Oryzon Genomics, S.A. announced that the FDA has approved the Investigational New Drug (IND) application to initiate a Phase II collaborative study with iadademstat in patients with relapsed/refractory high grade neuroendocrine carcinomas (NEC). This trial will be conducted under a collaborative clinical research agreement entered between Oryzon and the Fox Chase Cancer Center (FCCC), under which FCCC will be conducting different collaborative combination clinical trials with iadademstat, with Oryzon providing funding, the drug and technical expertise. The first collaborative Phase II trial will be an open-label basket study to be conducted by FCCC as sponsor, with Dr. Namrata Vijayvergia, MD, Associate Professor and member of the Cancer Epigenetics Institute at Fox Chase Cancer Center, as the principal investigator.

Neuroendocrine neoplasms are rare and heterogeneous cancers arising from neuroendocrine cells, representing 0.5% of all newly diagnosed malignancies, with a prevalence of 100,000 cases in the US. 22-27% of NETs are pulmonary (i.e., small cell lung cancer, SCLC), and the remainder are extrapulmonary, with gastrointestinal tract as the most common presentation followed by genito-urinary tumors. Some of these cancers are poorly differentiated NECs, which are very aggressive.

Patients often rapidly develop progressive disease after first line cytotoxic chemotherapy and lack clearly efficacious second line treatment options. Response rates for NECs and SCLC in second line are generally less than 5% and 20%, respectively, and survival is measured in months.