On October 4, 2018 Delcath Systems, Inc. (OTCQB: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported that results of a multicenter analysis of outcomes in patients with intrahepatic cholangiocarcinoma (ICC) treated with CHEMOSAT has been published in the journal European Radiology (Press release, Delcath Systems, OCT 4, 2018, View Source;p=RssLanding&cat=news&id=2370255 [SID1234529788]). The study is the first analysis on the use of Delcath’s PHP Therapy for the treatment of ICC.

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The retrospective analysis—Percutaneous Hepatic Perfusion (Chemosaturation) with Melphalan in Patients with Intrahepatic Cholangiocarcinoma: European Multicentre Study on Safety, Short Term Effects and Survival—was conducted by investigators in Germany, Italy, Netherlands, Spain and France with Dr. Steffen Marquardt of Hannover Medical School serving as lead author. The study evaluated 15 patients with ICC who were selected for PHP treatment after failing prior therapies. The patients were treated at nine hospitals throughout Europe between 2012 and 2016. Treatment outcomes were assessed by imaging every three months following PHP treatment.

Results of the study showed that after the first PHP treatment, one patient (7%) has a complete response (CR), two patients (13%) had a partial response (PR), and stable disease (SD) was observed in eight patients (53%). This equates to a control rate (CR+PR+SD) of 73%. The complete response patient was not retreated and is still alive. Three patients (20%) progressed after the first treatment and one patient died prior to post-procedure imaging. Five of the patients with SD received a second PHP treatment, resulting in one PR (20%), three SD (60%), and one PD (20%). During the follow-up phase two of the SD patients received additional PHP treatments.

Median overall survival (OS) was 26.9 months from initial diagnosis and 7.6 months from first PHP treatment. One-year OS from first PHP was 40%. Median progression free survival (PFS) was 122 days, and median hepatic progression free survival (hPFS) was 131 days.

In this retrospective data collection, side-effects were potentially under-reported but were considered by the investigators to be tolerable and comparable to other systemic and local therapies. Nevertheless, in the context of the patient selection, baseline characteristics and number of PHP treatments provided in this retrospective study, practitioners observed no adverse events of grades 3 or 4 severity during the PHP procedure. Post-procedurally, significant hematological toxicity was observed in the form of anemia and thrombocytopenia 5-7 days after the PHP procedure. Management with Granulocyte Colony Stimulating Factor (GCSF) was employed in some patients. These toxicities were considered consistent with those toxicities reported in the ABC 02 trial of systemic chemotherapy in this patient population.

Investigators concluded that PHP Therapy provides "promising response rates in patients with ICC," and that side-effects were tolerable and comparable to other treatment strategies.

Commenting on the study, Jennifer K. Simpson, PhD, MSN, CRNP, President & CEO of Delcath Systems, said, "Results of this study are very encouraging when you consider that PHP Therapy was used for these patients after failing prior therapy(ies) and that all patients had been heavily pre-treated. Additionally, many of the patients included in this retrospective analysis were treated before certain aspects of the PHP procedure had become standard, such as the prophylactic use of GCSF growth factors to mitigate certain side-effects. These data have been previously used to inform the trial design for our Phase 3 trial in ICC, and we look forward to further investigating the use of PHP Therapy in a disease that has particularly challenging patient outcomes."

On October 4, 2018 Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a clinical-stage biopharmaceutical company focused on the development of specialized CAR-T cell-based therapies, reported that clinical and preclinical data on the company’s pipeline of candidates will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting being held November 7-11, 2018, in Washington, D.C (Press release, Celyad, OCT 4, 2018, View Source [SID1234529760]). Ten different abstracts have been selected by the SITC (Free SITC Whitepaper) Program Committee attesting to a vigorous and ambitious research program.

"We view SITC (Free SITC Whitepaper) 2018 as an important meeting for a number of reasons", said David Gilham, Ph.D., VP of Research and Development at Celyad. "Firstly, we will provide a clinical update on our CYAD-01 program in solid tumors. Secondly, we will share how we’ve continued to develop the early academic NKG2D CAR-T asset into the commercially feasible clinical entity CYAD-01. We will provide an update on our next generation CAR-T pipeline, and in particular on our non-gene edited allogeneic CAR-T program. We believe we are on a trajectory to be a leading player in the autologous and allogeneic CAR-T cell therapy landscape in the years to come."

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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.

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.

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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."

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]).

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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."