On August 2, 2022 Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") reported 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 (Press release, Halozyme, AUG 2, 2022, View Source [SID1234617288]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The 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.