Oryzon receives FDA clearance for study with iadademstat in patients with neuroendocrine carcinomas

MADRID, 9 Nov.

Oryzon receives FDA clearance for study with iadademstat in patients with neuroendocrine carcinomas


Oryzon Genomics has received approval from the U.S. Food and Drug Administration (FDA) of the IND (Investigational New Drug application) to initiate a collaborative phase II study with iadademstat in patients with relapsed/refractory high-grade neuroendocrine carcinomas (NES), the company informed the National Commission of the Stock Market (CNMV).

Specifically, this trial will be carried out within the framework of a collaborative clinical research framework agreement signed between Oryzon and the Fox Chase Cancer Center (FCCC), by virtue of which the latter company will carry out different collaborative clinical trials of iadademstat in combination, with Oryzon providing funding, the drug and technical expertise.

The first collaborative phase II trial will be an open-label study sponsored by the FCCC, with Namrata Vijayvergia, MD, associate professor and member of the Institute for Cancer Epigenetics at Fox Chase Cancer Center, as principal investigator.

Neuroendocrine neoplasms are rare and heterogeneous cancers arising from neuroendocrine cells, accounting for 0.5% of all newly diagnosed malignancies, with a prevalence of 100,000 cases in the United States.

22-27% of neuroendocrine carcinomas are pulmonary, that is, small cell lung cancer, and the rest are extrapulmonary, with the gastrointestinal tract being the most common presentation, followed by genito-urinary tumors.

Some of these cancers are poorly differentiated NES, which are very aggressive. Patients often rapidly develop progressive disease after first-line cytotoxic chemotherapy and lack clearly effective second-line treatment options.

Second-line NEC and SCLC response rates are typically less than 5% and 20%, respectively, and survival is measured in months.

Iadademstat is a highly potent and selective and orally active inhibitor of the epigenetic enzyme LSD1, currently in clinical development for the treatment of hematologic cancers and certain solid tumors.

In an ongoing and patient-recruiting phase IIa trial (Alice trial) in front-line elderly acute myeloid leukemia (AML) patients, iadademstat has shown encouraging safety and efficacy data in combination with azacitidine.

The company is now initiating a phase Ib trial (Frida trial, with IND already FDA-approved) in combination with gilteritinib in patients with relapsed/refractory FLT3-mutated AML, and is preparing a new phase Ib/II trial ( Stellar assay) in combination with immune checkpoint inhibitors in SCLC.

Iadademstat has orphan drug designation for SCLC in the United States and for AML in the United States and the EU.