MAQTOX is collaborating with OncoThera Biotech to accelerate the development of their novel oncology drug, OncoThera-2, aimed at targeting aggressive forms of breast cancer. The project encompasses the entire preclinical development lifecycle, from compound optimization to the preparation of IND submission documents.
Key components of the project include:
- Preclinical Research and Testing: Conducting in vitro and in vivo studies to evaluate the efficacy and safety profile of OncoThera-2 in several models of aggressive breast cancer.
- Pharmacokinetics and Toxicology: Performing DMPK (Drug Metabolism and Pharmacokinetics) studies and safety/toxicity testing to understand the compound's pharmacodynamics and its potential risks.
- Regulatory and Clinical Trial Preparation: Preparing the necessary IND documentation and supporting clinical trial application (CTA) submissions to global regulatory authorities, including the FDA and EMA.
- Strategic Consulting: Offering insights and advice on clinical trial design, ensuring the project adheres to current best practices in oncology drug development and can meet stringent regulatory requirements.
The project is expected to significantly shorten the timeline for OncoThera-2's entry into clinical trials, with the goal of transforming breast cancer treatment options by introducing a targeted, innovative therapy.