Edison Investment Research - Oryzon Genomics (ORY) Oryzon Genomics - FDA green light for SCLC combination trial

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Edison Investment Research

Sean Conroy

Oryzon Genomics - FDA green light for SCLC combination trial

With the FDA investigational new drug (IND) application clearance, Oryzon can commence its Phase I/II cooperative research and development agreement (CRADA) trial sponsored by the National Cancer Institute (NCI; part of the National Institutes of Health) with Dr Noura Choudhury from the Memorial Sloan Kettering Cancer Center (MSKCC) as the principal investigator. This trial will evaluate iadademstat in combination with immune checkpoint inhibitors (ICIs) for the treatment of first-line extensive-stage small-cell lung cancer (SCLC). This is a key development for Oryzon as interim results from this study will influence the design of the company-sponsored Phase Ib/II STELLAR trial. The IND application for this is likely to be filed by end-2024 (trial commencing in 2025). ICIs atezolizumab and durvalumab are currently approved as first-line treatments in SCLC and Oryzon expects a combination with iadademstat to enhance immune activity in patients, increasing therapeutic efficacy. The CRADA-MSKCC trial will enrol 40–50 patients, with updates expected through 2024.

09/04/2024 1 EN

Underlying

Oryzon Genomics

Oryzon Genomics SA is a Spain-based biopharmaceutical company. It is engaged in the field of epigenetic medicine and in the development of therapeutic, biological solutions for cancer and neurodegenerative diseases. The Company's business model focuses on identifying biomarkers that can be translated in new therapeutic targets, as well as on investing in programs, mainly through the development of small molecules for two main indications: cancer and neurodegeneration. The Company develops investigational medicines till proof of concept (POC) phase and then partners the program with pharmaceutical entities, which are able to get the approval from drug agencies to bring these medicines to the patients. It cooperates with Roche. The Company is a subsidiary of Laboratorio Reig Jofre SA.

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ES0167733015 Madrid Stock Exchange Spain

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Edison Investment Research

Edison is an investment research and advisory company, with offices in North America, Europe, the Middle East and AsiaPac. The heart of Edison is our world renowned equity research platform and deep multi-sector expertise. At Edison Investment Research, our research is widely read by international investors, advisors and stakeholders. Edison Advisors leverages our core research platform to provide differentiated services including investor relations and strategic consulting.

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Analysts

Sean Conroy

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Oryzon Genomics - FDA green light for SCLC combination trial

ORYZON Secures Another Important Patent for its Lead CNS Asset, Vafidemstat

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

Sylvania Platinum - Annual guidance maintained, despite strike

1Spatial - Investing in the transformational SaaS opportunity

Datatec - FY24 underlying EPS more than doubles y-o-y

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