Navrogen has signed a cooperative research and development agreement (CRADA) with the US National Cancer Institute (NCI) researchers for the clinical development of NAV-001.
Under the deal terms, the company will provide funding for clinical development of its next-generation antibody-drug conjugate (ADC), NAV-001.
The experimental ADC targets and kills tumour cells which express mesothelin (MSLN) through the release of its toxic payload.
Navrogen has developed NAV-001 in collaboration with NCI researchers.
NAV-001 is currently being developed to treat advanced stage lung adenocarcinoma (mesothelin overexpressed in 54% of cases) and first-line mesothelioma (mesothelin over-expressed in 100% of epithelioid mesothelioma).
Navrogen chief scientific officer Luigi Grasso said: “Because of this collaborative team effort, we have been able to engineer an antibody that targets a unique region of mesothelin, which avoids immunosuppressive factors and is conducive to more effective delivery of NAV-001’s payload.
“NAV-001 has proven to be very effective with single, sub-mg/kg dosing against various patient-derived tumour types in mouse models, causing significant regression of the cancer lesions.”
The company stated that the CRADA represents a future step in advancing the NAV-001 to clinical investigation in highly responsive cancers, including non-small cell lung, metastatic colon, mesothelioma, and triple-negative breast cancers, which are identified from preclinical studies.
It is focused on discovering tumour-produced Humoral Immuno-Oncology (HIO) factors which are related to poor prognosis, suppressed humoral immunity, and limited therapeutic response of immune-mediated anti-cancer treatments.
Navrogen aims to develop new therapeutic agents that can overcome the immunosuppressive effects of HIO factors using its screening and engineering technologies and diagnostic assays.