Verrica Pharmaceuticals Announces FDA Acceptance of its IND Application for Potential First-in-Class Oncolytic Peptide-Based Immunotherapy for the Treatment of Basal Cell Carcinoma

Verrica Pharmaceuticals Inc. recently announced the US FDA has accepted its Investigational New Drug Application (IND) for LTX-315, a potential first-in-class oncolytic peptide, for the treatment of basal cell carcinoma. The company expects to initiate its Phase 2 trial of LTX-315 in basal cell carcinoma in the first quarter of 2022.

“We are excited to bring this novel immunotherapy to the clinic as a potential new non-surgical treatment for skin cancer,” said Ted White, Verrica’s President and Chief Executive Officer. “LTX-315, a non-surgical immunotherapy that targets cancerous skin cells, is a remarkably innovative approach to skin cancer and represents a new treatment paradigm beyond invasive surgery. With nearly 5 million diagnoses of non-melanoma skin cancer in the US each year, of which nearly 80 percent are basal cell carcinomas, there is a significant need for new treatment options.”

“LTX-315’s unique mechanism of action is clearly an innovative approach to potentially provide significant improvement over invasive surgery. LTX-315 has the potential to revolutionize one of the most common disease states in dermatology – non-melanoma skin cancer,” said Dr. Gary Goldenberg, Verrica’s Chief Medical Officer.

“It will be an honor to serve as the lead primary investigator in the Verrica LTX-315 trial for the treatment of basal cell carcinoma. Most of the current treatment options for non-melanoma skin cancers can cause pain, scarring and infection. LTX-315 has the potential for treating these malignancies in a non-surgical manner through intratumoral injection,” said Dr. Neal Bhatia, Director of Clinical Dermatology at Therapeutics Clinical Research in San Diego.

LTX-315 is a potential first-in-class oncolytic peptide immunotherapy administered directly into a tumor to induce immunogenic cell death, which may offer a non-surgical option for patients suffering from skin cancer. The technology is based on pioneering research in “host defense peptides” – nature’s first line of defense towards foreign pathogens. LTX-315 is administered intratumorally and works by inducing lysis of intracellular organelles of tumor cells such as mitochondria, thereby unleashing a broad spectrum of tumor antigens for T cell responses. Verrica has an exclusive worldwide license to develop and commercialize LTX-315 for dermatologic oncology indications and intends to focus initially on basal cell and squamous cell carcinomas as the lead indications for development. LTX-315 has demonstrated positive tumor-specific immune cell responses in multi-indication Phase 1/2 oncology trials.

Verrica is a dermatology therapeutics company developing medications for skin diseases requiring medical interventions. Verrica’s late-stage product candidate, VP-102, is in development to treat molluscum, common warts and external genital warts, three of the largest unmet needs in medical dermatology. Verrica is also developing VP-103, its second cantharidin-based product candidate, for the treatment of plantar warts. The company has also entered a worldwide license agreement with Lytix Biopharma AS to develop and commercialize LTX-315 for dermatologic oncology conditions. For more information, visit www.verrica.com.