VP-315 Demonstrates Positive Topline Results in Basal Cell Carcinoma

Basal cell carcinoma affecting the face | Image Credit: DermNet

Verrica Pharmaceuticals Inc. announced positive topline findings from part 2 of its phase 2 study on VP-315, a novel oncolytic peptide therapy, at the 2025 Winter Clinical Miami Dermatology Conference, held January 17-19, 2025, in Miami, Florida.¹

The data presented emphasized VP-315’s potential as a non-surgical treatment option for basal cell carcinoma (BCC), the most prevalent form of skin cancer.² These findings were showcased in 3 posters, one of which highlighted a 97% Calculated Objective Response Rate (ORR) based on a post-hoc analysis.

The phase 2 trial is a multicenter, open-label, dose-escalation study designed to evaluate the safety, pharmacokinetics, and efficacy of VP-315. The investigational therapy is administered intratumorally to adults with biopsy-confirmed BCC.³

A total of 92 subjects with at least 1 histologically diagnosed target tumor participated, with 82 patients enrolled in part 2, encompassing 91 tumors. This segment focused on optimizing dosing regimens for subsequent phase 3 trials.

A post-hoc analysis revealed a 97% ORR, defined as the proportion of patients achieving at least a 30% reduction in tumor size, with partial or complete response and no disease progression.

Approximately 51% of tumors achieved complete histological clearance. For patients with residual tumors, a substantial average reduction of 71% in tumor size was observed.

The study reported no treatment-related serious adverse events. Most adverse events were mild to moderate, reinforcing VP-315’s tolerability.

VP-315 represents a first-in-class oncolytic chemotherapeutic peptide immunotherapy. By inducing immunogenic cell death within the tumor, VP-315 triggers the release of tumor antigens, thereby activating a broad T-cell-mediated immune response.

Jayson Rieger, PhD, MBA, Verrica’s CEO, remarked on the therapy’s potential to shift the treatment paradigm for BCC.

“We believe these results will support the use of VP-315 as a potential first line therapy for use in both primary and neoadjuvant settings, and that VP-315 could provide the millions of basal cell carcinoma patients diagnosed in the United States each year with a non-surgical alternative to painful, invasive surgical treatments,” Rieger said in a news release.¹

Rieger also highlighted the therapy’s commercial potential, estimating a multi-billion-dollar market opportunity.

Verrica plans to continue advancing VP-315’s development in collaboration with regulatory bodies. Genomic and T-cell response data from the study are anticipated in Q1 2025. The company aims to engage with the FDA in the first half of 2025 to outline a phase 3 development pathway. The primary focus will be on optimizing VP-315 for use in basal and squamous cell carcinomas.

Reference

1. Verrica Pharmaceuticals announces presentation of three posters featuring positive preliminary topline results of VP-315 for the treatment of basal cell carcinoma at the 2025 Winter Clinical Dermatology Conference. News release. BioSpace. January 21, 2025. Accessed January 21, 2025. https://www.biospace.com/press-releases/verrica-pharmaceuticals-announces-presentation-of-three-posters-featuring-positive-preliminary-topline-results-of-vp-315-for-the-treatment-of-basal-cell-carcinoma-at-the-2025-winter-clinical-dermatology-conference
2. Types of skin cancer. American Cancer Society. Accessed January 21, 2025. https://www.aad.org/public/diseases/skin-cancer/types/common
3. Verrica Pharmaceuticals announces positive preliminary topline results from part 2 of phase 2 clinical study of VP 315 an investigational oncolytic peptide based immunotherapy for the treatment of patients with basal cell carcinoma. News release. Verrica Pharmaceuticals. August 14, 2024. Accessed January 21, 2025. https://verrica.com/press_release/verrica-pharmaceuticals-announces-positive-preliminary-topline-results-from-part-2-of-phase-2-clinical-study-of-vp-315-an-investigational-oncolytic-peptide-based-immunotherapy-for-the-treatment-of-pat/