MAIA Biotech Completes Enrollment For Phase 2 Trial Of Its Candidate THIO To Fight Non-Small Cell Lung Cancer
Detroit, Michigan
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February 29, 2024 08:15 AM Eastern Standard Time
By Meg Flippin, Benzinga
MAIA Biotechnology Inc. (AMEX: MAIA), the clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, completed enrollment for its phase 2 trial for THIO, its lead therapy to fight advanced non-small cell lung cancer or NSCLC.
NSCLC is a disease in which cancer cells form in the tissues of the lung. It’s the most common form of lung cancer in the U.S., accounting for 81% of lung cancer diagnoses. The five-year survival rate for this type of cancer is 28%.
THIO targets and compromises the function of telomeres, which play a key role in helping cancer cells live and spread. Telomeres are made from DNA sequences and proteins and sit at the end of chromosomes, capping and protecting them in the cell division progress. Telomeres can be regenerated with the support of telomerase, an enzyme present in the early stages of growth and development in humans and in very few cells of adults. Telomerase is present in nearly all cancers and is expressed in 80% of NSCLC tumors.
Evaluating The Effectiveness
THIO is recognized by telomerase, leading to the uncapping of telomeres and thus resulting in rapid tumor cell death. THIO induces telomerase-dependent telomeric DNA modification, DNA damage responses and selective cancer cell death. The phase 2 THIO-101 go-to-market clinical trial is designed to evaluate THIO sequenced with the immune checkpoint inhibitor cemiplimab (Libtayo®) in patients with NSCLC. In preclinical models in vivo, MAIA demonstrated that low doses of THIO followed by anti-PD-L1 or anti-PD1 therapy completely eliminated advanced tumors and produced cancer cell-specific memory to activate the immune system against the cancer cells after extended periods with no need for additional treatment.
Enrollment Reached Ahead Of Schedule
Earlier in February, the trial reached its enrollment target of 41 patients for the 180 mg dose. Initially, the trial was designed to test three dose levels but following the selection of 180 mg/cycle as the optimal dose in December all patients were enrolled at that dose level and trial enrollment was completed ahead of schedule, the company said in a press release.
“Enrollment in our Phase 2 THIO-101 trial has been strong from the start. With excellent results across all doses and our selection of the optimal dose in December 2023, we enrolled the necessary number of patients in the Simon 2-stage design to achieve our trial endpoints earlier than expected,” said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer when announcing the enrollment results. “THIO-101 preliminary data has demonstrated unprecedented rates of disease control and response to date, and we look forward to the long-term efficacy results as we continue to monitor the enrolled patients in the upcoming months.”
THIO Well Tolerated
The main objectives of the trial are to evaluate the safety, tolerability and preliminary clinical efficacy of THIO in patients with advanced NSCLC who have experienced disease progression or relapse after initial treatments with an immune CPI alone or in combination with chemotherapy. THIO is currently being developed as a second or later line of treatment for NSCLC patients who have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors. MAIA Biotechnology said treatment with THIO followed by cemiplimab (Libtayo®) followed by THIO has been generally well tolerated to date in a heavily pre-treated population.
“As the only direct telomere targeting agent currently undergoing clinical development in the field of cancer, we believe THIO holds a time-to-market advantage and strong potential to become a new standard of care for NSCLC,” said Vitoc.
While THIO is currently being tested for NSCLC, telomerase is present in 85% to 95% of human cancers and contributes to the proliferation and reproductive immortality of cancer cells. As a result, the company is studying THIO in models of several tumor types with active telomerase, including rate indications in liver, colorectal and brain cancers. That could result in further use cases for MAIA’s lead treatment.
Featured photo by National Cancer Institute on Unsplash.
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