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Innovative combination therapy against bladder cancer

Periodic Reporting for period 1 - INNOBCT (Innovative combination therapy against bladder cancer)

Reporting period: 2017-02-01 to 2017-07-31

The objective of the Phase 1 project was to lay foundation for the continued clinical development and commercialisation of MFA-370, a novel medication against Bladder Cancer (BC). BC is the ninth most common cancer worldwide. In Europe, more than 175,000 people are diagnosed with BC in Europe each year, and this number is increasing, especially among women. Compared to other major cancer types, the relative five-year survival rate in BC has remained unchanged for the past 20 years. The implications are clear: the development of new therapies targeting BC is thus warranted and in great demand among clinicians and BC patients. The established treatments are highly aggressive, leading to major side-effects and reduction in QoL among patients.

Recognizing large unmet clinical need, Ectin has developed a novel combination BC therapy consisting of a well-defined ratio of two commonly utilized pharmaceuticals with expired patents. In the pre-clinical studies, MFA-370 has shown to be able to induce cancer cell death without the addition of any chemotherapeutic or radiotherapeutic agent. This offers a new hope to BC patients. The pre-clinical evaluation of this medication is completed, enabling continued development process.

Fighting BC is an EU-wide challenge, as it is one of the most expensive malignancies to treat and affects all genders and age groups. At the same time, research targeting the disease is greatly underfunded in the EU and internationally. MFA-370 delivers in this context a strong EU-added value by its potential to induce tumour necrosis in BC and being based on well-documented compounds that are cost-efficient to manufacture.
Ectin's strategic operations are currently aligned to take the product to the Phase I/II level and thus reach the stage where interest and investment from external partners in the continued clinical development of the drug candidate is possible. The objective of the SME Instrument Phase 1 feasibility assessment was to confirm the market feasibility of MFA-370 and define a road map for the continued clinical development of the drug.

The feasibility assessment has been performed using the Strategic Business Planning Methodology as outlined in the project plan. This methodology has allowed us to progress from the primary market data collection and analysis, through the synthesis of the results, to the finalisation of the financial and out-licensing targets aligned with an overall business development strategy of the company. The data collected has provided valuable insights into the current trends and opportunities on the market, activities undertaken by the competitors and the recent clinical development results.

The analytical methods included desk research, analysis of the primary and secondary market data, in-terviews with KOLs, and scientific advisory meetings with BC experts. The overall results show that it is motivated clinically and marketwise for Ectin to pursue the innovation project further and enter into the Phase I/IIa clinical trial.
The feasibility study has shown that MFA-370 as a drug candidate against BC demonstrates a strong commercial and clinical viability.

The main conclusion from this feasibility study is that there exists a clear business opportunity to exploit on the global BC treatment market. Due to the significant market size, low number of existing treatment options, the limited number of new drugs in development, and a clear regulatory pathway for drug approval, the BC market provides a unique opportunity for Ectin and MFA-370 therapy.

The launch of immunotherapies will not fill the existing gap on this market and the high unmet needs related to treatment options for the BC are forecasted to remain underserved. Thus, the BC market will remain a lucrative opportunity for pharmaceutical companies developing novel efficacious treatments for both the NMIBC and metastatic BC. This is a business opportunity that Ectin aims to explore.

The possibility for Ectin to enter the market with MFA-370 are supported by the positive IPR environment. The patents on the pharmaceutical used in the therapy have expired. The externally evaluated patentability & FTO has been performed with positive results. European patent office has granted the patent application, thus securing IP in Europe. Patents are pending in the US, Australia and Canada. The preclinical activities have been summarized and externally evaluated.
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