Moving the Needle on Medication Delivery

Everyone has dreamt of a pain-free alternative to needles, while anticipating your annual flu shot or grimacing through self-injections. Luckily, this future may be close at hand, due to the work of a Boston-based startup founded by Tufts alumni.

Anodyne Nanotech draws on Tufts research to create patches of miniscule microneedles that are applied to the skin, offering a new form of drug delivery for both existing and novel therapeutics. The company’s HeroPatch transdermal patches, which are cast in molds through proprietary manufacturing, could be used to deliver a wide variety of medications using a highly adjustable, stable mechanism.

Konstantinos Tzortzakis and Jake Lombardo, both EG19 and Anodyne Nanotech co-founders, learned about the technology during a presentation from its developer, professor of electrical and computer engineering Sameer Sonkusale, during their master’s of science in innovation and management (MSIM) program at the Gordon Institute at Tufts. Sonkusale is a professor of electrical and computer engineering at Tufts University School of Engineering.

As undergraduates, both Tzortzakis and Lombardo had strong engineering backgrounds but wanted to understand what it takes to move a technology beyond the lab. “Engineering taught me how to solve hard technical programs and build cool things, but I was curious about the full picture,” Tzortzakis said. 

“I went to a couple of entrepreneurship competitions and quickly realized that, although I didn’t ‘speak the same language,’ science and engineering is only one part of the equation,” he said. “Building a business around it is equally important.”

Lombardo had a similar realization after meeting a researcher who had a number of patents for novel technologies, none of which was being used in the real world.

“He was solving problems that maybe made one of the physician’s—or the patient’s—life easier, but you still have to consider insurance, reimbursement, manufacturing, the unit economics, and whether there is a market opportunity for it, all at once,” Lombardo said.

This curiosity led both to enroll in the MSIM program, where they met both Sonkusale and Hojat Rezaei Nejad, Anodyne’s third co-founder who was at the time a postdoctoral researcher working with Sonkusale on the microneedle technology. Lombardo and Tzortzakis quickly grasped the potential of a technology that could deliver many types of medications using an inexpensive, highly adaptable technology. Pain-free delivery was a bonus that Tzortzakis, in particular, appreciated: “I’m also super needle-phobic, and I cannot swallow pills,” he added with a laugh.

The microneedles are filled with a drug’s solid form, and are thus stable at room temperature, eliminating the need for expensive refrigerated storage and distribution systems. This also improves access for consumers who lack reliable refrigeration.

The particulars of creating Anodyne’s transdermal HeroPatch can be modified to suit the needs of a specific drug, rather than having to adapt a drug to the delivery system. Whereas reformulating a drug for a given delivery system is a long and complicated process, adjusting the casting method is more efficient and affords a number of options for fine-tuning how quickly a medication is absorbed through the patch.

This advantage makes it much easier to produce combination therapies. Normally, combining medications requires them to be reformulated to coexist at a similar temperature and pH. This is complex in the best case and impossible in the worst—and also requires additional testing to ensure the reformulated drug affects the body in the same way. By adjusting the delivery system directly, though, the HeroPatch bypasses the need for reformulation.

From Pain Relief to Peptides

The team’s early development focused on using microneedles to deliver pain medication, a test case partially motivated by Lombardo’s experience as a college football player. “During my last year, I took a lot of ibuprofen and pain medication to get through the season, and I realized that’s not very healthy,” he said.

As one of the winners in 2019 of the Tufts New Ventures Competition (previously the Tufts $100K New Ventures Competition) sponsored by the Derby Entrepreneurship Center, the team had the opportunity to hone their pitch and improve their technology with feedback from expert judges from biotech and entrepreneurship. That same year, they received the Ricci Interdisciplinary Prize for their intradermal pain medication delivery system, and the experience laid the groundwork for spinning out Sonkusale’s technology into Anodyne Nanotech. 

In Sonkusale’s words, the competition “gave them the momentum, and the rest is history.”

While preparing for the competition, Anodyne realized the HeroPatch could be even more impactful as a mechanism for administering large molecules. Due to their size and complexity, large molecules generally must be administered as injections or intravenous infusions. Pivoting from pain medication, Anodyne began adapting the HeroPatch to deliver monoclonal antibodies, which stimulate an immune response and are used to treat autoimmune conditions, cancers, and infectious diseases, among others.

In addition to being non-invasive, the HeroPatch can administer medications in smaller, more frequent doses than an injection or infusion because it can stay on the skin and continue delivering medication for longer. This produces sustained levels of a drug in the body, whereas an injection or infusion produces peaks of a drug immediately after delivery, and very low levels between doses.

“Showing that we could deliver monoclonal antibodies with a patch is what allowed us to get subsequent funding and realize that there’s a huge opportunity here to change the way that medicine is delivered in general,” Lombardo said. Anodyne’s initial research into monoclonal antibodies was funded by angel investors and subsequently a grant from Massachusetts Life Sciences Center—and developed on equipment housed at Tufts.

Anodyne Nanotech is currently focused on delivering medications targeting glucagon-like peptide-1, the hormone that regulates blood sugar and appetite and has become a household name in recent years: about one in eight Americans are currently taking such medications. Although GLP-1 agonists can be administered at home already, the need remains to reduce drug costs and the patient burden of self-injections.

Anodyne recently completed a Series A funding round that will support clinical Phase 1 trials of GLP-1 agonists using the HeroPatch and help to scale up their manufacturing capabilities.

In addition to working with existing therapies, Tzortzakis and Lombardo envision pharmaceutical companies bringing the HeroPatch earlier into the development of novel medications. The ability to adjust drug absorption without reformulating the drug itself could enable viability for some medications that would otherwise not have been possible with another delivery method.

For example, the peptide apelin has been well-studied for its ability to promote muscle mass. However, its very short half-life means it would need to be given as a daily infusion or injection to have real benefits, which is justifiably a deal-breaker for many. Using its solid form, however, a daily patch takes the place of burdensome daily injections—a therapy Anodyne is currently working on for the treatment of sarcopenia, or age-related muscle loss, and which can be combined with its GLP-1 programs to promote healthier body composition.

Reflecting on the path from transdermal patches for pain medication to the HeroPatch’s ever-growing pipeline of biologics, Sonkusale sees opportunities far and wide: “The sky is the limit for this platform.”