HTI-1511 is a novel antibody-drug conjugate (ADC) targeting epidermal growth factor receptor (EGFR) to potentially treat solid tumors, including those with drug-resistant mutations. HTI-1511 was engineered to bind to EGFR at the low pH of the tumor microenvironment while decreasing or attenuating the binding at the neutral pH of skin. The result in preclinical studies is a targeted therapy with an encouraging safety profile. As a result, HTI-1511 has been selected for further study as an investigational new drug candidate (Pre-IND).
HTI-1511 has been developed as a next-generation ADC with a potent cytotoxin, monomethyl auristatin E to treat EGFR-positive tumors, including those with KRAS and BRAF mutations. In preclinical studies, HTI-1511 has demonstrated tumor growth inhibition or regression in colon, lung and cholangiocarcinoma models, including patient-derived xenograft (PDx) models with known KRAS and BRAF mutations.
The company has initiated a range of studies to prepare for an IND filing for HTI-1511.