AVEO Oncology, an LG Chem Company, has undergone a remarkable transformation since the game-changing acquisition that positions the company at the forefront of global oncology innovation. The US$571 million acquisition of AVEO Oncology by LG Chem in January 2023, following their October 2022 announcement to acquire AVEO at US $15.00 per share, represents far more than a corporate transaction—it’s the foundation of an ambitious vision to become a top 20 global oncology-focused biopharmaceutical company by 2030. This strategic partnership has unleashed resources, with LG Chem committing to the largest-ever R&D investment by any Korean pharmaceutical company, including over US $300 million in the integrated Life Sciences-AVEO operation and an additional $1.5 billion toward R&D over the next five years starting in 2023.
AVEO’s comprehensive expansion strategy seeks to combine robust internal clinical development programs with strategic acquisitions and licensing agreements.
Combined with LG Chem Life Science’s internal research, the companies aim to deliver additional US Food and Drug Administration (FDA-) approved oncology drugs and late-stage clinical programs that will directly benefit patients worldwide while strengthening partnerships across the healthcare ecosystem.
Onco’Zine: Please provide a summary of the current oncology mAb therapeutic area dynamics
Edgar Braendle, MD, Ph.D.: In oncology, the monoclonal antibody (mAb) therapeutic area is currently marked by rapid innovation, market expansion, and fierce competition. Key dynamics include the continued dominance of immune checkpoint inhibitors, the rise of next-generation therapies like antibody-drug conjugates (ADCs) and multispecific antibodies, and the increasing market presence of biosimilars. Bispecific mAbs offer a unique advantage over traditional monoclonal antibodies by targeting two different antigens, allowing for dual-action mechanisms such as redirecting immune cells to tumors or blocking multiple growth pathways at once.
Immune checkpoint inhibitors (ICIs) remain market leaders. Blockbuster ICIs like pembrolizumab (Keytruda®; Merck & Co/MSD) and nivolumab (Opdivo®; Bristol-Myers Squibb) continue to be major revenue drivers, especially the PD-1/PD-L1 class. Their success solidifies the importance of harnessing the immune system to fight cancer.
Bispecific antibodies are engineered antibody molecules that possess two distinct antigen-binding sites, enabling them to simultaneously bind to two different antigens or two different epitopes on the same antigen. This dual specificity allows bispecific antibodies to mediate unique biological functions, such as bringing immune effector cells into proximity with target cells (e.g., tumor cells), blocking two signaling pathways concurrently, or facilitating the formation of protein complexes that are not achievable with conventional monospecific antibodies.
Bispecific antibody drug conjugates (bsADCs) combine the dual-targeting ability of bispecifics with a cytotoxic payload. Preclinical and early clinical data are exploring approaches for dual payload delivery to overcome drug resistance. These bsADCs are experiencing rapid growth, with a wide pipeline of over 400 ADCs in development, including 24 in Phase III trials. ADCs address limitations of traditional chemotherapy and older mAbs by precisely delivering a toxic payload to cancer cells, minimizing side effects.
Onco’Zine: What are your responsibilities at AVEO Oncology, an LG Chem Company?
Edgar Braendle, MD, Ph.D.: As Chief Medical Officer at AVEO Oncology, I serve as a pivotal leader in advancing the company’s comprehensive oncology portfolio, overseeing critical functions that span clinical development, regulatory affairs, clinical operations, pharmacovigilance, biostatistics, and translational science.
This multifaceted role encompasses strategic oversight of both existing products and the emerging clinical pipeline, ensuring rigorous scientific standards while driving innovative therapeutic solutions forward. Following AVEO’s acquisition by LG Chem, the CMO uniquely functions as a strategic bridge between both organizations’ pipelines, fostering collaborative efforts that leverage the combined expertise and resources of both companies.
The position demands close coordination with LG Chem colleagues to accelerate the development of targeted therapies and immunotherapies, particularly focusing on antibody development and precision medicine approaches for diseases with high unmet medical needs. Through comprehensive clinical development leadership and strategic regulatory interactions, the CMO ensures that AVEO Oncology remains at the forefront of delivering breakthrough treatments to patients facing challenging oncological conditions, embodying the company’s mission to transform cancer care through scientific excellence and collaborative innovation.
