On July 18, 2018 BioCure Technology Inc. (CSE:CURE, OTCQB;BICTF) ("BioCure" or the "Company") reported that its wholly owned subsidiary BiocurePharm Corporation ("BP Korea"), has implemented the preclinical trial of Interferon Beta 1b since late 2017 and is pleased to update shareholders on their progress (Press release, Biocure Technology, JUL 18, 2018, View Source [SID1234628761]). BP Korea announces that it has completed most of the toxicity testing and has developed MCB (Master Cell Bank) and WCB (Working Cell Bank). Currently, BP Korea is in the middle of in-Vivo potency test. The Company has already produced 35,000 vials of Interferon Beta 1b for their pre-clinical trial and stability test at the GMP manufacturing facility in Korea. BP Korea expects the pre-clinical trial shall be completed by the end of Q1, 2019 and will advance to clinical trial in 3Q 2019.

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Dr. Sang Mok Lee, CEO comments "We are making every effort to commercialize Interferon Beta, 1b, the first Biosimilar of the Company by 2021. BP Korea is in discussion with potential foreign partners to implement a clinical trial and produce Interferon Beta 1b in their countries through a partnership, once the pre-clinical trial is completed in Korea. We strongly believe that such partnerships could provide patients in those countries with much more affordable access to Interferon Beta."

On July 18, 2018 EUSA Pharma (EUSA), a biopharmaceutical company focused on oncology and rare disease, reported that it has entered into a definitive agreement with Janssen Sciences Ireland UC, a subsidiary of Janssen R&D Ireland (Janssen) to acquire the global rights to SYLVANT (siltuximab) for $115 million in cash (Press release, EUSA Pharma, JUL 18, 2018, View Source [SID1234553163]). The transaction is subject to review under the United States Hart–Scott–Rodino Antitrust Improvements Act of 1976, as amended, and the parties expect to close following completion of this regulatory review period and the mutual satisfaction of other remaining closing conditions.

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SYLVANT is approved in more than 40 countries worldwide, including the United States, the European Union, the Republic of Korea and Canada, for the treatment of idiopathic multicentric Castleman’s disease (iMCD), a rare, life threatening and debilitating orphan condition. Idiopathic MCD is an inflammatory lymphoproliferative disorder, which causes the abnormal overgrowth of immune cells and shares many symptomatic and histological features with lymphoma.1 The disease can affect individuals at any age, with iMCD representing one-third to half of all multicentric Castleman’s disease (MCD).2

"iMCD is a devastating disorder with few treatment options for patients, because the underlying mechanisms are so poorly understood," said David Fajgenbaum, MD, MBA, MSc, Assistant Professor of Translational Medicine and Human Genetics, and Associate Director, Patient Impact, Orphan Disease Center, at the Perelman School of Medicine at the University of Pennsylvania.

SYLVANT is the only approved treatment for iMCD in the United States and Europe. It first received approval in the United States in 2014, with subsequent approvals occurring in a number of countries thereafter. Since then, SYLVANT has achieved rapid revenue growth.

The approval of SYLVANT was based on the MCD2001 study (NCT01024036); an international, randomised, double blind, placebo-controlled trial including 79 subjects. More than one-third of subjects in the SYLVANT arm had a durable tumour and symptomatic response to treatment plus best supportive care (BSC), compared to none of the subjects who received placebo plus BSC (34% versus 0% according to stringent criteria; 95% CI: 11.1, 54.8; p=0.0012).3

"The acquisition of SYLVANT represents a significant opportunity for EUSA Pharma. As the only approved treatment for this orphan condition, SYLVANT highlights the importance of ongoing research and development in areas where there are few patients yet high unmet medical needs", said Lee Morley, EUSA Pharma’s Chief Executive Officer. "Following the recent divestment of our critical care portfolio, EUSA Pharma has transformed into a rapidly growing biopharmaceutical company focused solely on oncology and rare disease, backed by leading life science investor EW Healthcare Partners. SYLVANT is a perfect fit with our ambitious plans to roll out innovative biopharmaceutical treatments to serve the oncology and rare disease community worldwide.

On July 18, 2018 DCprime bv, a clinical stage biotechnology company focused on cell-based cancer vaccines, and Glycotope GmbH, a clinical stage immuno-oncology company built on world-leading glycobiology expertise, reported that they have entered into a license agreement and research collaboration (Press release, DCPrime, JUL 18, 2018, View Source [SID1234529907]).

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Under the agreement, DCprime has obtained the global research and commercialization rights to certain process development patents owned by Glycotope. In addition, the companies have initiated a research collaboration to evaluate novel immunotherapeutic approaches to solid tumours, based on the combination of their proprietary technologies.

Henner Kollenberg, Managing Director, Glycotope commented: "This is an exciting opportunity and we look forward to working with DCprime. Through this collaboration we will look to draw on DCprime’s expertise in the development of dendritic cell therapies and combine this with our own knowledge of glyco-biology to evaluate potential new immunotherapies."

Erik Manting, CEO of DCprime added: "It is a pleasure to work with Glycotope based on their strong basis in process development and immuno-oncology. This collaboration allows us to pursue new and innovative combination therapies based on DCOne and immunomodulatory antibodies."

On July 18, 2018 Moleculin Biotech, Inc. (Nasdaq:MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company focused on the development of oncology drug candidates, all of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, reported it has begun preclinical toxicology testing of its WP1732, a fully water-soluble STAT3 inhibitor through its new subsidiary in Australia (Press release, Moleculin, JUL 18, 2018, View Source [SID1234528787]).

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"Based on preclinical testing, we believe the discovery of WP1732, a fully water-soluble STAT3 inhibitor, has the potential to be a breakthrough discovery for rare and difficult to treat cancers. As a result of our preclinical testing, we have recieved multiple requests to commence clinical trials and we are pleased to be taking the next steps in preparing for the appropriate clinical work," commented Walter Klemp, Chairman and CEO of Moleculin. "By utilizing our subsidiary in Australia and the attractive R&D tax credits it offers, we can accelerate the preclinical work of WP1732 and maintain a strong cash balance. We believe this will allow us to complete our IND-enabling work and meet FDA submission requirements before year-end while also reducing our total cost of development."

(Filing, Annual, Sellas Life Sciences, 2017, JUL 18, 2018, View Source [SID1234527760])

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