Lytix Biopharma AS
…improving nature’s own defense mechanisms
Lytix Biopharma is a privately owned, clinical stage biotech company, developing a novel anti-infective drug candidate and the next generation cancer treatment; immunotherapy. Research and Development of the company’s drug candidates started at the University in Tromsø (UiT) in 1994.
Its technology is based on nature’s own defense mechanism where bacteria and cancer cells are destroyed, activating the body’s immune system.
Lytix Biopharma has two drug candidates in development: LTX-315, an immuno-oncology compound expecting to report Proof of Concept
by mid 2015; and LTX-109, an anti-infective topical drug with a Proof of Concept study reporting results in Q2 2014. Both lead compounds are de novo designed peptides derived from membrane-active host defense peptides.
Lytix Biopharma’s technology is based on the naturally-occurring antimicrobial protein Lactoferrin found in milk. Based on knowledge gained from an active fragment of this protein (Lactoferricin), the researchers behind Lytix Biopharma designed two molecules combining properties required of a drug with the biological activities of Lactoferricin.
The drug candidate LTX-315 is a de novo designed peptide derived from a naturally occurring host defense peptide. LTX-315 has the potential to activate the innate immune system locally by its membrane destabilizing effect on the tumor cells followed by a release of endogenous adjuvants and natural danger signals, providing a strong rationale for using LTX-315 in combination with other types of immune-modulatory therapies. LTX-315 mounts strong and specific immune responses that are able to control disseminated tumors in animals. LTX-315 has potential as a novel treatment strategy to generate personalized tumor specific immune responses. LTX-315 is currently tested in a Phase I/IIa dose escalation clinical study.
LTX-315 clinical trials:
1. A Phase I dose-Escalation Study of LTX-315 in Patients with a Transdermally Accessible Tumour (Study C08-315-01); Completed
2. A Phase I combination, immunologic study of LTX-315 with GV1001 in patients following surgery with curative intent for malignant tumours (Study C09-315-02); Completed
3. A Phase I dose-Escalation Study of LTX-315 in Patients with Transdermally Accessible Tumours (Study C12-315-03); Recruiting
The drug candidate LTX-109 shows unique results in the treatment of infections. So far, Lytix Biopharma`s focus is on topical treatment of skin infections and nasal eradication of Staphylo-coccus, regardless of resistance. LTX-109 is a synthetic, bactericidal antimicrobial peptide-mimetic, which degrades the membranes of harmful micro-organisms.
Preclinically, LTX-109 has demonstrated:
A novel membrane lysing mode of action that causes selective, rapid membrane disruption
A low propensity to development of resistance and no in vitro target-specific cross-resistance with other classes of antibiotics
A broad spectrum of activity
An efficacy against antibiotic-resistant species
A superior efficacy compared to market leading antimicrobial drugs
A high activity against biofilm infection
LTX-109 clinical trials:
1. A first in man Phase I study to investigate tolerability and safety of topical LTX-109 in healthy subjects (Study C08-109-01); Completed
2. A Phase I/IIa pilot study to evaluate the safety, tolerability and efficacy of topical LTX-109 in subjects nasally colonized with methicillin-resistant/-sensitive Staphylococcus aureus (MRSA/ MSSA; Study C10-109-02); Completed
3. A Phase IIa pilot study to evaluate the safety, tolerability and efficacy of LTX-109 in patients with uncomplicated, Gram-positive, skin infection (Study C10-109-03); Completed
4. A Phase II, randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of two doses of LTX-109 (1 % and 2 %) versus placebo in impetigo (Study C12-109-04); Recruiting
The market for immune therapy of cancer is expected to have an explosive growth in the coming years and an annual turnover of USD 35 billions within 10 years (according to Citigroup). The market for topical treatment of skin infections is approximately USD 1 billion. There is a need for new topical drugs to treat skin infections locally to avoid systemic exposure.
Lytix Biopharma’s strategy is to develop its drug candidates to Proof of Concept. The company will then bring in partners for the final stages of product development and commercialization.
Lytix Biopharma’s experienced Board of Directors and highly competent employees.
Nordic Star Awards 2014
At the Nordic Life Science Days closing ceremony on Tuesday, September 9th 2014 in Stockholm, Sweden, three companies, including Lytix Biopharma, were awarded the 2014 Nordic Stars Award for their clear illustration of the power of innovation in Nordic life science.
“During the past year, Lytix Biopharma demonstrated several positive results and a strong commitment to take the lead in immuno-oncology. Their global ambition shows the power of a Nordic star!”