Lytix Biopharma is a clinical stage pharmaceutical company developing novel cancer immunotherapies, an area within cancer therapy that is aimed at activating the patient’s immune system to fight cancer.
Lytix’ product candidate LTX-315 is a first-in-class* oncolytic peptide with the potential to fully personalize immunotherapy. LTX-315 is developed for intratumoral treatment of solid tumors turning cold tumors hot. The phase I/II trial has demonstrated an acceptable and predictable safety profile with promising efficacy signals in monotherapy and combination therapy and the development is proceeding into phase II trials.
LTX-315 turns cold tumors hot by reshaping the tumor microenvironment through an effective release of potent immune stimulating molecules and tumor antigens. Reshaping the tumor microenvironment by LTX-315 triggers the immune system to recognize, infiltrate and attack the cancer cells, opening up the tumor for a variety of combination treatments including the marketed checkpoint inhibitors.
Currently, LTX-315 is developed for second line treatment of metastatic malignant melanoma and metastatic triple negative breast cancer (“TNBC”) in combination with checkpoint inhibitors, soft-tissue sarcoma as a pre-treatment with adoptive T cell therapy and as a neo-adjuvant (prior to curative surgery) therapy in head and neck cancer.
The Company believes LTX-315 is one of the most promising drug candidates with the potential to fully personalize immunotherapy by its mode of action to use the patient’s own tumor as its own vaccine, expose the immune system to one patient’s own cancer antigens, and to generate patient specific antitumor immunity. LTX-315 will convert cancers that are not recognized by the immune system and that are immunologically cold and unresponsive to immune therapy (the majority of cancers) to immunologically hot and, as a result, responsive to combination therapies with checkpoint inhibitors. LTX-315 has the potential to be used across several cancer indications, in various stages of cancer (early versus advanced), in combination with, or after, current standard of care therapy, primarily in combination with other immune therapies like checkpoint inhibitors or with chemotherapies.
* ’’First-in-class’’ refers to a pharmaceutical which often has a new mechanism of action which differs from existing therapies, FDA Novel Drugs Summary, 2016.