CHICAGO, July 23, 2024–(BUSINESS WIRE)–MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Firm”), a clinical-stage biopharmaceutical firm growing focused immunotherapies for most cancers, as we speak pronounces optimistic remedy updates from its Section 2 scientific trial, THIO-101, evaluating THIO sequenced with the immune checkpoint inhibitor (CPI) cemiplimab (Libtayo®) in sufferers with superior non-small cell lung most cancers (NSCLC) who failed two or extra standard-of-care remedy regimens.
The trial’s therapeutic routine is cycled each 3 weeks, with THIO 180mg administered in 60mg incremental doses on days 1, 2 and three, adopted by immune activation on day 4 (no dosing), and cemiplimab 350mg administered on day 5. As of the most recent scientific cutoff date, June 12, 2024:
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6 sufferers stay on remedy following no less than 12 months of remedy.
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Remedy with THIO adopted by cemiplimab has been properly tolerated all through the trial, with a lot decrease toxicity in comparison with standard-of care remedies.
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Persevering with remedy previous 12 months demonstrates security, efficacy and ongoing profit from MAIA’s novel telomere concentrating on NSCLC remedy.
“Our longest handled affected person to this point has accomplished 21 cycles of THIO sequenced with a CPI, and 6 sufferers who’ve crossed the 12-month survival follow-up are persevering with the remedy,” mentioned Vlad Vitoc, M.D., Chairman and Chief Govt Officer of MAIA. “With present therapies, second-line sufferers’ remedy length is often round 3-4 months1 and third-line is even decrease than that. It is rather encouraging to see that our sufferers can stay on remedy for for much longer. The continued advantages of THIO in longer-term sufferers are significantly notable, signifying THIO’s potential as a sturdy and efficacious remedy for superior NSCLC sufferers confronted with restricted choices.”
About THIO
THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent at the moment in scientific improvement to judge its exercise in Non-Small Cell Lung Most cancers (NSCLC). Telomeres, together with the enzyme telomerase, play a basic function within the survival of most cancers cells and their resistance to present therapies. The modified nucleotide 6-thio-2’-deoxyguanosine (THIO) induces telomerase-dependent telomeric DNA modification, DNA injury responses, and selective most cancers cell demise. THIO-damaged telomeric fragments accumulate in cytosolic micronuclei and prompts each innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential remedy with THIO adopted by PD-(L)1 inhibitors resulted in profound and chronic tumor regression in superior, in vivo most cancers fashions by induction of most cancers sort–particular immune reminiscence. THIO is presently developed as a second or later line of remedy for NSCLC for sufferers which have progressed past the standard-of-care routine of current checkpoint inhibitors.
About THIO-101, a Section 2 Scientific Trial
THIO-101 is a multicenter, open-label, dose discovering Section 2 scientific trial. It’s the first trial designed to judge THIO’s anti-tumor exercise when adopted by PD-(L)1 inhibition. The trial is testing the speculation that low doses of THIO administered previous to cemiplimab (Libtayo®) will improve and delay immune response in sufferers with superior NSCLC who beforehand didn’t reply or developed resistance and progressed after first-line remedy routine containing one other checkpoint inhibitor. The trial design has two major aims: (1) to judge the security and tolerability of THIO administered as an anticancer compound and a priming immune activator (2) to evaluate the scientific efficacy of THIO utilizing Total Response Fee (ORR) as the first scientific endpoint. Remedy with cemiplimab (Libtayo®) adopted by THIO has been typically well-tolerated to this point in a closely pre-treated inhabitants. For extra info on this Section II trial, please go to ClinicalTrials.gov utilizing the identifier NCT05208944.
About MAIA Biotechnology, Inc.
MAIA is a focused remedy, immuno-oncology firm targeted on the event and commercialization of potential first-in-class medicine with novel mechanisms of motion which are meant to meaningfully enhance and lengthen the lives of individuals with most cancers. Our lead program is THIO, a possible first-in-class most cancers telomere concentrating on agent in scientific improvement for the remedy of NSCLC sufferers with telomerase-positive most cancers cells. For extra info, please go to www.maiabiotech.com.
Ahead Wanting Statements
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