Verrica Pharmaceuticals has dosed the last patient in part two of the Phase II trial of VP-315, a new oncolytic peptide immunotherapy for basal cell carcinoma, the common form of cancer.
The Phase II trial is a two-part, open-label, multicentre, proof-of-concept, dose-escalation study designed to assess the therapy’s safety, pharmacokinetics, and efficacy when administered intratumorally to adult subjects with biopsy-proven basal cell carcinoma.
It aims to enrol approximately 80 adult subjects, and lesion clearance data from part two is anticipated in the second quarter of this year.
VP-315 is administered directly into the tumour to induce immunogenic cell death, potentially offering a non-surgical option for patients.
Based on research in “host defence peptides”, the therapy works by inducing lysis of tumour cell organelles, such as mitochondria, to trigger T cell responses.
Verrica holds an exclusive licence to develop and commercialise VP-315 for dermatologic oncology indications.
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Verrica president and CEO Ted White said: “We are pleased to announce that part two of our Phase II clinical trial of VP-315 for the treatment of basal cell carcinoma has been fully enrolled and the last patient has been dosed.
“Basal cell carcinoma is the most common form of skin cancer in the US each year and patients are in need of alternative solutions to surgery which can cause pain, infection and scarring. Verrica’s VP-315 programme is designed to provide for the targeted delivery of an oncolytic peptide engineered to stimulate the patient’s immune system and destroy cancer cells.
“Our study remains on track, and we look forward to sharing the data from our Phase II clinical trial later this year.”
In multi-indication Phase I/II oncology studies, VP-315 has demonstrated positive tumour-specific immune cell responses.