Lytix' lead candidate LTX-315 is a “first-in-class” oncolytic peptide with the potential to personalize immunotherapy. LTX-315 is developed for intratumoral treatment of solid tumors turning cold tumors hot.

LTX-315 is injected locally into a specific tumor. The unique membranolytic mode of action of LTX-315 leads to the release of potent immune stimulants and the patient’s personal tumor antigens due to lysis of the whole cancer cell. This trigger a strong and personal immune response resulting in infiltration of a broad range of tumor specific T cells attacking the patient’s tumor cells. Through these effects, LTX-315 can make tumors responsive to immune-checkpoint inhibitors and other therapies such as chemotherapy.

 

 

Lytix´ development strategy is to develop product candidates to be used and combined within immuno-oncology. Today, the majority of Lytix’ projects relate to the use of the Company’s clinical candidate LTX-315. Furthermore, the Company has a promising pipeline of new oncolytic compounds, such as LTX-401, for deep-seated tumors, i.e. hepatocellular carcinoma, liver metastases, lung and colorectal cancer.

 

ONGOING STUDY:

A phase I/II, open-label, multi-arm, multi-centre, multi-dose, dose escalation study with expansion cohorts of LTX-315 as monotherapy or in combination with either ipilimumab or pembrolizumab, in patients with transdermally accessible tumours.

 

ALL SOLID TUMOURS – LTX-315 monotherapy

LTX-315 monotherapy in patients with any solid tumour.

 

DESIGN

Phase I/II, open-labelled, dose escalation. Patients with advanced cancer and at least one lesion accessible for direct transdermal injection.

 

OBJECTIVES

Primary objectives:

               Assessment of safety and tolerability

Secondary objectives:

               Immune monitoring in biopsies and peripheral blood

               Anti-tumour activity

               Pharmacokinetic profile

 

Patient recruitment ongoing.

 

MALIGNANT MELANOMA – LTX-315 in combination with ipilimumab

LTX-315 in combination with ipilimumab in patients with unresectable/metastatic malignant melanoma.


DESIGN

Phase I/II, open-labelled, dose escalation study.

All patients must have received prior anti-PD-1 treatment as monotherapy or as part of combination for unresectable/metastatic melanoma.

LTX-315 in combination with standard approved ipilimumab, 3 mg/kg x 4 infusions.

 

OBJECTIVES

Primary objectives:

               Assessment of safety and tolerability

Secondary objectives:

               Immune monitoring in biopsies and peripheral blood

               Anti-tumour activity

               Pharmacokinetic profile

 

Patient recruitment ongoing.

 

TRIPLE NEGATIVE BREAST CANCER – LTX-315 in combination with pembrolizumab

LTX-315 in combination with pembrolizumab in patients with unresectable/ metastatic triple negative breast cancer (TNBC).

 

DESIGN

Phase I/II, open-labelled, dose escalation.

All patients must have received 1-4 prior treatment(s) for unresectable/metastatic TNBC and be anti-PD-1 treatment naive.

LTX-315 in combination with 200 mg pembrolizumab every 21 day.

 

OBJECTIVES

Primary objectives:

               Assessment of safety and tolerability

Secondary objectives:

               Immune monitoring in biopsies and peripheral blood

               Anti-tumour activity

               Pharmacokinetic profile

 

Patient recruitment completed.

 

PLANNED TRIALS

The Company plans to initiate three phase II trials with LTX-315 were recruitment of patients will start first half of 2018.

1.      Multi arm “pick the winner” design in combination with checkpoint inhibitors.

2.      Adoptive T cell therapy (ATCT) in patients with metastatic soft tissue sarcoma.

3.      Neoadjuvant trial in patients with head and neck cancer planned for curative intent surgery.