mmVira's oncolytic product MVR-T3011 IT Intratumoral Injection Receives FDA Fast Track Designation for HNSCC Treatment
SHENZHEN, China -- ImmVira has recently announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for oncolytic virus product MVR-T3011 IT (intratumoral injection) for the treatment of recurrent or metastatic head and neck squamous cell cancer with disease progression after platinum-based chemotherapy and at least one prior line of anti-PD1/PDL1 therapy. Fast track designation is intended to facilitate the development and expedite the review of drugs targeting serious conditions with unmet medical needs.
The Fast Track designation was sought based on the promising potential of MVR-T3011 IT to meet the unmet medical needs associated with HNSCC. Supporting evidence for this request was derived from Phase I/II trials conducted in both the United States and China, focusing on evaluating the efficacy, safety, and durability of response in patients with HNSCC.
HNSCC has become a growing public health concern, with increases in incidence rates as of 2023 statistics. Approximately 32% of patients face recurrence after curative therapy, and 3-10% present with metastatic disease at the time of diagnosis, emphasizing the aggressive nature and severity of this cancer. While immune checkpoint inhibitors such as PD-1/PD-L1 blockers have transformed HNSCC treatment, their benefits are confined to a modest 15-20% of patients. This treatment gap underscores the critical need for innovative therapies. Clinical data indicates that MVR-T3011 IT demonstrated the potential to overcome immunosuppression, and delivered favorable outcomes in terms of tumor shrinkage and control in patients who failed ICI treatments.
"Attaining Fast Track designation from the FDA marks a pivotal milestone and underscores MVR-T3011 IT's capacity to address the substantial unmet needs of HNSCC patients," said Grace Guoying Zhou, Chairwoman and CEO of ImmVira. "We are encouraged by the FDA's decision as it reflects the need for FDA approved and widely available treatments for these patients. This designation will allow us to work closely with the FDA to quickly advance MVR-T3011 IT, to make a meaningful difference for patients who require new treatment options."
March 18, 2024
