Periodic Reporting for period 1 - SCANRESIST (Reversal of anti-cancer drug resistance)
Periodo di rendicontazione: 2019-04-01 al 2019-09-30
Resistance to anti-cancer therapy is considered the main obstacle to successful clinical management of cancer patients. Worldwide in 2018, cancer was responsible for around 9.6 million deaths, and with a prediction of a further increase in incidence over the next years – which calls for urgent better treatment modalities to combat this deadly disease. Scandion Oncology A/S aims to solve one of the most important problems remaining in modern cancer treatment – the anti-cancer drug resistance. We are developing a new drug, the SCO-101, which effectively targets some of the most common molecular resistance mechanisms in cancer. SCO-101 represents a paradigm shift in treatment of drug-resistant cancer. SCO-101 has previously passed 4 clinical phase I studies and proved to be a safe oral drug with very limited toxicity. The innovation project aims at performing clinical validation studies in taxane resistant pancreatic patients with a randomized Phase II prospective clinical trial to establish Proof of Concept of SCO-101 as a safe and efficient treatment modality in patients with drug resistant cancer. This novel treatment will increase life expectancy and quality of life of millions of cancer patients.
The SME Instrument Phase 1 project allowed SCANDION to refine the market landscape analysis, evaluate the value proposition of SCO-101 against market needs, validate the clinical and regulatory strategy for further development and update SCANDION’s business plan. The study allowed also SCANDION to plan the Phase II clinical validation, including engagement with stakeholders, as well as refining the first target application for the novel drug.
Conclusions of the Feasibility Study support our willingness to proceed with the clinical validation of SCO-101 as we see a clear unmet need in the market for a drug with SCO-101´s features. The study reinforced SCO-101’s business opportunity supported by the unmet medical needs for efficient pancreatic cancer treatment. Moreover, based on reported cases, the likelihood to identify an industrial partner for the project pending positive outcome in phase II is considered highly likely - and experience with similar cases showed that deals made at this stage reaches the highest value. Furthermore, promising safety and tolerance results were obtained during Phase I clinical trials, and the next step in the clinical development will be a Phase II trial to validate our drug´s efficacy profile in pancreatic cancer patients. This will be complemented by intensive business development activities to maximize dialogues with potential future acquirers of SCO-101. Positive Phase II data will enable an attractive licensing deal and secure the further development and commercialization of SCO-101, allowing SCANDION to gain a market foothold in the cancer market, and supporting the company´s medium term strategic positioning as a unique provider of a new generation of drugs.