In addition to the NeuroNova and SuperNova products, Calidi is advancing engineered oncolytic virus constructs and allogeneic cell-based platforms for systemic (intravenous) administration.
Calidi’s next clinical trials will focus on the following indications: glioblastoma, metastatic unresectable melanoma, triple-negative breast cancer (TNBC), and advanced metastatic squamous cell head & neck carcinoma (HNSCC). These indications are associated with significant morbidity with limited treatment options and poor survival rates. Their treatment is not addressed adequately by currently available therapies, and therefore, they represent an unmet medical need. New therapeutic options are urgently needed for these patients.
Calidi’s clinical development plans include three clinical trials over the next 6-18 months:
- NNV1: Phase 2 clinical trial in patients with newly diagnosed glioblastoma (GBM)
- NNV2: Phase 1 clinical trial in patients with recurring GBM
- SNV1: Phase 1 clinical trial in patients with metastatic unresectable melanoma, triple negative breast cancer (TNBC), and advanced metastatic head and neck squamous cell carcinoma (HNSCC)
Following these studies, we plan to perform clinical trials of our NNV and SNV agents in combination with other immunotherapies, such as checkpoint inhibitors. These combinations offer synergistic therapeutic effects and carry non-overlapping toxicity profiles.