SHENZHEN, China, Feb. 9, 2023 /PRNewswire/ -- ImmVira's first intratumoral injected OV product MVR-T3011 IT has shown positive efficacy in the course of clinical studies in the U.S. and China as of January 2023, with which the monotherapy treatment significantly prolonged PFS to a median of 12.9 months among melanoma patients who had failed previous immune-oncology treatment. Currently, late-stage melanoma faces poor prognosis. Clinical studies have found that median PFS of only 1.7 months for stage IV patients, second-line mono immunotherapy achieved median PFS of 2.8 and 3.6 months, combination therapy of PD-1 Ab and VEGF inhibitor achieved median PFS of 4.2 months.
This Phase II clinical study commenced in mid-2021 in the U.S. and China. 19 patients with advanced melanoma who had failed prior PD-1 or PD-1/CTLA-4 combination treatment received MVR-T3011 IT monotherapy, and nearly 90% of subjects had distant metastasis and over 50% of subjects had baseline target lesion diameters that added up to more than five centimeters. After receiving local monotherapy of MVR-T3011 IT, the confirmed ORR and DCR (including low dosage cohorts in dose-escalation stage) was 21.1% (4/19) and 47.4% (9/19), respectively. Median PFS was 12.9 months, and 12-month PFS rate was 51.5%. Median PFS significantly increased, also showing MVR-T3011 IT's potential in reversing resistance of immune checkpoint inhibitors.
In the clinical studies KEYNOTE-151 and POLARIS-01, the ORR of PD-1 Ab (pembrolizumab/ toripalimab) in Chinese subjects with advanced melanoma treated with second-line monotherapy was 17.6% and 17.3%, respectively, with the median PFS of 2.8 months and 3.6 months, respectively. In LEAP-004, a Phase II study of second-line subjects with recurrent or metastatic melanoma who had failed prior PD-1 or PD-1/CTLA-4 treatment, the combination of VEGF inhibitor (lemvastinib) and PD-1 Ab (pembrolizumab) had an ORR of 21% and a median PFS of 4.2 months. Compare with the clinical studies in patients at a similar stage, the efficacy of MVT-T3011 IT monotherapy topical administration demonstrated encouraging results.
The inspiring efficacy results of MVR-T3011 IT monotherapy on melanoma clinically validated the unique design of packaging PD-1 Ab and IL-12 into the product, and it also enhanced our confidence in the combination treatment clinical trials with Roche's MEK inhibitor Cobimetinib in melanoma in the United States.
Melanoma is an aggressive and fatal form of skin cancer that results from the malignant transformation of melanocytes in the basal layer of the skin epidermis. Clinical studies have found that the median progression-free survival (PFS) is only 1.7 months for stage IV patients. In advanced melanoma cases that have metastasized, the one-year survival rate drops to 35% to 62%.
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.
ImmVira is a biotechnology company focused on development of new generation novel drug vectors driven by clinical benefits in oncology and non-oncology fields. Leveraging naturally evolved delivery mechanisms and proprietary precise gene engineering technology, our products include replicating and non-replicating herpes simplex virus vector and drug delivery exosome. The company has developed science, technology and know-how to support ongoing research, development and commercialization of best-in-class mono and combo therapies on the OVPENS (Open Vector+ Potent, Enabling, Novel & Safe) platform.
Our clinical stage and development stage pipelines target a wide range of solid tumors and hematologic malignancies as an initial validation of vector capability in oncology, to be used as single agent or combination treatment solutions for cancer patients at different stages, unresponsive to immunotherapy or with rare tumors, by various administration methods including intratumoral, as well as first-in-class intravenous and intraperitoneal/pleural/vesical injections. The first three oncolytic virus products are undergoing six Phase I or Phase II clinical trials in both United States and China.
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