Verrica's VP-315 Shows Promising Abscopal Effect in Basal Cell Carcinoma Phase 2 Trial
核心洞察
Verrica Pharmaceuticals' VP-315 demonstrated a potential abscopal effect in Phase 2 trials, with untreated basal cell carcinoma (搜索) lesions showing a 67% reduction in size following treatment of separate target lesions.
The oncolytic peptide immunotherapy achieved complete histologic clearance in 21% of non-treated lesions, suggesting broader immune activation beyond the injection site.
Results indicate VP-315 could address the significant unmet need for patients with multiple BCC lesions, as approximately one-third of patients develop additional primary tumors over their lifetime.
Verrica Pharmaceuticals has announced promising Phase 2 clinical data for VP-315 (ruxotemitide), demonstrating a potential abscopal effect in the treatment of basal cell carcinoma (搜索) (BCC). The novel oncolytic peptide immunotherapy showed therapeutic activity extending beyond directly treated lesions, with untreated tumors experiencing significant size reductions.
Phase 2 Trial Results Show Systemic Anti-Tumor Activity
In the open-label Phase 2 trial, 14 untreated non-target lesions (NTLs) in 9 subjects demonstrated an overall 67% reduction in lesion size following intratumoral VP-315 treatment of separate target lesions. The reductions ranged from 50-100% in superficial lesions and 25-100% in nodular lesions. Complete histologic clearance was observed in 21% of non-treated lesions (3 out of 14).
"The peripheral anticancer activity we are observing well beyond the injection site suggests that VP-315 could be exerting an abscopal effect for the treatment of basal cell carcinoma (搜索)," said Jayson Rieger, PhD, MBA, President and Chief Executive Officer of Verrica Pharmaceuticals. "Such activity may indicate a broader immune activation within the tumor microenvironment of non-target lesions."
Treatment Protocol and Mechanism of Action
Subjects received less than 8 mg of VP-315 (in 0.5mL) through intratumoral injections in up to 2 treated lesions. Up to 3 non-treated lesions per subject were monitored over 12 weeks. VP-315 is administered directly into tumors to induce immunogenic cell death, thereby unleashing a broad spectrum of tumor antigens for T-cell responses.
The therapeutic effects were observed across all non-target lesion locations, including proximal, distal and contralateral to treated lesions, with no skip lesions observed. Non-serious local skin reactions were reported in only 1 non-target lesion.
Clinical Significance for BCC Treatment
The findings address a significant clinical need, as patients with BCC frequently present with multiple tumors, and approximately one-third will develop additional primary tumors over their lifetime. Basal cell carcinoma (搜索) is the most common form of cancer in the U.S., with approximately 3.6 million diagnoses annually.
"We are excited about the potential of VP-315 to provide a primary and/or neoadjuvant treatment option for patients with BCC, whether it be their first lesion or multiple lesions after a long history of BCC," commented Noah Rosenberg MD, Verrica's Chief Medical Officer. "While the best outcome for patients is to completely eliminate the tumor, which we have observed in many patients in our Phase 2 study, overall tumor size was reduced on average by 86%, which is clinically meaningful."
Potential to Transform Treatment Paradigm
The observed abscopal effect could represent a significant advancement in BCC treatment, potentially offering a non-surgical option for patients suffering from skin cancer (搜索). Current treatment typically involves invasive surgery to remove tumors, which can cause pain, infection, bleeding and scarring.
Dr. Rosenberg noted that VP-315 has the potential to improve the patient experience by reducing the size and potential complexity of future procedures, even where surgical excision is ultimately required. The therapy could also benefit patients with difficult to detect, residual disease that can sometimes be left behind after surgical excision.
Development Program and Regulatory Path
Verrica holds an exclusive worldwide license to develop and commercialize VP-315 for certain dermatologic oncology indications, including non-metastatic melanoma (搜索) and non-metastatic merkel cell carcinoma (搜索). The company intends to focus initially on basal cell and squamous cell carcinomas as the lead indications for development.
VP-315 has previously demonstrated positive tumor-specific immune cell responses in multi-indication Phase 1/2 oncology trials. The current Phase 2 data will be presented at the 2026 Society for Investigative Dermatology Annual Meeting in Chicago from May 13-16, 2026.