San Diego-based Halozyme Therapeutics, Inc. is achieving increasingly positive results – and industry partnerships — for its proprietary ENHANZE technology, which speeds drug delivery to patients while also reducing the need for intravenous treatments.
Earlier this month (Aug. 2), the company announced that Swiss multinational Roche’s Phase III study evaluating a subcutaneous (SC) formulation of Tecentriq paired with Halozyme’s ENHANZE met its co-primary endpoints.
In 2018, Halozyme and Roche inked a licensing agreement for use of the ENHANZE platform worth a potential $520 million to Halozyme if all clinical trial milestones are reached.
Roche’s latest Phase III study showed non-inferior levels of Tecentriq in the blood when injected subcutaneously using ENHANZE, compared with intravenous (IV) infusion in cancer immunotherapy-naïve patients with locally advanced or metastatic non-small cell lung cancer for whom prior platinum therapy had failed.
Study results also demonstrated that the SC formulation was equally as safe as the IV-administered treatment.
Significantly Reducing Treatment Time
“These positive results further demonstrate the opportunity for a coformulation of ENHANZE to potentially benefit patients by reducing the treatment time of Tecentriq to 3-8 minutes as a SC delivery from 30-60 minutes for IV treatment,” said Dr. Helen Torley, president and CEO of Halozyme.
“We are delighted to announce these positive results, which represent our second positive Phase III trial announcement this year for our Wave Three products,” Dr. Torley added.
Officials at Roche also hailed the most recent test results achieved by using the ENHANZE platform to deliver their cancer drug.
“By reducing the administration time, this new Tecentriq formulation could help save time for patients and healthcare systems,” said Dr. Levi Garraway, chief medical officer and head of product development at Roche. “We are excited by the potential of bringing a subcutaneous cancer immunotherapy to patients globally, delivering on our commitment to improve the treatment experience of patients.”
Roche plans to share detailed findings of the Phase III study at an upcoming medical meeting and submit the data for regulatory approval to health authorities globally, including the U.S. Food and Drug Administration and the European Medicines Agency.
Halozyme’s ENHANZE drug delivery technology is based on its patented recombinant human hyaluronidase enzyme (rHuPH20), which has been shown to remove traditional limitations on the volume of biologics that can be delivered subcutaneously – or just under the skin.
By using rHuPH20, some biologics and compounds that are currently administered intravenously may instead be delivered subcutaneously.
Reducing Need for Multiple Injections
ENHANZE may also benefit subcutaneous biologics by reducing the need for multiple injections.
Having touched more than 600,000 patient lives in post-marketing use in five commercialized products across more than 100 global markets, Halozyme has licensed its ENHANZE technology to leading pharmaceutical and biotechnology companies including Roche, Baxalta, Pfizer, AbbVie, Eli Lilly, Bristol-Myers Squibb, Alexion, argenx, Horizon Therapeutics, ViiV Healthcare and Chugai Pharmaceutical.
Halozyme also develops, manufactures and commercializes, for itself or with partners, drug-device combination products using its advanced auto-injector technology that are designed to provide commercial or functional advantages such as improved convenience and tolerability, and enhanced patient comfort and adherence.
The company has a commercial portfolio of proprietary products including XYOSTED, TLANDO and NOCDURNA and partnered commercial products and ongoing product development programs with industry leading pharmaceutical companies including Teva Pharmaceutical, Covis Pharma, Pfizer and Idorsia Pharmaceuticals.
Halozyme posted $117.3 million in revenue for Q1 2022, representing a 32% YOY increase from Q1 2021. The company is forecasting $530 million to $560 million in revenue for 2022, which would represent 20-26% jump from 2021 revenue.
Headquartered in Sorrento Valley, Halozyme was founded in 1998 and went public in 2004. The company also has offices in Ewing, New Jersey, and Minnetonka, Minnesota, which is the site of its operations facility.
CEO: Dr. Helen Torley
HEADQUARTERS: San Diego
REVENUE: $117.3 million (Q1 2022)
STOCK: HALO (NASDAQ)
NOTABLE: Earlier this year (May 24), Halozyme completed its $960 million acquisition of New Jersey-based Antares Pharma.