On July 13, 2022 Novimmune SA (LCB), is an antibody discovery and development company located in Geneva, Switzerland (Press release, Light Chain Bioscience, JUL 13, 2022, View Source [SID1234616646]). LCB reported that the first patient was dosed in the Phase 1, first-in-human trial of NI-1801 in patients with advanced, metastatic, or recurrent solid malignancies expressing mesothelin (MSLN) . NI-1801 is a human IgG1 bispecific antibody based on LCB’s , targeting MSLN and CD47. "NI-1801 is the second κλ body entering clinical evaluation. This represents an important milestone in the development of LCB’s pipeline of bispecific antibodies featuring a truly native human IgG structure," said Nicolas Fischer, Chief Executive Officer.
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The surface protein CD47 is an innate immune checkpoint that allows tumor cells to escape immune surveillance, thus acting as a don’t eat me signal. LCB’s bispecific antibody approach simultaneously targets CD47 and a tumor-specific antigen, here MSLN, to selectively block CD47 on MSLN-expressing malignant cells. "As CD47 is ubiquitous, measures need to be taken to limit the immune response to tumor cells. NI-1801 represents a promising novel treatment approach for several cancers with high medical need. We are excited to further investigate this in our Phase 1 study," said Dr. med. Anja Seckinger, Chief Medical Officer.
The LCB-1801-001 Phase 1 trial is a multi-center, open-label, dose escalation and expansion, first-in-human clinical trial that is expected to enroll approximately 40 patients with MSLN-expressing triple-negative breast, non-squamous non-small cell lung or ovarian cancer. The primary objectives of the dose escalation portion (Part A) are to assess the safety and tolerability of escalating doses of NI-1801, with the goal of establishing a maximum-tolerated dose (MTD) and non-tolerated toxic dose. The expansion part (Part B) will further evaluate the safety and efficacy of NI-1801 administered at or below the MTD in up to 20 additional patients to determine the recommended Phase 2 dose. Additional objectives include evaluation of preliminary efficacy, pharmacokinetics (PK), pharmacodynamics and potential predictive biomarkers.
NI-1801 induces antibody-dependent cellular phagocytosis (ADCP) and antibody-dependent cell-mediated cytotoxicity of a variety of MSLN-positive cancer cell lines in vitro. ADCP is negligible or unaffected by a CD47-sink effect mimicked by CD47-expressing red blood cells. NI-1801 does not induce in vitro hemagglutination or platelet aggregation. In multiple preclinical (xenograft) models, NI-1801 inhibits tumor growth in mice. NI-1801 was well tolerated and demonstrated favorable pharmacokinetics in multiple non-human primate studies.