biomarck is a biopharmaceutical company with a patented technology platform. We utilize anti-MARCKS peptides in order to develop and license products targeted at difficult to treat diseases with unmet needs. We are located in Research Triangle Park, N.C..
Our company has a worldwide patented drug platform of over 100 peptides that inhibit the phosphorylation of the MARCKS protein, a well published primary mediator of an inflammatory cytokine release involved in respiratory disease and cancer progression.
biomarck is currently developing its lead compound, BIO-11006 for non small cell lung cancer (NSCLC) and acute respiratory distress syndrome (ARDS). We have active IND’s for both indications and are conducting Phase 2 clinical studies in patients with NCSLC and ARDS in 2017/2018.
The method of action (MOA) has been clearly delineated for both diseases. For NSCLC inhibition of phosphorylation of the MARCKS protein by the ten amino acid peptide BIO-11006 prevents PIP2 release from the cell wall into the cytoplasm and subsequent activation of tumor promoting agents such as FAK, P13 and AKT. Further it has been shown to hold the cell for long periods of time in the G2/M phase of division (G2/M arrest) allowing potentiation of the effect of platinum based therapies.
Studies in the two most predictive mouse models (orthotopic injection and tail vein injection of human lung cancer cells) have both shown BIO-11006 alone to have a dose dependant inhibition of metastasis (locally and peripherally) and reduction in primary tumor size. When combined with cisplatin the effect was significantly greater than cisplatin alone.
In ARDS the MOA has been shown to be an inhibition of the “cytokine storm” caused by the sudden tremendous influx of neutrophils following an acute lung injury. This has been confirmed in three separate mouse models for ARDS (LPS, LTA and Bacterial Pneumonia). BIO-11006 has been shown to prevent the development of ARDS and perhaps more excitingly reverse ARDS once it has been established.
BIO-11006 was originally being developed for the treatment of COPD until the more compelling data for NSCLC and ARDS became available. It does however have a complete pre-clinical package of toxicology and pharmacology data and has been through Phase 1 and 2 in the USA in over 200 patients. While significance was achieved for efficacy (trough FEV1) it also demonstrated a well accepted safety profile at doses up to 125m b.i.d.
The product is water soluble, stable and has been administered by nebulizer. It has also been given intravenously and as an intraperitoneal injection.
Both of these indications represent a clear unmet clinical need and would be expected to receive priority review by the FDA. We have received NIH grants to support our studies for these indications.
From a commercial point of view NSCLC presents in 90% of lung cancer, with an estimated prevalence of 330,000 cases per year. Excluding patients suitable for surgery, radiotherapy and immunotherapy and we estimate that annual peak sales will exceed $2 billion in this indication alone.
ARDS has a 30-60% mortality within 28 days and the only treatment option is mechanical ventilation and treatment of the underlying condition usually with antibiotics. We have commenced a Phase 2 double blind clinical study in the US and anticipate peak annual sales for this acute indication of $800 million. For prophylactic use annual sales will be much higher.