Pharmaceutical Business review

Navrogen signs agreement with US NCI for NAV-001 development

Navrogen will fund the clinical development of NAV-001 antibody-drug conjugate. Credit: National Cancer Institute on Unsplash.

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.