Gene therapy company Affinia Therapeutics has raised $40m in a Series C funding round, led by New Enterprise Associates (NEA).

New investor Eli Lilly & Company, along with previous backers including Mass General Brigham Ventures, Alexandria Venture Investments and Avidity Partners, also participated in the funding round.

This financing will support the development of the company's flagship programme, AFTX-201, aimed at treating Bcl2-associated athanogene 3 (BAG3) dilated cardiomyopathy (DCM), an inherited heart disorder known for its high death rate.

The capital influx will also facilitate the progression of the company’s gene therapy portfolio, which targets a range of severe diseases.

Affinia Therapeutics CEO Rick Modi stated: “We are grateful to this outstanding group of institutional and strategic investors who share our excitement about our novel, cardiotropic capsids and pipeline.

“This financing recognises the potential of our novel capsids and the value of our lead programme AFTX-201, bringing it one step closer to potentially become the first-in-class and best-in-class genetic medicine to treat BAG3 DCM.” 

Plans are in place for Affinia to file an investigational new drug (IND) application with the US Food and Drug Administration (FDA) for AFTX-201 in late 2025.

If approved, the company intends to commence the Phase I/II UPBEAT trial for BAG3 DCM patients in the first quarter of 2026.

AFTX-201 is in the midst of IND-enabling studies, which commenced following a pre-IND meeting with the US regulator.

AFTX-201, which is tailored to deliver a fully human BAG3 transgene via a cardiotropic capsid of the company, aims for selective cardiac transduction at lower doses.

It has enhanced the heart’s BAG3 protein levels and restored cardiac function in preclinical trials using animal disease models. These results were not replicated with a standard capsid at the same dosage.

AFTX-201 is intended to be administered as a single intravenous dose.