The clinical stageNorwegian biopharma company confirms the 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, Principal Investigator, Center for Cancer Immune Therapy, Herlev Hospital, Denmark.
About Lytix Biopharma’s Strategy:
Lytix Biopharma is now pursuing two strategies to utilise LTX-315 in the treatment of several cancer indications. LTX-315’s potential as a technology to invoke tumour specific T cells that can be cultured and infused as part of an adoptive transfer regimen is being explored in this study and potentially in other cancer indications. Based on the data from a recent Phase I study, LTX-315 intratumorally will be combined with immune modulators such as checkpoint inhibitors to address an unmet need in a selected group of indications.
About Lytix Biopharma AS: Based in Oslo, Norway, Lytix Biopharma is a clinical stage biotech company developing novel cancer immunotherapies, an area within cancer therapy that is aimed at activating the patient’s immune system to fight cancer. The Company’s technology is based on chemically optimized molecules generated from “host defence peptides” – natures first line of defence. Lytix Biopharma’s product candidate LTX-315 is a first-in-class oncolytic peptide providing access to the patient’s own tumor specific antigens and the potential to fully personalize immunotherapy.
www.lytixbiopharma.com