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.

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.

On January 9, 2018 BeiGene, Ltd. (NASDAQ:BGNE) and Boehringer Ingelheim Biopharmaceuticals (China) Ltd. reported that the two companies have entered into a commercial supply agreement for tislelizumab, BeiGene’s investigational anti-PD-1 antibody (Press release, BeiGene, JAN 9, 2018, View Source;p=RssLanding&cat=news&id=2325746 [SID1234523037]). Tislelizumab will be manufactured in Boehringer Ingelheim’s world-class biopharmaceutical manufacturing facility in Shanghai as part of a Marketing Authorization Holder (MAH) trial project pioneered by BeiGene and Boehringer Ingelheim.

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"As we advance tislelizumab towards potential regulatory approval and commercialization in China, we are pleased to have secured our commercial product supply from Boehringer Ingelheim BioXcellence, one of the world’s leading biopharmaceutical contract manufacturers. Over the years, working with the Boehringer Ingelheim team for our clinical supply, we have built a strong partnership based on a shared commitment to providing high-quality medicine to patients," said John V. Oyler, Founder, Chief Executive Officer, and Chairman of BeiGene. "In addition to working with Boehringer Ingelheim, we are also building our manufacturing facility for biologics commercial supply in Guangzhou, China, in a joint venture with the Guangzhou Development District, that we expect will further expand our capacity to meet anticipated demand for tislelizumab and other biologics in our pipeline."

Under the terms of the supply agreement, Boehringer Ingelheim will manufacture tislelizumab in China under an exclusive multi-year arrangement, with contract extension possible. In addition, BeiGene also obtained certain preferred rights for future capacity expansion by Boehringer Ingelheim in China.

"The agreement marks the first biopharmaceutical MAH trial project entering into commercial supply in China," said Dr. Jiali Luo, General Manager of Boehringer Ingelheim Biopharmaceuticals (China) Ltd. "Boehringer Ingelheim is focused on manufacturing innovative therapeutics to treat unmet medical needs of patients around the world. We are confident that our quality competence and contract manufacturing capabilities are best-in-class, and excited to plan for the commercial supply of tislelizumab, which has the potential to help patients with a broad array of cancers as both a monotherapy and in combination with other therapies."

About Tislelizumab (BGB-A317)

Tislelizumab is an investigational humanized monoclonal antibody that belongs to a class of immuno-oncology agents known as immune checkpoint inhibitors. It is designed to bind to PD-1, a cell surface receptor that plays an important role in downregulating the immune system by preventing the activation of T-cells. Tislelizumab has demonstrated high affinity and specificity for PD-1. It is differentiated from the currently approved PD-1 antibodies in an engineered Fc region, which is believed to minimize potentially negative interactions with other immune cells. Tislelizumab is being developed as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers. BeiGene and Celgene Corporation have a global strategic collaboration for tislelizumab for solid tumors outside of Asia (except Japan).

On January 8, 2018 Critical Outcome Technologies Inc. (TSX VENTURE:COT)(OTCQB:COTQF) ("COTI" or the "Company"), a clinical-stage pharmaceutical company advancing a pipeline of targeted therapies for the treatment of cancer, reported a name change from "Critical Outcome Technologies Inc." to "Cotinga Pharmaceuticals Inc (Press release, Critical Outcome Technologies, JAN 8, 2018, View Source [SID1234533160])." The effective date of the name change, approved by shareholders in December 2017, is expected to be January 10, 2018.

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This new brand signifies the Company’s evolution from a technology-driven company to a clinical-stage pharmaceutical company. The name is derived from the Cotingas, one of the world’s largest and most diverse bird species, and symbolizes the Company’s focus on developing innovative therapies to treat a wide spectrum of cancers.

"We are excited to officially introduce Cotinga Pharmaceuticals," said Alison Silva, President & CEO. "After a close review of the business, we have launched a new brand that reaffirms our identity, recognizes our achievements in the clinic, and underscores our continued commitment to develop therapeutics for patients suffering from various cancers. We have made considerable progress advancing our pipeline of targeted therapies to date, and we look forward to building on this progress in the year ahead as we continue the Phase 1 trial of our lead compound, COTI-2, in head and neck squamous cell carcinoma (HNSCC) and prepare our second compound, COTI-219, for an investigational new drug (IND) submission."

On January 8, 2018 Vericel Corporation presented Investor presentation on January 8, 2018 (Presentation, Vericel, JAN 8, 2018, View Source [SID1234522981]).

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