Ollin Biosciences, Inc. has officially launched as a new clinical-stage biopharmaceutical company targeting vision-threatening ophthalmic diseases.
First, a look at this company.
While Ollin was originally established in 2023, the Austin, Texas-based biotech company is making its renewed debut with $100 million in initial financing from several investors.
Its executive leadership comprises clinicians and scientists led by co-founder and CEO Jason Ehrlich, MD, PhD—former chief medical officer and chief development officer at Kodiak Sciences.
- Check out who’s on the company’s Board of Directors and Scientific Advisory Board.
And what’s the big-picture focus?
The company is advancing a pipeline of preclinical and late-stage novel therapeutics—rooted in “validated biologics”—aimed at addressing serious ocular diseases such as:
- Wet age-related macular degeneration (AMD)
- Diabetic macular edema (DME)
- Thyroid eye disease (TED)
Specifically: Dr. Ehrlich noted that Ollin’s first bispecific programs offer an opportunity to improve patient care with therapeutics that “target more than one pathway, given the multi-factorial nature of many eye diseases.”
Let’s get into these clinical programs.
We’ll start with the company’s lead clinical-stage program: OLN324, under clinical development in collaboration with Innovent Biologics.
What it is: A vascular endothelial growth factor (VEGF) / Ang2 bispecific antibody with a higher potency and molar dose as well as a smaller protein format.
- Its proposed indications: Wet AMD and DME.
“Both VEGF and Ang2 play important roles in the vascular pathologies that drive wet AMD and DME,” stated Charles C. Wykoff, MD, PhD, a member of Ollin’s Scientific Advisory Board.
So why is this higher potency significant?
Because OLN324’s anti-Ang2 potency is noted as being “substantially higher” than faricimab, the current market-leading treatment for these retinal diseases.
- Take note: Genentech’s Vabysmo (faricimab-svoa) was FDA-approved in 2022 as the first VEGF/Ang2 inhibitor for wet AMD and DME.
Importantly: This higher potency could enable OLN324 to achieve greater target coverage as well as the potential for extended treatment durability.
- “Dual targeting has the potential to improve anatomic outcomes and achieve more durable disease control compared to VEGF inhibition alone,” according to Dr. Wkyoff.
And what clinical investigation has it undergone so far?
The candidate was previously evaluated in a China-based single- and multiple-dose escalation phase 1 study involving DME patients.
- According to Ollin: OLN324 demonstrated “promising vision and anatomic improvements” as well as a favorable safety profile.
Currently: The phase 1b JADE study, a U.S.-based proof-of-concept clinical trial, is evaluating OLN324 versus faricimab in 150 wet AMD and DME patients.
- Its purpose: To determine potential areas of anatomic and durability differentiation (no other details are available at the moment).
When should we expect results from that study?
Topline data should be ready by early 2026.
Now, what other clinical programs should we know about?
Ollin’s second therapeutic: OLN102, a first-in-class Thyroid-Stimulating Hormone Receptor (TSHR) and the Insulin-like Growth Factor 1 Receptor (IGF-1R) bispecific antibody.
- Its proposed indication: TED
- And potential: May also extend to addressing Graves’ Disease in TED patients
Explain the focus on TSHR and IGF-IR.
- TSHR essentially stimulates the thyroid gland to produce thyroid hormones; however, when mutations develop in this gene, it can lead to various thyroid diseases (and reduced hormone production).
- IGF-IR, on the other hand, is crucial for normal cell growth, development, and survival. Unfortunately, it is also overexpressed in TED.
The interaction between these receptors is thought to be one of the underlying causes of TED, due to their “receptor cross-talk” and resulting creation of a complex signaling pathway.
- As such: Blocking their signaling could potentially lead to reduced disease activity, resulting in an effective treatment for TED.
And how does OLN02 do this?
The therapeutic inhibits IGF-1R and TSHR in order to, ideally, improve safety and efficacy in TED patients’ treatments more so than existing therapeutics.
- How: Through “precise tissue targeting and a wider therapeutic index.”
- For a deeper dive into tissue-targeting strategies, see here.
Has it undergone any clinical investigations?
Not so far; at least, there’s no data to report as of yet.
Olline noted that the therapeutic is still in the preclinical stage—investigational new drug (IND)-enabling—of development.
The plan: For OLN102 to enter clinical development next year.