FDA Fast Tracks ImmVira's Oncolytic Herpes Simplex Virus Therapy for Head and Neck Squamous Cell Cancer

Image credit: OlegKachura | stock.adobe.com

ImmVira's oncolytic herpes simplex virus (oHSV) therapy MVR-T3011 IT for intratumoral injection has been granted Fast Track designation by the FDA to treat patients with recurrent or metastatic head and neck squamous cell cancer (HNSCC) whose disease progressed following platinum-based chemotherapy and at least one prior line of an anti–programmed cell death protein 1 (PD-1)/programmed death-ligand 1 (PD-L1) therapy.¹ The novel oHSV treatment is a genetically engineered virus developed to produce replication potency in tumor cells as well as highly restricted replication in normal cells. The ability of MVR-T3011 to boost the immune response within the tumor microenvironment is increased by adding a PD-1 antibody and IL-12 into the construct, according to ImmVira.

"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," Grace Guoying Zhou, chairwoman and CEO of ImmVira, said in a press release. "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."¹

Between 15% and 20% of patients with HNSCC have been estimated to benefit from immune checkpoint inhibitor (ICI) therapy, according to ImmVira. For patients whose disease progressed during treatment with an ICI regimen, the company stated that MVR-T3011 IT has demonstrated the potential to overcome this immunosuppression to produce tumor shrinkage and control.

The FDA based the Fast Track designation on findings from a series of Phase I/II trials that demonstrated the efficacy, durability, and safety of the investigational therapy.

Data from an ongoing Phase I/II trial (NCT05602792) analyzing MVR-T3011 as monotherapy and from a Phase I/IIa trial (NCT04370587) of MVR-T3011 administered as monotherapy or combined with Keytruda (pembrolizumab) were released during the 2023 American Society of Clinical Oncology Annual Meeting.^2,3

In the monotherapy trial, patients with solid tumors administered MVR-T3011 showed a confirmed overall response rate (ORR) of 11% and disease control rate (DCR) of 49% as of the January 18, 2023, data cutoff. Among these patients with HNSCC, 12 whose disease progressed following platinum-based chemotherapy and anti–PD-1/PD-L1 therapy achieved a confirmed ORR of 25% and DCR of 50%. Three patients with HNSCC who achieved a partial response experienced a significant increase in tumor-infiltrating CD8-positive cell density.

Preliminary data as of January 17, 2023, from the ongoing trial showed that MVR-T3011 plus Keytruda was safe and tolerable in patients with advanced solid tumors. MVR-T3011 showed promising efficacy in patients with immune-resistant melanoma, demonstrating a confirmed ORR 25.0% and DCR of 33.3%.

In these trials, MVR-T3011 showed a favorable safety profile and clinical compliance, with no new safety signals reported with the combination therapy. The most frequently reported treatment-related adverse effect among the 90 participants administered MVR-T3011 monotherapy was pyrexia, with no dose-limiting toxicities reported.

"The development of intravenously administered oncolytic virus products has long been a challenging bottleneck. Oncolytic viruses must overcome numerous hurdles, such as neutralization by antibodies or the risk of cytokine storms, in order to effectively reach tumor sites with a sufficient number of viruses to achieve anti-tumor effects,” Zhou said in a November 2023 press release. “With the successful Phase I clinical study results of MVR-T3011 IV, global first clinical-stage intravenous oHSV product, our company is now fully confident and committed to expediting clinical explorations in colorectal cancer, non-small cell lung cancer, and other indications, including combination treatments with immune checkpoint inhibitor or chemotherapy. Our goal is to bring the benefits of intravenous oncolytic virotherapy to cancer patients as swiftly as possible."³

References

1. ImmVira's oncolytic product MVR-T3011 IT Intratumoral Injection Receives FDA Fast Track Designation for HNSCC Treatment. News release. ImmVira. March 15, 2024. Accessed March 21, 2024. https://www.prnewswire.com/news-releases/immviras-oncolytic-product-mvr-t3011-it-intratumoral-injection-receives-fda-fast-track-designation-for-hnscc-treatment-302090155.html

2. ImmVira presented latest encouraging clinical results of two proprietary products at ASCO 2023. News release. ImmVira. June 6, 2023. Accessed March 21, 2024. https://www.prnewswire.com/news-releases/immvira-presented-latest-encouraging-clinical-results-of-two-proprietary-products-at-asco-2023-301843794.html

3. MVR-T3011 IV, Global First Intravenous Oncolytic Product, Successfully Concludes Phase I Clinical Study in the U.S. with Outstanding Safety Results. ImmVira. November 9, 2023. Accessed March 21, 2024. https://www.prnewswire.com/news-releases/mvr-t3011-iv-global-first-intravenous-oncolytic-product-successfully-concludes-phase-i-clinical-study-in-the-us-with-outstanding-safety-results-301984123.html