High-Speed Biologic Injection Device Shown Feasible

(Steve Sewell, Pixabay. https://pixabay.com/photos/superbike-motorsport-fast-speed-930715/)

16 Oct. 2023. A developer of an auto-injection technology says its device can deliver a biologic drug under the skin in a fraction of the time of conventional syringes. Presenters from Halozyme Therapeutics Inc. in San Diego are scheduled to deliver findings from a clinical trial tomorrow (17 Oct. 2023) at the Partnership Opportunities in Drug Delivery or PODD conference in Boston.

Halozyme Therapeutics is a developer of alternative drug delivery technologies including subcutaneous devices for delivering drugs under the skin’s outer layers. The company’s main technology, called Enhanze, uses a synthetic enzyme that degrades hyaluronic acid, also known as hyaluronan, found in abundance in the extracellular matrix in skin and other soft connective tissues. Under the skin, says Halozyme, hyaluronan binds with water and forms a gel-like substance. And because of its relatively high volume, this gel acts as a barrier that physically slows the flow of liquids, including biologics and small molecule drug compounds.

The Enhanze enzyme, says the company, is similar to natural hyaluronidases or hyaluronan-degrading enzymes, but is designed to encourage dispersion and absorption of drugs under the skin. A related synthetic enzyme is designed for cancer treatments to break down hyaluronan accumulations in the tumor microenvironment. Once under the skin, the enzyme increases the flow of biologics through tissue under the skin, allowing for rapid dispersal and absorption into the blood stream. And Halozyme says its synthetic enzyme works only in immediate areas where injected with only temporary effects.

Pre-filled high-volume autoinjector

The company licenses it Enhanze technology to pharmaceutical companies for their products. In Sept. 2017, Science & Enterprise reported on Halozyme Therapeutics licensing its Enhanze platform to drug makers Roche and Bristol-Myers Squibb in deals totaling more than $2 billion.

The clinical trial enrolled 23 healthy volunteers to test delivery of a sample biologic drug, in this case an immunoglobulin that makes up antibodies in a 10 percent concentration. The active immunoglobulin was delivered with the Enhanze synthetic enzyme using a pre-filled high-volume autoinjector or HVAI device something like injector pens for administering epinephrine to people experiencing severe allergic reactions. The device in this trial delivered 10 milliliters of immunoglobulin in a single dose.

Halozyme says the HVAI devices delivered the 10 milliliters of immunoglobulin in 30 seconds. Mike LaBarre, chief technical officer of Halozyme, says in a company statement this speed and volume far exceeds conventional subcutaneous injection methods. “Traditional subcutaneous auto-injector delivery methods,” says LaBarre, “are typically limited to volumes less than 2 milliliters or require long delivery times at slow rates for higher volumes.” LaBarre is the lead presenter of Halozyme’s conference paper tomorrow.

In addition, says the company, most skin reactions such as swelling or redness, were mild and resolved within 90 minutes. Nearly all participants (90%) reported no or mild pain after the injections, and all but one of the participants said they would be willing to accept another injection. “Our Enhanze drug delivery and HVAI technologies,” adds Halozyme CEO Helen Torley, “have the potential to rapidly deliver large volume therapeutics subcutaneously with the potential for meaningful clinical benefits.”

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