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PES2020-Prosj.etabl.støtte H2020

Chemical synthesis of a new drug family to treat glioblastoma multiforme (GBM), the highest global unmet need in oncology

Tildelt: kr 0,20 mill.

Hemispherian AS is developing a novel group of compounds to combat glioblastoma multiforme (GBM). These compounds have shown promising pre-clinical results and our lead compound GLIX1 will enter pre-IND studies by 2021. The current process of synthesis for these compounds is expensive and not easily scalable, thus a new synthesis process needs to be developed and optimised. The SME Innovation Associate programme project is necessary for Hemispherian to initiate internal chemistry, manufacturing and control (CMC) activities to ensure the optimal synthesis method, and downstream purification and manufacturing processes, are developed at an early stage. Currently, we do not possess in-house expertise in production and process development of pharmaceuticals that are essential for this project and therefore looking to recruit an Innovation Associate with the required skill-set in CMC. Acquiring these skills is fundamental for Hemispherian to maintain a streamlined drug development process internally and maximise our chances for successful regulatory approval of our drug. Hemispherian have identified a promising synthesis method which requires further development. The project will address this goal, with the overall objectives including: - Optimise the chemical synthesis process along with purification scheme - Small scale synthesis ramping up to larger scale synthesis in preparation for large quantities for clinical studies - Overseeing use of drug in first pre-IND studies and establishing a regulatory pathway along with appropriate documentation The most critical R&D challenges in this project include: developing a chemical synthesis method with high enough yield and any regulatory hurdles. These will be minimised by onboarding the skilled Innovation Associate to the team, and appropriate use of external experts in chemical manufacturing and regulatory affairs.

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PES2020-Prosj.etabl.støtte H2020