New Data Suggest Potential of VP-315 as Treatment for Basal Cell Carcinoma

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In an announcement by Verrica Pharmaceuticals Inc., new phase 2 clinical data were presented at the 2025 Winter Clinical Dermatology Conference, highlighting the positive results identified in the efficacy and safety of the company’s investigational oncolytic peptide, VP-315, for basal cell carcinoma (BCC).¹

The Winter Clinical conference took place from January 17-19 in Miami, during which 3 posters were showcased highlighting VP-315’s efficacy for patients with BCC. BCC is a skin cancer that is the most frequently diagnosed cancer within the US, with rising global prevalence and current management typically requiring invasive surgical procedures for the removal of tumors.

“We remain highly encouraged by the positive preliminary topline results from Part 2 of the Phase 2 study for VP-315, which we believe support a potential change in the treatment paradigm for patients with basal cell carcinoma,” Jayson Rieger, PhD, MBA, the president and chief executive officer of Verrica, said in a statement.

VP-315 has the potential to address this unmet need by providing a less invasive alternative for patients with basal cell carcinoma. The medication is novel oncolytic chemotherapeutic peptide immunotherapy which was formulated for intratumoral administration, targeting tumors for the inducement of immunogenic cell death and potentially providing a non-surgical treatment alternative for individuals with skin cancer.

Findings on VP-315 were highlighted in 3 posters, with the first titled “Calculated Objective Response Rate (ORR) of 97% from Post-Hoc Analysis of a Phase 2 Multicenter Study to Evaluate the Efficacy of VP-315, an Investigational Therapy for Basal Cell Carcinoma (BCC).” There were 2 additional presentations showcasing the multicenter study’s findings on the treatment’s safety, tolerability, and efficacy.

The analysis itself was a 2-part, open-label, multicenter, dose-escalation, proof-of-concept study that also included a safety run-in phase. It was carried out to assess VP-315’s safety, pharmacokinetics, and efficacy when delivered directly into adult patients’ tumors provided they had biopsy-confirmed BCC.

There were 92 adult participants included in the analysis with histologically confirmed BCC in at least a single target lesion. As part of the team’s work, they evaluated different dosing regimens for the purposes of determining the optimal approach for an upcoming phase 3 trial.

The investigators’ findings indicated that approximately 51% of tumors among the subjects included in the study achieved complete histological clearance. Those who did not achieve complete clearance were shown to have an average tumor size reduction of around 71%.

The investigators also identified no treatment-related serious adverse events among participants. Adverse events that were identified were classified by the research team as being mild to moderate in severity.

The team also included a post-hoc analysis, the contents of which highlighted a calculated Objective Response Rate (ORR) of 97%. They defined ORR as the proportion of study subjects who were shown not to have any disease progression and were noted as having experienced 30% reduction in the size of their tumors at minimum.

Verrica is currently awaiting genomic and T-cell immune response data, which is expected in the first quarter of 2025. The company plans to meet with FDA officials within the initial half of 2025 for an End-of-Phase 2 meeting, with the aim being a discussion of VP-315’s next steps as a potential treatment 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 his statement. “We believe that VP-315 could represent a multi-billion-dollar commercial opportunity for Verrica. We look forward to our discussions with the FDA about designing a development path forward for VP-315 in 2025.”¹

References

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. Verrica Pharmaceuticals. January 21, 2025. https://www.globenewswire.com/news-release/2025/01/21/3012498/0/en/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-Winte.html.}