Technology Overview

Macrophages play a key role in many inflammatory, infectious and malignant diseases.

Very exclusively, macrophages express the hemoglobin scavenger receptor, CD163 on their surfaces. DELIVER PHARMA has produced and humanized an IgG4 monoclonal antibody, named Maclizumab, which binds CD163 leading to internalizing by macrophages. DELIVER PHARMAS lead compound, Maclizumab Dexamethasone, specifically targets and deliver the well-known and potent glucocorticoid to macrophages.

In the present form, a therapy based on Maclizumab Dexamethasone will be administered intravenously (IV). The initial focus for treatment with Maclizumab Dexamethasone is hepatic inflammation with steatohepatitis of AAH (acute alcoholic hepatitis) and NASH (non‑alcoholic steatohepatitis) being lead indications but its use for other inflammatory diseases is also an option.

Figure 1: Maclizumab Dexamethasone reduces inflammation 50-fold and shows no systemic side-effects in rats and pigs

Figure 2: Maclizumab Dexamethasone effectively inhibited progression of NASH, in terms of ballooning, fat accumulation and fibrosis as well as composite NASH score in the animal model of NASH

Stage of Development

Strong Proof-of-Concept data have been obtained, showing 50-fold increase in potency of dexamethasone without increase in adverse effect. Based on favourable pharmacokinetics and large scale producibility Maclizumab dexamethasone is ready for late pre-clinical and clinical development. Next development will focus on GMP production of the antibody-drug batch, the safety/toxicity testing of the GMP produced Maclizumab dexamethasone and hereafter early clinical testing in patients suffering from acute alcoholic hepatitis.

Opportunity

DELIVER PHARMA´s Maclizumab Dexamethasone is currently ready for development for the acute severe form of AAH as a first-line treatment. Maclizumab Dexamethasone could also potentially be offered to treat inflammation other therapeutic applications such as drug-induced hepatitis (e.g. caused by paracetamol), liver transplant rejection, autoimmune hepatitis and acute liver failure as well as for a range of other inflammatory diseases. There is a potential for broadening the platform by development of cancer drugs trough targeting of tumor associated macrophages.

SDU are looking for investment or partnering.

Maclizumab Dexamethasone - a CD163 Targeting Antibody Drug Conjugate directed Macrophages for Treatment of NASH and AAH

Patents

IP Status

Seeking