Endocyte and Nihon Medi-Physics (NMP) have entered into an agreement to develop and commercialize etarfolatide (EC20) in Japan. EC20 is a companion imaging diagnostic for cancer indications.
Endocyte will receive an initial up-front fee and is eligible for development and regulatory milestones and royalties on sales of EC20 in Japan. Approval will be sought from the regulatory authorities to use EC20 to select patients who will most likely respond to vintafolide, Endocyte's folate receptor (FR)-targeting small molecule drug conjugate (SMDC), by identifying tumors that express the FR.
EC20 and vintafolide are currently being evaluated in a Phase III, randomized, double-blind clinical trial for platinum-resistant ovarian cancer and a Phase IIb trial in patients with non-small-cell lung cancer. A Phase II randomized trial of vintafolide in FR-positive, triple-negative breast cancer is expected to be initiated later this year.
"This collaboration … validates [our] approach to personalized medicine by using noninvasive companion imaging diagnostics to select patients likely to respond to our targeted SMDCs," said Ron Ellis, president and CEO of Endocyte. "As the leader in single-photon emission computed tomography (SPECT) imaging in Japan, NMP has extensive commercial expertise across medical imaging facilities such as hospitals and clinics."
Endocyte, which previously entered into a worldwide exclusive license agreement for vintafolide with Merck, recently announced that the European Medicines Agency had accepted for review the marketing authorization application filings for vintafolide and EC20 for the targeted treatment of patients with FR-positive, platinum-resistant ovarian cancer in combination with pegylated liposomal doxorubicin. Both vintafolide and EC20 have been granted orphan drug status by the European Commission.