Inovio Pharmaceuticals and the Parker Institute for Cancer Immunotherapy Establish Clinical Development Collaboration To Evaluate Novel Cancer Immunotherapy Combinations

On January 9, 2018 Inovio Pharmaceuticals, Inc. (NASDAQ:INO) and the Parker Institute for Cancer Immunotherapy reported that they have entered into a clinical collaboration agreement that provides for Inovio and the Parker Institute to undertake clinical evaluation of novel combination regimens within the field of immuno-oncology (Press release, Inovio, JAN 9, 2018, View Source [SID1234523036]). The goal of the partnership is to design innovative studies that have the potential to address cancers with high unmet need. The initial trial under consideration between Inovio and the Parker Institute would address muscle invasive bladder cancer with INO-5401 in combination with checkpoint inhibitors and immune modulators.

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Under the agreement, the Parker Institute will have responsibility for clinical study execution, working in collaboration with its established network of the most pre-eminent clinical academic and industry cancer centers. Based on Parker’s novel approach to accelerating studies of cancer immunotherapies, Inovio will provide financial contributions if Inovio’s product(s) studied under the collaboration reaches the initiation of a Phase 3 study.

The collaboration with Inovio represents the Parker Institute’s first agreement within the field of DNA-based Immunotherapeutics. Inovio will benefit from the Parker Institute’s innovative research model which brings together top academic cancer institutions and companies to share resources, data, and technology, accelerate research through unifying and managing clinical trial design, and conduct multi-center clinical trials.

Dr. J. Joseph Kim, Inovio’s President and CEO, said, "We thank the Parker Institute for their confidence in our technology. This partnership aligns with our goal to address cancer with our ASPIRE immunotherapies. Through the Parker Institute’s unique business model, Inovio will be able to work with university research pioneers and combination oncology therapy partners while leveraging the Institute’s unique capabilities and expertise."

"This collaboration between the Parker Institute and Inovio exemplifies the mission of the Parker Institute for Cancer Immunotherapy to unlock the promise of immunotherapy by rapidly progressing next generation treatments into clinical trials," said Fred Ramsdell, PhD, Vice President, Research, Parker Institute for Cancer Immunotherapy. "If this collaboration leads to better cancer patient responses to immunotherapy, this would mark an important milestone for the field."

In addition to the work with the Parker Institute, Inovio also is collaborating to advance two immuno-oncology products through late-stage development for treatment of HPV-related cancers, advanced bladder cancer, and GBM. The products are being studied in combination with checkpoint inhibitors, in collaboration with Medimmune, Genentech, and Regeneron respectively.

About Inovio’s ASPIRE Immunotherapy Technology Platform

Inovio is advancing the medical potential of a unique class of immunotherapy technology. Its ASPIRE (Antigen SPecific Immune REsponses) immunotherapies platform, which is the foundation for all of Inovio’s products is unique in its ability to leverage the body’s naturally existing mechanisms to generate robust, highly targeted immune responses to prevent and treat disease – and to do so in the body without harmful side effects. Its SynCon immunotherapy design and CELLECTRA delivery transform novel genetic blueprints into functional antibody and killer T cell responses. Inovio was the first to report the activation – in the body – of significant, antigen-specific functional T cells correlated to statistically significant efficacy in a placebo-controlled, randomized, double-blind phase 2b clinical trial (HPV-related pre-cancer), with a very favorable safety profile. These data were published in The Lancet and independently described as a "major breakthrough" in the field by U.S. National Cancer Institute scientists. Inovio has achieved significant antigen-specific immune responses against multiple diseases and is advancing a growing pipeline of cancer and infectious disease immunotherapies and vaccines.

Positive Results From a Multi-Center Analysis of Delcath PHP Therapy Published in Journal of Surgical Oncology

On January 9, 2018 Delcath Systems, Inc. (OTCQB:DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, reported that results of a multi-center retrospective analysis of Delcath’s PHP Therapy have been published in the peer-reviewed Journal of Surgical Oncology (Press release, Delcath Systems, JAN 9, 2018, View Source;p=RssLanding&cat=news&id=2325720 [SID1234523035]). The study, Percutaneous Hepatic Perfusion with Melphalan in Uveal Melanoma: A Safe and Effective Treatment Modality in an Orphan Disease, was conducted by researchers from Moffitt Cancer Center (Moffitt) in Tampa, FL and the University Hospital Southampton (UHS) in the United Kingdom. The retrospective analysis of outcomes in 51 patients with liver metastases from ocular melanoma represents the largest data set compilation on the use of PHP Therapy in this tumor type outside of a clinical trial setting.

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Patients in the study were treated at the two centers between December 2008 and October 2016. Patients received up to four PHP treatments at UHS and up to six PHP treatments at Moffitt. All patients received at least one PHP treatment, the median number of treatments per patient was two, and a total of 134 PHP treatments had been administered.

Results showed that of the 51 treated patients, 22 (43.1%) showed a partial response, 3 (5.9%) showed a complete response, and 17 (33.3%) had stable disease. The six-month overall and hepatic disease control rates were 64.7% and 70.6% respectively. Survival analysis showed median overall survival of 15.3 months at the time of data cut off. One year overall survival was 64.6%.

Safety analysis showed that 19 patients (37.5%) had Grade 3 or 4 non-hematologic toxicity. Cardiovascular toxicity was seen in 17.6% of patients, a rate comparable to the company’s prior Phase 3 study. Further to implementation of the Gen 2 filter along with prophylactic use of growth factors, severe neutropenia was seen in 16 (31.3%) patients as opposed to 60 (85.7%) patients in the prior Phase 3 trial. Most significantly, as compared to the prior Phase 3, there were no treatment related deaths. Researchers stated that PHP Therapy "can be safely employed in appropriately selected ocular melanoma patients in institutions with appropriate expertise."

The study authors further concluded that "results clearly demonstrate that PHP Therapy appears to be an effective means of obtaining rapid intrahepatic disease control, and is a sensible option in patients with predominant liver disease." Researchers said their results support the use of PHP Therapy in an integrated approach to the management of metastatic ocular melanoma, and looked to the company’s Phase 3 FOCUS Trial to further quantify the benefit and optimize treatment strategies for these patients.

Commenting on the announcement, Jennifer K. Simpson, Ph.D., President and CEO of Delcath Systems, said, "gathered over a period of 8 years, this retrospective two-center study represents the most robust data demonstrating a durable response, manageable side effects and a trend toward prolonged survival in this patient population since our prior Phase 3 trial. These data provide confidence that our Phase 3 FOCUS Trial can confirm these findings and produce the evidence necessary to support an application for a labeled indication in this tumor type."

PHP Therapy with Melphalan/HDS was developed by Delcath Systems as a targeted, whole organ therapy for the liver. It is commercially available as a device in Europe, where it is marketed as CHEMOSAT. The system has not been approved by the U.S. Food and Drug Administration, and is undergoing Phase 3 clinical testing in the U.S. as an investigational product.

NanOlogy General Presentation (Jan 2018)

On January 9, 2018 NanOlogy presented General Presentation (Jan 2018) (Presentation, NanOlogy, JAN 9, 2018, View Source [SID1234523046])

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Investing to deliver growth in Durable franchises

On January 9, 2018 Valeant Pharmaceuticals presented its corporate presentation at 36th Annual J.P. Morgan healthcare Conference (Presentation, Valeant, JAN 9, 2018, View Source [SID1234523045]).

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Neuroscience Innovation Forum

On January 9, 2018 Neuralstem presented at the Neuroscience Innovation Forum (Presentation, Neuralstem, JAN 9, 2018, View Source [SID1234523044]).

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