Halozyme Announces Poster Presentation Of Data From Roche's Phase 1b Study Evaluating Atezolizumab For Subcutaneous Administration Utilizing Enhanze® In Non-Small Cell Lung Cancer

Rhea-AI Summary

Halozyme Therapeutics (NASDAQ: HALO) announced that Roche presented data from the Phase 1b study evaluating atezolizumab (Tecentriq) for subcutaneous use through Halozyme's ENHANZE technology at the ESMO Virtual Congress 2020. The study, involving 67 patients with advanced non-small cell lung cancer, showed that the subcutaneous formulation was well-tolerated and had similar exposure to the intravenous version. This supports further development in the Phase 3 study, potentially improving treatment efficiency by reducing administration time.

Positive

• Subcutaneous atezolizumab demonstrated similar exposure to the IV formulation, indicating potential effectiveness.
• Results support progression to Phase 3 study, enhancing development prospects for HALO's ENHANZE technology.
• Well-tolerated treatment in a cohort of 67 advanced NSCLC patients encourages further exploration.

Negative

• None.

SAN DIEGO, Sept. 17, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that its collaborator, Roche, presented a poster with data from Part 1 of its Phase 1b study (IMscin001) evaluating atezolizumab (Tecentriq^®) for subcutaneous administration utilizing Halozyme's ENHANZE^® technology in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) at the ESMO Virtual Congress 2020.

The Phase 1b dose-finding study enrolled 67 patients with advanced/metastatic NSCLC previously treated with chemotherapy (no prior cancer immunotherapy) in 3 cohorts.  The poster concluded that atezolizumab utilizing ENHANZE^® was well tolerated, provided similar exposure as atezolizumab IV and that results support further development of subcutaneous atezolizumab in IMscin001 Part 2, a confirmatory phase III study.

"We are pleased that the results from Roche's Phase 1b evaluating atezolizumab with ENHANZE^® support continued development in a Phase 3 study," said Dr. Helen Torley, president and chief executive officer.

The subcutaneous formulation of atezolizumab is being developed to potentially allow faster administration via subcutaneous injection under the skin, compared to the original intravenous (IV) formulation, thereby significantly reducing a patient's time spent receiving treatment.

About Halozyme
Halozyme is a biopharmaceutical company bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. Halozyme advises and supports its biopharmaceutical partners in key aspects of new drug development with the goal of improving patients' lives while helping its partners achieve global commercial success. As the innovators of the ENHANZE^® technology, which can reduce hours-long treatments to a matter of minutes, Halozyme's commercially-validated solution has positively impacted more than 400,000 patient lives via five commercialized products across more than 100 global markets. Halozyme and its world-class partners are currently advancing multiple therapeutic programs intended to deliver innovative therapies, with the potential to improve the lives of patients around the globe. Halozyme's proprietary enzyme rHuPH20 forms the basis of the ENHANZE^® technology and is used to facilitate the delivery of injected drugs and fluids, potentially reducing the treatment burden of other drugs to patients. Halozyme has licensed its ENHANZE^® technology to leading pharmaceutical and biotechnology companies including Roche, Baxalta, Pfizer, Janssen, AbbVie, Lilly, Bristol-Myers Squibb, Alexion and argenx. Halozyme derives revenues from these collaborations in the form of milestones and royalties as the Company's partners make progress developing and commercializing their products being developed with ENHANZE^®. Halozyme is headquartered in San Diego. For more information visit www.halozyme.com.

Safe Harbor Statement

In addition to historical information, the statements set forth above include forward-looking statements including, without limitation, the product development and approval efforts of Halozyme's ENHANZE^® partners, including the potential continued evaluation of atezolizumab with ENHANZE^® in a Phase 3 clinical study, and statements concerning the possible activity, benefits and attributes of ENHANZE^®, the possible method of action of ENHANZE^®, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs, and statements concerning certain other potential benefits of ENHANZE^® including facilitating more rapid delivery of injectable medications through subcutaneous delivery and lowering the treatment burden for patients. These forward-looking statements also include statements. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are typically, but not always, identified through use of the words "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue," and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including uncertainties concerning whether the collaborative product referred to in this press release is ultimately developed, approved or commercialized, unexpected expenditures and costs, unexpected results or delays in development and regulatory review including any potential delays caused by the current COVID-19 global pandemic, unexpected regulatory approval requirements, unexpected adverse events or patient outcomes and competitive conditions. These and other factors that may result in differences are discussed in greater detail in Halozyme's most recent Annual and Quarterly Reports filed with the Securities and Exchange Commission. Except as required by law, Halozyme undertakes no duty to update forward-looking statements to reflect events after the date of this release.

Tecentriq^® (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.

Contact:
Al Kildani
Vice President, Investor Relations and Corporate Communications
858-704-8122
ir@halozyme.com

View original content to download multimedia:http://www.prnewswire.com/news-releases/halozyme-announces-poster-presentation-of-data-from-roches-phase-1b-study-evaluating-atezolizumab-for-subcutaneous-administration-utilizing-enhanze-in-non-small-cell-lung-cancer-301132876.html

SOURCE Halozyme Therapeutics, Inc.

FAQ

What were the results of the Phase 1b study for atezolizumab presented by Roche?

The Phase 1b study showed that subcutaneous atezolizumab was well-tolerated and had similar exposure as the IV formulation, supporting further development.

What is the significance of the Phase 3 study for Halozyme and atezolizumab?

The Phase 3 study will evaluate the efficacy of subcutaneous atezolizumab, potentially improving treatment times for patients with advanced NSCLC.

How does the ENHANZE technology impact treatment administration time?

ENHANZE technology allows for faster subcutaneous administration, significantly reducing the time patients spend receiving treatment compared to traditional IV methods.

What type of patients were involved in the Phase 1b study of atezolizumab?

The study enrolled 67 patients with advanced or metastatic non-small cell lung cancer who had previously received chemotherapy but no prior cancer immunotherapy.

What company is collaborating with Halozyme on the atezolizumab study?

Roche is collaborating with Halozyme on the development of atezolizumab utilizing Halozyme's ENHANZE technology.