Lytix Biopharma AS today announces that promising full data results from a Phase I study of its lead candidate LTX-315 were published in Clinical Cancer Research, a peer-reviewed journal of the American Association for Cancer Research.
The study was an open-label multicenter study of LTX-315 with multiple intralesional injections in patients with solid tumors for whom alternative treatment options were not available or suitable. Thirty-nine patients were enrolled, receiving LTX-315 injections into accessible tumors, including melanoma, breast and head and neck. The primary objective was to assess the safety and tolerability of this approach, with antitumor and immunomodulatory activity as secondary objectives. Tumor biopsies were collected at baseline and posttreatment for analysis of immunologic parameters.
A number of patients experienced significant tumor regression in injected lesions. Substantial volume reduction of injected tumors occurred in 29 percent of the patients. More importantly, abscopal responses in distant untreated tumor deposits occurred in several patients, consistent with the concept of local tumor 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 tumor microenvironment and contributes to immune-mediated anticancer activity.
“A major and persistent challenge in today’s cancer treatment is lack of tumor 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 tumors more vulnerable for immune cell attack and hence induce efficient local and systemic tumor-specific immune responses,” said Dr. Øystein Rekdal, Lytix Biopharma’s CEO.
In January, the U.S. Food and Drug Administration (FDA) approved Lytix Biopharma’s Investigational New Drug application where LTX-315 will be evaluated in combination with the immune checkpoint inhibitor pembrolizumab, which blocks tumor cells’ ability to inhibit the body`s immune response. The planned multicenter study is designed to assess the efficacy in several types of solid tumors including metastatic breast cancer and head and neck squamous cell carcinoma.