Verrica's oncolytic peptide clears half of skin cancer lesions in mid-stage study

Verrica Pharmaceuticals aims to meet with the FDA in the first half of 2025 to discuss the future of its experimental oncolytic peptide, VP-315, following promising preliminary results from a Phase II study on basal cell carcinoma (BCC). Nevertheless, the company might struggle to maintain its financial runway until that meeting, having reported around $32 million in cash in its second-quarter earnings, which is projected to fund operations only into the first quarter of next year. Despite the positive results for VP-315 in BCC, the company's precarious financial status has seemingly unsettled investors, leading to a significant drop in Verrica’s share price by over 40%.

Histological Clearance and Study Details
The Phase II trial involved 92 adult participants, each with one of 93 histologically confirmed BCC lesions, who received intratumoral injections of VP-315. The immunotherapy achieved complete histologic clearance in 51% of the lesions, meaning no residual cancer cells were detected. For patients with remaining tumor tissue, VP-315 showed a 71% reduction in tumor size. The first quarter of 2025 is expected to bring further genomic and immunological response data.

Expert Opinions on VP-315
Dr. Jonathan Kantor, a dermatologist and skin cancer surgeon at the Florida Center for Dermatology, where the highest number of trial participants were enrolled, remarked on the potential of VP-315 to revolutionize BCC treatment. He suggested that patients might be cured with simple injections of the therapy.

Safety Profile and Comparisons
VP-315 was well-tolerated by patients, showing no dose-limiting toxicities or serious adverse events related to the treatment. The most common side effect was a mild-to-moderate cutaneous reaction. According to Verrica’s Chief Medical Officer, Gary Goldenberg, the safety profile of VP-315 could set it apart from existing treatments, which often have systemic side effects. Goldenberg expressed confidence in VP-315’s potential to significantly improve patient outcomes compared to current therapies and surgical procedures.

Licensing and Future Potential
In 2020, Verrica acquired the rights to VP-315 through a global licensing deal with Lytix Biopharma. This agreement allows Verrica to develop and commercialize the oncolytic peptide for skin cancers, excluding metastatic melanoma and Merkel cell carcinoma. Lytix Biopharma’s CEO, Øystein Rekdal, highlighted the Phase II outcomes as indicative of VP-315’s potential to serve either as a standalone treatment or in combination with surgery for early-stage BCC. He even suggested that the therapy could be used as a first-line treatment for BCC. The agreement also stipulates that Lytix Biopharma could earn up to $110 million in clinical, regulatory, and sales milestones.

In summary, Verrica Pharmaceuticals is ambitiously planning to discuss the regulatory future of VP-315 with the FDA based on its encouraging Phase II results for BCC. However, the company faces a significant challenge in its financial sustainability, which has cast uncertainty on the long-term viability of its promising therapy.

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