Our lead candidate, LTX-315, has been studied in several completed Phase I/II studies that in total enrolled almost 100 patients with various solid cancer types (e.g. melanoma, breast cancer, soft tissue sarcoma and head and neck cancer).
While demonstrating the versatility of the Lytix technology platform, we have chosen to focus on skin cancers in two ongoing Phase II and planned Phase II studies with LTX-315.
Based on the results from the previous Phase I/II studies we have optimized the dosing regimen of LTX-315. In the ongoing Phase II ATLAS-IT-05 study, LTX-315 is administered to patients with advanced melanoma in combination with the immune checkpoint inhibitor pembrolizumab (Keytruda). All enrolled patients have been treated with checkpoint inhibitors (PD-1/PD-L1 inhibitors) previously and have documented disease progression. The enrollment of 20 melanoma patients is completed and interim results from the first enrolled patients were presented in October 2023 at the ESMO conference.
Verrica Pharmaceuticals Phase II study
The study is performed in basal cell carcinoma (BCC) patients by our partner Verrica Pharmaceuticals, a US-based dermatology-specialist company. In this study LTX-315 (VP-315) is administered as monotherapy. Results from the first part of this study were presented in August 2023 at the American Academy of Dermatology 2023 Innovation Academy Meeting and showed encouraging clinical efficacy with LTX-315 demonstrating positive clinical and histologic clearance. Verrica has now increased the number of participating clinical sites and expects to complete the study in the first half of 2024.
An investigator led Phase II study with LTX-315 is currently planned to start recruitment in H1 2024. This study will explore neo-adjuvant LTX-315 (administered before surgery) in combination with standard of care pembrolizumab (Keytruda) in patients with resectable melanoma. The objective of this study is to demonstrate that LTX-315 improves outcomes in these patients and prevents disease recurrence.