Onco’Zine: Where were you before AVEO? Where did you train?
Edgar Braendle, MD, Ph.D.: Before joining AVEO Oncology in 2024, I served in a number of clinical roles at different companies. Before AVEO, I was Chief Development Officer at Autolus Therapeutics plc. I also served as Executive Vice President, Chief Medical Officer, and Global Head of Development for Sumitomo Dainippon Pharma Oncology. Also, over the course of 10 years, I worked at Novartis Oncology as Senior Vice President and Global Head of Precision Medicine; Vice President, Global Head of Oncology Biologics; and Unit Head of Exploratory Clinical Development, Oncology. I am proud to have worked on the development and commercialization of six different oncology drugs.
Finally, I conducted my training in Germany. I am a licensed MD with specialty training in oncology, as well as a PhD. I have specialty training in oncology, pharmacology and urology.
Onco’Zine: Can you provide our readers with an overview of AVEO Oncology’s strategy for developing therapeutic mAb’s?
Edgar Braendle, MD, Ph.D.: AVEO Oncology has strategically positioned itself as an innovative biopharmaceutical company focused on developing targeted therapeutic monoclonal antibodies to address critical unmet needs in oncology, particularly in renal cell carcinoma, head and neck cancer, and cancer-related cachexia.
We are currently developing two monoclonal antibodies. Ficlatuzumab* (also known by research code AV-299 and SCH 900105), a potent humanized investigational IgG1 monoclonal antibody that targets hepatocyte growth factor (HGF) and demonstrates differentiated inhibition of HGF/cMET downstream signaling. Ficlatuzumab is currently advancing through a multicenter Phase 3 clinical trial (FIERCE-HN; NCT06064877) in combination with cetuximab for recurrent or metastatic HPV-negative head and neck squamous cell carcinoma.[1][2]
AV-380 (rilogrotug)**, an investigational IgG1 monoclonal antibody that targets growth differentiation factor 15 (GDF-15) to prevent severe weight and muscle loss in cancer patients.
AVEO’s mission reflects the broader industry trend toward precision oncology, as the company aims to grow into a global oncology leader with a foundational portfolio that provides targeted solutions to the cancer community. AVEO’s competitive advantage lies in leveraging existing collaborations while strategically pursuing new partnerships to advance each product candidate, positioning them to capitalize on the expanding therapeutic antibody market that continues to drive innovation in cancer treatment.
Onco’Zine: Can you provide an overview of AVEO Oncology’s pipeline?
Edgar Braendle, MD, Ph.D.: The company’s pipeline centers on the two promising monoclonal antibodies of ficlatuzumab and rilogrotug.
The FIERCE-HN trial is underway and we are looking forward to the data we will accrue from this important pivotal study.
Rilogrotug is being studied in an open-label Phase 1b ascending dose study designed to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of rilogrotug in cancer patients with cachexia. AVEO is currently enrolling patients in this study.
If we look at the LG Chem Life Science portfolio, it is not focused on antibodies. Their portfolio includes broad platforms, including biologics, small molecules, antibodies, and CAR T-cell therapies. Similarly, AVEO Oncology will pursue a broad portfolio of drugs targeted to treat diseases with high unmet medical needs. We believe our focus on oncology development will help LG Chem to achieve their goal of becoming a global oncology leader in the next 10 years.
Onco’Zine: What else would you like to share?
Edgar Braendle, MD, Ph.D.: AVEO Oncology has and continues to prioritize development opportunities for its flagship drug, tivozanib (Fotivda®)***, for advanced kidney cancer.
In 2024, the results from the TiNivo-2 Phase 3 trial, investigating low-dose tivozanib combined with nivolumab for advanced renal cell carcinoma, were published in The Lancet. The results showed that the addition of nivolumab to low-dose tivozanib following prior immunotherapy did not enhance efficacy over full-dose tivozanib; as such, the study did not meet its primary endpoint. Insights from the study showed that sequencing IO therapies in RCC does not benefit patient outcomes, and full-dose, single-agent tivozanib is a well-tolerated and effective treatment following IO combination therapy in the first line.
