rilogrotug (AV-380) / LG Chem - LARVOL DELTA

Decoding GDF15: Impact on prostate cancer metabolism, chemoresistance, and clinical applications. (PubMed, Chin Med J (Engl)) - "Clinically, GDF15 has shown potential as a biomarker, offering diagnostic precision and prognostic value, particularly when combined with established markers such as prostate-specific antigen. The review concludes with a discussion on several monoclonal antibodies targeting GDF15 in clinical trials, such as AV-380, NGM120, Visugromab, and AZD8853, highlighting promising strategies for novel therapies and precision medicine."

Journal • Cachexia • Genito-urinary Cancer • Metabolic Disorders • Oncology • Prostate Cancer • Solid Tumor • GDF15

Advancements of investigational agents for cancer cachexia: what clinical progress have we seen in the last 5 years? (PubMed, Expert Opin Investig Drugs) - "This review covers key investigational therapies developed over the past five years, with a focus on agents targeting Growth Differentiation Factor 15 (GDF-15), including ponsegromab, AV-380, and NGM120. Additional agents include ghrelin receptor agonists (e.g. anamorelin), anabolic/catabolic modulators (ACM-001), and cannabinoids (ART27.13). The evolving role of low-dose olanzapine is also discussed in the 2023 ASCO guideline update...The lack of standardized endpoints, heterogeneity of the syndrome, and absence of FDA-approved treatments remain major barriers to treatment implementation. Multimodal strategies combining pharmacological treatment with nutritional and rehabilitative support are likely to define future therapeutic success."

Journal • Cachexia • Oncology • GDF15

GDF-15 Drives NETosis and Macrophage Polarization in Diabetic Kidney and Cardiac Injury: Dual-Organ Inflammatory Axis and Therapeutic Target (KIDNEY WEEK 2025) - "Mice were grouped into controls, AV-380 treated controls (7.5 or 20 mg/kg), T2D, and AV-380 treated T2D groups...Conclusion These findings identify a conserved GDF-15-driven inflammatory axis involving NETosis and macrophage modulation in DKD and DCM. GDF-15 inhibition represents a novel adjunct strategy to mitigate diabetes-associated cardiorenal complications through a mechanism not targeted by current therapies."

Cardiomyopathy • Cardiovascular • Chronic Kidney Disease • Diabetes • Diabetic Nephropathy • Fibrosis • Glomerulonephritis • Immunology • Inflammation • Metabolic Disorders • Nephrology • Renal Disease • Type 2 Diabetes Mellitus • CCL2 • CCL22 • CD86 • CXCL10 • CXCL9 • GDF15 • STAT6 • TGFB1 • TNFA

A phase 1b dose escalation study of AV-380 (anti-GDF15 monoclonal antibody) in combination with standard-of-care therapy in cancer patients with cachexia. (ASCO 2025) - P1 | "Statistical analyses will be completed by cohort and summarized descriptively. Clinical trial information: NCT05865535."

Clinical • Combination therapy • P1 data • Anorexia • Cachexia • Congestive Heart Failure • Heart Failure • Myocardial Infarction • Oncology • Respiratory Diseases • Solid Tumor • GDF15

Next-gen Korean cancer fighters to showcase innovation at ASCO 2025 (Korea Biomedical Review) - "Among the companies presenting clinical results is LG Chem, which will showcase phase 3 data for Fotivda (ingredient: tivozanib), its targeted therapy for metastatic renal cell carcinoma, developed by its U.S. subsidiary AVEO...Results demonstrated favorable progression-free survival in the monotherapy arm, particularly among patients who had previously received Yervoy and Opdivo. AVEO will also present phase 3 data on ficlatuzumab, an HGF-targeting antibody in head and neck cancer, and phase 1b data for AV-380, an anti-GDF15 antibody in development for cancer cachexia."

Clinical data • Cachexia • Renal Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Poster Title: "A phase 1b dose escalation study of AV-380 (anti-GDF15 monoclonal antibody) in combination with standard-of-care therapy in cancer patients with cachexia."– (Abstract: TPS12142; Poster: 159a) (PRNewswire) - "AVEO presented a second trial in progress poster for their AV-380 phase 1b dose escalation study. During the meeting, the company also announced the official molecule name for AV-380: rilogrotug (pronounced rye-low-grow-tug). Rilogrotug is an immunoglobulin (Ig) G1 monoclonal antibody (mAb) intended to bind circulating human growth differentiation factor 15 (GDF-15), a cytokine involved in cancer-induced cachexia. This open label ascending dose study is designed to evaluate the safety, pharmacokinetics, pharmacodynamics, and immunogenicity of rilogrotug in cancer patients with cachexia."

