H3 Biomedicine’s Preclinical Data Highlighting Novel Discovery Research in Hepatocellular Carcinoma Published in December Issue of Cancer Research

On December 15, 2017 H3 Biomedicine Inc., a clinical stage biopharmaceutical company specializing in the discovery and development of precision medicines for oncology and a member of Eisai’s global Oncology Business Group, reported that data on one of its clinical programs has been published in the current issue of Cancer Research (Press release, H3 Biomedicine, DEC 15, 2017, View Source [SID1234522668]). The title of the paper, "H3B-6527 is a Potent and Selective Inhibitor of FGFR4 in FGF19-driven Hepatocellular Carcinoma," was composed by H3 scientists with Anand Selvaraj, PhD, Senior Investigator as lead scientist on the study.

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"We are encouraged by the pre-clinical data of H3B-6527 and the article published in Cancer Research highlights the strength of H3’s unique drug discovery platform that successfully targets specific drivers of hepatocellular carcinoma," said Markus Warmuth, M.D., President and CEO of H3 Biomedicine. "We feel this new research continues to underscore our commitment to FGFR4 inhibition as a novel treatment approach in this therapeutic area and we look forward to advancing this program."

The data were recently presented at the International Liver Cancer Association annual meeting held in Seoul, Republic of Korea.

The publication reports that an oral dosing of H3B-6527 in mice led to dose-dependent pharmacodynamic modulation of FGFR4 signaling and tumor regression in FGF19 altered HCC xenograft models. These data served as proof-of-concept for the approach and led to the clinical introduction of H3B-6527.

The data published in Cancer Research show promising pre-clinical activity of H3B-6527 in hepatocellular carincoma models," said Pete Smith, Ph.D., Chief Scientific Officer, H3 Biomedicine. "H3B-6527 is currently in a Phase I clinical trial and we look forward to discussing the progress of the trial in the coming months."

About H3B-6527
H3B-6527 is a selective, orally bioavailable, and potent inhibitor of fibroblast growth factor receptor 4 (FGFR4) that is being investigated for the treatment of advanced hepatocellular carcinoma (HCC). Aberrant signaling through the FGF19-FGFR4 axis has been shown to drive tumor development and dependency in pre-clinical models of HCC. H3B-6527 has shown sustained tumor regressions in several preclinical models of HCC where FGF19-FGFR4 signaling is aberrantly activated. The safety and preliminary efficacy of H3B-6527 will be explored in patients that are selected using a companion diagnostic that identifies HCC with activated FGF19-FGFR4 pathway activity. H3B-6527 is currently in Phase 1 clinical trials. For more information on the clinical trial, please click here.

Cancer Research UK announces drug discovery collaboration with Celgene Corporation

On December 15, 2017 Cancer Research UK reported the signing of a five-year drug-discovery collaboration between its subsidiary, Cancer Research Technology (CRT), and Celgene Corporation, to discover, develop and commercialise new anti-cancer treatments (Press release, Cancer Research Technology, DEC 15, 2017, View Source [SID1234523153]).

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This arrangement represents an expansion of Cancer Research Technology’s theme-based translational model that now encompasses six industry partnerships, including this new collaboration with Celgene.

The collaboration is centred on mRNA translation, the cellular process of assembling proteins, which is a promising area of research with the potential to produce treatments that can target a fundamental characteristic of cancer cells.

Dr Iain Foulkes, Cancer Research Technology’s CEO, said: "This bold and exciting collaboration between one of industry’s leading innovators, Celgene, and CRT is part of our theme-based drug discovery approach and helps leverage our understanding of cancer biology and the needs of patients to drive the most promising discoveries into the clinic.

"This is our largest drug discovery collaboration to date and represents a major endorsement of the reputation and scale of our capacity and expertise in both drug discovery and clinical development by a leading industry partner."

Cancer Research Technology will lead drug discovery R&D activity and can progress clinical candidates through phase one trials.

Under the terms of the agreement*, Celgene will pay an upfront fee to Cancer Research Technology, and have the option to secure US rights to projects resulting from the collaboration, subject to the payment of additional option fees. Celgene will also have the option to secure Global rights to such projects at the end of phase one clinical trials, subject to the payment of additional option fees.

Cancer Research Technology can receive downstream royalties and development milestones from licensed programs.

Incyte to Present at Upcoming Investor Conference

On December 14, 2017 Incyte Corporation (Nasdaq:INCY) reported that it will present at the 36th Annual J.P. Morgan Healthcare Conference on Monday, January 8, 2018 at 1:30 pm (PST) in San Francisco (Press release, Incyte, DEC 14, 2017, View Source;p=RssLanding&cat=news&id=2322704 [SID1234522646]).

