Ir CPI

Topline data expected in second half of 2024THIO-101 will be the first completed clinical study of a telomere targeting agent in the field of cancer drug discovery and treatment CHICAGO, IL, Feb. 22, 2024 (GLOBE NEWSWIRE) -- MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced that enrollment is now complete in its Phase 2 THIO-101 go-to-market clinical trial evaluating THIO sequenced with the immune checkpoint inhibitor (CPI) cemiplimab (Libtayo®) in advanced non-small cell lung cancer (NSCLC). 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. “Enrollment in our Phase 2 THIO-101 trial has been strong from the start. With excellent results across all doses and our selection of the optimal dose in December 2023, we enrolled the necessary number of patients in the Simon 2-stage design to achieve our trial endpoints earlier than expected,” said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer. “THIO-101 preliminary data has demonstrated unprecedented rates of disease control and response to date, and we look forward to the long-term efficacy results as we continue to monitor the enrolled patients in the upcoming months. As the only direct telomere targeting agent currently undergoing clinical development in the field of cancer, we believe THIO holds a time-to-market advantage and strong potential to become a new standard of care for NSCLC.” The main objectives of the THIO-101 trial are to evaluate the safety, tolerability, and preliminary clinical efficacy of THIO in patients with advanced NSCLC who have experienced disease progression or relapse after initial treatments with an immune CPI alone or in combination with chemotherapy. About THIO THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer (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 (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 (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with THIO followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. 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. About THIO-101, a Phase 2 Clinical Trial THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate THIO’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of THIO administered prior to cemiplimab (Libtayo®) will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of THIO administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of THIO using Overall Response Rate (ORR) as the primary clinical endpoint. Treatment with cemiplimab (Libtayo®) followed by THIO has been generally well-tolerated to date in a heavily pre-treated population. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944. About MAIA Biotechnology, Inc. MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is THIO, a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com. Forward Looking Statements MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries. Investor Relations Contact +1 (872) 270-3518ir@maiabiotech.com

Funding will enable Bioxodes to continue clinical development of drug candidate for patients with intracerebral hemorrhage Recruitment of first patient for phase IIa proof-of-concept clinical trial due before end of Q4, 2023 GOSSELIES, Belgium I November 21, 2023 I Bioxodes SA, a biopharmaceutical company specializing in the development of novel therapies for the prevention and treatment of thrombotic and inflammatory diseases, today announces €12 million ($13M) in a Series A funding from historic investors. This financial backing includes €8.6 million ($9.3M) in capital and €3.4 million ($3.7M) in non-dilutive funding from the Wallonia region. It comes on top of the €27 million ($29.2M) in capital and subsidies previously raised by Bioxodes, bringing to €39 million ($42.2M) the total funding secured by the company since its creation. This new funding will allow Bioxodes to continue the clinical development of its main drug candidate, Ir-CPI, for patients with intracerebral hemorrhage (ICH), right through to the end of phase IIa. The company also intends to use the proceeds to pursue new preclinical R&D work into the effect of Ir-CPI on neutrophils, which are key components in the neuro-inflammatory process. “We’re excited to embark on the next strategic phase for Bioxodes, which will enable us to generate clinical data around the safety and efficacy of our drug candidate for patients with intracerebral hemorrhage,” said Marc Dechamps, CEO at Bioxodes. “I want to thank our historic investors for their renewed support. Our aim now is to keep our clinical development program moving forward by launching plans for our phase IIb efficacy trial, which is scheduled for 2025. With this important milestone on the horizon, we are already preparing for a Series B funding round in Q2, 2024.” “I am proud of this latest funding round for Bioxodes,” said Pierre Detrixhe, chairman of the board at Bioxodes. “The company’s drug candidate offers real potential for treating patients with intracerebral hemorrhage. The clinical data collected during the phase IIa trial will be vital in securing future funding for the business, notably for the upcoming phase IIb trial.” “This latest funding round represents an important milestone in the clinical development of Ir-CPI. Currently there is no treatment available for patients following an intracerebral hemorrhage,” said Hans Warrinnier, chief medical officer at Bioxodes. “Our drug candidate answers a key unmet medical need identified by clinical experts in this indication. By generating clinical data around intracerebral hemorrhage, we are taking an important step forward in treating this condition.” Strokes are currently the leading cause of disability and the second-leading cause of death worldwide. Data from 2022 indicates that the risk of someone suffering a stroke has increased by 50% in the last 20 years. It is now estimated that one in four people will experience a stroke at some point in their lifetime. Every year, more than 3.4 million people suffer an intracerebral hemorrhage, which equates to 28% of all stroke cases worldwide. Legal adviser: Attorney at Law - Ms. Francine Messinne, CEW-Partners About Ir-CPI Ir-CPI is a first-in-class drug candidate. Thanks to its unique mode of action, it prevents both the formation of unwanted blood clots and any increased risks of bleeding (action on factors XIa and XIIa). By inhibiting neutrophils activation, it also prevents the acute neuroinflammatory events associated with intracerebral hemorrhage. Derived from a tick’s saliva, this product could become the first injectable antithrombotic drug suitable for use in patients within the first 72 hours of intracerebral hemorrhage. The market for an injectable form of such a molecule, primarily for use in hospitals, is estimated to be worth more than one billion dollars per year. About Bioxodes Bioxodes specializes in the development of novel therapies for the prevention and treatment of thrombotic and inflammatory diseases. Since its founding in 2013, Bioxodes has developed its own flagship program based around its Ir-CPI molecule. Ir-CPI is a first-in-class drug candidate aimed at patients with thromboinflammatory disease. The company, which is based in Gosselies in Belgium, has so far secured €39 million in funding from Belgian investment funds and business angels, including €8.5 million in non-dilutive funding from the Wallonia region. Worldwide, Bioxodes holds both granted and pending patents associated with Ir-CPI. www.bioxodes.com SOURCE: Bioxodes