MAIA Biotechnology(US:MAIA)2022-11-03 15:57Pipeline and Clinical Trials - THIO-101 is in a Phase 2 trial for Non-Small Cell Lung Cancer (NSCLC), combining THIO with LIBTAYO® (cemiplimab), with plans to evolve into a pivotal trial including US sites and a readout expected in 2024 and potential accelerated approval filing in 2025[2] - THIO-102 is planned to initiate a pivotal Phase 2 trial in 2023 for CRC, HCC, and SCLC, sequenced with Libtayo, Keytruda, or Tecentriq[2] - The company anticipates 30-60% ORR (Overall Response Rate) with THIO → LIBTAYO in NSCLC, compared to 11-23% with current SOC (chemo)[14] - The company anticipates 6-12 months PFS (Progression-Free Survival) with THIO → LIBTAYO in NSCLC, compared to 4-4.5 months with current SOC (chemo)[14] - The company anticipates 14-20 months OS (Overall Survival) with THIO → LIBTAYO in NSCLC, compared to 8.1-10.5 months with current SOC (chemo)[14] THIO Mechanism and Preclinical Data - Telomerase is present in over 85% of human cancer cells across various tumor types[4] - Preclinical studies showed complete response with no recurrence in lung, colorectal, and liver cancers using THIO[3] - THIO induces telomere dysfunction-induced foci (TIFs) in telomerase-positive cancer cells, but not in normal cells[51] - In vivo studies in colorectal cancer (CRC) showed that THIO followed by PD-L1 blockade turned immunologically cold tumors "hot" and was curative[56] Market and Financials - The Immune Checkpoint Inhibitors market had sales of $23 billion in 2021[28] - NSCLC drug sales accounted for $12 billion of the $23 billion total checkpoint inhibitor sales in 2021[28] - As of June 30, 2022, the company had a cash balance of $8,150,012, with gross proceeds of $11.5 million from an IPO completed on August 1, 2022[33]