Lytix Biopharma AS announces that the U.S. Food and Drug Administration (FDA) has accepted Verrica Pharmaceutical Inc's (“Verrica”) (NASDAQ: VRCA) Investigational New Drug Application (“IND”) for LTX-315 for the treatment of basal cell carcinoma. LTX-315 is a first-in-class oncolytic molecule representing a new and superior in situ therapeutic vaccination principle to boost anti-cancer immunity.
“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. ”
Verrica is a dermatology therapeutics company developing medications for skin diseases requiring medical interventions. In August 2020, Lytix licensed its lead candidate, LTX-315, to Verrica, for the treatment of dermatologic oncology indications. Verrica intends to focus initially on basal and squamous cell carcinomas as the lead indications for development of LTX-315. The American Cancer Society has estimated that about 5.4 million basal cell carcinoma (BCC) and squamous cell carcinomas are diagnosed in the US annually. With about 80% of these skin cancers being BCC, there is a significant need for new treatment options.
Verrica expects to initiate its Phase II trial of LTX-315 in basal cell carcinoma in the first quarter of 2022.
“The collaboration with Verrica Pharmaceuticals constitutes an essential part of our development program for LTX-315, and the FDA approval for the initiation of Verrica’s Phase II study in basal cell carcinoma adds substantial value to our development program as well. LTX-315 is intended for use in solid tumors accessible for intratumoral injections, and the estimated timeline for the further development program indicates that we will find LTX-315 in two separate and independent Phase II studies in the first quarter of 2022”, CEO of Lytix, Øystein Rekdal concludes.
Under the terms of the license agreement, Lytix is entitled to receive an upfront payment, contingent regulatory milestones based on achievement of specified development goals, and sales milestones, with aggregate payments of up to $113.5 million, of which the upfront and the first regulatory milestone payments, totaling USD 2.5 million, have been paid. In addition, Lytix is entitled to receive tiered royalties based on worldwide annual sales. The agreed upon royalty rates start in the low double digits and increase to the mid-teens.
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