Pipeline
VUJ-100:
- Vuja De prioritized VUJ-100 as our 1st product for clinical trials
- Proprietary combination of two oral drugs with robust preclinical and clinical data informing development as anti-metastatic recurrence and progression therapy
- IND cleared by the FDA September 11, 2024
- Vuja De to launch a Phase 1/2 clinical trial with a focus on pediatric osteosarcoma (Phase 1 part includes also advanced sarcomas)
- Mechanisms of Metastatic Endurance in OS are shared across many cancer types, enabling extension of therapies from OS into other cancers
- VUJ-100 is a patented oral clinical stage (Phase 2) epigenetic regulator, Class I selective HDAC inhibitor Domatinostat, plus low-dose FDA-approved oral mTOR inhibitor, Sirolimus
- Enhanced activity derived from combo versus single drug regimens
- Combination reduces risk of resistance to single drug
About VUJ-100
In order to identify drugs that prevent recurrences, Vuja De established the first-ever biotech screening platform that mimics the conditions and biology of micro-metastatic tumors. This platform is based on cutting-edge science form our team at the national cancer institute and other institutions.
Vuja De screened 3,000 clinical-stage drugs, since they are de-risked and much faster and cost effective to market. The screen identified several 2-drug combination therapy candidates. We believe that we must use a combination and not focus on single agents.
VUJ-100 provides a combination effect targeting networks that regulate a broad range of critical cancer cell functions essential for Metastatic Endurance.
Domatinostat was developed by 4SC AG, a German biopharmaceutical company. Vuja De has exclusive access to world-wide rights to this promising drug from 4SC for its further development. Through this strategic partnership, Vuja De has also obtained access to drug tablets and API, patent portfolio, and regulatory, CMC and clinical documentation, in support of its upcoming Phase 1/2 trial and other indications.
Domatinostat Highlights
- Epigenetic regulator, Class I selective, oral, HDAC inhibitor that regulates transcription and signaling of critical networks in various cancers
- Demonstrated clinical and preclinical immuno-oncology tumor microenvironment effects. Increases MHC class I and tumor associated antigens, as well as immunomodulatory molecules, increases infiltration of CD8+ T cells, reduces myeloid-derived suppressor cells (MDSCs) and known synergy with checkpoint inhibitors
- Tested in multiple Phase 1-2 clinical trials
- Robust preclinical data, 2 US INDs, clinical data from multiple Phase 1 and 2 oncology trials, CMC package, API, and drug product (tablets) available for clinical trials via agreement with 4SC, well established human PK/PD and safety