Highly prioritized clinical programs
Dovitinib is a Pan-Tyrosine Kinase Inhibitor (TKI)
- Exclusively in-licensed (globally) from Novartis
- Efficacy in Phase 3 trial in Renal Cell Carcinoma (RCC) and in Phase 2 trials in 4 other cancers
- Mechanism-of-Action: Small molecule, targeted inhibitor of FGFR, VEGFR, and other RTKs
- GMP & FDA approved Drug manufacturing is completed- clinical drug supply available.
- Dovitinib DRP® is validated in 5 different cancers: RCC, GIST, liver, metastatic breast, and endometrial
- Clear Regulatory Approval Pathway- Pre-NDA meeting (U.S. FDA) for “non-inferiority” vs. Sorafenib in RCC targeted for 2020. Subsequent NDA filing for RCC with Dovitinib DRP®
- Large market potential with high unmet market need: Global RCC therapeutics market projected to grow to $6.3B by 2022. Annual sales of Nexavar® = $715 M in 2018.
Stenoparib (formerly 2X-121) has a novel dual-inhibitory action against both PARP 1/2 and Tankyrase 1/2
- Exclusively in-licensed (globally) from Eisai.
- Efficacy in Phase 1 trial, including ovarian and pancreatic cancer
- Multi Target Mechanism-of-Action: First in class small molecule targeted inhibitor of DNA damage repair enzymes (PARP)1 and telomerase maintenance enzymes (Tankyrase).
- Multi-targeted inhibitor: PARP 1/2 and Tankyrase 1/2
- Limited drug resistance: Lack of transport by P-glycoprotein potentially overcomes resistance to PARP inhibitors
- GMP & FDA approved drug manufacturing is completed – clinical drug supply available.
- Stenoparib DRP® is validated.
- Clear Clinical Development Pathway – Phase 2 trials ongoing in ovarian cancer (Dana-Farber Cancer Institute, Boston, MA USA). Completion of Phase 2 trials targeted for 2021.
- Broad Combination Therapy – as mono-agent or combination with DNA damaging agents with immuno-oncology drugs
- Possibly a therapy against Coronavirus, based on properties of a comparable PARP inhibitor.
Ixempra® (ixabepilone) is a cell-cycle specific antimicrotubule agent. It attaches to a section of the microtubule and thereby acts on the microtubule structure and function of the cell. Oncology Venture's Ixempra study has not yet commenced.
Ixempra (US), owned by R-Pharm
- Exclusively in-licensed (Europe) from R-PHARM U.S.
- Approved in the U.S. for mBC patients.
- Mechanism-of-Action: Small molecule targeted inhibitor of microtubules (cell cytoskeleton components crucial to cell division and stability)
- GMP & FDA approved Drug manufacturing is completed – clinical drug supply available.
- IXEMPRA® DRP® is validated in metastatic breast cancer.
- Clear Clinical Development Path – Phase 2 trial front-line, neoadjuvant therapy in newly diagnosed breast cancer.
- Enrollment of Phase 2 trials targeted for 2020.
- Large market potential with high unmet market need: Global breast cancer therapeutics market projected to grow to $25Billion by 2024. Market potential for IXEMPRA® as front-line neoadjuvant therapy in newly-diagnosed breast cancer.
Other clinical programs
Oncology Venture has a wide pipeline of anti-cancer treatments. Dovitinib, Stenoparib and Ixempra® are high-priority clinical programs.
LiPlaCis, 2X-111, and Irofulven are other assets in the company's pipeline.
Enables a more targeted delivery at the tumor site of cisplatin
Glutathione-enhanced, PEGylated Liposomal Doxorubicin
This drug candidate is a synthetic drug candidate based on a naturally occurring substance that exploits a deficiency in the DNA repair mechanism of cancer cells in a manner similar to a PARP inhibitor.
Irofulven is a unified product consisting of a synthetic drug and an accompanying DRP®, Oncology Venture’s unique companion diagnostic.
The irofulven drug alkylates DNA and protein macromolecules, forms adducts, and arrests cells in the S-phase of the cell cycle. This agent requires NADPH-dependent metabolism by alkenal/one oxidoreductase for activity.