| Candidates | Preclinical | Phase 1 | Phase 2 | Phase 3 | reg. filing | marketed | partner |
|---|---|---|---|---|---|---|---|
| FOTIVDA VEGFR TKI | TIVO-3 US (RCC following two+ prior systemic therapies) | ||||||
TIVO-1 Ex-US (RCC 1st line)* |  | ||||||
TiNivo-2 (+/- OPDIVO® in RCC following prior CPI)** |  | ||||||
DEDUCTIVE (+ IMFINZI® in HCC)*** |  | ||||||
| Ficlatuzumab Anti-HGF/c-MET IgG1 mAb | HNSCC (+/- ERBITUX® in refractory disease) | ||||||
Pancreatic (+ Nab-paclitaxel + gemcitabine) | |||||||
CyFi-1 (+HiDac in AML) | |||||||
| AV-380 Anti-GDF15 IgG1 mAb | Cachexia/Oncology | ||||||
| AV-203 Anti-ERBB3 IgG1 mAb | Oncology | ||||||
| AV-353 Anti-Notch 3 IgG1 mAb | Oncology | ||||||
| FOTIVDA | ||||||
| Progress | Preclin | Phase 1 | Phase 2 | Phase 3 | Reg. Filing | Marketed |
TIVO-3 US (RCC following two+ prior systemic therapies) | ||||||
TIVO-1 Ex-US (RCC 1st line)* | ||||||
TiNivo-2 (+/- OPDIVO® in RCC following prior CPI)** | ||||||
DEDUCTIVE (+ IMFINZI® in HCC)*** | ||||||
| Ficlatuzumab | ||||||
| Progress | Preclin | Phase 1 | Phase 2 | Phase 3 | Reg. Filing | Marketed |
HNSCC (+/- ERBITUX® in refractory disease) | ||||||
Pancreatic (+ Nab-paclitaxel + gemcitabine) | ||||||
CyFi-1 (+HiDac in AML) | ||||||
| AV-380 | ||||||
| Progress | Preclin | Phase 1 | Phase 2 | Phase 3 | Reg. Filing | Marketed |
Cachexia/Oncology | ||||||
| AV-203 | ||||||
| Progress | Preclin | Phase 1 | Phase 2 | Phase 3 | Reg. Filing | Marketed |
Oncology | ||||||
| AV-353 | ||||||
| Progress | Preclin | Phase 1 | Phase 2 | Phase 3 | Reg. Filing | Marketed |
Oncology | ||||||
*Partnered with EUSA Pharma (Europe)
**Partnered with Bristol Myers Squibb
***Partnered with AstraZeneca
AVEO Oncology is a commercial stage, oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for patients with cancer. AVEO currently markets FOTIVDA® (tivozanib) in the United States. FOTIVDA is AVEO’s first commercial product and was approved by the U.S. Food and Drug Administration (FDA) for marketing and sale in the United States on March 10, 2021 for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies. AVEO continues to develop tivozanib in immuno-oncology combinations in RCC and other indications, and AVEO has other investigational programs in clinical development.
Based on FOTIVDA’s demonstrated anti-tumor activity, tolerability profile and reduction of regulatory T-cell production, AVEO and its collaboration partners are continuing to develop tivozanib in RCC and in additional cancer indications with significant unmet medical needs including, hepatocellular carcinoma, and tumors that are resistant to immunotherapy, or immunologically cold tumors, in combination with immune checkpoint inhibitors. In addition, AVEO is evaluating tivozanib as a monotherapy and cholangiocarcinoma. AVEO and AVEO’s collaboration partners or independent investigators sponsor the development of tivozanib through preclinical studies and clinical trials conducted under collaboration agreements and investigator sponsored trial agreements or AVEO’s Cooperative Research and Development Agreement with the National Cancer Institute’s Surgical Oncology Program.
AVEO is also seeking to advance its pipeline of four wholly owned immunoglobulin G1 monoclonal antibody product candidates, ficlatuzumab, AV-380, AV-203 and AV-353. AVEO aims to leverage its existing collaborations and partnerships and enter into new strategic collaborations and partnerships to continue to advance each of its product candidates.
Human Response Platform
THE HUMAN RESPONSE® Platform allows rapid development of targeted oncology therapeutics based on AVEO’s proprietary, genetically-defined mouse models of human cancer, in which each model is engineered to contain signature genetic mutations that are present in human disease.
AVEO uses its capabilities to develop its own pipeline of oncology therapeutics and has engaged in partnerships with leading biotechnology companies to leverage THE HUMAN RESPONSE® Platform. AVEO has used THE HUMAN RESPONSE® Platform in developing clinical therapeutic candidates, including Hepatocyte Growth Factor (HGF) (ficlatuzumab), ErBB3 (AV-203) and Notch3 (AV-353), as well as targeting Growth Differentiation Factor 15 (GDF15) for chemotherapy-induced cachexia (AV-380).
