NI-1801 / Light Chain Biosci - LARVOL DELTA

The combination of Innate immunity, activating tumor associated macrophages and adaptive immunity, a promising therapeutic approach in heavily treated platinum resistant ovarian cancer patients (ITOC 2026) - P1 | "Combination with anti-PD-1 antibodies can enhance both adaptive and innate immune responses through blockade on activated T cells and PD-1 in tumor associated macrophages.2 Preliminary safety and efficacy data on PROC patients treated with NI-1801 monotherapy or in combination with pembrolizumab was presented at ESMO 2025 (abstract no 1512O). Conclusion Combination of innate and adaptive immunity, blocking CD47 and PD-1 is a promising and safe therapeutic option for PROC patients that have received more than 3 chemotherapy lines, a fragile population of patients with ovarian cancer where chemotherapies and ADCs have not demonstrated clinical benefit. This study showed that surrogate endpoints for OS like ORR or PFS that were not predictive in PROC patients treated with chemotherapy, are predictive when treating PROC patients with this combination of innate and adaptive immunotherapies."

Clinical • Platinum resistant • Oncology • Ovarian Cancer • Solid Tumor • MSLN • SIRPA

Bispecific antibodies targeting EGFR and HER2 for effective killing of solid tumor cells via a safe CD47-SIRPA modulation (AACR 2026) - "The "unbalanced affinities" design of TAA/CD47 bispecific antibodies effectively addresses the safety and pharmacokinetic liabilities observed with monospecific CD47 antibodies. Importantly, our clinical experience with NI-1801 (MSLN×CD47) validates both the safety and the potential clinical benefit of this tumor-restricted CD47-blocking strategy (1). Together, these findings support TAA/CD47 bsAbs as a valuable addition to the anti-cancer armamentarium, with the EGFR/CD47 and HER2/CD47 bsAbs described here representing promising development candidates."

Bispecific • Tumor cell • Oncology • Ovarian Cancer • Solid Tumor • CD47 • EGFR • HER-2 • MSLN • SIRPA

NI-1801, a mesothelin x CD47 bispecific antibody: Safety and activity as single agent and in combination with pembrolizumab, in heavily pretreated (≥ 4 prior lines) mesothelin expressing platinum-resistant epithelial ovarian cancer patients (ESMO 2025) - P1 | "The combination with pembrolizumab showed enhanced efficacy, with a promising response rate of 28%, durable responses and a clinical benefit rate (ORR + SD) of 44%. Notably, this clinical benefit was achieved with a chemotherapy free regimen, which was well tolerated and had a favorable safety profile."

Clinical • Combination therapy • Platinum resistant • Epithelial Ovarian Cancer • Oncology • Ovarian Cancer • Solid Tumor • MSLN • PROC • SIRPA

Positive Safety and Efficacy of NI-1801 in Platinum Resistant Ovarian Cancer Patients Presented in Proffered Paper Oral Presentation at ESMO 2025 (PharmiWeb) - "The Phase 1b study of NI-1801 in combination with pembrolizumab showed an overall survival (OS) rate at one year of 75.2% in 21 patients at the data cutoff (August 2025), with a median follow-up of 11 months (15 patients alive and 6 patients ongoing). The immature progression-free survival (PFS) rate was 32.7% at 9 months with a confirmed response rate by RECIST criteria of 28.5% and a clinical benefit rate (CBR) of 48%. In the monotherapy Phase 1 study, NI-1801 showed an OS rate at one year of 35.3% in 21 patients, with a median follow-up of 19 months and 7 patients alive at the data cutoff....With standard of care chemotherapy, previous studies reported a median OS ranging from 9 to 12 months, in a PROC patient population that received at least one chemotherapy line."

P1 data • Platinum resistant • Ovarian Cancer

A Study of NI-1801 in Patients with Mesothelin Expressing Solid Cancers (clinicaltrials.gov) - P1 | N=70 | Recruiting | Sponsor: Light Chain Bioscience - Novimmune SA | N=40 ➔ 70 | Trial completion date: Sep 2025 ➔ Sep 2026 | Trial primary completion date: Jun 2025 ➔ May 2026

Combination therapy • Enrollment change • Trial completion date • Trial primary completion date • Breast Cancer • Gastrointestinal Cancer • Hepatology • Lung Adenocarcinoma • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor • Triple Negative Breast Cancer • MSLN

A Phase 1, open-label, dose finding study of NI-1801, a bispecific mesothelin x CD47 engaging antibody, in patients with mesothelin expressing solid cancers (SITC 2022) - P1 | "Adverse events are assessed according to CTCAE v5, tumor response is determined according to RECIST 1.1. Key inclusion criteria include (1) histologically or cytologically confirmed diagnosis of epithelial ovarian cancer (high-grade serous or endometroid), triple-negative breast cancer, or non-squamous non-small cell lung cancer, (2) advanced, metastatic, or recurrent disease, and (3) MSLN expression with staining intensity of ≥2+ as per immunohistochemistry in ≥60% of tumor cells."

Clinical • IO biomarker • P1 data • Breast Cancer • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Triple Negative Breast Cancer • CD47 • MSLN

A Study of NI-1801 in Patients With Mesothelin Expressing Solid Cancers (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: NovImmune SA

New P1 trial • Breast Cancer • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Triple Negative Breast Cancer • MSLN