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Halozyme Publication In The Journal Clinical Cancer Research Highlights New Nonclinical Data Supporting Multiple Effects Of PEGPH20 On The Tumor Microenvironment

On October 4, 2018 Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, reported the publication of nonclinical data for PEGPH20 in Clinical Cancer Research, an American Association for Cancer Research (AACR) (Free AACR Whitepaper) journal (Press release, Halozyme, OCT 4, 2018, View Source [SID1234529759]). PEGPH20 is the PEGylated version of Halozyme’s proprietary recombinant human hyaluronidase enzyme, rHuPH20, that temporarily degrades hyaluronan (HA). HA is a naturally occurring glycosaminoglycan that can accumulate in the tumor microenvironment (TME) of certain solid tumor types.

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The paper further characterizes the biological and physical changes associated with HA-accumulating (HA-high) tumors in mouse models demonstrating an association with increased collagen content, high tumor interstitial pressure (tIP), vascular collapse, hypoxia, drug resistance and increased metastatic potential. Treatment with PEGPH20 at the human equivalent dose degraded HA in the TME reversing these changes, and also depleted an important proangiogenic growth factor, VEGF-A165, suggesting that treatment with PEGPH20 may diminish the angiogenic potential of the TME.

"The publication of this preclinical work highlights PEGPH20’s encouraging anti-tumor activity profile through the degradation of hyaluronan. In addition, for the first time, it presents evidence that PEGPH20 depletes stores of VEGF-A165, a key proangiogenic growth factor, suggesting that PEGPH20 may diminish the angiogenic potential of the tumor microenvironment," said Dr. Helen Torley, president and chief executive officer. "These data expand our understanding of the PEGPH20 mechanism of action and provide additional support for the potential for meaningful clinical responses in high hyaluronan accumulating tumors."

The accumulation of HA is common in many cancers, particularly in pancreatic cancer where increased HA accumulation predicts a less favorable outcome. A Phase 3 study evaluating the ability of PEGPH20 plus Abraxane (nab-paclitaxel) and gemcitabine to increase Progression Free Survival and Overall Survival versus Abraxane and gemcitabine alone in metastatic pancreatic ductal adenocarcinoma patients, is under way.

Key findings from the Clinical Cancer Research publication included:

Accumulation of HA in tumors correlated with high tIP, vascular collapse, hypoxia, drug resistance and increased metastatic potential
HA accumulation also correlated with increased collagen content and was associated with an increase in α-SMA
Remodeling of the tumor microenvironment is mediated by the enzymatic removal of tumor HA
Treatment with PEGPH20 at the human equivalent dose depleted tumor-associated VEGF-A165 to an undetectable level potentially reducing the angiogenic potential of the TME
The paper, titled "Parallel Accumulation of Tumor Hyaluronan, Collagen, and Other Drivers of Tumor Progression" was published online in Clinical Cancer Research on September 27, 2018.

Propanc Biopharma Initiates European Validation of its Lead Patent

On October 4, 2018 Propanc Biopharma, Inc. (OTCQB: PPCB) ("Propanc Biopharma" or the "Company"), a clinical stage biopharmaceutical company focusing on development of new and proprietary treatments for cancer patients suffering from solid tumors such as pancreatic, ovarian and colorectal cancers, reported initiation of European (EP) validation of its lead patent in most major commercial markets in Europe (Press release, Propanc, OCT 4, 2018, View Source [SID1234529748]). EP validation is the process of converting a single granted European patent application into a national patent in one or more contracting member and extension states of the European Patent Convention.

The Company’s lead patent, which describes a pharmaceutical composition for treating cancer, is currently undergoing validation in 14 European countries – Belgium, Czech Republic, Denmark, France, Germany, Ireland, Italy, Netherlands, Portugal, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Once validated, the Company will have the rights associated with a granted patent in each of these 14 European countries.

"We continue to make significant progress with the growth of our intellectual property portfolio this year. In addition to commencing validation of our lead patent in Europe, we entered national phase with another two patents and are planning to enter a third into national phase later this year," said James Nathanielsz, the Company’s Chief Executive Officer. "A strong intellectual property portfolio is a cornerstone to a biotech company and will serve to increase the value of ours. In addition to growing our IP portfolio, we also recently initiated the next phase of our POP1 drug discovery program with the University of Jaén, our research partner, to develop a backup compound to our lead product candidate, PRP, which is set to enter clinical development. We continue to build a strong foundation for our Company and its potential for future growth for our shareholders, which is most important."

