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Biotechnology News Magazine

Positive Results Announced from Phase III IMscin001 Study Evaluating Subcutaneous Formulation of Tecentriq® with ENHANZE® in Advanced Non-Small Cell Lung Cancer

Subcutaneous formulation with ENHANZE® reduced treatment time to 3-8 minutes compared to 30-60 minutes for standard intravenous infusion

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Halozyme Therapeutics, Inc. (NASDAQ: HALO) (“Halozyme”) today announced that Roche’s Phase III IMscin001 study evaluating a subcutaneous (SC) formulation of Tecentriq® (atezolizumab) with Halozyme’s ENHANZE® technology met its co-primary endpoints.

The IMscin001 study showed non-inferior levels of Tecentriq® in the blood (pharmacokinetics), when injected subcutaneously, compared with intravenous (IV) infusion in cancer immunotherapy-naïve patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) for whom prior platinum therapy has failed. The safety profile of the SC formulation was consistent with IV Tecentriq®.

“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,” commented Dr. Helen Torley, president and chief executive officer 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.”

Roche will share detailed findings of the IMscin001 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.

About ENHANZE® Technology: Halozyme’s proprietary ENHANZE® drug delivery technology is based on its patented recombinant human hyaluronidase enzyme (rHuPH20). rHuPH20 has been shown to remove traditional limitations on the volume of biologics that can be delivered subcutaneously (just under the skin). By using rHuPH20, some biologics and compounds that are administered intravenously may instead be delivered subcutaneously. ENHANZE® may also benefit subcutaneous biologics by reducing the need for multiple injections.

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