Ascelia Pharma strengthens its oncology product portfolio


CMC Contrast AB acquires Oncoral Pharma Aps to further strengthen its product portfolio within oncology. In connection with the acquisition, the company is re-named to Ascelia Pharma AB. 

“Through the acquisition, Ascelia Pharma is truly established as a pioneer in developing novel medicinal products to address unmet medical needs for people living with cancer. The acquisition of Oncoral broadens our oncology product portfolio and fits well with our existing lead drug candidate MangoralTM. With Oncoral, we now have two clinical stage medicinal product candidates in our pipeline and both candidates have the potential to become global leaders in their indications as they will have significant advantages compared to currently available products”, says Magnus Corfitzen, Chief Executive Officer of Ascelia Pharma.

Both drug candidates underscores Ascelia Pharma’s strategy to develop underappreciated and de-risked medicinal product candidates which are differentiated and targets an unmet medical need: MangoralTM, an imaging drug for detection and localization of liver metastases, and Oncoral, a novel tablet based formulation of the well-known chemotherapeutic agent, irinotecan, which today is only available as an intravenous infusion product.

Ascelia Pharma’s lead product candidate, MangoralTM, is a novel Magnetic Resonance Imaging (MRI) drug for detection of liver metastases and is ready for the phase 3 clinical development program. All currently marketed MRI contrast agents are based on gadolinium, whereas MangoralTM does not contain gadolinium and therefore is being developed for use in patients where gadolinium based contrast media may be medically inadvisable. MangoralTM has been granted US Orphan Drug Designation by FDA for use in this indication. Gadolinium based contrast media can cause Nephrogenic Systemic Fibrosis, a debilitating and potentially life threatening condition which can occur in people with severe renal insufficiency who receive gadolinium based contrast agents, and therefore all gadolinium products carry regulatory warnings. MangoralTM has successfully been studied in 6 clinical trials and provided a strong enhancement of the liver tissue on MRI scans and demonstrated a good safety profile.

Oncoral is currently in phase 1 clinical development at Herlev Hospital in Denmark. It is a novel proprietary tablet formulation of irinotecan, a widely used chemotherapeutic agent with a documented effect on certain solid tumors. This novel tablet formulation has potential to overcome important side-effects and is convenient for the patient to be taken at home. 


Information regarding transfer of shares in Ascelia Pharma AB from CMC SPV

Ascelia Pharma AB (publ) (ticker: ACE) (“Ascelia Pharma” or the “Company”) today announced that it has been informed of that CMC SPV of 3 April 2017 AB (“CMC SPV”) today has divested 687,606 shares in the Company in a private placement to institutional investors and distributed 2,250,000 shares in the Company to its shareholders, including Sunstone and certain members of the board of directors and management of Ascelia Pharma. Followi ...

Ascelia Pharma presents clinical development plan for Oncoral as a novel chemotherapy

Ascelia Pharma AB (publ) (ticker: ACE) today announced the clinical development plan for Oncoral. With Oncoral, Ascelia Pharma has the opportunity to develop a novel oral chemotherapy with the potential to offer both efficacy and safety benefits to cancer patients. The planned Phase 2 study, for the treatment of gastric cancer, is expected to start in H2 2021. Further details of the Oncoral development plan can be found on its dedicated website.

Ascelia Pharma gets US patent for second generation Mangoral

Ascelia Pharma AB (publ) (ticker: ACE) today announced that the US Patent Office (USPTO) has issued a new patent covering a second-generation formulation of lead drug candidate Mangoral, currently in the pivotal Phase 3 study SPARKLE. The new patent further improves the unique value proposition of the Mangoral franchise and provides patent protection until year 2040 in the US.