During the feasibility assessment, Inflection Biosciences has completed a full analysis of the technical and business potential of IBL-302/202. Inflection Biosciences checked and confirmed the minimum viable product and produced a work plan, detailing the main steps to make it ready for market uptake: CTA/IND studies, Clinical Phases I, II & III, and EMA/FDA approval. In particular, the Company focused on the next steps that will be necessary to develop the IBL project to the stage where it can be partnered with a pharma company - potentially after the successful completion of the CTA/IND studies but more likely following the Phase IA/B clinical studies. To fulfil this aim, Inflection Biosciences reviewed the manufacturing and formulation strategy for the drug to be used in the CTA/IND and Phase I human trials. Inflection Biosciences identified and contacted the third parties needed for the conduct of the CTA/IND and Phase I trials (both CMOs and CROs); and it requested quotations from CMOs to start planning the manufacturing and safety/toxicology campaigns. As the second key step, Inflection Biosciences contacted potential CROs and based on their feedback, it completed a road map for the conduct of the Phase I trials. The CTA/IND studies will include drug formulation, manufacturing and toxicology and the Phase I clinical study will include trial site establishment, subject recruitment and execution of trials. The company also sought key opinion leader input on the likely positioning of and demand for a therapeutic like IBL.
Inflection Biosciences also analyzed in detail its business model and go-to-market strategy to define the approach for accelerated and effective market uptake. Inflection Biosciences estimates it will need an investment of around €4 million to successfully perform the IND studies and €10 million for Phase I clinical studies and engage in the licensing agreement with a partner pharma company. The CTA/IND studies will be funded using internal resources and grant support from EIC Accelerator, whereas the Phase I clinical studies will be supported by securing equity investment from EIC Accelerator Fund’s SPV. This will allow the drug production activities to be performed in the most suitable conditions and will result in a faster entry into the Phase II study. Inflection Biosciences contacted over 100 pharma companies around the globe of all sizes in the past 3 years explore interest in its pipeline and therapeutic approach. There are over 50 companies which have shown a level of interested in the company’s programs. Assuming partnering is secured following successful Phase IA/B results, initial revenue streams will be represented by the upfront fees from a licensing deal, followed by milestone payments and royalties.
