Biologic drugs are on the rise, but designing convenient delivery routes for those meds isn't always easy. Boston-based biotech Elektrofi, founded by a team of MIT engineers and scientists, has pursued better biologics dosing options since it first went online in 2016; now, it's snagged a fresh licensing deal with its first-ever partner to turn out convenient dermatology injections.
Under the pact, Danish dermatology specialist LEO Pharma will create subcutaneous antibodies using Elektrofi's patented microparticle suspension drug delivery platform, Elektrofi said recently. Those antibodies will target a specific dermatology indication that's still under wraps, Daniel Dadon, Ph.D., Director of Scientific Strategy at Elektrofi, said.
In exchange for Elektrofi's high-concentration, low-volume delivery tech, LEO will fork over a cash sum, plus payments for predetermined clinical, regulatory and commercial milestones, as well as royalties from sales. The companies are keeping mum on the exact financial terms of the deal.
Work will take place across both Elektrofi and LEO Pharma's sites, the companies said via email. The partners are keeping the exact licensure details close to the vest, but Elektrofi in general can transfer its drug delivery tech to partners' internal facilities or provide it through third-party CDMOs, Dadon said.
While Elektrofi couldn't speak to the timeline for the recently-unveiled pact, the biotech expects to enter the clinic with several partners by 2022, according to Dadon.
Elektrofi has teamed up with more than 10 leading biopharma developers on a range of late-stage or commercial monoclonal antibodies, plasma-derived therapies and other protein-based therapeutics, Dadon added—all part of the company's quest to ease treatment burden on patients and healthcare systems, which have taken a heavy beating amid the ongoing COVID-19 pandemic.
Elektrofi's platform is compatible with all large-molecule therapies, Dadon said, potentially transforming the way medicines are used to treat a wide array of diseases like cancers and autoimmune diseases, among others. The biotech's below-the-skin approach enables self-administration with off-the-shelf items like auto-injectors.
Elektrofi's microparticle tech is used to engineer ultra high-concentration, low-viscosity protein formulations deliverable via speedy, low-volume subcutaneous injections.
Whereas other high-concentration biologics formulations are often too viscous to administer below the skin, Elektrofi's particle suspensions can reach concentrations greater than 400-milligrams-per-milliliter without sacrificing biologic activity or exceeding viscosity limits, thanks to a patented particle manufacturing method that places less thermal stress on the proteins. This results in a microparticle comprising at least 70% protein, Elektrofi says—a potential boon in the increasingly competitive biologics field.
Applying that technology to more biologic drugs—typically administered via hours-long infusions—could reduce treatment time to a matter of seconds and shift administration away from the clinic, a salve for hospitals overburdened by the pandemic, Dadon said.
It could also help drugmakers differentiate their protein-based products from competitors': Elektrofi's platform is the only one of its kind that can turn out pre-filled versions of biologic drugs with equal—if not enhanced—stability, Dadon said. That factor could make adherence to drug regimens easier for patients, thanks to the introduction of an at-home biologics option—and save hospitals and insurance companies money, too, he figures.
Plus, Elektrofi thinks its platform may have a convenience edge over rival drug delivery technologies from companies such as Halozyme. The San Diego outfit has inked a number of high-profile deals on the strength of Enhanze, its drug delivery technology that uses the enzyme hyaluronidase to break down hyaluronan, a natural sugar chain that forms a gel in the innermost layer of the skin. The approach allows for just-under-the-skin injections of drugs such as Johnson & Johnson's multiple myeloma med Darzalex.
But Halozyme's formulations are high-volume, low-concentration—a reversal of the formulation properties Elektrofi's tech corners. Those Enhanze-paired therapeutics also require a trained clinician to administer them, typically resulting in an injection process that takes around 10 minutes.
"You can't put that treatment into a prefilled syringe. It requires preparation on-site and administration by a healthcare professional," Dadon said.
On its own time, LEO Pharma has been ratcheting up its skin health business for the better part of the last half-decade; its latest licensing deal with Elektrofi fits into the Danish drugmaker's broader 2030 strategy to boost R&D efforts and "rapidly diversify" its portfolio of innovative medicines for dermatology, including rare diseases, a company spokesperson said in an email.
In 2018, the company picked up Bayer's prescription dermatology business, which delivered €280 million ($328 million) in 2017 sales. Through the purchase, LEO snared Bayer's topical acne drug Skinoren, plus Travogen and Travocort for fungal skin infections, along with a suite of topical steroids like Advantan, Nerisona and Desonate, and a host of other dermatology meds.
That deal followed LEO's $725 million buyout of Astellas' dermatology business, which closed in 2016.
LEO first set its sights on Elektrofi in 2017; the Danish drugmaker announced a partnership with Elektrofi in October of that year via its U.S. R&D unit, the LEO Science & Tech Hub, which tapped the biotech to explore enhanced delivery methods for dermatology drugs.
That deal marked Elektrofi's first partnership, Dadon said, citing the drug delivery up-and-comer's "longstanding and fruitful" relationship with LEO.
In 2019, LEO expanded its initial Elektrofi deal, leveraging an option for the biotech to co-develop improved delivery formulations of two LEO antibodies, with the goal to enable a lower injection volume for subcutaneous dermatology meds.