FDA Grants Coordination Pharmaceuticals IND Approval for CPI-100, a Novel Antitumor Nanomedicine

On October 3, 2018 Coordination Pharmaceuticals, Inc. (CPI), a privately held and clinical-stage biopharmaceutical company focused on nanotechnology-based cancer immunotherapy, reported that the U.S. Food and Drug Administration (FDA) has approved the Company’s Investigational New Drug (IND) application to initiate a first-in-human Phase 1 clinical study of CPI-100 in patients with advanced tumors (Press release, Coordination Pharmaceuticals, OCT 3, 2018, View Source [SID1234532212]).

CPI-100 is a structurally optimal core-shell nanoparticles based on CPI’s proprietary nanoscale coordination polymer (NCP) platform technology to selectively deliver immunostimulatory chemotherapeutic combinations to tumors, providing a new approach to initiate and stimulate immune-mediated eradication of cancer cells using synergistic nanomedicines. "FDA’s timely acceptance and approval of CPI-100 IND is an important milestone for the company. We are excited about the opportunity to study the first NCP-based product in clinical trials." said Wenbin Lin, Ph.D., founder and chairman of CPI and also the James Franck Professor of Chemistry, Radiation & Cellular Oncology, and the Ludwig Center for Metastasis Research at the University of Chicago. "We expect this study will generate important insights into the safety of CPI-100 and its preliminary therapeutic efficacy in cancer patients."

Japan MHLW Grants Orphan Drug Designation to Axicabtagene Ciloleucel for Treatment of Certain Types of B-Cell Lymphoma

On October 3, 2018 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) reported that axicabtagene ciloleucel (formerly KTE-C19) has been granted Orphan Drug designation by the Japan Ministry of Health, Labour and Welfare (MHLW) for the treatment of diffuse large B-cell lymphoma (DLBCL), primary mediastinal (thymus) large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma (HGBL) and transformed follicular lymphoma (TFL), which are aggressive forms of non-Hodgkin lymphoma (NHL) (Press release, Daiichi Sankyo, OCT 3, 2018, View Source [SID1234530246]).

"Receiving Orphan Drug designation is an important step in expediting the development of axicabtagene ciloleucel in Japan and underscores the unmet needs of patients with these aggressive forms of relapsed or refractory B-cell lymphomas," said Kouichi Akahane, PhD, MBA, Executive Officer, Head of Oncology Function, R&D Division, Daiichi Sankyo. "This designation represents the third Orphan Drug designation granted for an investigational therapy in our oncology pipeline, demonstrating our commitment to transforming innovative science into value for patients. We look forward to working closely with the Japan Health Authority to bring this important cell therapy to patients in Japan as soon as possible."

The Japan MHLW Orphan Drug designation system is designed to promote research activities and support the development of orphan drugs for serious, difficult-to-treat diseases that affect fewer than 50,000 patients in Japan, and for which significant unmet medical need exists. An investigational therapy can qualify for Orphan Drug designation if there is no approved alternative treatment option or if there is high efficacy or safety compared to existing treatment options expected. Therapies receiving Orphan Drug designation qualify for several measures intended to support development including, but not limited to, guidance and subsidies for research and development activities, priority consultation for clinical development and priority review of applications.

Axicabtagene ciloleucel is a chimeric antigen receptor T cell (CAR T) therapy directed against CD19 (a cell membrane protein), which harnesses a patient’s own immune system to fight certain types of B-cell lymphoma. In January 2017, Daiichi Sankyo received exclusive development, manufacturing and commercialization rights for axicabtagene ciloleucel in Japan from California-based Kite Pharma, Inc., a Gilead company. Based on the results of a Phase 1/2 study (ZUMA-1), axicabtagene ciloleucel has been approved in the U.S. and Europe. A Phase 2 study similar to the ZUMA-1 study is currently being planned in Japan.

Onxeo to Present at the 11th Edition of the “Rencontres de la Cancérologie Française” Oncology Conference

On October 3, 2018 Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO FR0010095596), a clinical-stage biotechnology company specializing in the development of innovative drugs in oncology, in particular against rare or resistant cancers, reported its participation in the 11th edition of the Rencontres de la Cancérologie Française (RCFr), a major event dedicated to innovation in oncology to be held on 27 and 28 November 2018 in Paris (Press release, Onxeo, OCT 3, 2018, View Source [SID1234530186]).

This edition on the theme of "Anticipation in cancer" will be inaugurated by the French Minister of Health, Mrs Agnès Buzyn.

On this occasion, ONXEO will address a panel of experts during the session "Valorisation des projets scientifiques de technologies émergentes" (Valuation of scientific projects for emerging technologies), organized in partnership with the École polytechnique and Angels Santé.

"We are pleased to participate in this event and to have the opportunity to present to experts our lead project AsiDNA in the promising field of DNA damage response," said Olivier de Beaumont, Medical Director of Onxeo.

Session: Valuation of scientific projects for emerging technologies

Date: Tuesday, November 27, 2018

Time: 7:45 pm

Location: Chatoform’ Eurosites George V (Paris), France

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