The Phase I/II trial enrolling 45-50 patients will be conducted and sponsored by the National Cancer Institute (NCI). Credit: Mongkolchon Akesin via Shutterstock.

Oryzon Genomics is set to commence a Phase I/II clinical trial of iadademstat (ORY-1001) plus immune checkpoint inhibitors (ICI) in patients with first-line small cell lung cancer (SCLC).

The development comes after the US Food and Drug Administration (FDA) cleared the Spain-based biotech’s investigational new drug application (IND) to initiate the study.

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The Phase I/II trial (NCT06287775) will be conducted and sponsored by the National Cancer Institute (NCI), enrolling 45-50 patients. In the first phase, patients will receive iadademstat on days 1, 8, 15, and 22 or days 1 and 15 of each cycle. Patients will also continue to receive their initial ICI treatment, Tecentriq (atezolizumab) intravenously (IV), or Imfinzi (durvalumab) IV over 60 minutes on day one of each cycle. Cycles will repeat every 28 days in the absence of disease progression or unacceptable toxicity.

In the second phase of the study, patients are randomised to two different arms where half will stay on the iadademstat and ICI combination therapy, and the other half will only receive their ICI therapy.

A comparison of progression-free survival (PFS) between the combination of iadademstat plus immune checkpoint inhibitors Tecentriq and Imfinzi versus ICI maintenance alone is the primary objective of the study. Secondary objectives include assessing the safety of the combination treatment and comparing objective response rate (ORR) and overall survival (OS) between treatment arms.

ICIs work by blocking certain proteins in the immune system, known as checkpoints, which help the immune system recognise and destroy cancer cells more effectively. ICIs have so far shown impressive improvement in disease outcomes in certain cancer patients. However, some patients acquired drug resistance and others showed a lack of response in immunosuppressive or certain cancer types, which are some of the drawbacks of the drug class. Thus, researchers are trialling new candidates in combination with ICIs.

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Iadademstat is a small oral molecule that selectively inhibits the epigenetic enzyme lysine-specific demethylase 1 (LSD1). The asset has shown a good differentiating effect in haematologic malignancies in previous studies. According to GlobalData’s Pharma Intelligence Center, iadademstat is forecast to generate $225m in sales in 2029.

GlobalData is the parent company of Clinical Trials Arena.

In the announcement accompanying the IND, Oryzon’s CEO Carlos Buesa said: “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.”