Halozyme Announces First Clinical Dosing In Bristol-Myers Squibb's Phase 1 Trial Of BMS-986179 With Enhanze® Technology
SAN DIEGO, Oct. 25, 2018
SAN DIEGO, Oct. 25, 2018 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that Bristol-Myers Squibb (NYSE: BMY) has dosed the first subject in a clinical trial evaluating the safety, pharmacokinetics and pharmacodynamics of BMS-986179, an investigational anti-CD-73 antibody, using Halozyme's proprietary ENHANZE® drug delivery technology.
"Since the signing of our collaboration with Bristol-Myers Squibb in September 2017, we have formed multiple joint program teams and have made rapid progress to begin assessment of ENHANZE with Bristol-Myers Squibb's extensive immuno-oncology portfolio," said Dr. Helen Torley, president and chief executive officer of Halozyme. "In addition to their initial selection of the PD-1 targeted asset, Bristol-Myers Squibb has chosen to evaluate BMS-986179 in combination with ENHANZE in certain cancers. We look forward to continuing our pursuit of improving the patient treatment experience."
Initiation of the study triggered a $5 million milestone payment to Halozyme under the Collaboration and License Agreement between the companies.
Halozyme's ENHANZE technology is based on a proprietary recombinant human enzyme (rHuPH20) that temporarily degrades hyaluronan, a glycosaminoglycan or chain of natural sugars in the body, to aid in the dispersion and absorption of other injected therapeutic drugs.
Halozyme Collaboration with Bristol-Myers Squibb
In September 2017, Halozyme and Bristol-Myers Squibb entered into an ENHANZE collaboration and license agreement. Under the terms of the agreement, Halozyme has granted to Bristol-Myers Squibb a worldwide license to develop and commercialize products for up to eleven targets, combining rHuPH20 with Bristol-Myers Squibb's immuno-oncology assets. Halozyme received an initial payment of $105 million, and is eligible to receive additional payments upon Bristol-Myers Squibb's achievement of specified development, regulatory and sales-based milestones, totaling up to $160 million per target. Halozyme is also entitled to tiered royalty payments based on net sales of products using the 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. This delivery has been shown in studies to reduce health care practitioner time required for administration and shorten time for drug administration.
Bristol-Myers Squibb & Immuno-Oncology: Advancing Oncology Research
At Bristol-Myers Squibb, patients are at the center of everything we do. Our vision for the future of cancer care is focused on researching and developing transformational medicines, including Immuno-Oncology (I-O) therapeutic approaches, for hard-to-treat cancers that could potentially improve outcomes for these patients.
We are leading the integrated scientific understanding of both tumor cell and immune system pathways, through our extensive portfolio of investigational compounds and approved agents. Our differentiated clinical development program is studying broad patient populations across more than 50 types of cancers with 24 clinical-stage molecules designed to target different immune system pathways. Our deep expertise and innovative clinical trial designs position us to advance the I-O/I-O, I-O/chemotherapy, I-O/targeted therapies and I-O radiation therapies across multiple tumors and potentially deliver the next wave of therapies with a sense of urgency. We also continue to pioneer research that will help facilitate a deeper understanding of the role of immune biomarkers and how a patient's tumor biology can be used as a guide for treatment decisions throughout their journey.
We understand making the promise of transformational medicines like I-O therapies a reality for the many patients who may benefit from these therapies requires not only innovation on our part but also close collaboration with leading experts in the field. Our partnerships with academia, government, advocacy and biotech companies support our collective goal of providing new treatment options to advance the standards of clinical practice.
Halozyme Therapeutics is a biotechnology company focused on developing and commercializing novel oncology therapies that target the tumor microenvironment. Halozyme's lead proprietary program, investigational drug pegvorhyaluronidase alfa (PEGPH20), applies a unique approach to targeting solid tumors, allowing increased access of co-administered cancer drug therapies to the tumor in animal models. PEGPH20 is currently in development for the treatment of several cancers and has the potential to be used in combination with different types of cancer therapies. In addition to its proprietary product portfolio, Halozyme has established value-driving partnerships with leading pharmaceutical companies including Roche, Baxalta, Pfizer, Janssen, AbbVie, Lilly, Bristol-Myers Squibb and Alexion for its ENHANZE® drug delivery technology. Halozyme is headquartered in San Diego. For more information visit www.halozyme.com.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol-Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube and Facebook.
Halozyme Safe Harbor Statement
In addition to historical information, the statements set forth above include forward-looking statements including, without limitation, 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, the number of collaborative targets actually chosen, whether such products are ultimately developed or commercialized, whether milestones triggering milestone payments will be achieved, and statements concerning facilitating more rapid delivery of injectable medications through subcutaneous delivery that involve risk 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 unexpected expenditures and costs, unexpected results or delays in development and regulatory review, regulatory approval requirements, unexpected adverse events and competitive conditions. These and other factors that may result in differences are discussed in greater detail in the Company's most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission.
Robert H. Uhl
Westwicke Partners, LLC
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SOURCE Halozyme Therapeutics, Inc.