Boehringer Inglheim and Re-Vana Therapeutics have launched a new strategic collaboration and license agreement targeting the development of extended-release therapies for ophthalmic diseases.
First, let’s get familiar with these companies.
We’ll start with Boehringer. With U.S. headquarters in Ridgefield, Connecticut, the private German biopharmaceutical company is a research-based group of companies developing therapies and vaccines in three business units:
- Human pharma
- Animal health
- Biopharmaceutical contract manufacturing
And in the ophthalmic space?
The company has expanded its global research and development activities to address retinal disease—ultimately seeking to stop preventable vision loss via partnerships with external partners.
- Among its areas of focus:
- Neovascular age-related macular degeneration (nAMD) and geographic atrophy (GA)
- Diabetes-related eye diseases (diabetic retinopathy [DR]; diabetic macular edema [DME]; diabetic macular ischemia [DMI])
- Inherited eye disease (Stargardt disease)
- Glaucoma
- Myopic macular degeneration
Specifically: Boehringer shared it is pursuing both oral and intravitreal (IVT) treatments, while taking a more holistic approach to targeting key mechanisms in the pathogenesis of retinal diseases.
Which brings us to … Re-Vana?
Indeed.
Re-Vana was launched in 2016 as a spin-off of Queen’s University Belfast in Belfast, Ireland.
- The venture-backed, ocular therapeutics and drug delivery company is a wholly-owned subsidiary of Tampa, Florida-based Re-Vana Holding, Inc.
Its scientific approach: Involves the development of two proprietary platform technologies based on a novel photo-crosslinked technology to address sustained drug delivery.
- Quick note: Photo-crosslinking is a chemical crosslinking process, triggered by ultraviolet (UV) light and a photoinitiator, that allows hydrogel to form at a physiological pH and room temperature
- In other words: This technique uses light to create stable connections between molecules
Got it. So tell me about the two technologies.
- EyeLief/EyeLief-SD
- A biodegradable, pre-formed implant administered via a narrow-gauge needle that releases an estimated 1 microgram (mcg) of biologic on a daily basis over a 6-month period.
- Is suitable for biologics, peptides, and large / small molecules
- OcuLief
- Designed for higher biologic doses, this is a biodegradable, in situ-forming implant that facilitates the liquid state delivery (via a fine-gauge needle) of a biologic
- This delivery transforms the liquid biologic into a solid form (via photo-crosslinking with visible light) to enable prolonged drug release for up to 12 months
- Is also suitable for biologics, peptides, and large / small molecules requiring higher release rates of ≥2 µg/day
Take note: Each implant can reportedly carry up to 50% of their weight in active pharmaceutical ingredients (APIs).
Go on …
The photo-crosslinked implants are designed to enable manufacturing of products at room temperature and with no (virtual) change in internal pH.
- Via this photo-crosslinking: The implants restrict water movement to maintain the drug’s stability within the implant matrix and control swelling.
Check out the process for each.
Re-Vana Technology Animation Demonstrates Sustained Release Biologics
So what’s the intended result?
“Enhanced protein stability for extended drug delivery” that reduces the need for frequent IVT injections, as is common in retinal disease treatments like AMD and DR.
How: This is due in part to three key components that allow a drug’s delivery rate and duration to be customized:
- Degree of photo-crosslinking (crosslink density)
- Percentage of drugs loaded into the implant
- Implant dimension (6mm in length, 0.38 mm in diameter)
And in the long-term?
Both implants are designed to fully biodegrade within a year of implantation, allowing for repeated dosing.
Alrighty, so how does this relate back to the Boehringer partnership?
The plan, according to the companies, is for Boehringer to utilize Re-Vana’s biodegradable implants with its pre-existing pipeline of four investigational candidates currently in phase 1 and 2 development.
- See here for details on each. (Hint: Two of the four target DR and GA.)
Note: No specific details were released as of yet on which biodegradable implant will be used for each asset.
And the intent moving forward?
A few stipulations of this collaboration:
- Both companies will jointly oversee Re-Vana’s feasibility and development activities for the extended-release programs
- Boeheringer will:
- Add up to three projects (per year) across therapeutic modalities (in the retinal disease space)
- Assume sole responsibility for the products’ clinical development, regulatory approval, and global commercialization
- Receive target exclusivity
- Provide for upfront, development, regulatory, and commercial milestone payments to Re-Vana
Lastly, while we’re on the subject of monetary value …
This deal is estimated to potentially value over $1 billion for Boehringer’s initial three phase-2 assets—plus royalty payments on net sales.