Lytix Biopharma has announced promising full data results from a Phase I study of its lead candidate LTX-315 lysing solid tumours, which have been published in Clinical Cancer Research.
The study was an open-label multicentre study of LTX-315 with multiple intralesional injections in patients with solid tumours for whom alternative treatment options were not available or suitable. 39 patients were enrolled, receiving LTX-315 injections into accessible tumours, including melanoma, breast and head and neck. The primary objective was to assess the safety and tolerability of this approach, with antitumour and immunomodulatory activity as secondary objectives. Tumour biopsies were collected at baseline and post-treatment for analysis of immunologic parameters.
Several patients experienced significant tumour regression in injected lesions. Substantial volume reduction of injected tumours occurred in 29% of the patients. More importantly, abscopal responses in distant untreated tumour deposits occurred in several patients, consistent with the concept of local tumour lysis giving rise to a systemic anticancer immune response. In conclusion, the study demonstrated that LTX-315 has an acceptable safety profile, is clinically active, induces significant T cell infiltration in the tumour microenvironment and contributes to immune-mediated anticancer activity.
“A major and persistent challenge in today’s cancer treatment is lack of tumour infiltrating T cells in the majority of cancer patients, making it difficult for the immune system to attack the cancer cells. The results prove that LTX-315 increases the number of T cells making the tumours more vulnerable for immune cell attack and hence induce efficient local and systemic tumour-specific immune responses,” said Dr. Øystein Rekdal, Lytix Biopharma’s CEO.