While not an AVEO-sponsored trial, in early 2025, a large, National Clinical Trials Network (NCTN) sponsored trial known as the STRIKE trial began to evaluate tivozanib combined with pembrolizumab in the adjuvant setting for eligible kidney cancer patients. We look forward to seeing the data from this NCTN-sponsored trial.
While AVEO Oncology possesses considerable strength and expertise in antibody development, we are also considering other oncology therapeutic classes for drug development. For instance, we are seeking additional development opportunities for our pipeline, including novel combinations in solid tumors and hematologic cancers.
Onco’Zine: Dr Braendle, thank you for your time today.
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Note: * Ficlatuzumab (also known by research code AV-299) is an investigational monoclonal antibody that targets the human hepatocyte growth factor (HGF), a signaling molecule involved in tumor growth and resistance to cancer drugs. The drug is being studied in clinical trials for various cancers, including recurrent/metastatic head and neck squamous cell carcinoma (HNSCC), where it has shown promise in combination with other drugs like cetuximab. While the FDA has not approved it, a recent Phase 2 trial showed a significant benefit in progression-free survival for HNSCC patients with HPV-negative tumors treated with ficlatuzumab and cetuximab.
** AV-380, also known as rilogrotug, is an investigational drug in clinical development for the treatment of cancer-associated cachexia and certain metastatic cancers. It is a humanized monoclonal antibody that works by inhibiting growth differentiation factor 15 (GDF-15), a cytokine linked to cancer-induced cachexia and weight loss.
*** Tivozanib (Fotivda®) is a tyrosine kinase inhibitor prescribed for adult patients diagnosed with relapsed or refractory advanced renal cell carcinoma (RCC).
Clinical trials
Study to Compare Tivozanib in Combination With Nivolumab to Tivozanib Monotherapy in Subjects With Renal Cell Carcinoma – ClinicalTrials.gov ID NCT04987203
Ficlatuzumab and Cetuximab in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) – ClinicalTrials.gov ID NCT02277197
Ficlatuzumab w/wo Cetuximab in Patients with/Cetuximab-Resistant, Recurrent or Metastatic Head/Neck Squamous Cell Carcinoma – ClinicalTrials.gov ID NCT03422536
A Study of Ficlatuzumab in Combination With Cetuximab in Participants With Recurrent or Metastatic (R/M) HPV Negative Head and Neck Squamous Cell Carcinoma (FIERCE-HN) – ClinicalTrials.gov ID NCT06064877
A Dose Escalation Study of AV-380 in Cancer Patients With Cachexia – ClinicalTrials.gov ID NCT05865535
Highlights of Prescribing Information
Tivozanib (Fotivda®; AVEO Oncology)[Prescribing information]
Pembrolizumab (Keytruda®; Merck & Co/MSD) [Prescribing Information]
Nivolumab (Opdivo®; Bristol-Myers Squibb) [Prescribing Information]
Cetuximab (Erbitux®; Eli Lilly and Company; outside the US and Canada: Merck KGaA, Darmstadt, Germany). [Prescription Information][Summary of Product Characteristics]
References
[1] Bauman JE, Saba NF, Roe D, Bauman JR, Kaczmar J, Bhatia A, Muzaffar J, Julian R, Wang S, Bearelly S, Baker A, Steuer C, Giri A, Burtness B, Centuori S, Caulin C, Klein R, Saboda K, Obara S, Chung CH. Randomized Phase II Trial of Ficlatuzumab With or Without Cetuximab in Pan-Refractory, Recurrent/Metastatic Head and Neck Cancer. J Clin Oncol. 2023 Aug 1;41(22):3851-3862. doi: 10.1200/JCO.22.01994. Epub 2023 Mar 28. PMID: 36977289.
[2] Bauman JE, Ohr J, Gooding WE, Ferris RL, Duvvuri U, Kim S, Johnson JT, Soloff AC, Wallweber G, Winslow J, Gaither-Davis A, Grandis JR, Stabile LP. Phase I Study of Ficlatuzumab and Cetuximab in Cetuximab-Resistant, Recurrent/Metastatic Head and Neck Cancer. Cancers (Basel). 2020 Jun 11;12(6):1537. doi: 10.3390/cancers12061537. PMID: 32545260; PMCID: PMC7352434.
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