Lytix Biopharma AS announces dosing of first patient in a Phase II study of its first in class oncolytic peptide, LTX-315, administered in combination with adoptive T-cell therapy in patients with advanced soft tissue sarcoma

The objective of the trial is to assess the safety and efficacy of intratumoral administration of LTX-315 and adoptive T-cell therapy in patients with advanced soft tissue sarcoma. This proof of concept study will evaluate the potential for LTX-315 to induce T-cell infiltration prior to isolation and expansion of tumor infiltrating lymphocytes (TILs) followed by infusion of the cultured TILs to the patient. An extensive immune profile will be generated to characterise the immune status and nature of anti-tumor immune response. Objective clinical response and duration of response will be assessed.

The first patient has commenced dosing with LTX-315 and will proceed to resection of the injected lesion followed by TIL expansion and infusion (upon positive TIL generation and identification).

Soft tissue sarcoma is an indication with progressive subtypes and limited treatment options. We were greatly encouraged by the results of a recent LTX-315 Phase I study indicating that LTX-315 has the potential to turn cold tumours hot, which may prove to be a vital therapeutic pathway for patients with sarcoma who otherwise would not be able to benefit from immune therapy. We look forward to the outputs of this program to help address a crucial unmet need as well as understand the potential of this combination for other cancer indications. Said Hamina Patel, CMO of Lytix Biopharma AS.

We are really pleased that the first patient has been recruited into the study and will undergo combination treatment with LTX-315 and T-cell therapy. This is an area of substantial unmet need and new, effective treatment options for patients with sarcoma are needed. We anticipate that LTX-315 can provide a viable treatment when utilized in combination with T-cell therapy, since it has already been demonstrated that LTX-315 has the potential to attract relevant immune cells into tumors. Said Inge Marie-Svane, MD, Principle Investigator, Center for Cancer Immune Therapy, Herlev Hospital, Denmark.