Building on Novozymes Biopharma’s recombinant human albumin Recombumin, Denmark-based Serendex Pharmaceuticals’ leading drug candidate Molgradex — a Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) — has entered Phase I clinical trials.
Molgradex leverages Novozymes Biopharma’s recombinant human albumin, Recombumin to enable development of a stable drug formulation for novel pulmonary (inhalable) delivery. Recombumin, acting as a stabilizer, prevents unwanted derivatization of the labile therapeutic protein by scavenging against generation of reactive species, thereby helping reduce risk of unwanted immunological responses.
Novozymes’ rAlbumin Human USP-NF* Recombumin is the world’s first and only commercially available, animal-free, recombinant human albumin, approved for use in the manufacture of human therapeutics. Recombumin is an effective and versatile stabilizer particularly suited for use in the formulation of protein and peptide drugs that are not readily stabilized with standard excipients. Through various modes of action, Recombumin protects biological products from degradation, adsorption and aggregation. For example, Recombumin has been shown to reduce particle formation in high-concentration protein formulations as well as stabilize various peptide and protein therapeutics by hindering fibrillation and protein aggregation, respectively.
Molgradex, a recombinant version of the human GM-CSF, is intended for treatment of rare pulmonary diseases such as Pulmonary Alveolar Proteinosis (PAP), Acute Respiratory Distress Syndrome (ARDS), Bronchiectasis (BE) and Cystic Fibrosis (CF). The drug is being developed as the first inhalable treatment option for these diseases with marketing authorization for treating PAP expected in 2018.
Leading up to the clinical trials, Novozymes Biopharma and Serendex Pharmaceuticals have been collaborating research on using albumin in the final drug formulation.
“Novozymes Biopharma has been instrumental in smoothly moving our drug candidate through development and regulatory filings. Their regulatory and technical product support has been of great value to us in preparation for our clinical trials,” says Serendex CEO Kim Arvid Nielsen in a release. “It has also been important for us to have a partner capable of providing an undisputed product safety profile as well as supply security.”
Recombumin is already a constituent of some currently marketed drugs, and is being evaluated in late-stage clinical trials both under US and EU regulations.
“We are excited about our collaboration with Serendex Pharmaceuticals,” says Novozymes Biopharma Vice President Peter Rosholm. “I consider it additional proof that our unique recombinant albumin products offer superior stabilizing benefits when other stabilization options fail. This provides further evidence that our well-documented products and technical support deliver value to our customers and help moving better therapies to market faster.”
“This whole process has been very fast and the collaboration with Novozymes has enabled us to quickly move to clinical trials and ultimately closer to market,” says Kim Arvid Nielsen.
Novozymes, a biotech company with a strong focus on enzyme production with over 6,200+ employees working in research, production, and sales around the world, is the world’s largest provider of enzyme and microbial technologies, its bioinnovation enabling higher agricultural yields, low-temperature detergents, energy-efficient production, renewable fuel and many other benefits today and in the future. the company’s enzyme production gives Novozymes an estimated 48 percent of the global enzyme market share.
The company philosophy is that by using industrial biotechnology it can potentially re-engineer thousands of everyday products to deliver enhanced sustainability performance, incorporating energy cost savings, and decreased raw material costs for its customers.
Novozymes’ biosolutions enable an array of benefits ranging from removal of trans fats from food to advancements in renewable energy sources. The company holds more than 6,000 patents, and continuously and proactively seeks partners to license or inlicense patents within its interest areas.
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Serendex Pharmaceuticals A/S develops drugs to treat severe respiratory conditions such as PAP (pulmonary alveolar proteinosis), ARDS (acute respiratory distress syndrome), BE (bronchiectasis), CF (cystic-fibrosis-related lung infections) and DAH (diffuse alveolar hemorrhage). These conditions are acute or chronic and there is an unmet need for medical treatments. All Serendex drugs are inhaled or induced to the patient’s lungs, a delivery mode that improves the risk/efficacy ratio of drug and treatment. Serendex has obtained orphan drug designation (ODD) for several indications in both Europe and USA. The company’s sole business focus is drug repositioning, i.e. finding new indications and administration routes for existing drugs, focusing on respiratory conditions with drugs that can be used for inhalation. The company notes that repositioning has many advantages, including mainly its low development risks and costs.
The pulmonary diseases on which Serendex concentrates its efforts have a high medical need. Some of them have orphan status, due to their relative rareness, however the potential of the Serendex pipeline is estimated to be treatment of more than 700.000 persons annually in the EU and US alone. Serendex Pharmaceuticals is listed at Oslo Axess. P
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*Meets National Formulary (NF) standards as published by United States Pharmacopeia (USP).