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Amunix Presents Preclinical Data at American Academy of Cancer Research (AACR) Annual Meeting from Lead Program AMX-818 Demonstrating Robust Efficacy in HER2 Tumor Models and Enhanced SafetyAMX-818 is the lead program in Amunix’s XPAT® (XTENylated Protease-Activated T cell engager) platform designed to improve the toxicity profile of T cell engagers for the treatment of HER2-expressing solid tumors In vivo, preferential cleavage of AMX-818 was demonstrated in xenograft tumors relative to healthy organs (average % unmasked AMX-818 was 25.2% in tumors vs. 1.6% in combined other organs), corroborating the protease-cleavable mechanism of action Amunix expects to file a Clinical Trial Application (CTA) for AMX-818 by the end of 2021 SOUTH SAN FRANCISCO, April 12, 2021 (GLOBE NEWSWIRE) -- Amunix Pharmaceuticals, Inc. (“Amunix”), a biopharmaceutical company focused on developing masked, protease-activated immune-oncology therapeutics to bring the promise of these potent therapies to patients with solid tumor cancers, today announced data were presented from its lead program AMX-818 (HER2-XPAT), at the AACR Annual Meeting. The data demonstrate that AMX-818, a masked T cell engager (TCE) that targets HER2 expressing tumors, is preferentially activated, as designed, in the protease-rich tumor microenvironment leading to robust tumor regression in HER2 tumor models and in non-human primates (NHP) achieved concentrations approximately 450 times higher than the unmasked TCE without causing cytokine release syndrome (CRS) or systemic T cell activation characteristic of T cell engagers. “These data demonstrate the potential of our Pro-XTEN protease-releasable masking technology applied to our XPAT platform that expands the utility and safety profile of T cell engagers,” said Angie You, Ph.D., chief executive officer of Amunix. “Notably, we observed substantial tumor regression with AMX-818 treatment in both HER2 high and HER2 low expressing tumors, with the latter being an area of significant unmet need with no approved HER2 therapies. We are progressing this program towards the clinic and look forward to bringing the potential of this drug to patients, in particular to those with tumor types where cancer immunotherapies have failed to date.” Amunix expects to file a CTA for AMX-818 by the end of 2021. The studies presented at AACR demonstrate the potential for a wide safety margin with 400-fold higher protection against in vitro cytotoxicity for AMX-818 relative to the unmasked version. A 450-fold higher maximum tolerated exposure compared to the unmasked version was observed in non-human primates (NHP) -- cytokine release was dose limiting in the unmasked version and not observed at doses up to 50mg/kg. In vivo, preferential cleavage of AMX-818 was demonstrated in established HER2 In HER2low HT-55 xenograft models, AMX-818 induced protease-dependent tumor regressions that were comparable to the unmasked (active) TCE, but required higher doses. With the wide safety margins demonstrated in the preclinical models, AMX-818 has the potential to expand into HER2 lower expressing tumors. Poster Presentation Details A copy of the poster is available here. About Amunix’s Platform About Amunix Pharmaceuticals For additional information about the company, please visit www.amunix.com. Contacts Company Contact: Media Contact: Investor Contact: |