NovaSpira wins MFDS approval to begin first-in-human NS-342 trial

NovaSpira Biotherapeutics received approval from South Korea’s Ministry of Food and Drug Safety to start a Phase 1 study of NS-342 in patients with refractory advanced hepatocellular carcinoma and other GPC3-expressing solid tumors. The trial could open a new path for a bispecific designed to improve tumor targeting and safety in hard-to-treat cancers.

Why it matters: - Advanced hepatocellular carcinoma remains difficult to treat after standard systemic therapy stops working. - NS-342 is designed to target GPC3-positive tumors while activating 4-1BB signaling, a combination NovaSpira says could improve tumor specificity and safety. - The Phase 1 study will test whether the drug can produce early signs of activity in a patient population with few durable options.

What happened: - NovaSpira Biotherapeutics said South Korea’s Ministry of Food and Drug Safety approved the company’s updated Phase 1 clinical trial plan for NS-342 on Aug. 31, 2026. - The approval clears the way for the first-in-human study in patients with refractory advanced hepatocellular carcinoma and other GPC3-expressing solid tumors. - NovaSpira CEO Han Li said the approval marks an important milestone for the company and for patients with advanced HCC who need new treatment options.

The details: - NS-342 is a next-generation GPC3x4-1BB bispecific designed to improve tumor specificity and safety in difficult-to-treat solid tumors. - The Phase 1 trial will evaluate safety, tolerability, pharmacokinetics and preliminary clinical activity. - Eligible patients include those with advanced HCC and other GPC3-expressing malignancies. - NovaSpira says NS-342 is its lead candidate and is already in Phase 1 clinical development. - The company describes itself as a U.S.-based biotech developing bispecific T-cell and immune cell activator therapy for GPC3-positive solid tumors, including liver and lung cancers. - NS-342 was previously known as PRS-342 and BOS-342. - Preclinical data showed GPC3-dependent T-cell activation, increased IL-2 production, tumor-infiltrating lymphocytes in HCC xenograft mice and anti-tumor activity. - The company’s announcement includes a More information link.

Between the lines: - The approval signals that NovaSpira can now move from preclinical and planning stages into human testing. - The focus on refractory HCC reflects a broader drug-development push in cancers where existing immunotherapy combinations often lose durability over time. - NovaSpira is positioning NS-342 as a more selective approach to immune activation, which could matter if early safety data support that design.

What's next: - NovaSpira will begin the Phase 1 study and collect early safety and activity data. - The company will need to show that NS-342 can be tolerated in humans before advancing into later-stage testing. - Early results will help determine whether the program can expand beyond HCC into additional GPC3-expressing tumors.

The bottom line: - MFDS approval gives NovaSpira a green light to test a first-in-class-style bispecific in one of oncology’s hardest-to-treat settings.