ImmVira clinical snapshot: Intratumoral injected OV (MVR-T3011 IT) monotherapy achieved ORR of 25% on late-stage HNC patients, indicating significant advantage over SOC and PD-1 treatment

SHENZHEN, China, Feb. 15, 2023 /PRNewswire/ -- Following the recent publication of efficacy data on advanced melanoma, ImmVira's intratumoral injected OV product MVR-T3011 IT has also shown positive efficacy in the treatment of advanced head and neck cancer. As of January 2023, it achieved a confirmed Objective Response Rate ("ORR") of 25.0% in monotherapy treatment, which is significantly better than standard treatment (ORR: 5.8%/10.1%) and PD-1 immunotherapy (ORR: 13.3%/14.6%) for second-line and above patients.

This Phase II clinical study commenced in mid-2021 in China. 19 patients with advanced head and neck squamous cell carcinoma ("HNSCC") (except nasopharyngeal carcinoma) received MVR-T3011 IT monotherapy (1*108 PFU/mL), of which 18 patients (94.7%) failed from previous platinum-based chemotherapy and PD-1 immunotherapy, 17 patients (89.5%) had distant metastases, and 6 patients (31.6%) had baseline target lesion diameters of more than 5 centimeters. Median Progression Free Survival ("PFS") was 3.9 months（95%CI: 0.89, NA). Of the 12 evaluable subjects, the confirmed ORR and Disease Control Rate ("DCR") were 25.0% (3/12) and 50.0% (6/12), respectively. Meanwhile, 72.7% (8/11) of injected target lesions and 57.1% (4/7) of non-injected target lesions were observed to have reduced lesion volume, which clinically validated the abscopal effects of MVR-T3011 IT.

As a local single-drug treatment, MVR-T3011 IT's efficacy on second-line and above subjects after PD-1 and platinum-based chemotherapy is encouraging, with improved ORR and PFS compared to PD-1 monotherapy (see below), and it has shown advantages in subjects that have failed from chemotherapy and immunotherapy in single-agent clinical development.

Results of PD-1 monoclonal antibody as second-line therapy for relapsed and metastatic HNSCC

For advanced HNSCC, patients have limited treatment options after first-line and second-line standard treatment. The efficacy of CSCO-recommended monotherapies cannot meet clinical needs with ORRs generally below 10%. MVR-T3011 IT monotherapy can achieve a significantly improved ORR of 25%, and we expect to see a significant extension of Overall Survival ("OS") with longer follow-up periods. With the fact that patients enrolled all progressed after standard chemotherapy and immunotherapy, we also observed that those patients can receive PD-1/PD-L1 treatment after disease progression from MVR-T3011 and reversed resistance to immunotherapy with significant responses, clinically validated potential breakthrough synergy in combination treatment of MVR-T3011 and immunotherapy.

About Head and Neck Cancer

Head and neck tumors refer to tumors occurring in the mouth, nose, pharynx, throat, etc. More than 90% are squamous cell carcinoma and its variants, collectively referred to as head and neck squamous cell carcinoma (HNSCC). According to the statistics of 2020 GLOBOCAN, it is estimated that the number of new cases of head and neck tumors (except nasopharyngeal carcinoma) in 2020 is about 798,577, accounting for 4.14% of all new cases of malignant tumors. The estimated number of deaths was 387,117, accounting for 3.9% of all malignant tumor deaths, ranking eighth in both the number of new cases and the number of deaths. More than 60% of HNSCCS have progressed to stage III or IV disease at presentation, while 15% to 40% of locally advanced patients will relapse or metastasize after treatment, with a 5-year survival rate of less than 50%.

About MVR-T3011

MVR-T3011, ImmVira's proprietary 3-in-1 oHSV, is a novel genetic engineered oHSV which aims to achieve the most favorable profile of attenuated HSV-1 with replication potency in tumor cells and highly restricted replication in normal cells. Its incorporation of two latest and well-validated exogenous genes, PD-1 antibody and IL-12, further enhances immune responses in the tumor microenvironment.

About ImmVira

ImmVira is a biotechnology company focused on developing and synthesizing biological vector delivery platform. The company has constructed a fully integrated OVPENS (Open Vector+ Potent, Enabling, Novel & Safe) platform with solid science, technology and CMC know-how, and  three derivative subplatforms including Oncolytic Virus, Cancer Vaccine and Biosynthetic Exosome, to support ongoing R&D, clinical studies and commercialization of best-in-class mono and combo therapies driven by clinical benefits in oncology and non-oncology fields.

SOURCE ImmVira