MAIA :THIO combo with checkpoint immune therapies showed tumor inhibition

MAIA Biotechnology announced it intends to initiate its second Phase 2 go-to-market trial evaluating THIO, the world’s first telomere-targeting agent, in patients with four cancer indications. The FDA has awarded MAIA‘s lead anti-cancer agent THIO two Orphan Drug Designations, based on the preclinical efficacy data, for liver, hepatocellular carcinoma, and small cell lung cancer models. The trial is designed to evaluate THIO in sequential combination with the immunotherapies pembrolizumab or atezolizumab, which are the most used checkpoint inhibitors in Oncology. A third immunotherapy checkpoint inhibitor could be added later such as nivolumab, durvalumab, dostarlimab, etc. The trial previously demonstrated positive and encouraging preclinical results in colorectal, liver, and small cell lung cancer models. Treatment with THIO sequentially followed by pembrolizumab results in highly potent anticancer effect, as compared to the effects of pembrolizumab alone. THIO converts immunologically "cold" non-responsive SCLC tumor into "hot" and responsive to pembrolizumab. Treatment with THIO in combination with IR and atezolizumab results in a complete regression of aggressive HCC tumors. At the same time, the combination of IR and atezolizumab is just partially efficacious. "The THIO-102 trial is operationally on track to begin enrolling patients later this year," said Mihail Obrocea, MD, MAIA’s Chief Medical Officer. "Based on the data generated on these indications, we are targeting accelerated approvals in these tumor types; in addition, we have now added a fourth arm which includes solid tumors of all types, that will serve as a signal generation arm; we will include telomerase positive breast, prostate, gastric, pancreatic, ovarian, along with potentially other tumor types." "These are patients that are facing very limited treatment options, usually chemotherapy with minimal efficacy and high toxicity," said MAIA Chairman and Chief Executive Officer Vlad Vitoc, M.D. "THIO sequenced with an immune checkpoint inhibitor has demonstrated complete tumor regression in several cancer preclinical models. We are very confident THIO can substantially improve on the limited clinical efficacy shown so far by atezolizumab, pembrolizumab and others. This go-to-market trial – THIO 102 – may provide THIO with more than 9 additional indications. Our existing trial with non-small cell lung cancer is another indication, potentially giving THIO more than 10 indications in total. Most oncology compounds at this stage of development have only one. We have 10 shots on goal!""