Scandion Oncology A/S (“Scandion” or the “Company”) has submitted an amendment to the Danish Medicines Agency regarding the PANTAX study. The amendment is based on the learnings obtained from treating the first 12 patients in the CORIST study and will contribute to an optimization of the PANTAX clinical trials. The processing time for the amendment is expected to be approximately four weeks, which on top of the current impact of the COVID-19 pandemic could delay the planned readout from the study into Q4 2021.
In Scandion’s PANTAX Ib study, patients with inoperable or metastatic pancreatic cancer are offered SCO-101 treatment as a first line therapy add-on to their standard chemotherapy. The submitted amendment will optimize the PANTAX study based on the learnings obtained from treating the first 12 patients in the CORIST study: The Company’s other study with SCO-101 in clinical phase. The amendment describes that patients will receive standard doses of chemotherapy with adjusted escalating doses of SCO-101 in cohorts of three patients in each dose level.
Scandion now expects delays in the planning of the PANTAX Ib study as a result of the additional time needed for approval of the amendment. The Company is also foreseeing potential delays due to uncertainties relating to the COVID-19 pandemic, which has impacted Scandion’s clinical sites. Scandion’s assessment is that the planned readout from the PANTAX study might be delayed into Q4 2021 from previously planned Q2-Q3 2021.
Scandion expands to international sites to secure recruitment at a higher pace:
In order to recruit patients at a higher pace, Scandion is planning to include more national and international oncology centers in the PANTAX study.
The first cohort in the Company’s CORIST study provided important learnings:
CMO Peter Michael Vestlev: “The PANTAX study is our second clinical study where SCO-101 is combined with chemotherapy. We have selected pancreatic cancer as one of the key indications for SCO-101 treatment, since these patients have a poor prognosis, with most patients being chemotherapy resistant at the time of diagnosis and with most of the remaining patients developing drug resistance during the course of therapy. Thus, the medical need for new treatment interventions is high and I am looking forward to finalizing this phase Ib study which will lead us to the phase II PANTAX clinical study.”
CEO Bo Rode Hansen: “I find it very productive to internationalize our trials and that we use an adaptive design between our clinical protocols and thereby optimize our clinical trials. This ensures that we perform the clinical studies within the shortest time frame and reduces the cost of the studies to the benefit of patients and our shareholders.”
For further information, please contact:
Bo Rode Hansen, CEO
Phone: +45 38 10 20 17
This information is information that Scandion Oncology A/S is obliged to publish in accordance with the EU Market Abuse Regulation. The information was provided by the contact person above for publication on 28 January 2021.
About Scandion Oncology
Scandion Oncology A/S is a clinical stage II biotechnology company currently developing first-in-class, oral add-on drugs to existing market leading anti-cancer therapies. As add on to standard anti-cancer therapies, it introduces an effective treatment approach for cancer, which is or has become resistant to cancer-fighting drugs, offering the potential for better response rates, longer survival and improved quality of life. The first-in-class lead candidate, SCO-101, is currently in clinical Phase II. The Company is targeting cancer drug resistance in various treatment modalities including, chemotherapy, anti-hormonal therapy and immunotherapy. The Company is conducting a list change from Spotlight to Nasdaq First North Growth Market Sweden in February 2021. Ticker code: SCOL.