VladVitoc, Founder and CEOAs a leading targeted immune-oncology company, MAIA Biotechnology capitalizes on our expertise in telomeres and telomerase to develop drugs with new mechanisms of action that can improve the lives of people with cancer. “Our novel anti cancer agent THIO is the first-of-its-kind small molecule targeting telomeres in cancer cells and may have potential curative effect against a number of tumors types,” says Vlad Vitoc, the Founder and CEO of MAIA. Based on the designed efficient and fast mechanisms of action to treat telomere-positive cancers, THIO can selectively kill cancer cells by modifying telomeric DNA structure and function through utilizing of telomerase activity.
The telomerase enzyme in the human cancer cells quickly recognizes THIO’s in situ formed metabolite and then incorporates it into the de novo synthesized telomere structures. Thus, the THIO-incorporated telomeres rapidly induce DNA damage recognition in cancer cells without affecting other normal telomerase-silent tissues. In addition, THIO can create telomeric DNA-mediated innate immune system sensing and activation of immune responses helping not only to improve anti-tumor effect, but also potentially maintain long-term efficacy in cancer patients.
The administration of THIO is a simple process that takes place in two phases. In the first phase, the drug is injected intravenously, once a day for 3 consecutive days.
Behind the ongoing success of MAIA lies its leadership team of physicians, oncologists, and industry experts who hold extensive experience in clinical research and drug development in the oncology space. Vitoc himself has developed and commercialized several novel anti-cancer drugs for multiple tumor types.
The second phase of administration begins two days after the completion of the first stage. Here, THIO is administered with a checkpoint inhibitor Libtayo, developed by Regeneron Pharmaceuticals, to complete the therapy cycle. This treatment regimen should generate an anti tumor-specific immune memory in patients that may prevent tumor recurrence. The cycle is repeated every three weeks.
At present, MAIA has one clinical development program underway, THIO 101, with another two additional programs to follow. In THIO 101, the company is using the drug in sequential combination with (cemiplimab) Libtayo© to evaluate its safety and immunogenicity in non-small cell lung cancer. As a dose optimization trial, MAIA is testing four different doses of THIO to select the optimal one based on the overall response rate.
MAIA is looking for potential partnerships to begin Phase 2 trials of its THIO 102 program that focuses on colorectal cancer. Since colorectal cancer is an “immunologically cold” type, the checkpoint inhibitors used in immunotherapy are often inefficient in treating it. THIO makes the tumor “immunologically hot” to ensure the effectiveness of immunotherapy in colorectal cancer therapeutics. In addition, MAIA plans to initiate its THIO 103 Phase 2 study, a basket trial that may involve up to six different tumor types, including HCC, glioblastoma, prostate, breast, ovarian, and pancreatic cancer. “We envision testing THIO against a large number of tumor types and to use a variety of immune checkpoint inhibitor combinations to realize the full therapeutic potential benefit of this novel approach” says Vitoc.
We envision testing THIO against as many tumor types and checkpoint combinations as possible to realize its full potential to benefit a large population of patients
As an agile startup, MAIA continues to add several professionals with deep expertise in oncology clinical development to its team. Dr. Vitoc and his team are confident about making MAIA a prominent biotech company by 2025 with IPO plans in the pipeline.
MAIA Biotechnology Announces Updates in Enrollment in Phase II Clinical Trial: THIO-101 Has Enrolled 29 Patients
Wednesday, June 21, 2023
CHICAGO - MAIA Biotechnology, Inc. (NYSE American: MAIA) announced today that 29 patients have been dosed in MAIA’s Phase 2 clinical trial, THIO-101, evaluating THIO in patients with advanced Non-Small Cell Lung Cancer (NSCLC). With the addition of sites in Hungary, Poland, and Bulgaria in March 2023, THIO-101 has rapidly increased the number of patients enrolled and dosed with THIO. Thirteen sites were activated with another two new additional sites ready to open in the coming weeks.
THIO is an innovative anti-cancer drug that specifically targets telomeres in cancer cells. It is used in combination with a checkpoint inhibitor (CPI). The primary goals of the THIO-101 clinical trial are to assess the safety, tolerability, and early clinical effectiveness of THIO in individuals with advanced non-small cell lung cancer (NSCLC). These patients have encountered disease progression or relapse after receiving initial treatment with an immune CPI alone or in combination with chemotherapy. The trial enrolled its inaugural participant in Australia in July 2022 and later expanded to involve patients from Europe in March 2023.
“We are very pleased with the progress of enrollment in Europe. Since our last update, we have more than doubled the number of patients dosed to 29, bringing us closer to our target of 184 patients planned to be treated in the trial. With a large number of lung cancer cases in Europe, we anticipate a robust rate of enrollment in the upcoming weeks,” stated Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer.
“With rapid enrollment in the trial, we project a substantial number of patients completing 3-6 months of treatment by the fall which will allow us a preliminary evaluation of the treatment efficacy,” added Mihail Obrocea, MD, MAIA’s Chief Medical Officer.
