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Lytix enrols first patient in combination study


Norwegian Lytix Biopharma has enrolled the first patient in the Phase 1 study of LTX-315 in combination with immune checkpoint inhibitors (ICIs).

Since LTX-315 turns immunogenically “cold” tumours “hot” it may be an ideal combination with other immunotherapies. The majority of cancer patients do not respond to marketed immunotherapies when given as monotherapy. The promise of combination immunotherapy is that it may improve the response rate observed with ICIs.

LTX-315 is a novel first-in-class oncolytic peptide immunotherapy in development for the treatment of solid tumours as triple negative breast cancer (TNBC) and malignant melanoma. As monotherapy, LTX-315 has demonstrated a significant increase in CD8 T cells infiltration in injected tumours. Since LTX-315 is turning immunogenically “cold” tumours “hot” it has the potential to enhance the proportion of patients responding to ICIs.

“We look forward to gaining further understanding of the potential for LTX-315 as a key component in immunotherapy. Due to LTX-315’s ability to induce strong and diverse tumour specific T cell responses, we believe it is an ideal combination partner for ICIs,” said Håkan Wickholm, Lytix Biopharma CEO.

“LTX-315 can make immunogenically “cold” tumours “hot” and has demonstrated strong synergy in combination with ICIs in preclinical experiments. This represents a strong rationale for us to evaluate this combination in cancer patients,” commented Andrew Saunders, Lytix Biopharma CMO.

The Phase 1 trial is designed to investigate the safety and efficacy of LTX-315 in combination with either anti-PD1 or anti-CTLA4 Immune Checkpoint Inhibitor (ICI) antibodies in either Triple Negative Breast Cancer (TNBC) or malignant melanoma. The first patient enrolled in the study is a TNBC patient that will receive LTX-315 in combination with anti-PD1. LTX-315 is injected twice a week for 3 weeks, and a total of 14 investigational sites in Europe are participating in the study.

The Phase 1 study is an open-label, multi-arm, dose escalation study of LTX-315 as monotherapy or in combination with either anti-CTLA4 or anti-PD1 in patients with transdermally accessible tumours with the aim of identifying an optimal dose regimen to take into Phase 2.

Recent data indicate that in a Phase 1 trial population with advanced/metastatic tumours, LTX-315 is generally well tolerated with complete and partial regression in 31% of injected tumours and stable disease (SD) in 50% of evaluable patients.

Source: Oslo Cancer Cluster