WALTHAM, Mass.–(Enterprise WIRE)–Xilio Therapeutics, a biotechnology organization acquiring tumor-selective immuno-oncology therapies for patients with most cancers, today announced that the U.S. Food stuff and Drug Administration has recognized its Investigational New Drug application (IND) to examine its checkpoint inhibitor product or service prospect, XTX101, as a potential treatment for people with sound tumors. XTX101 is a tumor-selective anti-CTLA-4 monoclonal antibody created to improve upon the therapeutic index of existing anti-CTLA-4 therapies by conquering their historical potency and tolerability limitations.
“This initial IND acceptance for Xilio represents a significant milestone for us as we transition to a clinical-phase group,” said Marty Huber, M.D., main professional medical officer of Xilio Therapeutics. “It is nicely known that checkpoint inhibitors maintain important clinical possible even so, therapy with anti-CTLA-4 therapies has been constrained because of complicated autoimmune toxicities. Employing our geographically precise alternatives (GPS) system, we have engineered XTX101 with the objective of boosting the attractive attributes of an anti-CTLA-4 antibody even though restricting the regarded liabilities. We seem ahead to starting Period 1 growth to examine the opportunity that XTX101 may perhaps present as equally a monotherapy and blend agent for clients in have to have.”
Leveraging its proprietary GPS platform, Xilio designed XTX101 to be activated in the tumor microenvironment with the prospective to final result in localized scientific action without dose-limiting toxicities. In preclinical studies, XTX101 exhibited tumor-selective organic exercise and robust tumor growth inhibition, which includes complete responses in murine cancer versions, with favorable tolerability. These knowledge exhibit improved action and an improved tolerability profile in contrast to an analog of ipilimumab, a CTLA-4 blocking antibody authorized for the treatment of specified reliable tumor cancers. XTX101 has also shown increased tumor development inhibition and tolerability when administered in mixture with an anti-PD-1 in vivo.
Xilio expects to initiate a Phase 1 medical demo in the 2nd half of 2021 to examine XTX101 as a monotherapy, as very well as a blend remedy with KEYTRUDA® (pembrolizumab), for the procedure of people with reliable tumors.
About Xilio Therapeutics
Xilio Therapeutics is a privately-held biotechnology company centered on harnessing the immune procedure to reach deep and resilient scientific responses to make improvements to the life of individuals with cancer. The corporation is employing its proprietary geographically precise options (GPS) system to fast engineer novel molecules, which includes cytokines and other biologics, that are created to improve their therapeutic index. These molecules are built to localize activity in just the tumor microenvironment with no systemic impact, ensuing in the potential to attain increased anti-tumor activity. Xilio is constructing a pipeline of wholly owned, tumor-selective, GPS-enabled cytokine and checkpoint inhibitor packages, including XTX202, a tumor-selective IL-2 item candidate XTX101, a tumor-selective anti-CTLA-4 monoclonal antibody and tumor-selective IL-12 and IL-15 investigation plans. For much more information, remember to go to www.xiliotx.com.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, Usa.