AVEO Oncology is committed to discovering, developing and commercializing therapies to improve the lives of cancer patients. To support these efforts, AVEO continues to evaluate opportunities to collaborate with other pharmaceutical and biotechnology companies that share AVEO’s vision for oncology drug development, and seek partnerships that align with AVEO’s strategic, long-term corporate goals.

License Agreements

Kyowa Kirin Co.

AVEO’s license agreement with Kyowa Kirin Co. (“KKC”) grants AVEO an exclusive, sublicensable license to develop, manufacture and commercialize tivozanib in all territories in the world except for Asia and the Middle East, where KKC retained the rights to tivozanib (the “KKC Agreement”). Under the KKC agreement, AVEO also has exclusive rights to tivozanib in the AVEO territory under certain KKC patents, patent applications and know-how for the diagnosis, prevention and treatment of all human diseases and conditions. In August 2019, AVEO entered into an amendment to the KKC Agreement pursuant to which KKC repurchased the non-oncology rights to tivozanib in our territory, excluding the rights AVEO has sublicensed to EUSA (defined below) under the EUSA Agreement. AVEO and KKC each have access to and can benefit from the other party’s clinical data and regulatory filings with respect to tivozanib and biomarkers identified in the conduct of activities under the KKC agreement, as related to oncology development.

EUSA

AVEO has an exclusive license agreement with EUSA Pharma (“EUSA”) to grant EUSA with the European rights to tivozanib for the treatment of advanced renal cell carcinoma (“RCC”). The agreement also includes a number of additional territories outside North America, including South America and South Africa, and additional potential indications. Under terms of the agreement, EUSA may utilize data from the study for regulatory or commercial purposes in exchange for a research and development funding to AVEO. Recordati, S.p.A. acquired EUSA on March 16, 2022.

Collaboration Agreements

As part of AVEO’s corporate strategy and long-term corporate goals, AVEO’s collaborations advance life-cycle development for FOTIVDA (tivozanib) to support its potential utility in immuno-oncology and other combinations in RCC and other indications. AVEO expects to continue leveraging its existing strategic collaborations and enter into new strategic collaborations that can contribute to its ability to efficiently develop AVEO’s product candidates to provide a better life for patients with cancer.

NiKang

AVEO and NiKang Therapeutics Inc. (“NiKang”) are parties to a clinical trial collaboration and supply agreement to evaluate tivozanib in combination with NKT2152, NiKang’s small molecule that inhibits hypoxia inducible factor 2α (“HIF2α”). The Phase 2 clinical trial is designed to evaluate the safety and efficacy of the combination of tivozanib and NKT2152 in clear cell RCC patients who have not responded to or relapsed from prior therapies. NiKang is the sponsor for the trial. AVEO expects the Phase 2 clinical trial to commence in 2022.

BMS

AVEO and Bristol-Myers Squibb Company (“BMS”) are parties to a clinical trial collaboration and supply agreement in which BMS is supplying OPDIVO® (nivolumab), its anti-PD-1 therapy, for the TiNivo-2 trial with FOTIVDA® (tivozanib) in RCC patients. The TiNivo-2 trial is a randomized, open-label, controlled Phase 3 clinical trial designed to evaluate the safety and efficacy of tivozanib in combination with nivolumab as compared to tivozanib as a monotherapy, in RCC patients who have progressed following prior immune checkpoint inhibitor  therapy.

AstraZeneca

AVEO and a wholly owned subsidiary of AstraZeneca PLC (“AstraZeneca”) are parties to a clinical supply agreement to evaluate the safety and efficacy of AstraZeneca’s IMFINZI (durvalumab), a human monoclonal antibody directed against programmed death-ligand 1, in combination with tivozanib, in the DEDUCTIVE trial to treat hepatocellular carcinoma (“HCC”). The DEDUCTIVE trial is an open-label, multi-center, randomized Phase 1b/2 clinical trial of tivozanib in combination with IMFINZI (durvalumab). The DEDUCTIVE trial was amended in the third quarter of 2021 to include second-line treatment of patients with advanced, unresectable HCC who have progressed after first-line bevacizumab and atezolizumab treatment, or cohort B.

Academic and Institution Partnerships

Clinical Development of Tivozanib in Cholangiocarcinoma

AVEO and the National Cancer Institute’s Surgical Oncology Program are parties to a Cooperative Research and Development Agreement to conduct a Phase 1/2 clinical trial designed to evaluate the safety and efficacy of tivozanib in cholangiocarcinoma (“CCA”). The Phase 1/2 clinical trial is an open-label, single-center, non-randomized study. CCA is an aggressive biliary tract malignancy that remains a clinical challenge with limited treatment options and poor survival rates.

Clinical Development of Tivozanib in Immunologically Cold Tumors

AVEO has an investigator sponsored trial agreement with the University of Florida to conduct a Phase 1b/2 clinical trial to evaluate the safety and efficacy of tivozanib in combination with atezolizumab in immunologically cold tumors. Immunologically cold tumors are solid tumors that lack or have few tumor-infiltrating lymphocytes and remain a clinical challenge.

If you would like more information on current partnering opportunities with AVEO, we invite you to contact aveobd@aveooncology.com.