Boston-based hearing loss gene therapy biotech Akouos is gunning for a $100 million IPO amid a near invulnerable market for public-seeking biotechs.
This comes just three months after it grabbed a $105 million series B funding round from a host of big names including the likes of 5AM Ventures, New Enterprise Associates, Novartis Venture Fund and Partners Innovation Fund as well as new participants Cowen Healthcare Investments, Polaris and Pivotal bioVenture Partners, which led the round.
Back in March, and in conjunction with its raise, the biotech also appointed Vertex and Biogen research veteran Vicki Sato, Ph.D., and Pivotal bioVenture Partners Managing Partner Heather Preston, M.D., to its board.
Now, in the middle of a pandemic, it wants to follow many other biotechs and gun for an IPO worth $100 million to help push its lead program AK-OTOF into the clinic.
The biotech is targeting monogenic forms of sensorineural hearing loss. These forms arise when changes to single genes cause sensory cells or nerve fibers in the inner ear to malfunction.
In its SEC-1 filing, the biotech said that, after speaking with the FDA: “We are designing our phase 1/2 trial to include auditory brainstem response (ABR) as an efficacy endpoint. We believe that this will enable us to quickly determine a clinical response and potentially result in rapid advancement towards a pivotal trial.
“We plan to submit an investigational new drug application for AK-OTOF for OTOF-mediated hearing loss to the FDA in 2021, and we expect to report preliminary clinical data in 2022.”
As it sees it, there is a great hope for gene therapy for hearing loss, but the issue is delivery: “We believe genetic medicine development for hearing disorders has been hindered by the unique anatomical delivery challenges of the inner ear,” it said in its filing.
To get around this, the biotech has combined a proprietary vector library of synthetic adeno-associated viruses (AAVs) that recreates the evolutionary lineage of current naturally occurring viruses, known as ancestral AAV, or AAVAnc, and a new, what it says is a “minimally invasive delivery approach,” that allows it to use AAV-enabled multimodal capabilities, including viral delivery, “to the target cell population where the full-length transgene is split into two vectors, known as a dual vector method.”
It plans to file on the Nasdaq under the ticker "AKUS."
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