The FDA has accepted Eluminex Bioscience Limited’s investigational new drug (IND) application for its novel trispecific antibody, currently in clinical development to treat diabetic macular edema (DME).
Refresh me on this company.
Launched in 2020 and headquartered in Suzhou, Jiangsu, China—with a U.S. office in Mountain View, California—the privately-held biotechnology company is developing advanced engineered protein therapeutics for:
- Dermal facial aesthetics
- Regenerative medicine
- Retinal disease
Eluminex has a business unit that focuses on its aesthetics platform features full length, triple helix recombinant human type III collagen (rhCIII), which is a key dermal protein whose natural production progressively declines as humans age.
And its ophthalmic focus?
Meanwhile, its secondary business unit is an ophthalmics platform which includes a portfolio of next-generation therapeutics, including:
- Trispecific humanized antibodies for retinal diseases
- More on these below!
- Bispecific antibodies
- Thyroid eye disease (TED)
- EB-401 (pre-IN stage)
- Corneal blindness
- EB-301 (phase 3 stage)
- Coming soon: Collagen-based treatments for corneal disease
- Intended as an alternative to cadaveric corneal allografts
Let’s narrow in on these trispecific antibodies.
Administered via intravitreal injection, these proprietary therapies include:
- EB-105 (our topic of interest)
- EB-107*
- For wet age-related macular degeneration [AMD])
- EB-110*
- For inhibition of multiple angiogenic factors to treat retinal vascular diseases in patients who demonstrated sub-optimal or no response to prior anti-vascular endothelial growth factor (VEGF) therapies
*Currently in pre-IND stage of clinical development
Now EB-105.
This therapeutic is a novel trispecific fusion formulated with “functional units for inhibition of multiple clinically-validated factors” that could lead to vascular leakage, angiogenesis, and retinal inflammation.
Its purpose: (ideally) to treat DME by targeting the following:
- VEGF-A (plus isomers)
- Protein-coding gene that promotes angiogenesis
- VEGF-B
- Protein-coding gene responsible for inducing blood vessel growth in most organs
- Placental growth factor (PGF)
- Protein-coding gene predominantly expressed in the placenta
- Angiopoietin-2 (Ang-2)
- Protein-coding gene responsible for promoting cell death and disrupting vascularization
- A key regulator of angiogenesis
- Interleukin-6 receptor (IL-6R)
- Multi-functional cytokine (small protein) with pro- and anti-inflammatory properties which may induce VEGF production and facilitate vascular leakage
Why IL-6?
Prior research has identified elevated levels of IL-6 in the vitreous of DME patients—even in those receiving ongoing anti-VEGF treatments, according to Quan Dong Nguyen, MD, MSc, FARVO, FASRS, professor of Ophthalmology (Retina and Uveitis) at the Byers Eye Institute, as well as professor of Medicine and Pediatrics at Stanford University School of Medicine.
Dr. Nguyen, a strategic alliance partner (SAP) of Eluminex, also noted that IL-6 is often over-expressed and can contribute to inflammation and vascular permeability in other retinal disorders:
- Wet AMD
- Retinal vein occlusion (RVO)
- Uveitic macular edema
Gotcha. So what’s the significance of targeting all of these pathways?
Blocking the pathways simultaneously via just one agent “offers compelling potential for further incremental benefits in patients with retinal diseases,” Dr. Ngyen stated.
Is there any clinical data on EB-105 yet?
Per the company, it has already completed all pre-clinical pharmacology studies as well as chemistry, manufacturing, and controls (CMC) development.
Eluminex noted that ongoing IND-enabling preclinical studies will support “the first-in-human clinical trial in patients in the United States with DME in … 2024.”
And when will we learn of new data?
The company is presenting new data on the investigational candidate at the following conferences over the next month:
EB-105: A Novel Trispecific Antibody for DME
- Presented by Charles P. Semba, MD
- Chief Medical Officer (CMO) of Eluminex
- Where:
- Ophthalmology Innovation Summit (OIS) Meeting, Four Seasons Hotel, Seattle, Washington
- When:
- May 4, 2024; 2:15 – 3:30 pm PST
EB-105: A Novel Trispecific Fusion Antibody for Diabetic Macular Edema
- Poster B0123, Abstract 4027224
- Presented by Weiyong Shen, MD, PhD
- Senior Vice President, Preclinical Development of Eluminex
- Where:
- Association for Research in Vision and Ophthalmology (ARVO) meeting
- Exhibit Hall – Seattle Convention Center, Seattle, Washington
- When: May 9, 2024, 11:45 am to 1:30 pm PST
EB-105: When Three is Not a Crowd – A Novel Trispecific Antibody for Retinal Disease
- Presented by Charles P. Semba, MD
- CMO of Eluminex
- Where:
- Clinical Trials at the Summit Meeting
- Pendry Park City Hotel, Park City, Utah
When: June 8, 2024