In an exclusive interview with The Fly, MAIA Biotechnology's (MAIA) CEO Vlad Vitoc talked about the company, its pipeline, upcoming milestones, and much more.
LEAD ASSET THIO: MAIA Biotechnology is a targeted therapy, immune-oncology company, focused on development of first-in-class drugs with novel mechanisms of action that are intended to "meaningfully improve and extend the lives of people with cancer." "MAIA Biotechnology is a clinical stage oncology company. Here, we develop drugs for the treatment of cancer and focus on the telomere targeting agents," Vitoc explained in an exclusive interview with The Fly. The company's lead asset THIO is an investigational dual mechanism of action drug candidate incorporating telomere targeting and immunogenicity. THIO is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer, or NSCLC.
Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2'-deoxyguanosine, or THIO, induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. THIO-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate and adaptive immune responses. The sequential treatment with THIO followed by PD-L1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory, the company says. THIO is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.
HIGH QUALITY DATA: Late last month, MAIA Biotechnology reported a 100% Disease Control Rate in second-line treatment for NSCLC in its ongoing phase 2 trial, THIO-101. The preliminary efficacy data is "promising given that the number surpasses the standard-of-care DCR, which ranges from 53% to 64%," the company said. Additionally, 88% DCR was achieved in third-line treatments in the trial, far exceeding the approximate 30% DCR reported in existing studies. The ongoing THIO-101 Phase 2 clinical trial has two primary objectives, namely to evaluate safety and assess clinical efficacy using Overall Response Rate as the primary clinical endpoint. "We presented data of the highest quality. I've never seen numbers like this. With a standard of care therapy, in first line of therapy, disease control rates are 70%, in second are 50%, and in third they're 30," the executive added.
THIO TRIALS: Aside from the trial in NSCLC, the company has two additional THIO trials planned. One of those is in colorectal, HCC, small cell lung cancer, while the other is a confirmatory/definitive approval basket study. "We have two trials planned and in fact, we'll have an additional one designed soon. There will be three trials soon. The drug THIO has a very broad spectrum of activity. So, we developed data in several tumor types, preclinically. Lung is one, but also liver -- extraordinary data in liver cancer, which is very difficult to treat --, brain cancer, small cell lung cancer, and colorectal cancer. We are planning to develop THIO in this indication as well," Vitoc explained.
SECOND-GENERATION PROGRAM: The company's THIO program drives the development pipeline of second-generation telomere targeting agents, which are still in a very early stage. "The second-generation program started about 18 months ago and we invented 84 new molecules. These molecules all work in the same manner, same mechanism of action, which is telomere targeting and immunogenic effect, training the immune system to attack the tumor and kill the tumor cells. And we tested them all in vitro and then in vivo, in animal models. Seven of them proved to be an order of magnitude compared to the original molecule in certain tumor types. So, we were developing them. Two of them started pre-IND development, then preclinical development towards IND, and we'll go to the clinic next year. And a third will start soon. We have four others in reserve that we're planning to start a new one every six to 12 months," MAIA's CEO told The Fly.
SEVERAL CATALYSTS AHEAD: Looking out over the remainder of the year and into early next year, MAIA's Vitoc highlights several upcoming catalysts. "We'll have several, but the most important catalyst coming up will be efficacy data from THIO 101. The first stop for efficacy was disease control rate and that is now in the bag. Next will be response rate. So, we're looking to see the tumors shrink. We are already seeing the shrinking effect in many patients, more to come. I think this will come in Q4 this year or at JPMorgan's conference. Then next year, we're going to plan a major beta release at ASCO in June in Chicago. And at that point, we will have selected the dose. We will have completed the enrollment in part B of the trial, which is the dose selection part, and selected a dose. And we'll be enrolling -- well underway -- in a registration cohort for accelerated approval, which we plan to finish by the end of next year. And then we plan to file for accelerated approval in 2025 with potential approval by end of 2025 or 2026" the executive says.
"Meet the Company" is The Fly's recurring series of exclusive short interviews with Executive Officers to offer a deeper look inside the company.