Periodic Reporting for period 1 - IBL-302 (Inflection Bioscience unique dual mechanism, small molecule, orally available therapeutic targeting major unmet medical needs in breast cancer)
Période du rapport: 2019-06-01 au 2019-09-30
The prevalence of various types of cancer is rising at an alarming rate due to aging populations and changing lifestyles. While significant progress has been made across a range of cancer settings, few if any offer a cure, with many patients failing to respond to treatment or relapsing due to the development of resistance. New innovative treatments are urgently needed to address this growing medical need. Chronic Lymphocytic Leukaemia (CLL) is a part of a group of cancers called B-cell lymphoma and most commonly affects older adults and where unmet needs remains. CLL occurs in blood and bone marrow — the spongy tissue inside bones where blood cells are made. CLL causes bone marrow to make too many lymphocytes, which do not function properly and do not undergo normal removal (apoptosis) from the blood stream. They crowd out healthy white blood cells, red blood cells, and platelets, resulting in infection, anemia, and easy bleeding. There has been considerable progress in the CLL over the past ten years. Targeted therapeutics which interfere with critical CLL cellular signaling including the B-cell receptor (eg. BTK inhibitors, PI3K inhibitors) and Bcl-2 signalling (eg Venclexta®) have provided new and improved options across first, second and third line. Critically however, a key feature of CLL is the emergence of treatment resistance, meaning there are still no curative medicines and most patients ultimately relapse on all available treatment therapies. Inflection Biosciences’s strategy is to progress first-in-class, small molecule cancer therapeutic through pre-clinical and early clinical stages before seeking partners for later stage clinical development and commercialisation.
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.
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.
IBL-202 targets two important cancer pathways increasing the efficacy and reducing the chance of emergence of resistance. Its further potential in treatment of resistant CLL was more recently demonstrated in assays which mimic the hypoxic microenvironment of the bone marrow, where CLL cells can shelter from most standard therapeutics. It can be synthesized to gram quantities and possess very good ‘drug-like’ properties supporting is onward development into the clinic.It offers a number of potentially important clinical advantages such as i) greater efficacy due to its unique targeting to two critical CLL singaling pathways (BCL-2 and B-cell receptor), ii) reducing risk of treatment resistance due to its ability to inhibit the CLL cells ability to move towards the bone marrow microenvironment, and iii) ability to complement existing therapeutics, all of which should translate in to a more effective therapy for patients resulting in prolonged survival. With increased efficacy of treating cancer (CLL) and potential to be priced competitively it is expected have a low cost per quality-adjusted life-year than the present available solutions. The treatment can be offered at costs below the willingness to pay threshold of €135,000 per QALY gained.