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

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

MAIA Biotechnology Inc. 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 REGN 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.

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