Pipeline
VUJ-100
- Vuja De prioritized VUJ-100 as our 1st product for clinical trials. VUJ-100 is a patented oral clinical stage (Phase 2) epigenetic regulator, Domatinostat, plus low-dose FDA-approved oral mTOR inhibitor, Rapamycin
- Vuje De held a successful pre-IND meeting with the FDA and is in final stages of preparing and filing an IND
- Phase 1/2 clinical trial to be launched in pediatric osteosarcoma (Phase 1 part includes also advanced sarcomas)
- Expansion to other cancers
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 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 derisked 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