About VUJ-100
- Vuja De prioritized VUJ-100 as our 1st product for clinical trials by screening 3,000 clinical-stage drugs using our novel anti-metastasis discovery platform
- Proprietary, de-risked, oral combination therapy that includes domatinostat, our patented Phase 2-stage drug, Class I selective HDAC inhibitor, epigenetic regulator, and tumor microenvironment modulator, and low-dose FDA-approved oral mTOR inhibitor, sirolimus
- 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) in collaboration with the Sunshine Project™/National Pediatric Cancer Foundation, with over 30 leading children’s hospitals across the US
- Mechanisms of Metastatic Endurance in OS are shared across many cancer types, enabling extension from OS into other cancers
- We believe that in-order-to effectively inhibit metastatic cancer recurrence and progression it is essential to use a combination of drugs with acceptable safety profiles and potential for continuous long-term dosing of patients that continue to show benefit
- VUJ-100 targets multiple broad networks that cancer cells selectively rely on for Metastatic Endurance. Our goal is to achieve long-lasting effects to disable Metastatic Endurance and achieve substantial patient benefits related to recurrence, progression and overall survival.
- Epigenetic regulation and mTOR provide outstanding targets to control primarily non-overlapping pathways potentially overcoming OS tumor heterogeneity and acquired resistance to any single agent
- Epigenetic regulator, Class I selective, oral, HDAC inhibitor that regulates transcription and signaling of critical networks in various cancers, and tumor microenvironment modulator
- 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, well established human PK/PD and safety
- 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 clinical data and documentation from multiple Phase 1 and 2 oncology trials, CMC package, API, and drug product (tablets), patent portfolio, and regulatory documentation including 2 US INDs, in support of its upcoming Phase 1/2 trial and other indications.
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