Novaspira Unveils Promising Early Trial Results for Advanced Liver Cancer Therapy
San Diego, Saturday, 7 November 2026.
Novaspira’s experimental drug produced durable tumor reduction lasting over two years in advanced liver cancer patients with zero severe treatment-related toxicities, validating a novel targeted immunotherapy approach.
Groundbreaking Phase 1 Results Presented at SITC 2026
Novaspira Biotherapeutics [GPT], a clinical-stage biotech company developing next-generation immunotherapies, presented late-breaking Phase 1 clinical data for its experimental bispecific antibody BOS-342 (NS-342) at the 41st Annual Meeting of the Society for Immunotherapy of Cancer (SITC) in Phoenix, Arizona, on November 6, 2026 [1][2]. The first-in-human trial evaluated the therapy in 12 heavily pretreated patients with advanced hepatocellular carcinoma (HCC) who had progressed on prior PD-(L)1 inhibitors and VEGF-targeted therapies. At the highest dose level, the drug demonstrated an objective response rate (ORR) of 28.571% (2 of 7 evaluable patients), including one durable partial response lasting over 24 months [1][2].
Unprecedented Safety Profile with Zero Severe Toxicities
BOS-342 exhibited a notably manageable safety profile, with no dose-limiting toxicities (DLTs), no Grade 4 or 5 treatment-related adverse events, and no cases of cytokine release syndrome (CRS) reported [1][2]. Infusion-related reactions were identified as the most common manageable adverse event. Dr. Hong Jae Chon, principal investigator of the study and presenting author at SITC 2026, emphasized that ‘BOS-342 demonstrated a well-manageable safety profile together with preliminary evidence of durable antitumor activity in heavily pretreated patients’ [1][2]. The absence of severe toxicities contrasts sharply with conventional immunotherapies, which often face dose-limiting hepatotoxicity and CRS [GPT].
Clinical Efficacy Signals in Treatment-Resistant Liver Cancer
The trial’s 12-week disease control rate (DCR) reached 50% across all dose levels, indicating that half of the treated patients experienced either stable disease or partial response within three months [1][2]. Notably, the durable partial response exceeding 24 months in one patient represents a rare and clinically meaningful outcome in this treatment-refractory population [1][2]. Novaspira’s bispecific design—targeting glypican-3 (GPC3) and the 4-1BB costimulatory receptor—may explain this activity, as preclinical studies showed potent T-cell activation and tumor cell lysis specifically in GPC3-positive cells [1][2].
Expanding Clinical Development with Novel Mechanism
Building on these results, Novaspira announced plans to initiate a new Phase 1 clinical study (NS-342-101) across South Korea, Taiwan, and the United States, with additional biomarker and translational analyses scheduled for future scientific meetings [1][2]. The company’s CEO, Han Li, Ph.D., highlighted that the late-breaking presentation at SITC 2026 ‘underscores the growing interest in next-generation, tumor-targeted immunotherapies’ and expressed optimism about advancing BOS-342 for patients with advanced liver cancer [1][2]. This follows preclinical data from the American Association for Cancer Research (AACR) 2019, which demonstrated T-cell infiltration and tumor growth inhibition in GPC3-positive xenograft models [1][2].