Halozyme Expands Oncology Pipeline With Two Compounds Designed For Activity In The Tumor Microenvironment

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04/18/2016

Adenosine Targeting Immune-Checkpoint Inhibitor and Anti-EGFR Antibody-Drug Conjugate Demonstrate Tumor Growth Inhibition in Pre-Clinical Studies

SAN DIEGO, April 18, 2016 /PRNewswire/ -- Halozyme Therapeutics (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, today announced preclinical data for the discovery and early development of two potential drug candidates, an immune checkpoint inhibitor targeting adenosine and a novel antibody-drug conjugate (ADC) targeting epidermal growth factor receptor (EGFR). 

These new preclinical programs complement Halozyme's lead oncology asset, PEGPH20, an investigational new drug (IND) under clinical evaluation for the treatment of pancreatic, lung and gastric cancers.

The potential drug candidates are PEGylated adenosine deaminase 2, or PEG-ADA2, an immune checkpoint inhibitor that targets immuno-suppressive adenosine, which may accumulate to high levels in the tumor microenvironment. PEG-ADA2 is currently in early preclinical development with the next milestone expected to be final drug candidate selection by the end of 2016.

HTI-1511 is a novel anti-EGFR ADC to treat solid tumors, including those with drug-resistant mutations. It is also in pre-clinical development, with a drug candidate selected, good laboratory practices (GLP) toxicity studies planned for 2017 and chemistry, manufacturing and controls (CMC) development activities to support a future IND filing underway.

"We expand our oncology pipeline today with two assets that complement our growing body of research into the structural, biochemical and immunological properties of the tumor microenvironment," said Dr. Helen Torley, president and chief executive officer. "Our new PEG-ADA2 and HTI-1511 anti-EGFR ADC show early promise as our scientists continue to characterize them for potential clinical study in the future.

"In addition, our ongoing research of lead asset, PEGPH20, continues to build scientific evidence of potential benefits in remodeling the tumor microenvironment, including the potential to increase access of immune therapies and chemotherapies. This week we will share new research in animal models showing increased tumor regression when immune checkpoint inhibitors are used in combination with PEGPH20 in tumor models with high levels of hyaluronan."

The new studies are being introduced during poster presentations at the American Association for Cancer Research (AACR) annual conference, taking place April 17-20 in New Orleans.

PEG-ADA2

Halozyme's PEG-ADA2 was engineered to decrease the concentration of adenosine in the tumor microenvironment, and PEGylated to prolong its circulation in the body. Accumulation of adenosine is believed to contribute to a suppressed immune response to certain solid tumors.

In preclinical studies, Halozyme's PEG-ADA2 demonstrated tumor growth inhibition in certain colon, lung and pancreatic cancer models. Treatment with PEG-ADA2 resulted in an increase in infiltration of T cells and lowering of tumor adenosine levels. Halozyme scientists have also identified a potential biomarker for tumors that may respond to PEG-ADA2 therapy.

The company plans to continue its ongoing study and characterization of PEG-ADA2 with the goal of determining its suitability as a targeted therapy for clinical study.

HTI-1511 Anti-EGFR ADC

Halozyme's HTI-1511 was engineered to bind to EGFR at the low pH of the tumor microenvironment while decreasing or attenuating the binding at the neutral pH of skin. The result in preclinical studies to date is a targeted therapy with an acceptable safety profile.

HTI-1511 has been developed as a next generation ADC with a potent cytotoxin, monomethyl auristatin E to treat EGFR-positive tumors, including those with KRAS and BRAF mutations. In preclinical studies, HTI-1511 has demonstrated tumor growth inhibition or regression in colon, lung and cholangiocarcinoma models, including patient derived xenograft (PDx) models with known KRAS and BRAF mutations.

The company has initiated a range of studies to prepare for an IND filing for HTI-1511 with the target of initiating early clinical study in 2018.

Halozyme Webcast and Conference Call

Dr. Torley and Halozyme Chief Scientific Officer, Dr. Michael LaBarre will host a meeting for investment professionals today, Monday, April 18 at 4 p.m. ET (3 p.m. CT, 1 p.m. PT). The event will be webcast live through the "Investors" section of Halozyme's corporate website and a recording will be made available following the close of the event.

To access the webcast and additional documents related to the event, please visit www.halozyme.com approximately fifteen minutes prior to the start time to register, download and install any necessary audio software. The live event may be accessed by calling (877) 410-5657 (domestic callers) or (334) 323-7224 (international callers) using passcode 987221. A telephone replay will be available after the event by dialing (877) 919-4059 (domestic callers) or (334) 323-0140 (international callers) using replay passcode 13259083.

Halozyme's AACR Poster Presentations include:

  1. PEGylated recombinant hyaluronidase PH20 enhances pemetrexed antitumor efficacy in a human non-small cell lung cancer model, Sun., April 17, 1-5 p.m. CT
  2. Preclinical evaluation of a next-generation EGFR targeting antibody-drug conjugate that promotes regression in KRAS and BRAF tumors, Mon., April 18, 8 a.m.noon CT
  3. Enzymatic depletion of adenosine by PEGylated, engineered adenosine deaminase 2 (PEG-ADA2): a novel immunotherapeutic approach to treat solid tumors, Mon., April 18, 8 a.m.noon CT
  4. PEGPH20 increases the anticancer activity of standard chemotherapy combinations, vincristine (VIN) and D actinomycin (DACT), in a Wilms xenograft model, Mon., April 18, 1-5 p.m. CT
  5. PEGylated recombinant hyaluronidase PH20 (PEGPH20) enhances checkpoint inhibitor efficacy in syngeneic mouse models of cancer, Weds., April 20, 8 a.m.noon CT

About PEGPH20

PEGPH20 is an investigational PEGylated form of Halozyme's proprietary recombinant human hyaluronidase under clinical development for the potential systemic treatment of tumors that accumulate hyaluronan. FDA granted orphan drug designation to PEGPH20 for treatment of pancreatic cancer and fast track for PEGPH20 in combination with gemcitabine and nab-paclitaxel for the treatment of metastatic pancreatic cancer.

Additionally, the European Commission, acting on the recommendation from the Committee for Orphan Medicinal Products of the European Medicines Agency, designated investigational drug PEGPH20 an orphan medicinal product for the treatment of pancreatic cancer.

About Halozyme

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 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 metastatic pancreatic cancer, non-small cell lung cancer, gastric cancer, metastatic breast cancer and has potential across additional cancers 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 and Lilly for its ENHANZE™ drug delivery platform. 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, statements concerning the possible activity, benefits and attributes of PEGPH20, PEG-ADA2 and HTI-1511, their possible method of action, potential application to improve cancer therapies and statements concerning future actions and clinical trials relating to their development) 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 Annual Report on Form 10-K recently filed with the Securities and Exchange Commission.

Contacts:
Jim Mazzola
858-704-8122
ir@halozyme.com

Chris Burton
858-704-8352
ir@halozyme.com

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