Trial status • Cachexia • Oncology

AVEO Oncology, an LG Chem company, Announces Three Poster Presentations at ASCO 2025 Annual Meeting (PRNewswire) - "AVEO Oncology, an LG Chem company...announced today that three abstracts were accepted for presentation at the upcoming American Society of Clinical Oncology (ASCO) 2025 annual meeting this May 30-June 3, 2025, in Chicago, IL."

P1 data • P3 data • Cachexia • Renal Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

A Dose Escalation Study of AV-380 in Metastatic Cancer Patients with Cachexia (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: AVEO Pharmaceuticals, Inc. | Trial completion date: Sep 2025 ➔ Jun 2026 | Trial primary completion date: Jul 2025 ➔ Dec 2025

Combination therapy • Metastases • Trial completion date • Trial primary completion date • Cachexia • Oncology • CCL2 • GDF15

A Dose Escalation Study of AV-380 in Metastatic Cancer Patients With Cachexia (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: AVEO Pharmaceuticals, Inc. | Trial completion date: Mar 2025 ➔ Sep 2025 | Trial primary completion date: Nov 2024 ➔ Jul 2025

Combination therapy • Metastases • Trial completion date • Trial primary completion date • Cachexia • Oncology • CCL2 • GDF15

A Dose Escalation Study of AV-380 in Metastatic Cancer Patients With Cachexia (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: AVEO Pharmaceuticals, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Cachexia • Oncology • Solid Tumor • GDF15

A Phase 1 Study of AV-380 in Healthy Subjects (clinicaltrials.gov) - P1 | N=51 | Completed | Sponsor: AVEO Pharmaceuticals, Inc. | Active, not recruiting ➔ Completed

Trial completion • Cachexia • CCL2 • GDF15

A Dose Escalation Study of AV-380 in Metastatic Cancer Patients With Cachexia (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: AVEO Pharmaceuticals, Inc.

Combination therapy • Metastases • New P1 trial • Cachexia • Oncology • Solid Tumor • GDF15

AVEO Oncology Highlights Recent Progress and 2022 Outlook (GlobeNewswire) - "Completed enrollment in the first-line cohort of the ongoing Phase 1b/2 DEDUCTIVE trial...The Company expects to present the data from the first-line cohort at ASCO GI in January 2022; Announced plans to initiate a potential registrational Phase 3 clinical trial for ficlatuzumab in HPV negative HNSCC in the first half of 2023. AVEO has begun the manufacturing scale up and expects to commence manufacturing of ficlatuzumab clinical supply in the second quarter of 2022; [For AV-380] AVEO plans to initiate a Phase 1b clinical trial in cancer patients in mid-2022."

Commercial • New P1 trial • New P3 trial • P1/2 data • Gastrointestinal Cancer • Head and Neck Cancer • Hepatocellular Cancer • Oncology • Squamous Cell Carcinoma of Head and Neck

A Phase 1 Study of AV-380 in Healthy Subjects (clinicaltrials.gov) - P1; N=56; Active, not recruiting; Sponsor: AVEO Pharmaceuticals, Inc.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Cachexia • CCL2 • GDF15

A Phase 1 Study of AV-380 in Healthy Subjects (clinicaltrials.gov) - P1; N=56; Recruiting; Sponsor: AVEO Pharmaceuticals, Inc.

Clinical • New P1 trial • Cachexia • CCL2 • GDF15

AVEO Oncology Reports Third Quarter 2020 Financial Results and Provides Business Update (Aveo Oncology Press Release) - "Preparations Ongoing to Support Commercial Launch of Tivozanib in the U.S. Following the PDUFA Date (March 31, 2021). In preparation for the potential commercial launch of tivozanib in the U.S., the Company continues to expand its sales, marketing, market access and medical affairs teams, and is working to put in place its U.S. distribution capabilities by the end of the year...AVEO plans to submit an IND application to the FDA for AV-380, its first-in-class, potent, humanized inhibitory antibody targeting GDF15, for the treatment of cancer cachexia by year-end."

IND • Launch US • PDUFA date • Cachexia • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma

AVEO Oncology Reports Second Quarter 2020 Financial Results and Provides Business Update (Aveo Oncology Press Release) - "AV-380 Update: Company on Track for IND Application Submission by Year-end, with Phase 1 Clinical Study Planned for the First Quarter of 2021."

IND • New P1 trial • Cachexia

"But $NVS instead advanced clinical dev of their owned Bimagrumab and Ruxolitinib in Cachexia yet AV-380 seems to have a competitive advantage. Isn't it weird? " (@pogcat1714)

Clinical