FDA Grants Orphan Drug Designation to MAIA Biotechnology for THIO as a Treatment for Glioblastoma
Monday, November 20, 2023
• Third orphan drug designation (ODD) granted to THIO by the FDA; drug also holds ODDs for hepatocellular carcinoma and small cell lung cancer
• Benefits include 7 years of U.S. market exclusivity after drug approval and tax credits for qualified clinical testing
• Expected glioblastoma market growth from $2.2 billion to $3.2 billion globally in the next three years
CHICAGO -- MAIA Biotechnology, Inc., announced today that the U.S. Food and Drug Administration (“FDA”) has granted orphan drug designation to its lead asset THIO, a cancer telomere-targeting agent, for the treatment of glioblastoma. This is the third orphan drug designation granted to THIO, following the receipt of orphan drug designations for hepatocellular carcinoma (HCC) and small cell lung cancer (SCLC) in 2022.
“We are pleased to receive a third orphan drug designation for THIO, further highlighting FDA’s recognition of THIO’s potential in the treatment of multiple cancer indications, including rare ones such as glioblastoma,” said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer. “Each year, globally, more than 300,000 people are diagnosed with brain tumors, of which, 25,000 are in the United States. Glioblastoma represents the majority of these cases in the U.S., with 15,000 new patients diagnosed and more than 10,000 deaths yearly, making it an orphan indication. Given this prevalence there is significant room for growth in the $2.2 billion glioblastoma market, which is expected to reach $3.2 billion globally in the next three years.1 We consider this ODD an important milestone for our development strategy and for glioblastoma patients who could benefit from a potentially revolutionary therapy.”
“In the data presented to the FDA, THIO successfully penetrated the blood brain barrier (BBB) in syngeneic and humanized mouse models of telomerase-expressing brain cancers. Treatment with THIO resulted in potent anticancer activity and significant expansion of the animal lifespan for several difficult to treat cell lines and xenograft mouse models,” added Sergei Gryaznov, Ph.D., MAIA’s Chief Scientific Officer. “These results stem from THIO’s remarkable mechanism of action and its BBB penetrating property that allows for direct targeting of brain tumors in vivo and potentially in glioblastoma patients.”
“Glioblastoma is the most aggressive and most common type of cancer that originates in the brain. With very limited treatment options available, glioblastoma patients have exceptionally short survival durations, and only 7% remain alive five years after being diagnosed with the condition,”2 said Mihail Obrocea, MD, MAIA’s Chief Medical Officer. “We are optimistic about our telomere-targeting agent’s ability to provide clinical benefit in patients with glioblastoma, and we look forward to studying THIO for the treatment of this highly unmet medical indication in a future trial.”
Enrollment is ongoing in a Phase 2 trial of THIO, THIO-101, evaluating the drug candidate in patients with advanced non-small cell lung cancer (NSCLC). THIO is the only direct telomere targeting agent currently in clinical development.
MAIA Biotechnology Provides Positive Phase 2 Clinical Updates for Lead Anticancer Agent and Outlines Targeted Milestones for 2024
Friday, January 19, 2024
• Lead candidate THIO maintains unprecedented disease control rates in Phase 2 non-small cell lung cancer (NSCLC) clinical trial
• Multiple clinical milestones ahead for THIO-101 Phase 2 trial
• Company enters 2024 with robust clinical pipeline in multiple hard-to-treat cancer indications
CHICAGO - MAIA Biotechnology, Inc., announced new interim data for its ongoing THIO-101 Phase 2 trial in non-small cell lung cancer (NSCLC) and outlined key clinical milestones for 2024.
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.
“We are entering 2024 with strong momentum and great excitement about our programs and pipeline,” said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer. “To date, preliminary Phase 2 data on THIO in NSCLC has demonstrated unprecedented rates of disease control and response — measures that vastly outperform the standard of care.”
“In addition to NSCLC, our pipeline of immuno-oncology therapies includes THIO orphan drug designations for multiple hard-to-treat cancers, and our research includes THIO-like second-generation telomere-targeting agents. The main objective for the second-generation program is to discover new compounds with potentially improved specificity towards cancer cells relative to normal cells and with potentially increased anticancer activity,” Dr. Vitoc continued.
“Multiple milestones are on target for 2024 as enrollment continues in THIO-101, including long-term efficacy as a major clinical inflection point.”
Key 2023 Achievements
Positive Preliminary Efficacy Data: Key findings from THIO-101 included:
100% preliminary disease control rate (DCR) in second-line and 88% in third-line, in highly difficult-to-treat patients who already progressed through previous lines of treatment.
DCR across all dose levels met pre-determined statistical requirements earlier than expected to proceed to next stage of the trial.
Third orphan drug designation (ODD) granted to THIO: MAIA’s portfolio of immuno-oncology therapies with ODDs now includes a third hard-to-treat cancer, glioblastoma, the most aggressive and most common type of brain cancer with only limited treatment options.
U.S. FDA Investigational New Drug (IND) Clearance: The FDA cleared U.S.-based evaluation for THIO as part of THIO-101. The trial drew a strong pace of enrollment in 2023 compared with previous NSCLC trials by other drug developers.
Dose Selection: A 180mg/cycle dose of THIO was selected for THIO-101 based on stronger efficacy compared to other doses. The selected dose showed unprecedented disease control and overall response rates for a NSCLC clinical trial.
Next Generation Telomere Targeting Agents: MAIA’s second-generation telomere-targeting program is engaged in research and development for new prodrugs derived from lipid-modified THIO molecules. Capable of acting through similar mechanisms of activity as THIO, the higher potency of these compounds at lower dose levels will be investigated further in 2024.
THIO is the only direct telomere targeting agent currently undergoing clinical development in the field of cancer drug discovery and treatment.
