Scandion Oncology

Overcoming cancer drug resistance

The board of directors of Scandion Oncology ("Scandion" or the "Company") has today, on 19 April 2024, resolved on the intention, subject to authorizations by the annual general meeting of the Company on 6 May 2024, to carry out a new issue of shares and warrants ("Units") with preferential rights for the Company's existing shareholders (the "Rights Issue"). Each Unit consists of four (4) shares, three (3) warrants of series TO 2 and one (1) warrant of series TO 3. The warrants are issued at no additional charge. The Rights Issue primarily intends to finance (i) progression of the CORIST trial into the very final step before starting a larger randomized study (90%) and (ii) design and preparation of the phase IIb randomized study, including IND preparations (10%). In connection with the Rights Issue, the Company has received subscription commitments of approximately SEK 0.4 million from an existing shareholder and all members of the Company’s board of directors up for re-election and several members of management, including the Company’s CEO, CFO and CMO. Furthermore, the Company has received guarantee commitments of approximately SEK 30.2 million from existing shareholders and external investors, corresponding to approximately 50 per cent of the Rights Issue. The Rights Issue is in total covered by subscription undertakings and guarantee commitments of SEK 30.6 million, corresponding to approximately 51 per cent of the Rights Issue. Upon full subscription in the Rights Issue, Scandion will receive initial proceeds of approximately SEK 60 million before issue costs. The Rights Issue is subject to an authorization from the annual general meeting on 6 May 2024. The notice to the annual general meeting will be announced in a separate press release. Summary of the terms of the Rights Issue The Rights Issue comprises Units and will provide Scandion with initial proceeds of up to approximately SEK 60 million before issue costs. Each Unit consists of four (4) shares, three (3) warrants of series TO 2 and one (1) warrant of series TO 3. One (1) warrant of series TO 2 and series TO 3 will entitle the holder to subscribe for one (1) share in the Company. The warrants are intended to be admitted to trading on Nasdaq First North Growth Market. In the event the warrants are exercised for subscription of new shares, the Company will receive additional proceeds in November 2024 and April 2025. Final terms of the Rights […]

Scandion Oncology (Scandion), an innovative drug efflux pump inhibition company using biomodulation capabilities to revert drug resistance, today announced updated positive interim results from Part 3 – the last part of the ongoing CORIST Phase IIa trial. Optimized dosing schedules were explored and caused the expected changes in exposure to SCO-101 and the chemotherapy. A novel potential biomarker – the UGT1A1 genotype – was positively associated to longer progression free survival (PFS) and overall survival (OS). The promising safety and efficacy results were observed in heavily pretreated patients, showcasing the potential of SCO-101 to enhance treatment outcome. The updated Part 3 interim data confirm the rationale for the optimized dosing schedule in terms of pharmacokinetic data, biomarker potential, early signs of efficacy and interim OS data. Early signs of efficacy have been reported in terms of long Progression Free Survival (PFS), Clinical Benefit Rate and partial tumor responses in two patients. In alignment with the Part 2 data, a low Bilirubin Index (BI) was also in Part 3 found to be clearly associated to increased PFS and improved OS with 6 of 9 patients still alive in the “low BI” group. The UGT1A1 genotype was investigated and patients with UGT1A1 wildtype had both longer PFS and OS than patients with mutated UGT1A1. Noteworthy, in the UGT1A1 wildtype patients the current mPFS is 7.04 months and the mOS is 13.74 months. These interim data are very promising, and final data are expected in H2 2024. “These encouraging results confirm the rationale behind our optimized dosing strategy and highlight the significant potential of SCO-101 and our innovative mechanism of action to enhance treatment outcomes in this challenging patient population,” said Francois Martelet, CEO of Scandion Oncology. ”Our next step is to expand the Part 3 data by adding one or more smaller patient cohorts to potentially further optimize the dosing regimen to be applied in a randomized trial.” The optimized dosing schedules resulted in the expected changes in PK and data demonstrated a slight decrease (app. 20%) in the maximum peak value (Cmax) of the active chemotherapy (SN-38) and an increase in the maximum peak value of SCO-101. The overall exposure to SN-38 and SCO-101 remained largely unchanged compared to CORIST Part 1. Additionally, SCO-101 caused a clear increase in the plasma levels of SN-38, caused a 5-fold shift in the ratio between active SN-38 and inactive SN-38 and an increase in […]