ORYZON GENOMICS SA - ORYZF STOCK NEWS

Oryzon Genomics, a clinical-stage biopharmaceutical company, has published a paper in ACS Pharmacology & Translational Science comparing its LSD1 inhibitor, iadademstat, with other inhibitors in cancer treatment. The study reveals that iadademstat is the most active and effective compound at low concentrations, outperforming four other clinical LSD1 inhibitors. Dr. Jordi Xaus emphasized its lower dose requirements, reducing potential toxicity, particularly in challenging tumor environments. The findings support iadademstat's promise in treating hematologic and solid tumors.

Oryzon Genomics, a clinical-stage biopharmaceutical company, is set to present new clinical data and updates at several prominent conferences in November and December 2021. Notably, Dr. Carlos Buesa will give a corporate update at the Jefferies Virtual Healthcare Conference on November 16 and the Evercore ISI HealthCONx Conference on November 30. Additionally, a 36-month clinical update on the Phase II ALICE trial, evaluating iadademstat in acute myeloid leukemia, will be unveiled at the ASH-2021 Congress on December 13. The data will highlight the drug's safety and efficacy in AML treatment.

Oryzon Genomics reported its Q3 2021 financial results, highlighting ongoing clinical trials. The ALICE trial for iadademstat in AML is fully enrolled, showing promising efficacy with an 83% overall response rate. The company is preparing new trials FRIDA and STELLAR to potentially support accelerated approval for AML and SCLC. Vafidemstat's PORTICO trial for BPD has commenced recruitment in the US, and EVOLUTION for schizophrenia is set to start soon. Oryzon's cash position stands at $35.83 million, funding operations until 1Q 2023.

Oryzon Genomics announced the enrollment of its first patient in the U.S. for the Phase IIb PORTICO trial of vafidemstat, an LSD1 inhibitor targeting Borderline Personality Disorder (BPD). This trial aims to assess efficacy and safety, focusing on reducing aggression and agitation in 156 patients. The trial has received approval in multiple European countries and is based on prior positive data from the REIMAGINE studies. Vafidemstat has shown promise in treating various psychiatric conditions and has been well-tolerated in previous trials.

Oryzon Genomics presented findings from its SATEEN Phase II trial on vafidemstat for multiple sclerosis at ECTRIMS-2021. The treatment was safe and tolerated over up to 2 years, with 72% of participants being female and a median age of 49. Improvements in anti-inflammatory responses were noted, but the study was not designed to establish definitive efficacy, resulting in no significant differences in clinical evaluations. The data highlight vafidemstat's potential for reducing neuroinflammation, with some patients showing positive clinical outcomes.

Oryzon Genomics presented new clinical data and participated in several key international conferences in September and October 2021. Highlights include the presentation of preliminary data on Phelan McDermid Syndrome at the ICA-2021 and updates on its ongoing Phase IIb trials for vafidemstat in borderline personality disorder and schizophrenia. Significant events include a KOL panel discussion at BIO Spain 2021 and presentations at ECNP 2021 and ECTRIMS 2021 showcasing the ongoing SATEEN trial for multiple sclerosis. Oryzon continues to solidify its position in precision medicine in CNS disorders.

Oryzon Genomics announced the initiation of a new clinical trial named HOPE, focusing on the efficacy of vafidemstat in treating Kabuki syndrome, aided by a one million USD grant.

This Phase I/II trial, expected to commence in early 2022, will be a multicenter, double-blind study testing the drug's safety and effectiveness in children and young adults. The trial collaborates with the Kennedy-Krieger Institute and aims for accelerated FDA and EMA approval based on positive outcomes. Vafidemstat is already in Phase IIb trials for other conditions.

Oryzon Genomics reported financial results for the first half of 2021, showing a net loss of $3.9 million, compared to $2.5 million in the same period last year. The company confirmed positive results from its iadademstat Phase II trial in acute myeloid leukemia, with an overall response rate of 83%. Key advancements include FDA approvals for vafidemstat trials in Borderline Personality Disorder and Schizophrenia. As of June 30, cash reserves totaled $40.1 million, ensuring funding for ongoing projects.

Oryzon Genomics has received approval from the Spanish Drug Agency for a Phase IIb clinical trial of vafidemstat in schizophrenia patients. The multicenter study, titled EVOLUTION, will enroll 100 adults under stable antipsychotic treatment. It aims to assess vafidemstat's effects on negative symptoms and cognitive impairments over 24 weeks. This trial builds on positive findings from previous studies, highlighting vafidemstat's potential in treating severe mental disorders without common side effects associated with current medications.