FDA clears Oryzon’s phase 1/2 trial for lung cancer treatment
Betsy Goodfellow | April 10, 2024 | News story | Research and Development | FDA, Oncology, Oryzon, lung cancer
Oryzon Genomics has announced that the US Food and Drug Administration (FDA) has approved its investigational new drug (IND) application to initiate a phase 1/2 trial with iadademstat plus immune checkpoint inhibitors in the first line treatment of small cell lung cancer (SCLC) patients with extensive disease.
This trial will be the first to test this combination of iadademstat with immune checkpoint inhibitors.
It is planned that the trial will be conducted and sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health (NIH). It is hoped that it will enroll 45-50 patients.
Dr Noura Choudhury, from the Memorial Sloan Kettering Cancer Center and main principal investigator on this trial, commented: “This trial presents a novel opportunity to translate promising results derived from the laboratory indicating a role for LSD1 inhibition in small cell lung cancer.”
Dr Carlos Buesa, chief executive officer of Oryzon, added: “We are very pleased that NCI has received the regulatory approval from the FDA to initiate this first-in-human phase 1/2 combination trial with iadademstat plus immune check point inhibitors. The molecular mechanisms underlying the ability of iadademstat to render SCLC cells visible to the immune system while simultaneously enhancing immune activity to aggressively target these malignant cells have been clearly elucidated. These unique anti-cancer epigenetic actions of iadademstat should greatly enhance the activity of the current standard of care in this critically underserved patient population.”
Betsy Goodfellow
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