On July 10, 2023, we announced updates on preliminary survival data in the Part A
safety lead-in of THIO-101. The first 2 patients enrolled in the study continued to be alive, approximately 12.2 and 11.5 months respectively, from treatment initiation.
Both patients have advanced Stage IV metastatic disease and failed 2 prior lines of therapy, including one line with an immune checkpoint inhibitor (CPI), and platinum-based chemotherapy. Following the conclusion of study treatment, they have
remained free of disease progression for 10.2 and 8.5 months, respectively, without requiring any additional therapy.
On July 11,
2023, we announced updates on disease control data in the part A safety lead-in of THIO-101. Of the first 11 patients enrolled in
THIO-101 to complete at least 1 post baseline response assessment, 9 (82%) met the primary endpoint of disease control (defined as a Complete Response, Partial Response, or Stable Disease per RECIST 1.1). All
patients enrolled have previously failed 2 or more prior lines of treatment including an immune CPI and platinum-based chemotherapy for advanced NSCLC.
On October 24, 2023, we reported unprecedented interim disease control rate (DCR) of 100% in second-line of treatment that far surpasses
standard of care (SoC) DCR of 53-64%, presented at ESMO 2023. DCR is far stronger than overall response rate (ORR) in predicting overall survival benefit, as shown in a recent meta-analysis of 74 clinical
trials worldwide in NSCLC.
On December 19, 2023, we announced dose
selection for THIO-101, a Phase 2 clinical trial evaluating its lead asset, THIO, in sequential combination with
Regenerons anti-PD-1 cemiplimab (Libtayo®) in patients with
advanced non-small cell lung cancer (NSCLC). During the dose-finding stage of THIO-101, patients were administered either 60mg, 180mg, or 360mg of
THIO per cycle, followed by 350mg of cemiplimab (Libtayo®). The selected dose, 180mg/cycle, presented better safety profile and outperformed the other doses in the key measures of efficacy for
NSCLC trials. Subsequently, all future trial participants will be treated with THIO 180mg/cycle.
On January 17, 2024, we announced
new interim data for our ongoing THIO-101 Phase 2 trial in non-small cell lung cancer (NSCLC). In the latest available data from
THIO-101 (November 13, 2023), 60 patients had been dosed with THIO in sequential combination with Libtayo®. The patients received either 60mg, 180mg, or
360mg of THIO per dose, and 42 had at least one post baseline assessment completed. The observed disease control was well sustained compared to previous scans.
On February 7, 2024, we announced publication of international Patent Cooperation Treat (PCT) application titled Dinucleotides and Their
Use in Treating Cancer. The new dinucleotides disclosed in the patent application are telomere-targeting molecules, such as THIO fragments or other THIO analogues. These compounds are key next-generation telomere-targeting agents, an important
extension of MAIAs innovative cancer treatment platform. The PCT system streamlines the process for obtaining patent protection globally. Under the PCT, applicants can seek patent protection in a large number of countries.
On February 22, 2024, we announced completion of enrollment in Phase 2 THIO-101 go-to-market clinical trial. The trial reached the enrollment
target of 41 patients for the 180mg/dose on February 19, 2024. As of the latest data available for the trial, 79 patients had received either 60mg (24 patients), 180mg (41 patients) or 360mg (14 patients). The original trial design targeted up to
182 patients, including all patients in the safety lead-in and 41 patients in each of the 3 tested doses (60mg, 180mg, and 360mg). Following the selection of 180 mg/cycle as the optimal dose in December 2023, all patients were subsequently enrolled
at the 180mg/cycle dose and trial enrollment was completed ahead of schedule.
On March 6, 2024, we announced interim efficacy data for
THIO-101 Phase 2 trial in NSCLC. In the latest data available (January 8, 2024), the overall response rate (ORR), characterized as partial or complete response to therapy, was 38% (3 out of 8 patients) in the efficacy evaluable population for
combination THIO 180mg + cemiplimab in third-line treatment for NSCLC patients who failed treatment with immune checkpoint inhibitors in prior lines of therapy, with or without chemotherapy.