AV-380 / LG Chem - LARVOL DELTA

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 | "Clinical Trial Registration Number: NCT05865535 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Clinical • Combination therapy • P1 data • Cachexia • Oncology • GDF15

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