ORYZON GENOMICS SA - ORYZF STOCK NEWS

Oryzon Genomics has received FDA approval for its Investigational New Drug application (IND) allowing the initiation of the Phase Ib clinical trial for iadademstat in patients with relapsed/refractory Acute Myeloid Leukemia (AML). The trial, named FRIDA, will study iadademstat in combination with gilteritinib, focusing on safety, tolerability, and establishing the Recommended Phase 2 Dose (RP2D). If successful, Oryzon aims to develop this combination further with the FDA's guidance, targeting a significant portion of AML patients.

Oryzon Genomics, a clinical-stage biopharmaceutical company focusing on epigenetics, has announced its participation in several high-profile conferences in February and March 2022. CEO Dr. Carlos Buesa and Global CBO Dr. Saikat Nandi will provide corporate updates at the BIO CEO & Investor Conference in New York and the Barclays Global Healthcare Conference in Miami, among others. Oryzon's innovative therapies, including LSD1 inhibitors Iadademstat and Vafidemstat, are currently in Phase II clinical trials, targeting significant unmet medical needs in hematologic and neurological diseases.

Oryzon is advancing its epigenetic drugs, iadademstat for oncology and vafidemstat for CNS indications. The company focuses on rapid, small trials for proof-of-concept data. Recent insights have led to plans for new pivotal trials with iadademstat. The updated valuation stands at €739 million or €13.9 per share, an increase from €591 million or €11.1 per share previously. Key indications include AML, SCLC, Alzheimer's, and bipolar disorder, while schizophrenia has been added as a new opportunity.

Oryzon Genomics reported its Q4 2021 financial results, highlighting significant progress in its clinical pipeline. The company completed patient enrollment in the Phase II trial of iadademstat for acute myeloid leukemia (AML) and plans new trials in AML and small cell lung cancer. Vafidemstat's Phase IIb trials for borderline personality disorder and schizophrenia are ongoing. Despite increased R&D expenses, Oryzon ended the quarter with a solid cash position of $32.5 million, providing funding through Q1 2023.

Oryzon Genomics has appointed Dr. Ana Limón as Senior Vice President of Clinical Development and Global Medical Affairs, enhancing its presence in the US. Dr. Limón brings extensive oncology experience from Deciphera Pharmaceuticals and Takeda. This strategic move aims to strengthen partnerships with US hospitals and advance Oryzon's clinical pipeline, including two LSD1 inhibitors in Phase II trials. CEO Dr. Carlos Buesa emphasized her expertise as a key asset for clinical success, while Dr. Limón expressed excitement about developing innovative drugs for oncologic and CNS diseases.

Oryzon Genomics has received approval from Serbia's Medicines and Medical Devices Agency to conduct a Phase IIb clinical trial with vafidemstat for Borderline Personality Disorder (BPD). This trial, named PORTICO, is already active in Spain, Bulgaria, Germany, and the USA. It aims to include approximately 160 patients and evaluate the drug's efficacy in reducing agitation and aggression in BPD patients. The trial will have an interim analysis after 90 participants, anticipated by the end of 2022, to assess variability and placebo effects.

Oryzon Genomics announced its participation in several key international healthcare conferences in January 2022, including the J.P. Morgan Healthcare Conference and Biotech Showcase 2022. CEO Dr. Carlos Buesa will be featured in a panel discussion on January 7. The company aims to provide updates on its progress in developing therapies targeting unmet medical needs, particularly through its lead candidates, iadademstat and vafidemstat, both in Phase II clinical trials.

Oryzon Genomics has reported significant efficacy data from its Phase IIa ALICE trial, showing a remarkable objective response rate (ORR) of 78% in acute myeloid leukemia (AML) patients. Among these, 62% achieved complete remission (CR/CRi), with 77% of these responses lasting more than six months. Notably, the longest remission exceeded 1,000 days. The safety profile of the combination therapy with iadademstat and azacitidine remained favorable, supporting its potential as a treatment option for elderly or unfit AML patients.

Oryzon Genomics has appointed Dr. Saikat Nandi as Global Chief Business Officer to enhance its US presence and strategic partnerships. Previously with AIG Investments, Dr. Nandi brings 15 years of experience in life sciences and investment management. Dr. Nandi's role will focus on advancing partnerships crucial for the company’s pipeline. Oryzon, a biopharmaceutical company specializing in epigenetics, has two compounds in Phase II clinical trials and operates from Spain and the US. This appointment aims to strengthen ties with US capital markets.