Lytix Biopharma enters milestone agreement with Verrica Pharmaceuticals for its lead candidate LTX-315
Lytix Biopharma AS licenses its lead candidate LTX-315, a first-in-class oncolytic peptide based immunotherapy, to Verrica Pharmaceuticals, for the treatment of dermatologic oncology indications. Lytix is entitled to receive an up-front payment, contingent regulatory milestones based on achievement of specified development goals, and sales milestones, with aggregate payments of more than $110M, as well as tiered royalty payments in the double-digit teens once Verrica successfully commercializes LTX-315 in dermatologic oncology indications.
Lytix Biopharma AS (“Lytix”) today announces that the Company has entered into an exclusive worldwide license agreement with Verrica Pharmaceuticals Inc. (“Verrica”) (NASDAQ: VRCA), to develop and commercialize LTX-315 for dermatologic oncology indications.
Photo: Håvar Haug
“We are pleased to enter into this collaboration with Verrica, which has significant expertise within the field of dermatology” said Øystein Rekdal, Lytix`s CEO. “Our lead drug candidate, LTX-315, has shown very promising efficacy and safety signals in cancer patients during Phase I/II studies and we are excited that this partnership with Verrica will expand the applications for LTX-315”
“Local administration of LTX-315 in pre-clinical cancer models and in cancer patients with intradermally accessible lesions has shown promising abilities to induce anti-tumor immune responses” said Sandra Demaria who is a member of Lytix Scientific Advisory Board and internationally recognized expert in development of focal radiotherapy and cancer immunotherapy combinations. “I believe that LTX-315 with its novel mechanism of action could represent a first in class treatment for dermatologic oncology indications, if approved.”
LTX-315 is a first-in-class oncolytic peptide that is injected directly into a tumor to induce immunogenic cell death. The compound has demonstrated positive tumor-specific immune cell responses in multi- indication Phase I/II oncology trials.
Verrica Pharmaceuticals is a dermatology therapeutics company developing medications for skin diseases requiring medical interventions. The company intends to focus initially on basal cell and squamous cell carcinomas as the lead indications for development of LTX-315.
“Skin cancer is the most common cancer in the U.S., with 5 million diagnoses of basal and squamous cell carcinomas each year,”* said Darrel Rigel, MD Clinical Professor of Dermatology at NYU. “Patients are typically treated with surgery, which can result in damage to healthy tissue, pain, and permanent scarring. LTX-315 is a clinical stage, non-surgical immunotherapy product candidate that directly targets cancerous skin cells, with the potential to transform the treatment of skin cancer by offering a therapeutic alternative to surgery."
“This is an important milestone in the broadening of Verrica’s strategy to bring breakthrough treatments for skin diseases to patients and physicians, as dermatologic cancers are a highly prevalent and potentially life-threatening subset of the oncology space,” said Dr. Gary Goldenberg, Verrica’s Chief Medical Officer. “Innovation in dermatology is one of the primary drivers that prompted me to recently join Verrica full-time, and LTX-315’s unique mechanism of action is clearly an innovative approach to potentially provide a significant improvement over invasive surgery.”
Under the terms of the agreement, Lytix will be 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 totals USD 2.5 million, in addition to tiered royalties based on worldwide annual sales. The agreed upon royalty rates start in the low double digits and increase to the mid-teens based on net sales achieved.
Verrica is solely responsible for the development, regulatory filings and commercialization of LTX-315 in dermatology, while Lytix is responsible for manufacturing the active pharmaceutical ingredient. The license includes worldwide rights for Verrica to develop and commercialize LTX-315 for all malignant and pre-malignant dermatological indications, except for metastatic melanoma and metastatic Merkel cell carcinoma.