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® (trifluridine and tipiracil) film-coated tablets for oral use. The combination of Oncoral and LONSURF is investigational at this time and not approved for use in gastric cancer or any other disease.
As part of the agreement, Taiho Oncology will supply LONSURF as well as provide scientific expertise for the study. Depending on the results, the collaboration may be extended for further development of the two agents. Ascelia Pharma retains full development and commercialization rights to Oncoral.
“This is an important agreement for Ascelia Pharma, which shows the potential for Oncoral to be a new treatment regimen for gastric cancer. We believe this investigational all-oral tablet combination has the potential to provide a significant treatment benefit to patients suffering from this very aggressive cancer form where there is a massive unmet medical need,” said Magnus Corfitzen, CEO of Ascelia Pharma.
Following an initial dose-escalation the Phase 2 study will be a randomized controlled multicenter study of Oncoral added to LONSURF compared to LONSURF alone. The primary endpoint will be progression-free survival, with secondary endpoints including response rate, overall survival, pharmacokinetics, safety, and tolerability.
The study is planned to start in H2 2021 and will include approximately 100 patients with metastatic gastric cancer. The initial portion of the planned global study will be conducted at hospitals and clinics in Europe.