On April 9, 2018 Horizon Pharma plc (Nasdaq:HZNP) reported that its first-quarter financial results will be released on Wednesday, May 9, 2018 (Press release, Horizon Pharma, APR 9, 2018, View Source [SID1234525217]). Following the announcement, Horizon’s management will host a live webcast at 8 a.m. Eastern Time to review the Company’s financial and operating results.

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The live webcast and replay may be accessed at View Source Please connect to the Company’s website at least 15 minutes before the live webcast to ensure adequate time for any software download that may be needed to access the webcast.

On April 9, 2018 IONTAS Limited (IONTAS), a leader in the discovery and optimisation of fully human antibodies, reported that it will collaborate with IGEM Therapeutics (IGEM), an immuno-oncology company developing novel immunoglobulin E (IgE) antibodies to treat cancer (Press release, IGEM Therapeutics, APR 9, 2018, View Source [SID1234525218]). The project will add to IGEM’s pipeline of drugs and expand upon IGEM-F, an IgE targeting ovarian and other cancers, currently in a Phase 1/2a study. IONTAS will utilise its proprietary antibody discovery technology to help IGEM identify novel IgE antibodies against two targets.

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IgE antibodies have been shown to permeate tumour tissue more effectively, exhibit enhanced effector functions and stimulate significantly greater levels of cytotoxicity and phagocytosis than IgG antibodies. IONTAS will apply its proprietary antibody discovery libraries and technologies to identify specific, high-affinity antibodies against two tumour-associated targets. Functional screening of IgE-formatted antibodies will be carried out to identify the most appropriate candidates for therapeutic development.

John McCafferty, CEO at IONTAS, commented: "This collaboration capitalises on the antibody discovery capabilities at IONTAS which enable the generation of high-quality therapeutic antibodies using phage-display or mammalian-display. We maintain a strong interest in developing novel therapeutic approaches and recognise IgE therapeutics as an important addition to the armoury of novel cancer therapies. We are delighted to have the opportunity to work with fellow innovators at IGEM on these two exciting projects."

Tim Wilson, CEO at IGEM, commented: "IONTAS was selected as our development partner of choice because of their extensive experience and track record in delivering therapeutic antibodies. The combination of the IGEM IgE platform and the discovery capability of IONTAS will rapidly expand our portfolio of antibodies and help meet our ambitions to progress new leads into the clinic."

On April 9, 2018 Protagen AG and Gustave Roussy have reported the start of a collaboration to utilize Protagen’s SeroTag technology to help identify biomarkers that predict and monitor immune-related adverse events (irAEs) in cancer patients treated with checkpoint inhibitors (Press release, Protagen, APR 9, 2018, View Source [SID1234525247]).

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Checkpoint inhibitors offer enormous potential for the treatment of many cancer indications, including melanoma and renal cell carcinoma. Yet, only a subset of patients respond favorably to treatment and it is not currently possible to predict which patients will benefit from therapy. In addition, checkpoint inhibitors can also trigger (often severe) irAEs, which has led to the FDA halting clinical trials in the past. Through this new collaboration, Protagen and Gustave Roussy will utilize Protagen’s proprietary immune system profiling platform, SeroTag, to monitor patients, detect irAEs and ultimately conduct comprehensive risk profiling for those undergoing cancer immunotherapy. This project is part of the ongoing Gustave Roussy Immunotherapy Program (GRIP), which aims at developing immunotherapy access and best practice.

Dr. Aurelien Marabelle, clinical director of the Gustave Roussy Immunotherapy Program commented: "Although immunotherapies like checkpoint inhibitors have shown great promise for treating those suffering from cancer, response rates for these therapies are still low (often around 10-20%). In addition, our efforts to improve therapeutic outcomes via the implementation of combination therapies can increase the risk of the patient developing debilitating and sometimes fatal irAEs." He continued: "It is therefore vital that we try to understand more about the immunological responses patients are exhibiting to cancer, both before and during therapy. Utilizing Protagen’s SeroTag platform will enable us to ask these questions, and we very much look forward to this collaboration."

Dr. Peter Schulz-Knappe, Protagen’s Chief Scientific Officer, added: "Our unique SeroTag technology has already demonstrated its ability to stratify patients into homogenous disease subgroups for a number of autoimmune indications, thereby supporting the development of novel therapies. Due to the strong link between immuno-oncology and autoimmune disease, we believe that applying our technology and approach to the immuno-oncology field will result in improved patient selection for novel immuno-therapies and support the risk profiling of patients for the development of irAEs. We feel privileged that Gustave Roussy shares this view and we are excited about our collaboration."

About Gustave Roussy

Gustave Roussy, the largest comprehensive cancer center in Europe, is a pole of expertise dedicated to the comprehensive care of patients, employing 3100 health professionals for health care, research and teaching. Gustave Roussy is the European leader in cancer immunotherapy in terms of clinical trials and number of patients treated – www.gustaveroussy.fr/en

On April 9, 2018 Innovation Pharmaceuticals, (OTCQB:IPIX) ("the Company"), a clinical stage biopharmaceutical company, reported that further data analysis from its successfully completed Phase 2 clinical trial of Brilacidin-OM (see NCT02324335) for the indication of decreasing the incidence of Severe Oral Mucositis (SOM) in Head and Neck Cancer (HNC) patients receiving chemoradiation (Press release, Innovation Pharmaceuticals, APR 9, 2018, View Source [SID1234525806]).

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Brilacidin-OM Subgroup Analysis (by Chemotherapy Regimen)

Brilacidin-OM was more effective in decreasing the incidence of SOM in HNC patients receiving the more aggressive chemotherapy regimen—cisplatin administered in a higher concentration (80-100 mg/m2), every 21 days—as compared to lower concentrations of cisplatin (30-40 mg/m2) administered weekly.

For the Modified Intent-to-Treat (mITT) population, Brilacidin-OM in the aggressive chemotherapy regimen reduced the incidence of SOM by 65.0% ([incidence control- incidence active]/incidence control) as compared with placebo (Brilacidin: 25.0%; placebo: 71.4%; p=0.0480). For the Per Protocol (PP) population, Brilacidin-OM in the aggressive chemotherapy regimen similarly reduced the incidence of SOM by 80.3% as compared with placebo (Brilacidin: 14.3%; placebo: 72.7%; p=0.0249). Treatments appeared well-tolerated with good safety.

These data, with additional analysis forthcoming based on the Clinical Study Report, further support Brilacidin’s potential as a promising, and clearly differentiated, late-stage OM drug candidate and will help inform the planning and design of future trials. Brilacidin-OM is being developed under FDA Fast Track Designation.

"We are delighted to see Brilacidin-OM demonstrate such high, statistically significant efficacy in patients receiving aggressive treatment for HNC," said Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals. "Reducing incidence of SOM sets the gold standard and is key to capturing the large HNC market currently lacking any approved drugs. With this new expanded information on the effectiveness of Brilacidin-OM, coupled with our previously reported successful primary results, we think our novel compound continues to raise the bar as the leading SOM drug in development."

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On April 6, 2018 AbbVie (NYSE: ABBV) reported its first-quarter 2018 financial results on Thursday, Apr. 26, 2018, before the market opens (Press release, AbbVie, APR 6, 2018, View Source [SID1234525199]). AbbVie will host a live webcast of the earnings conference call at 8 a.m. Central time (9 a.m. Eastern). It will be accessible through AbbVie’s Investor Relations website investors.abbvie.com. An archived edition of the session will be available later that day.

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