Scandion Oncology A/S (”Scandion”) today announced that SCO-101 tablets have successfully been produced as a pilot production by Solural Pharma Aps, Denmark (“Solural”). Scandion is thus following the timelines for SCO-101’s clinical development. The SCO-101 raw material is produced by Cambrex in Sweden and then transferred to Solural in Denmark where it is formulated into tablets. Scandion expects to initiate its first clinical Phase II study with SCO-101 in patients with drug resistant cancer in late 2019.
Scandion’s ”First in Class” product – SCO-101 – has successfully been produced as tablets by Solural, Denmark. SCO-101 inhibits key resistance mechanisms of cancer cells by inhibiting drug efflux pumps and by targeting specific kinases involved in drug resistance. Scandion’s first clinical Phase II study with SCO-101 will be in patients with metastatic drug-resistant colorectal cancer. SCO-101 will be given as a daily tablet in combination with the chemotherapy. By giving SCO-101 as a complementary additive to standard cancer treatment to patients who have developed drug-resistant cancer disease, Scandion expects that a number of the patients will benefit from the treatment.
CEO Nils Brünner comments:
“We are pleased to announce that Solural has successfully produced a pilot drug product (tablets) of SCO-101 in accordance with our time plan. SCO-101 is manufactured in two strengths and will be given as a daily oral treatment in combination with chemotherapy. We have thus passed yet another important milestone and are now preparing a Clinical Trial Application (CTA) for our first Phase II clinical trial with SCO-101 in chemotherapy-resistant colorectal cancer patients. The study will be initiated in Q4, 2019.”
CEO Peter Nielsen, Solural comments:
“The manufacture of technical batches of two tablet strengths went completely as expected and ahead of time, and the batches fully passed all the Pharmacopeial requirements. We are now ready to manufacture the clinical supplies needed for initiating the upcoming clinical study for this important product.”
For more information regarding Scandion, please contact:
Nils Brünner, CEO
Phone: +45 26 14 47 08
E-mail: nb@scandiononcology.com
http://www.scandiononcology.com
Scandion Oncology A/S is a biotechnology company founded in 2017 for the purpose of addressing and tackling one of the greatest challenges in modern oncology – the effective treatment of cancer which contains drug resistant cell clones or which has developed resistance to a previously prescribed cancer-fighting drug. In preclinical animal studies, the company’s leading candidate drug, SCO-101, was found to significantly enhance the efficacy of certain standard cancer treatments when given in combination. In addition SCO-101 restores chemotherapy sensitivity in in vitro grown resistant cancer cells. Scandion Oncology will in Q4 2019 initiate a clinical phase II study with SCO-101 in combination with chemotherapy. Scandion Oncology was listed on Spotlight, Sweden in November 2018.