FDA Clears IND for EGFR/HER3 Bispecific ADC AVZO-1418/DB-1418
The FDA cleared an investigational new drug application for AVZO-1418/DB-1418, and a phase 1/2 trial in advanced solid tumors will begin later this year.
US FDA
- The FDA has cleared the investigational new drug application (IND) for AVZO-1418/DB-1418.
- AVZO-1418/DB-1418 is a potential best-in-class, novel EGFR/HER3 bispecific antibody-drug conjugate (ADC).
- A phase 1/2 first-in-human trial will evaluate the ADC in patients with advanced solid tumors later this year.
The FDA cleared the IND for AVZO-1418/DB-1418, a potential best-in-class, novel EGFR/HER3 bispecific ADC being developed for the treatment of patients with advanced solid tumors.1
A first-in-human, open-label, phase 1/2 clinical trial is expected to launch later this year under an active IND. The phase 1 dose-escalation portion will evaluate the safety, tolerability, and initial antitumor activity of AVZO-1418/DB-1418 both as monotherapy and in combination regimens for the treatment of patients with advanced solid tumors.
On January 7, 2025, DualityBio and Avenzo Therapeutics announced an exclusive global licensing agreement (excluding Greater China) for AVZO-1418/DB-1418. Under the terms of the agreement, Avenzo will lead the clinical development, manufacturing, and global commercialization of the investigational agent.
“DualityBio has a strong track record of developing and advancing a pipeline of differentiated ADCs that target a broad range of indications,” said Athena Countouriotis, MD, co-founder, president and chief executive officer of Avenzo Therapeutics, in a press release.2 “By targeting both EGFR and HER3 with its differentiated design, AVZO-1418/DB-1418 has the potential to provide clinical benefit across multiple solid tumor types. We are excited to add this drug candidate to our clinical pipeline and look forward to collaborating with DualityBio to quickly progress this program into clinical studies.”
AVZO-1418/DB-1418 is a bispecific ADC targeting both EGFR and HER3, leveraging a topoisomerase I inhibitor payload and developed using DualityBio’s proprietary DIBAC (Duality Innovative Bispecific Antibody Conjugate) platform. This next-generation ADC has demonstrated enhanced tumor cell binding affinity in preclinical models and shows broad antitumor activity across multiple solid tumor types, including those characterized by EGFR resistance, low EGFR expression, or HER3 resistance.
Initial preclinical findings, presented at the 2025 AACR Annual Meeting, demonstrated the promise of AVZO-1418/DB-1418.1 The was shown to have features a novel bispecific design with enhanced binding affinity for EGFR and HER3, specifically targeting co-expressing tumor cells. In vivo studies demonstrated robust antitumor efficacy across multiple solid tumor models, including a non–small cell lung cancer model resistant to EGFR tyrosine kinase inhibitors.
These data support the rationale for advancing AVZO-1418/DB-1418 into clinical development.
REFERENCES:
FDA clearance of investigational new drug application received for novel EGFR/HER3 bispecific antibody-drug conjugate AVZO-1418/DB-1418. News release. Duality Biotherapeutics. May 22, 2025. Accessed May 27, 2025. https://tinyurl.com/2r54736b
Avenzo Therapeutics And DualityBio announce exclusive global license for potential best-in-class EGFR/HER3 antibody-drug conjugate. News release. January 7, 2025. Accessed May 27, 2025. https://tinyurl.com/4atuhxxx
