MedPath

ORY-1001

Generic Name
ORY-1001
Drug Type
Small Molecule
Chemical Formula
C16H24N2
CAS Number
1401966-39-9
Unique Ingredient Identifier
XC0UT08SNJ
Clinical Trials
Related News

Oryzon Genomics Secures €13.26 Million EU Grant for Rare Disease Research

• Oryzon Genomics has been awarded €13.26 million through the Med4Cure initiative, a pan-European project focused on developing therapies for rare diseases with no current treatment options. • The grant will fund the 44-month VANDAM project, which aims to develop personalized epigenetic therapies for rare neurodevelopmental disorders and neuroendocrine tumors caused by chromatin regulation gene mutations. • Combined with recent €30 million equity financing, this non-dilutive funding strengthens Oryzon's financial position as it advances its clinical pipeline, including Phase III-ready vafidemstat for borderline personality disorder.

FDA Grants Fast Track Status to Pyxis Oncology's PYX-201 for Advanced Head and Neck Cancer

• Pyxis Oncology's novel antibody-drug conjugate PYX-201, targeting Extradomain-B Fibronectin, receives FDA Fast Track Designation for treating recurrent or metastatic head and neck squamous cell carcinoma. • The designation addresses a critical unmet need in head and neck cancer treatment, particularly for patients who have progressed after platinum-based chemotherapy and anti-PD-(L)1 therapy. • Two clinical trials are currently recruiting patients: a monotherapy study and a combination trial with Merck's KEYTRUDA, highlighting the drug's potential in multiple treatment approaches.

Vafidemstat Phase IIa Results Published: Shows Promise in Treating Psychiatric Aggression

• Oryzon Genomics' Phase IIa REIMAGINE trial results demonstrate vafidemstat's effectiveness in reducing agitation and aggression across BPD, ADHD, and ASD patient populations. • The groundbreaking basket trial establishes LSD1 inhibition as a novel therapeutic approach for managing psychiatric aggression, with findings published in Psychiatry and Clinical Neurosciences. • Following successful Phase IIb results and FDA discussions, Oryzon is advancing to PORTICO-2 Phase III trial for vafidemstat in borderline personality disorder treatment.

Oryzon's Iadademstat Enters Phase I Trial for Myelodysplastic Syndrome

• Oryzon Genomics has announced the dosing of the first patient in a Phase I trial of iadademstat for myelodysplastic syndrome (MDS). • The trial, led by the Medical College of Wisconsin, will assess the safety, tolerability, and optimal dose of iadademstat with azacitidine. • Iadademstat, a selective LSD1 inhibitor, aims to address the differentiation block in hematopoietic progenitor cells characteristic of MDS. • The study hopes to improve outcomes for MDS patients, where current treatments have limited efficacy, especially in higher-risk cases.

Oryzon Genomics Advances CNS and Oncology Programs, Prepares for Phase III Trial of Vafidemstat in BPD

• Oryzon Genomics presented final Phase IIb PORTICO trial data for vafidemstat in Borderline Personality Disorder (BPD) at ECNP 2024, showing significant improvements in agitation and aggression. • Following positive FDA feedback, Oryzon is preparing for a Phase III PORTICO-2 trial with vafidemstat, focusing on agitation/aggression in BPD as a primary indication. • The company is expanding its oncology efforts with iadademstat, including investigator-initiated studies in first-line AML, and continues to enroll patients in the FRIDA Phase Ib trial. • Oryzon is strengthening its intellectual property portfolio for vafidemstat with new patents granted and intentions to grant in key markets, extending protection to at least 2038.

Oryzon Genomics Advances CNS and Oncology Programs, Prepares for Phase III Trial of Vafidemstat in BPD

• Oryzon Genomics presented final Phase IIb PORTICO trial data for vafidemstat in Borderline Personality Disorder (BPD) at the ECNP conference, showing significant improvements in agitation and aggression. • Following positive feedback from the FDA, Oryzon is preparing for a Phase III trial (PORTICO-2) of vafidemstat in BPD, with a target enrollment of 350 patients. • The first cohort has been dosed in an investigator-initiated Phase Ib study of iadademstat with venetoclax and azacitidine in first-line AML, expanding Oryzon's oncology efforts. • Oryzon continues to strengthen its intellectual property position for vafidemstat with additional "intention to grant" communications for patents covering its use in treating aggression, social withdrawal, and BPD.
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