Potential of AVEO Oncology acquired by LG Chem

Acquires FDA new drug approvals and conquers intractable cancers

Head and neck cancer drug ficlatuzumab enters Phase III trial

New candidate drugs for triple-negative breast cancer, cachexia etc. in development.

LG Chem's subsidiary AVEO Oncology is showing results in intractable cancers.

 

AVEO, which was acquired by LG Chem in 2022 for about KRW 750 billion, specializes in developing new anticancer drugs and has recorded annual sales of about KRW 200 billion.

 

AVEO owns Fotivda (tivozanib), which has been approved in the U.S.

 

for the treatment of Stage III or higher renal cell carcinoma.

 

In addition to Fotivda, AVEO is developing first-in-class drugs for refractory cancers such as head and neck cancer and triple-negative breast cancer through novel mechanisms of action.

 

According to industry sources on the 23rd, AVEO’s head and neck cancer drug candidate, ficlatuzumab, recently entered Phase III clinical trials.

 

Ficlatuzumab is a new head and neck cancer drug candidate that targets hepatocyte growth factor, or HGF, and c-MET.

 

In the trial, AVEO is evaluating the efficacy and safety of ficlatuzumab in combination with Merck’s Erbitux(cetuximab) in patients with recurrent or metastatic (R/M) human papillomavirus(HPV)-negative head and neck squamous cell carcinoma.

 

In the Phase II study, ficlatuzumab+Erbitux demonstrated superior efficacy compared with Erbitux monotherapy.

 

After 2 years of follow-up in 58 patients with head and neck cancer, the ficlatuzumab plus Erbitux combination achieved a median progression-free survival (PFS) of 3.7 months and an objective response rate (ORR) of 19%.

 

Two patients achieved a complete response (CR) and four patients achieved a partial response (PR).

 

Overexpression of c-Met was associated with a reduced risk of disease progression in the HPV-negative arm.

 

The efficacy of Erbitux monotherapy was not demonstrated during the same period.

 

AVEO is also exploring the potential of ficlatuzumab in combination with chemotherapy in patients with pancreatic cancer and acute myeloid leukemia in early clinical trials.

 

In both studies, ficlatuzumab demonstrated efficacy activity and an acceptable tolerability profile.

 

AVEO plans to further evaluate the efficacy of ficlatuzumab in various solid tumors.

 

AVEO develops candidate substances for intractable cancers, including triple-negative breast cancer and pancreatic cancer In addition, AVEO is also accelerating the development of its oncology pipeline.

 

Among them, the new drug candidate in the fastest clinical stage is AV-203.

 

AV-203 is designed to inhibit both ligand-dependent and -independent HER3 signaling.

 

Ligand specifically binds to the receptor.

 

HER3 is a receptor whose expression has been identified in a number of solid tumors, and to date, no new cancer drugs have been developed that target this biomarker.

 

In addition to AV-203, Daiichi Sankyo's patritumab is currently being evaluated for HER3-mutated breast cancer.

 

AVEO has completed a Phase Ia study of AV-203 in patients with advanced solid tumors.

 

AV-203 was well tolerated in multiple tumor models, including breast, head and neck, lung, ovarian, and pancreatic cancers.

 

In the trial, AV-203 demonstrated early signs of activity in HER3-responsive ligands, heregulin or neuregulin, that was consistent with those confirmed through preclinical data.

 

Therefore, AVEO plans to continue to a Phase 1b study.

 

AVEO is also conducting clinical trials for its AV-380.

 

AV-380 is an innovative new drug candidate that targets growth differentiation factor 15 (GDF15).

 

GDF15 is a pro-inflammatory cytokine whose elevated circulating levels have been correlated with cachexia in cachectic cancer patients and several animal models of cancer cachexia.

 

Cancer cachexia is a complex metabolic syndrome characterized by malnutrition and severe involuntary weight loss due to the loss of muscle and fat tissue.

 

80% of cancer patients are known to suffer from cachexia.

 

Preclinical data confirmed that inhibiting GDF15 with AV-380 can reverse the effects of cachexia.

 

In addition, AVEO is also conducting a preclinical study for AV-353 in patients with triple-negative breast cancer in collaboration with the Mayo Clinic in Minnesota, USA.

 

AV-353 is an inhibitory antibody specific to Notch 3, a signaling pathway that is important in cell-to-cell communication involving gene regulation mechanisms that control multiple cell differentiation processes during the entire life cycle.

 

The Notch 3 receptor pathway has been implicated in multiple diseases, including cancer, cardiovascular diseases, and neurodegenerative conditions.

 

AVEO is leveraging its Human Response Platform to secure its drug pipeline.

 

All of its drug candidates in development including ficlatuzumab, AV-203, AV-380, and AV-353, were developed using AVEO's proprietary Human Response Platform.