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The presentation and Q&A session will be webcast live and can be accessed at www.incyte.com in the Investors section under "Events and Presentations." Investors interested in listening to the live webcast should log on before the start time in order to download any software required.

Scancell and Cancer Research UK collaborate to advance novel cancer immunotherapy into clinical trials

On December 14, 2017 Scancell Holdings PLC, a developer of novel immunotherapies for the treatment of cancer, and Cancer Research UK, the world’s leading cancer charity dedicated to saving lives through research, reported that they have entered into a Clinical Development Partnership to develop Scancell’s ImmunoBody vaccine, SCIB2, for the treatment of patients with solid tumours, including non-small cell lung cancer (NSCLC) (Press release, Cancer Research Technology, DEC 14, 2017, View Source [SID1234523154]).

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Scancell’s ImmunoBody immunotherapy platform activates the body’s immune system by enhancing the uptake and presentation of cancer antigens to help target and eliminate cancer cells. SCIB2, Scancell’s second ImmunoBody therapy, targets an antigen called NY-ESO-1, which is expressed on a range of solid tumours, including NSCLC and oesophageal, ovarian, bladder and prostate cancers, as well as neuroblastoma, melanoma and sarcoma.

Under the terms of the Clinical Development Partnership, Cancer Research UK will fund and sponsor a UK-based Phase 1/2 clinical trial of SCIB2 in combination with a checkpoint inhibitor in patients with solid tumours, focusing on NSCLC in the first instance. The charity’s Centre for Drug Development (CDD) will be responsible for manufacturing the clinical trial supplies of SCIB2, conducting pre-clinical testing, sponsoring and managing the clinical trial, including the clinical trial timelines.

Following completion of the Phase 1/2 clinical trial, Scancell will have the option to acquire the rights to the data to support further development of SCIB2 itself. If Scancell elects not to exercise the option, Cancer Research UK will retain the right to take the SCIB2 programme forward in all indications.

Professor Lindy Durrant, Chief Scientific Officer of Scancell, commented: "We are delighted to announce this partnership with Cancer Research UK, which is a significant endorsement for our ImmunoBody technology. The charity’s world-renowned expertise will no doubt be invaluable as we progress SCIB2 through the clinic. In pre-clinical studies, we have shown that a combination of SCIB2 and checkpoint inhibition produces enhanced tumour destruction and significantly longer survival times than when either treatment was used alone. We believe SCIB2 has the potential to provide a much needed treatment option for patients suffering from a range of common solid tumours."

Dr Nigel Blackburn, Cancer Research UK’s director of drug development, said: "We’re excited to be giving our extensive expertise and experience in drug development to move this immunotherapy treatment into the clinic.

"This collaboration will ensure that this innovative vaccine reaches patients sooner and could bring about urgently needed improvements for some cancers which can be hard to treat, including lung cancer – a disease where survival rates remain stubbornly low."

PROVECTUS BIOPHARMACEUTICALS RECEIVES THIRD CANCER COMBINATION THERAPY PATENT FROM THE UNITED STATES PATENT AND TRADEMARK OFFICE

On December 14, 2017 Provectus Biopharmaceuticals, Inc. (OTCQB: PVCT, www.provectusbio.com), ("Provectus" or the "Company"), a clinical-stage biotechnology company developing a novel therapeutic platform based on halogenated xanthenes for the treatment of multiple diseases, including cancer and inflammatory dermatoses, reported the United States Patent and Trademark Office (the "USPTO") has granted U.S. patent ("USP") 9,839,688 for the combination of intralesional ("IL") PV-10 with systemic immunomodulatory therapy, including anti-PD-1 and anti-PD-L1 agents, for the treatment of solid tumor cancers (Press release, Provectus Pharmaceuticals, DEC 14, 2017, View Source [SID1234522643]). This new patent is a continuation of USP 9,107,887, Provectus’ first cancer combination therapy patent granted by the USPTO in 2015, and is related to USP 9,808,524, the Company’s second cancer combination therapy patent granted by the USPTO in November 2017. Pfizer, Inc. is a co-assignee on all three patents.

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Dominic Rodrigues, Chairman of the Company’s Board of Directors, said, "This third patent represents our further efforts to increase the potential commercial value of Provectus’ clinical development program in cancer combination therapy. Notably, the new addition to this part of the Company’s patent estate includes coverage for multiple solid tumor cancers that are already in our research and development pipeline."

Mr. Rodrigues added, "Over time, Provectus and our research and clinical collaborators have jointly or independently shown, on a preclinical or clinical basis, the combination of PV-10 and another class of agent or therapy, including checkpoint inhibition, chemotherapy, and radiation, in multiple cancer indications, including hepatocellular carcinoma, melanoma and pancreatic cancer. These data have been presented at conferences of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) and Society for Melanoma Research, and published in the Journal of Surgical Oncology, and Melanoma Research."