered prior to a checkpoint inhibitor 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 agent and a priming immune system agent (2) to assess the clinical efficacy of THIO using Overall Response Rate (ORR) as the primary clinical endpoint. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.

About THIO

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a telomere-targeting agent currently in clinical development to evaluate its activity in non-small cell lung cancer (NSCLC), in sequential administration with Regeneron’s anti-PD1 therapy, Libtayo (cemiplimab). Telomeres play a fundamental role in the survival of cancer cells and their resistance to current therapies. THIO is being 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.