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. 


Ascelia Pharma’s Food Effect Study with Orviglance successfully completed

Ascelia Pharma AB (publ) (ticker: ACE) today announced that the last patient visit has been completed in the study to evaluate the effect of food intake on the absorption of Orviglance (Mangoral). This Food Effect Study is part of the ongoing pivotal clinical program for Orviglance and will be included in the marketing authorization package to the health authorities including FDA and EMA.

Ascelia Pharma Signs Clinical Collaboration Agreement With Taiho Oncology, Inc. for the Development of Oncoral in Combination with LONSURF®

Ascelia Pharma AB (publ) (ticker: ACE) today announced that it has signed a clinical collaboration agreement with Taiho Oncology Inc., a subsidiary of Taiho Pharmaceutical Co., Ltd. The collaboration concerns an upcoming global Phase 2 clinical study in gastric cancer. In this all-oral combination study, Ascelia Pharma’s irinotecan chemotherapy tablet Oncoral (ASC-201) will be evaluated in combination with Taiho Oncology’s LONSURF® (trifluri ...

Quarterly Report Q2 2021: Preparing Oncoral for the next level

Ascelia Pharma AB (publ) (ticker: ACE) today published its quarterly financial report for Q2 2021 (April – June 2021), which is now available on the company’s website: