Shenzhen-based biopharma ImmVira has revealed that its first intra-tumoral injection oncolytic virus (OV) product, MVR-T3011 IT, has produced positive signs of efficacy as a treatment for melanoma in late-stage patients who have failed previous immunotherapy. In a Phase II clinical study conducted in China and the United States, monotherapy treatment using MVR-T3011 IT produced a median progression-free survival (PFS) of 12.9 months, which is highly favorable compared to current treatment options.
MVR-T3011 IT: Mechanism and Design
MVR-T3011 IT is an oncolytic herpes simplex virus (oHSV) that embodies immunotherapeutic genes encoding IL-12 and anti-PD-1 antibody. It is designed for intra-tumoral injection to bypass the problems of viral dilution faced by other oncolytic viruses. This innovative approach aims to enhance the therapeutic effect and reduce the side effects associated with traditional treatments.
Clinical Study Results
ImmVira recruited 19 patients with advanced melanoma who had previously failed PD-1 or PD-1/CTLA-4 combination treatment, and 90% of whom had distant metastases. MVR-T3011 IT was administered as a monotherapy, producing an overall response rate (ORR) of 21.1% and a disease control rate (DCR) of 47.4%. The median PFS was 12.9 months, and the 12-month PFS rate was 51.5%.
Comparison with Current Treatments
In comparison, clinical studies for PD-1 inhibitors pembrolizumab and toripalimab (KEYNOTE-151 and POLARIS-01) in stage IV melanoma patients produced median PFS readings of only 2.8 or 3.6 months, respectively. Additionally, in the LEAP-004 study, a combination of PD-1 and VEGF inhibition in patients who previously failed immune-oncology treatment produced a median PFS of 4.2 months. These results highlight the potential of MVR-T3011 IT to significantly improve outcomes for patients with advanced melanoma.
Potential to Reverse Resistance
ImmVira views the results as showing that its product candidate could potentially reverse the resistance to immune checkpoint inhibitors. This finding is particularly significant as it suggests a new therapeutic approach for patients who have not responded to existing immunotherapies, offering hope for improved treatment options and outcomes.-Fineline Info & Tech
