The National Institutes of Health’s (NIH) National Eye Institute (NEI) has awarded RevOpsis Therapeutics a $1.8 million Small Business Innovation Research (SBIR) grant to fund its ongoing clinical development of an investigational candidate for two retinal diseases:
- Neovascular age-related macular degeneration (wet AMD)
- Diabetic eye disease
First: Explain this SBIR grant.
This grant is part of the NEI’s SBIR and Small Business Technology Transfer (STTR) programs.
Their purpose: To encourage U.S.-based small businesses to engage in federal research or research and development with the potential for commercialization via collaboration with a research institution.
That being said: This SBIR grant is intended to provide funding for a small business to continue research and development of a specific technology.
- To note: A company may only submit one application for this grant; if rejected, the company is unable to resubmit.
Interesting … now give me a rundown on RevOpsis.
The privately-held, next-generation biopharmaceutical company is developing multispecific antibody biologics to target multiple dominant biologic pathways in complex multifactorial ophthalmic diseases.
In addition to wet AMD and diabetic eye disease, these diseases include:
- Dry AMD
- Diabetic macular edema (DME)
- Retinal vein occlusion (RVO)
- Uveitic macular edema
- Thyroid eye disease (TED)
And how is the company targeting these diseases?
Via its fully human, multispecific, proprietary Rev-Mod Platform.
What this platform does: Utilizes a modular “plug-and-play” method to streamline and expedite the “efficient discovery and development of multispecific biologics targeting a wide spectrum of chronic, prevalent, large diseases,” according to RevOpsis.
- Plus: It features a library of nearly 30 billion fully human antibody components in a structured phage display system
And what purpose does this platform serve?
The Rev-Mod is intended to rapidly identify and assemble a process of multispecific products that effectively creates multispecific biologics.
These biologics are designed to address unmet needs in the following major therapeutic areas:
- Ophthalmology (our focus)
- Oncology
- Immune-mediated diseases
So what does this have to do with this grant?
The platform is leveraged in RevOpsis’s investigational candidate: RO-104—the focal point of this SBIR grant—which we’ll get to in a moment.
Specifically: The grant will provide the company with “nondilutive financing to accelerate” the clinical development of RO-104 via preclinical studies as well as “pave the way for future clinical trials,” according to RevOpsis CEO Ram Bhandari.
- Even further: It’s also significant in that the grant “validates our RevMod platform,” Bhandari stated.
Alrighty, now let’s talk RO-104.
RO-104 is a first-in-class, fully human modular tri-specific biologic intended to address three dominant angiogenic pathways behind retinal vascular disease (RVD) progression:
Its purpose: To target, neutralize, and bind to all three angiogenic pathways with a “high, matched affinity” in order to not only improve outcomes for wet AMD patients but also extend disease remission.
And how does this compare to other anti-VEGF therapies?
Most notably, the difference between those with RO-104 is their target.
Standard therapies typically only target one pathway (VEGF-A) and require repeat monthly injections for treating wet AMD.
With RO-104: All three angiogenic pathways are targeted.
- See here for a more in-depth explanation of why targeting one pathway isn’t as effective in the long run.
Is there any clinical data on this candidate yet?
Not in humans … however, the company reported that RO-104 has demonstrated efficacy and safety via preclinical research from animal models.
Gotcha. So what’s the plan moving forward?
Similar to what the company reported earlier this year (when it raised $16.5M in a first seed funding round), its acceleration of preclinical studies on RO-104 is anticipated to enable an investigational new drug (IND) application “in preparation for its advancement into first in human clinical trials in late 2025.”