Reducing solvent-related toxicity in a widely used oncology therapy
We are planning the development of a differentiated intravenous formulation of a well-established anticancer medicine used across multiple solid tumours. Although the active drug has demonstrated substantial clinical value, its conventional formulation relies on a synthetic solvent system to overcome extremely poor water solubility.
This solvent system is associated with important treatment burdens, including acute hypersensitivity reactions, and, in severe cases, potentially life-threatening anaphylactoid responses. Patients therefore commonly require premedication with corticosteroids and antihistamines before treatment.
The conventional formulation may also contribute to peripheral neuropathy, altered drug distribution, nonlinear pharmacokinetics, infusion-related toxicity, and additional strain on vulnerable oncology patients. Administration can require prolonged infusion, close monitoring, specialised tubing or filters, and restrictions on certain container materials, increasing chair time, nursing workload, and treatment cost.
Our concept is to remove the problematic solvent system and replace it with an advanced, biocompatible drug-delivery platform. The objective is to preserve the established anticancer activity of the molecule while improving solubilisation, infusion compatibility, pharmaceutical stability, and administration convenience.
The product concept has been confirmed, and the development strategy, target product profile, intellectual property approach, clinical bridging plan, and regulatory pathway have been defined. Experimental formulation development has not yet commenced.
The next phase will include formulation screening and optimisation, platform characterisation, dilution stability, in-vitro release, impurity control, sterilisation strategy, stability studies, process scale-up, GMP manufacture, and comparative pharmacokinetic and tolerability studies.
About Off Targets Limited
Off Targets Limited is a pharmaceutical innovation company headquartered in London that specializes in the development of complex injectable formulations and the identification of new therapeutic indications for existing drugs. The company utilizes a multidisciplinary approach that combines various artificial intelligence and machine learning platforms with biochemical and cell-based assays. By integrating computational and experimental methodologies, the company aims to create a systematic, logical framework for drug discovery that is more efficient than serendipitous methods. Their R&D operations, which include a presence in Bangalore, India, focus on delivering ready-to-transfer technologies across areas such as central nervous system (CNS) disorders, oncology, and critical care.
This work is particularly significant for addressing unmet medical needs, especially regarding rare, neglected, and difficult-to-treat diseases. By focusing on drug repurposing, the company leverages existing safety, pharmacokinetic, and manufacturing data to expedite the development of innovative medications. This approach provides a streamlined path for bringing specialized treatments to hospital and institutional markets globally. Through its focus on complex injectables and strategic R&D, Off Targets Limited positions itself as a partner for pharmaceutical development, aiming to advance healthcare solutions through its specialized technological capabilities.
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