Aviceda Therapeutics announced the closing of $207.5 million in Series C financing to support its ongoing phase 2b and phase 3 clinical trials of AVD-104 for geographic atrophy (GA).
Let’s get a refresh on Aviceda.
Based in Cambridge, Massachusetts, the private, clinical-stage biotech company has developed a proprietary High Affinity Ligands Of Siglecs (HALOS) nanotechnology platform and a pipeline of candidates in the following therapeutic areas:
- Ophthalmology
- Fibrosis
- Immunology
- Neurology
- Oncology
Explain this HALOS platform.
The proprietary tech incorporates glycobiology (the study of saccharides' structure, biology, and evolution) to modulate the innate immune system in order to develop immuno-oncology-focused therapeutics.
- Via the use of sialic acid kinetics (SAMS), the immune cell engagement is extended beyond only T-cells, “allowing us to modify the behavior of most classes of innate and adaptive immune cells,” according to the company.
- Key to this process: Siglecs (sialic-acid binding immunoglobulin-like lectins), which are located on the surface of all immune cells.
Now before we get too into the clinical details, talk financing.
With Omega Funds and TCGX, both healthcare funds, serving as lead investors, this latest funding round also included participation from a number of investment firms, including:
- Enavate Sciences
- Blue Owl Healthcare Opportunities
- OrbiMed
- Jeito Capital
- Catalio Capital Management
Aviceda’s Board Chair David Guyer, MD, stated: “With this upside financing, the company is well-capitalized to advance a pivotal program for AVD-104 in GA.”
Anything else to note before we get into the clinical details?
In conjunction with this financing: Aviceda also announced the following additions to its leadership:
- New Board of Directors members:
- Bernard Davitian (Omega Funds)
- Chen Yu, MD, MBA (TCGX)
- Appointment of former Iveric Bio COO Evelyn Harrison, MBA, as an independent contractor
- New Board of Observers members:
- Sara Nayeem, MD (Enavate Sciences)
- Rafaéle Tordjman, MD, PhD (Jeito Capital)
Now to the focus of this funding.
That would be AVD-104, Aviceda’s investigational asset currently under investigation for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
- To note: It’s also in clinical development for diabetic macular edema (DME).
What it is: A glyco-immune therapeutic (GIT) and sialic acid-coated nanoparticle designed using the company's proprietary HALO nanotechnology platform to target a specific area of the innate immune response relating to AMD.
And what’s the goal for it, exactly?
Ideally, AVD-104 is designed to prevent dysregulated activity and activate cellular machinery within retinal tissue back into a reparative state.
How this differs from other AMD therapies: Those typically focus on shutting down humoral components of the innate immune response to target AMD.
Sounds unique … any notable clinical statuses?
Clinical trials aside, the company has submitted an application for Fast Track Designation.
Plus: The FDA has already cleared the candidate’s investigational new drug (IND) application (in April 2023).
And its clinical progress?
Thanks to this IND approval, Aviceda initiated the (still ongoing) phase 2 SIGLEC trial (NCT05839041) in June 2023, in which AVD-104 is evaluated against avacincaptad pegol (IZERVAY).
The study is divided into two parts:
- Part 1 (2a): Multicenter, open-label safety, and dose escalation (experimental)
- Part 2 (2b): Multicenter, double-masked, randomized (active comparator)
- See here for details on both.
Those findings so far?
Positive data released in October 2023 from the phase 2a trial indicated continued safety of AVD-104 with no drug-related or serious adverse events as well as no evidence of any significant dose-limiting toxicity for the first three months of the study.
Following those findings, Aviceda reported new data in January 2024:
- No drug-related ocular or systemic adverse reactions
- A greater reduction in GA lesion progression at 3 months compared to historic standard-of-care outcomes
- Significant gains in best-corrected visual acuity (BCVA) were sustained by the end of the 3-month mark.
See more details on those findings.
Nice! So what can we expect from that study this year?
While the SIGLEC trial (now fully enrolled) isn’t expected to conclude until 2026, Aviceda expects to release 12-month primary endpoint data from the phase 2b portion of the study by the second half (H2) of 2025.
As for that planned pivotal phase 3 trial … stay tuned for updates on a study design and anticipated initiation.