On January 8, 2018 Melinta Therapeutics, Inc. (NASDAQ:MLNT), a commercial-stage company developing and commercializing novel antibiotics to treat serious bacterial infections, reported the successful completion of its previously announced acquisition of The Medicines Company’s (NASDAQ: MDCO) infectious disease business (Press release, Cempra, JAN 9, 2018, View Source [SID1234523042]).

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"The completion of this acquisition marks yet another milestone in what has been a very exciting time for Melinta as we focus on creating the leading pure-play antibiotics company," said Dan Wechsler, President and CEO of Melinta. "The combination of our two companies gives us a world-class infectious disease portfolio led by renowned experts in antibiotics discovery, development, and commercialization. We are eager to build upon our synergies and leverage our collective expertise and scale to offer patients and providers battling serious bacterial infections with additional life-saving treatment options."

Expanded Portfolio and Pipeline

The close of the acquisition solidifies Melinta’s position as the world’s largest pure-play antibiotics company, and expands upon the company’s existing product Baxdela (delafloxacin) by adding three additional marketed products to its portfolio: Vabomere (meropenem and vaborbactam), Orbactiv (oritavancin), and Minocin (minocycline) for Injection.

Melinta’s existing portfolio of approved medicines has peak combined sales potential of more than $1 billion. As the new Melinta moves into its next stage of growth, the company will focus on seamless continuity of additional clinical studies designed to enhance and expand the potential for its four marketed products.

Strong Combined Commercial Capabilities

The close of the acquisition will also allow the company to deploy its expanded sales force cross-portfolio to increase efficiencies and drive incremental value, and deepen its global relationships with both new and existing partners.

Melinta also announced that The Medicine Company’s Mike McGuire has joined the new organization’s leadership team as Senior Vice President, Commercial. He replaces Melinta Chief Commercial Officer, John Temperato, who left the company to pursue other opportunities. McGuire, who reports to Dan Wechsler, has over 25 years of commercial experience in launching and commercializing antibiotics.

The combined company has a broad global footprint with potential to expand and a novel proprietary discovery platform that make it the leading pure-play antibiotics company from discovery to commercial.

The company’s President and Chief Executive Officer Dan Wechsler will present additional details on the company’s strategic priorities post-close at the 36th Annual J.P. Morgan Healthcare Conference in San Francisco, CA from January 8-11, 2018. Melinta’s presentation will take place on Wednesday, January 10, 2018 at 10:30 am Pacific Time.

A webcast of the presentation can be accessed on the investor page of Melinta’s website at View Source A replay of the webcast will also be archived on Melinta’s website following the conference.

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

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On January 9, 2018 4SC AG (4SC, FSE Prime Standard: VSC) reported its participation at upcoming conferences and investor events. 4SC’s management will be available for one-on-one meetings at these events (Press release, 4SC, JAN 9, 2018, View Source [SID1234523022]).

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4th annual Biotech and Money / Medtech and Money World Congress
5 February 2018
etc.venues
London, United Kingdom

BioCapital Europe 2018
6 February 2018
Sofitel Legend Amsterdam The Grand
Amsterdam, The Netherlands

Non Deal Roadshow: Amsterdam
7 February 2018
Amsterdam, The Netherlands

2018 BIO CEO & Investor Conference
12 – 13 February 2018
New York Marriott Marquis
New York, USA

Non Deal Roadshow: New York
14 February 2018
New York, USA

Non Deal Roadshow: Scandinavia
19 – 20 February 2018
Scandinavia

12th ODDO BHF German Conference (micro, small & mid cap)
21 – 22 February 2018
The Westin Grand Hotel
Frankfurt am Main, Germany

Non Deal Roadshow: Zurich
28 February 2018
Zurich, Switzerland

Non Deal Roadshow: Geneva
1 March 2018
Geneva, Switzerland

Non Deal Roadshow: Luxembourg / Belgium
16 March 2018
Luxembourg / Belgium

Munich Stock Exchange Day 2018
17 March 2018
MOC Veranstaltungscenter
Munich, Germany

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.