Date: 2016-04-18
Type of information: Preclinical data
phase: preclinical
Announcement: preclinical data
Company: Halozyme Therapeutics (USA - CA)
Product: HTI-1511
Action
mechanism: antibody drug conjugate (ADC)
Disease:
Therapeutic area: Cancer - Oncology
Country:
Trial details:
Latest
news: * On April 18, 2016, Halozyme Therapeutics announced preclinical data for the discovery and early development of HTI-1511, a novel antibody-drug conjugate (ADC) targeting epidermal growth factor receptor (EGFR). This new preclinical program complements Halozyme's lead oncology asset, PEGPH20, an investigational new drug (IND) under clinical evaluation for the treatment of pancreatic, lung and gastric cancers. HTI-1511 is a novel anti-EGFR ADC to treat solid tumors, including those with drug-resistant mutations. It is also in pre-clinical development, with a drug candidate selected, good laboratory practices (GLP) toxicity studies planned for 2017 and chemistry, manufacturing and controls (CMC) development activities to support a future IND filing underway. 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 to date is a targeted therapy with an acceptable safety profile. 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 with the target of initiating early clinical study in 2018.
