ORYZON announces U.S. FDA clearance of CTEP-CRADA Phase I/II clinical trial sponsored by NCI for iadademstat plus immune checkpoint inhibitors in 1L extensive stage Small Cell Lung Cancer

In combination with either atezolizumab or durvalumab.

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Oryzon Genomics S.A., (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company leveraging epigenetics to develop therapies in diseases with strong unmet medical need, announced today that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application to initiate a Phase I/II trial with iadademstat plus immune checkpoint inhibitors in first line small cell lung cancer (SCLC) patients with extensive disease. This will be the first clinical trial testing the combination of iadademstat with immune checkpoint inhibitors.

The trial (NCT06287775) is entitled “A Phase I Dose Finding and Phase II Randomized Trial of Iadademstat Combined With Immune Checkpoint Inhibition Maintenance After Initial Chemoimmunotherapy in Patients With Extensive-Stage Small Cell Lung Cancer”. This Phase I/II clinical study will be conducted and sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health, where Dr. Noura Choudhury from the Memorial Sloan Kettering Cancer Center (MSKCC) will be the main PI for this trial and will be implemented by a number of prestigious cancer centers in the US, including the MSKCC, the JHU Sidney Kimmel Comprehensive Cancer Center and many others. The trial plans to enroll 45-50 patients and will be carried out under a Cooperative Research and Development Agreement (CRADA) that Oryzon has in place with the NCI.

Dr. Noura Choudhury stated “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.” 

“We are very pleased that NCI has received the regulatory approval from the FDA to initiate this first-inhuman Phase I/II combination trial with iadademstat plus immune check point inhibitors” stated Dr. Carlos Buesa, Chief Executive Officer of Oryzon. “The molecular mechanisms underlying the ability of iadademstat to render small cell lung cancer 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.”

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