The report provides a detailed analysis essential for establishing a dalazatide production plant. It encompasses all critical aspects necessary for dalazatide production, including the cost of dalazatide production, dalazatide plant cost, dalazatide production costs, and the overall dalazatide production plant cost. Additionally, the study covers specific expenditures associated with setting up and operating a dalazatide production plant. These encompass production processes, raw material requirements, utility requirements, infrastructure needs, machinery and technology requirements, manpower requirements, packaging requirements, transportation requirements, and more.
Dalazatide, alternatively known as ShK-186, is a synthetic peptide analogue of the sea anemone toxin ShK that selectively blocks the Kv1.3 potassium channel, targeting T effector memory cells to modulate autoimmune responses. It has been investigated in clinical trials to treat conditions like psoriasis, lupus, rheumatoid arthritis, multiple sclerosis, and inflammatory bowel disease. Its formulations include subcutaneous injections, topical creams, and eye drops showing good safety and efficacy in reducing inflammation. It is developed by companies such as TuHURA Biosciences (formerly Kineta). It shows high selectivity and tolerability in human studies.
Dalazatide's market drivers depend on the high unmet need in autoimmune diseases like psoriasis, lupus, rheumatoid arthritis, multiple sclerosis, and vasculitis, where its selective Kv1.3 channel inhibition targets effector memory T-cells to reduce inflammation without broad immunosuppression. The positive clinical data showing PASI score improvements, biomarker reductions, and good tolerability in psoriasis patients highlight its potential in a market projected to grow for kinase and ion channel inhibitors in autoimmunity, amid rising disease prevalence. Additionally, durable responses post-treatment and a novel mechanism differentiating it from existing therapies propel market expansion. However, cost pressures, including high synthesis expenses due to its peptide nature (derived from sea anemone toxin ShK), limited economies of scale from low-volume research demand, and free estimate platforms like DDA for competitive pricing, impact industrial dalazatide procurement.
Raw Material for Dalazatide Production
According to the dalazatide production plant project report, the various raw materials for dalazatide production include Fmoc-protected amino acids.
Production Process of Dalazatide
The extensive dalazatide production cost report consists of the following major industrial production process:
- Production via solid-phase peptide synthesis: The production process of dalazatide occurs via solid-phase peptide synthesis (SPPS), where Fmoc-protected amino acids are sequentially coupled onto a resin support, incorporating key modifications like a Dap-phosphotyrosine residue at position 9 to boost Kv1.3 selectivity. The process proceeds with formation of three disulfide bridges from six cysteines for cyclisation, selective deprotection of side chains, and cleavage from the resin. The final purification utilises reversed-phase high-performance liquid chromatography (RP-HPLC) to attain >98% purity. The process produces a stable, lyophilised white powder optimised for GMP-compliant production suitable for subcutaneous, topical, or ocular formulations.
Properties of Dalazatide
Dalazatide (ShK-186), a 37-amino acid synthetic peptide derived from sea anemone toxin ShK, has the molecular formula C184H296N57O55PS7 and a molecular weight of 4442.1 g/mol, appearing as a white to off-white lyophilised powder. It is highly soluble in DMSO (25 mg/mL) but has limited water solubility, requiring storage at -20 degrees Celsius or below in sealed, moisture-free conditions for stability. Its peptide structure is modified by a phosphotyrosine residue to enhance plasma half-life and resist enzymatic degradation. It potently and selectively inhibits the Kv1.3 potassium channel (IC50 ~86 pM) with >100-fold selectivity over Kv1.1/Kv1.6, supporting its use in topical, subcutaneous, or ocular formulations for autoimmune disease research.
