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 9, 2018 Otsuka Pharmaceutical Co., Ltd. reported that it has entered into an agreement with Takara Bio for co-development and exclusive sales rights in Japan for Takara’s NY-ESO-1 siTCRTM (TBI-1301, TBI-1301-A) and CD19 CAR (TBI-1501), both gene therapy products in development for cancer applications (Press release, Takara Holdings, APR 9, 2018, View Source [SID1234591489]).

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Under the agreement, the companies will aim for early regulatory approval for the manufacture and sale of the two therapeutic products in Japan. Takara Bio will be responsible for manufacturing and quality control of the two investigational products, while Otsuka will be responsible for clinical trials, other clinical studies, regulatory submissions, product sales and safety data collection. There are no limitations on the target indications in the agreement. Otsuka also holds a right of first refusal for nine Asian countries outside Japan.

Takara Bio will receive upfront and milestone payments from Otsuka, dependent upon the achievement of specified development targets. Takara Bio will supply Otsuka with the products based on specified financial terms. For the NY-ESO-1 siTCRTM gene therapy product, Takara Bio will receive milestone payments upon the achievement of target sales in addition to a running royalty on net sales. The upfront and milestone payments will be up to a maximum total amount of approximately 6.3 billion yen.

Toshiki Sudo, executive director, Research and Otsuka board member noted that, "We are striving to develop innovative products that contribute to the health of humankind around the world, a part of which is co-development cooperation with Takara Bio. We know from our collaboration with Takara Bio on their oncolytic virus HF10 that they have highly advanced biotechnologies and manufacturing facilities dedicated to cell therapy. We aspire jointly to advance biologics research including gene and cell therapy to satisfy currently unsatisfied medical needs."

Masanobu Kimura, Takara Bio board member and president of the Gene Therapy Business Unit, commented that the collaboration with Otsuka, which has broad experience in clinical development, pharmaceutical affairs and sales of pharmaceutical products, will contribute to the development, commercialization and value maximization of the therapeutic products. "We are convinced of further progress on the effective development, aided by the designation of NY-ESO-1・siTCRTM gene therapy product under "SAKIGAKE Designation System" (prioritized review) by the Japanese Ministry of Health, Labour and Welfare on March 27, 2018."

For more information about Takara Bio, please click here: View Source

On April 9, 2018 Kura Oncology, Inc. (Nasdaq:KURA), a clinical-stage biopharmaceutical company focused on the development of precision medicines for oncology, reported that three abstracts relating to the company’s lead product candidate, tipifarnib, and ERK inhibitor, KO-947, will be presented at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2018, which will be held from April 14-18, 2018 in Chicago (Press release, Kura Oncology, APR 9, 2018, View Source [SID1234525219]).The following abstracts are now available on the AACR (Free AACR Whitepaper) website at www.aacr.org.

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Tipifarnib is Highly Active in HRAS Mutant Lung Squamous Carcinoma Tumor
Models (Abstract # 4917)
Session Category: Experimental and Molecular Therapeutics
Session Title: Pharmacokinetics and Pharmacodynamics
Session Date and Time: Tuesday, April 17, 2018, 1:00 p.m. – 5:00 p.m.
Location: McCormick Place South, Exhibit Hall A, Poster Section 41

11q13 Amplification Selects for Sensitivity to the ERK Inhibitor KO-947 in
Squamous Cell Carcinomas (Abstract # 3885)
Session Category: Experimental and Molecular Therapeutics
Session Title: Pharmacogenetics and Pharmacogenomics
Session Date and Time: Tuesday, April 17, 2018, 8:00 a.m. – 12:00 p.m.
Location: McCormick Place South, Exhibit Hall A, Poster Section 37

Preclinical Activity of Tipifarnib in Cutaneous T-cell Lymphoma (Abstract # 1873)
Session Category: Experimental and Molecular Therapeutics
Session Title: Experimental Agents and Combinations for Hematologic Malignancies 2
Session Date and Time: Monday, April 16, 2018, 8:00 a.m. – 12:00 p.m.
Location: McCormick Place South, Exhibit Hall A, Poster Section 38

Following presentation at the meeting, the posters will be available on Kura’s website at www.kuraoncology.com.