NAV-001 / Navrogen - LARVOL DELTA

NAV-001, a high-efficacy antibody-drug conjugate targeting mesothelin with improved delivery of a potent payload by counteracting MUC16/CA125 inhibitory effects. (PubMed, PLoS One) - "Single-dose NAV-001-PNU demonstrated robust tumor regression of a number of patient-derived xenografts from different tumor types regardless of MUC16/CA125 expression. These findings suggest that identification of HIO-refractory antibodies to be used in ADC format may improve therapeutic efficacy as observed by NAV-001 and warrants NAV-001-PNU's advancement to human clinical trials as a monotherapy to treat mesothelin-positive cancers."

IO biomarker • Journal • Oncology • MSLN • MUC16

Navrogen Announces Publication of NAV-001 Antibody-Drug Conjugate Development and Efficacy in Humoral Immunosuppressed Cancers (PRNewswire) - "Navrogen...announces today a publication describing new criteria for antibody-drug conjugate (ADC) development and preclinical efficacy of NAV-001 ADC against mesothelin-expressing tumor types....The publication in PLOS ONE shows that NAV-001 has robust single-dose efficacy against multiple mesothelin-expressing cancers and that tumor-produced Humoral Immunology-Oncology (HIO) factors negatively impact antibody drug internalization and efficacy."

Preclinical • Oncology • Solid Tumor

NAV-001, a high-efficacy antibody-drug conjugate targeting mesothelin with improved delivery of potent payload by counteracting MUC16/CA125 effects (AACR 2023) - "Single-dose NAV-001-PNU demonstrated robust tumor regression of a number of patient-derived xenograft models from different tumor types regardless of MUC16/CA125 expression. These findings suggest that identification of HIO-refractory antibodies to be used in ADC format may improve therapeutic efficacy as observed for NAV-001 and warrants NAV-001-PNU’s advancement to human clinical trials as a monotherapy to treat mesothelin-positive cancers."

Clinical • IO biomarker • Oncology • MSLN • MUC16

Navrogen Presents Preclinical Data on NAV-001 Antibody-Drug Conjugate and NAV-003 Bispecific Programs at the 2023 American Association for Cancer Research Annual Meeting (PRNewswire) - "Navrogen...will be presenting new preclinical data on its NAV-001 antibody-drug conjugate (ADC) and NAV-003 bispecific programs at the 2023 American Association for Cancer Research (AACR) Conference....NAV-001 and NAV-003 both target mesothelin, a cell surface protein over-expressed on various malignancies, including breast, colon, lung and mesothelioma cancers....These drug candidates have demonstrated significant in vivo efficacy across a wide array of mesothelin-positive cancer models."

Preclinical • Breast Cancer • Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Mesothelioma • Oncology • Solid Tumor • Thoracic Cancer

Navrogen Enters into CRADA with The U.S. National Cancer Institute for the Clinical Development of NAV-001, an Anti-Mesothelin Antibody-Drug Conjugate (PRNewswire) - "Navrogen, Inc. announced today that it has entered into a Cooperative Research and Development Agreement (CRADA) with researchers at the U.S. National Cancer Institute (NCI), part of the National Institutes of Health. Under this CRADA, Navrogen will sponsor the clinical investigation of the experimental antibody-drug conjugate, NAV-001, under the supervision of Dr. Raffit Hassan, Chief of Thoracic and GI Malignancies Branch at the NCI....Based on the robust efficacy of NAV-001, this CRADA represents a stepping-stone to advance the program to clinical testing in highly responsive cancers identified from preclinical studies, including triple-negative breast, metastatic colon, non-small cell lung, and mesothelioma cancers."

Licensing / partnership • Breast Cancer • Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Mesothelioma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer • Triple Negative Breast Cancer

Navrogen Presents Preclinical Data on Its NAV-001 Antibody-Drug Conjugate Program at the 12th World ADC Conference in London (PRNewswire) - "Navrogen...will be presenting new preclinical data on its NAV-001 antibody-drug conjugate (ADC) program at the 12th World ADC Conference in London, UK....With the BRITE feature and a novel payload, NAV-001 has demonstrated significant in vivo efficacy across a wide array of mesothelin-positive cancer models....'Single-dose NAV-001 at sub-milligram levels was able to cause durable tumor regression against a variety of tumor types, including triple-negative breast, metastatic colon, non-small cell lung, and mesothelioma cancers.'."

Preclinical • Breast Cancer • Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Mesothelioma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer • Triple Negative Breast Cancer

Navrogen Closes $3.0M Seed Financing To Advance Its Preclinical Pipeline Targeting Humoral Immunosuppressed Cancers And Immune-Related Disorders (PRNewswire) - "Navrogen...announced today that it has raised $3.0M from an equity financing to support its Humoral Immuno-Oncology (HIO) discovery platform and preclinical therapeutic pipeline activities. HIO is a process by which tumors produce factors that suppress a patient's humoral immune response against malignant tissues. The major use of proceeds will focus on advancing the company's lead HIO-refractory, anti-mesothelin NAV-001 antibody drug conjugate program and its NK cell activator platforms that specifically address HIO suppressed cancers and immune-mediated diseases. The financing was led by Tellus BioVentures along with existing investors."

Financing • Oncology