Full Press Release Details
Biotechnology Announces Positive Efficacy Updates for Phase 2 THIO-101 Trial in Advanced Non-Small Cell Lung Cancer
| Median overall survival (OS) from THIO treatment extends to 16.9 months | ||
| Newest data strengthens regulatory strategy |
- February 04, 2025 - MAIA Biotechnology, Inc., (NYSE American: MAIA) ("MAIA", the "Company"), a clinical-stage
biopharmaceutical company developing targeted immunotherapies for cancer, today announced positive updated data from its THIO-101 pivotal
Phase 2 clinical trial evaluating its lead clinical candidate, THIO, sequenced with Regeneron's immune checkpoint inhibitor (CPI)
cemiplimab (Libtayo ) in patients with advanced non-small cell lung cancer (NSCLC) who failed two or more standard-of-care
of January 15, 2025, third line (3L) data showed median overall survival (OS) of 16.9 months for the 22 NSCLC patients who received at
least one dose of THIO (the intent-to-treat population) in parts A and B of the trial. The analysis demonstrated a 95% confidence interval
(CI) lower bound of 12.5 months and a 99% CI lower bound of 10.8 months. The treatment has been generally well-tolerated to date in this
heavily pre-treated population1. Studies of standard-of-care (SOC) chemotherapy treatments for NSCLC in a similar setting
have shown OS of 5 to 6 months.2
with THIO now shows a 99% probability that overall survival will extend past chemotherapy's measure by a wide margin," said
Vlad Vitoc, M.D., CEO of MAIA. "THIO's efficacy in advanced stages of NSCLC continues to exceed our expectations, especially
in third-line treatment where the cancer is typically even more resistant to therapy. Our findings suggest great benefits to patients
with unmet medical needs who see little hope for the future.
our latest overall survival results, our outlook for potential FDA commercial approval of THIO is stronger than ever," Dr. Vitoc
on its regulatory strategy, MAIA believes there could be an opportunity for accelerated FDA approval of THIO depending on final results
from the ongoing expansion of the THIO-101 trial.
(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.
Details on safety can be found on the previously announced SITC 2024 presentation available on MAIA's website.
Girard N, et al. J Thorac Onc 2009;12:1544-1549.
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
THIO followed by cemiplimab (Libtayo ) 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.
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