Nutcracker Therapeutics, Inc. has presented the first set of preclinical data for its lead oncology mRNA therapeutic, NTX-250, at the 37th annual Society for Immunotherapy of Cancer meeting. \n\n\n\nThe company said the data demonstrate that NTX-250 has the ability to elicit strong anti-tumor responses in C3.43 murine tumor models and induce an immune response in non-human primates specific to human papillomavirus (HPV).\n\n\n\nNTX-250 is being developed for tumors driven by HPV16, which includes cervical cancer and its precursor, cervical intraepithelial neoplasia (CIN). \n\n\n\nStudy details\n\n\n\nIn the study, NTX-250 induced complete regression of large tumors – greater than 120 mm3 in volume – resulting in long-term, tumor-free survival of all 10 treated animals.\n\n\n\n“We’re excited to share Nutcracker Therapeutics’ first set of data on NTX-250 with the scientific community,” said chief medical officer Robert J. Schott. \n\n\n\n“It’s been our long-held belief that the RNA drug class presents a unique opportunity to create safe and effective immunotherapies. The preclinical data we presented today is compelling in this regard, and shows that NTX-250 is able to induce a strong immune response and completely regress tumors in a murine model.”\n\n\n\nNTX-250 is composed of three unique and synergistic mRNA molecules in an mRNA therapeutic. This triple mechanism is designed to induce a robust antitumor T-cell response in addition to opening the tumor microenvironment to enhance immune cell activity and reduce immunosuppression. All three components have been shown to enhance long-term efficacy against HPV-driven tumors in model systems.\n\n\n\nMore than 90% of cervical cancers and CIN lesions, and 70% of head and neck cancers, are linked to infections with high-risk HPV. HPV16 is the most prevalent high-risk strain, accounting for nearly half of infections. The company believes that there is an increasing need to not just target cervical cancer itself, but also CIN, as a significant percentage of women with high-grade CIN lesions progress to invasive cancer, if left untreated.\n\n\n\nNutcracker Therapeutics’ therapy suited to mRNA\n\n\n\n“Developing a therapy that includes all the necessary cancer-killing components efficiently is uniquely suited to mRNA,” Schott said. \n\n\n\n“Nutcracker Therapeutics’ proprietary RNA development platform was created to bring forward therapies, such as NTX-250, quickly and efficiently. Designing the three individual mRNAs, manufacturing the mRNA molecules, and encapsulating them within our Nutshell delivery vehicles was done using our end-to-end workflow within our platform. We look forward to using our in-house technology and expertise to develop much-needed therapies for other types of cancer.”\n\n\n\nA phase I clinical trial for NTX-250 is planned for 2023, pending the clearance of an investigational new drug application by the Food and Drug Administration.