MAIA Biotechnology Reports Positive Phase 2 Clinical Trial Data On Its Treatment For Non-Small Cell Lung Cancer

Rhea-AI Summary

MAIA Biotechnology reports positive phase 2 clinical trial data on its treatment for non-small cell lung cancer, showing a 100% Disease Control Rate (DCR) in second-line treatment and an 88% DCR in third-line treatment, surpassing standard-of-care rates. The trial is ahead of schedule and aims to evaluate the efficacy of THIO followed by PD-(L)1 inhibition.

Positive

• MAIA Biotechnology's phase 2 trial for its treatment of non-small cell lung cancer (NSCLC) has shown promising results. The trial reported a 100% Disease Control Rate (DCR) in second-line treatment, exceeding the standard-of-care rate of 53% to 64%. In third-line treatment, the trial achieved an 88% DCR, far surpassing the approximate 30% DCR reported in existing studies. These results demonstrate the potential efficacy of MAIA Biotechnology's treatment compared to standard-of-care treatments.
• The trial, known as THIO-101, is the first to evaluate the anti-tumor activity of THIO followed by Regeneron's anti-PD-1 cemiplimab (Libtayo®). It aims to enhance and prolong immune response in patients with advanced NSCLC who did not respond to or developed resistance after first-line treatment with a checkpoint inhibitor. The preliminary efficacy data released ahead of schedule met statistical requirements, boosting confidence in the trial's advancement and the eventual availability of the novel treatment for advanced-stage NSCLC patients.
• The exceptional preliminary results of the THIO-101 trial highlight the potential impact of MAIA Biotechnology's treatment on NSCLC. The perfect Disease Control Rate in second-line treatment and the strong correlation between DCR and overall survival benefit demonstrate the efficacy of the treatment. These results have the potential to significantly improve the response to NSCLC, a deadly disease.

Negative

• None.

New results from a targeted therapy and immuno-oncology company show the promising potential efficacy of one of its first-in-class treatments.

CHICAGO, IL / ACCESSWIRE / October 31, 2023 / MAIA Biotechnology Inc. (NYSE:MAIA) is focused on the development and commercialization of drugs that improve and extend the lives of people with cancer. The company's lead program is THIO, an investigational telomere-targeting agent that is currently being developed as a second or later line of treatment for Non-Small Cell Lung Cancer (NSCLC) for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

On Oct. 24, MAIA Biotechnology reported a 100% Disease Control Rate (DCR) in second-line treatment for NSCLC in its ongoing phase 2 trial, THIO-101. The preliminary efficacy data including a 100% Disease Control Rate (DCR) observed in the second-line treatment of NSCLC is promising given that the number surpasses the standard-of-care DCR, which ranges from 53% to 64%.

Additionally, 88% DCR was achieved in third-line treatments in the trial, far exceeding the approximate 30% DCR reported in existing studies. These results even outperform the standard-of-care 71% DCR in first-line treatment, and further lend credence to the utility of DCR as a strong predictor of overall survival benefit.

Ahead Of Schedule

THIO-101 is the first trial designed to evaluate THIO's anti-tumor activity when followed by PD-(L)1 inhibition. The ongoing THIO-101 phase 2 clinical trial has two primary objectives: Evaluating safety and assessing clinical efficacy using Overall Response Rate (ORR) as the primary clinical endpoint.

The trial is testing a studied hypothesis by experts who believe that low doses of THIO administered before Regeneron's anti-PD-1 cemiplimab (Libtayo®) will enhance and prolong immune response in patients with advanced NSCLC - specifically those who previously did not respond or developed resistance and progressed after a first-line treatment regimen containing a checkpoint inhibitor.

Overall, the data released on Oct. 24 met pre-determined statistical requirements ahead of schedule, bolstering the company's confidence in advancing the trial and, eventually, bringing the novel treatment to patients with advanced-stage NSCLC. MAIA Chief Executive Officer Dr. Vlad Vitoc emphasized the unparalleled nature of these results, especially impressive given they were obtained in a highly difficult-to-treat patient population who had already progressed through previous lines of treatment.

DCR was recently established by a meta-analysis of 74 NSCLC clinical trials in second-line treatment and beyond. As a result, the probability of commercial approval success has increased. In NSCLC patients who received at least one line of therapy, DCRs have shown to be excellent predictors of overall survival. Corroborated by recent meta-analysis, these exceptional preliminary results underscore the company's confidence in advancing the trial to bring MAIA Biotechnology's novel treatment to advanced-stage NSCLC patients, Vitoc said.

Even as an ongoing phase 2 trial from MAIA Biotechnology, THIO-101's unprecedented preliminary efficacy data, which reported a perfect Disease Control Rate in second-line treatment for Non-Small Cell Lung Cancer, is a significant breakthrough for the response to this deadly disease. With results that underscore the utility of DCR as a strong predictor of overall survival benefit, this new data shows THIO's potentially significant impact on NSCLC treatment.

For more information on this phase 2 trial, visit clinicaltrials.gov using the identifier NCT05208944.

Featured photo by National Cancer Institute on Unsplash.

Contact:

Investor Relations
ir@maiabiotech.com

SOURCE: MAIA Biotechnology

View source version on accesswire.com:
https://www.accesswire.com/797993/maia-biotechnology-reports-positive-phase-2-clinical-trial-data-on-its-treatment-for-non-small-cell-lung-cancer

FAQ

What are the results of MAIA Biotechnology's phase 2 clinical trial for non-small cell lung cancer?

The trial reported a 100% Disease Control Rate (DCR) in second-line treatment and an 88% DCR in third-line treatment, surpassing standard-of-care rates.

What is the objective of the THIO-101 trial?

The THIO-101 trial aims to evaluate the efficacy of MAIA Biotechnology's treatment for advanced NSCLC when followed by Regeneron's anti-PD-1 cemiplimab (Libtayo®).

What is the significance of the preliminary efficacy data from the trial?

The preliminary efficacy data demonstrates the potential of MAIA Biotechnology's treatment compared to standard-of-care treatments, with a perfect Disease Control Rate in second-line treatment and a strong correlation between DCR and overall survival benefit.

What is the impact of these results on the response to non-small cell lung cancer?

The results have the potential to significantly improve the response to non-small cell lung cancer, a deadly disease.