Lytix Biopharma currently has the following ongoing program:

 

 

ALL SOLID TUMOURS LTX-315 monotherapy

LTX-315 monotherapy in patients with any solid tumour.

 

DESIGN

  Phase I, open-labelled, dose escalation, 9-12 patients.
  Patients with advanced cancer and at least one lesion accessible for direct transdermal injection.
  Three dosage groups. In each cohort, a minimum of one lesion will be treated with a fixed dose of LTX-315 given as a single agent.

 

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, open-labelled, dose escalation, 9-12 patients.
  All patients must have received prior anti-PD-1 treatment for unresectable/metastatic melanoma.
  Three dosage groups. In each cohort, a minimum of one lesion will be treated with a fixed dose of LTX-315 in combination with standard approved ipilimumab    
  dose (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, open-labelled, dose escalation, 9-15 patients.
  All patients must have received 1-4 prior treatment(s) for unresectable/metastatic TNBC and be anti-PD-1 treatment naive.
  Three dosage groups. In each cohort, a minimum of one lesion will be treated with a fixed dose of LTX-315 in combination with pembrolizumab dose 200 mg  
  (every 21 days).
 
 
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.

 

DEEP-SEATED TUMOURS – New lead compound

Extend pipeline with new lead compound for deep-seated tumours.

Lead compound selection 2h 2017.


RATIONALE FOR LTX-315 MONO AND COMBINATION THERAPY

LTX-315 is a first in class oncolytic peptide, which binds to the surface of tumour cells and kill these cells by destroying the cell membrane. LTX-315 induces a unique immunogenic cell death mode of action leading to infiltration of cytotoxic T cells and enhanced T cell clonality in the tumour microenvironment.

There are indications that the clinical efficacy of immune checkpoint inhibitors (ICIs) (ipilimumab or pembrolizumab) is correlated with the level of T cell inflammation in the tumour microenvironment. Due to the mode of action of LTX-315, it may be ideal for combining with ICIs.

To break local immune tolerance and build an effective and sustainable systemic immune response, frequent and multiple doses of LTX-315 will be administrated at 2 consecutive days each week, for 3 weeks.

DESIGN

  Phase I, open-label, multi-arm, multi-centre, multi-dose, dose escalation study of LTX-315 as monotherapy or as combination therapy with either ipilimumab or  
  pembrolizumab in patients with transdermally accessible tumours (cutaneous, subcutaneous, oral or lymph node lesions).
 
 
OBJECTIVES
  Primary:    
  Assessing safety and tolerability of multiple, intra-tumoural doses of LTX-315.
  Secondary:
  Evaluate the immune effects and anti-tumour effect in injected tumour lesions of LTX-315.