On November 30, 2017 Kyowa Hakko Kirin Co., Ltd. (Tokyo: 4151 President and CEO: Nobuo Hanai; "Kyowa Hakko Kirin") reported the submission of a supplemental application to remove the requirement for pre-treatment diagnostic testing and change the dosage and administration in patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL) * for mogamulizumab* (code name: KW-0761; brand name: POTELIGEO) to the Ministry of Health, Labor and Welfare in Japan (Press release, Kyowa Hakko Kirin, NOV 30, 2017, View Source [SID1234522309]).

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The application is supported by data from the MAVORIC (Mogamulizumab anti-CCR4 Antibody Versus ComparatOR In CTCL)* study, the largest global randomized clinical trial of systemic therapy in CTCL. The MAVORIC study did not require identification of CCR4 positive cells in patients before enrollment into the study. The application is intended to remove the requirement for diagnostic testing for CCR4 expression before administration of the drug for CTCL, which is required in the current approval of CTCL, and to change the dosage schedule for CTCL.

"We are happy to file the application of mogamulizumab in CTCL in Japan," said Mitsuo Satoh, Ph.D., Executive Officer, Vice President Head of R&D Division of Kyowa Hakko Kirin. "We believe results of the MAVORIC study indicates mogamulizumab can help to treat CTCL in an expanded patient population."

Mogamulizumab currently has no approved indications outside of Japan, and has been recently submitted Marketing Authorization Application in EU and Biologics License Application in the US.

The Kyowa Hakko Kirin Group companies strive to contribute to the health and well-being of people around the world by creating new value through the pursuit of advances in life sciences and technologies.

About CTCL (Cutaneous T-cell Lymphoma)
CTCL is a rare type of non-Hodgkin’s T-cell lymphoma. The two most common types of CTCL are mycosis fungoides (MF) and Sézary syndrome (SS), and depending on the stage, the disease may involve skin, blood, lymph nodes, and viscera. In advanced stage CTCL is associated with significant morbidity and mortality.

About Mogamulizumab (KW-0761)
Mogamulizumab is a humanized monoclonal antibody (mAb) directed against CC chemokine receptor 4 (CCR4), which is frequently expressed on leukemic cells of certain hematologic malignancies including CTCL. Mogamulizumab was produced using Kyowa Hakko Kirin’s proprietary POTELLIGENT platform, which is associated with enhanced antibody-dependent cellular cytotoxicity (ADCC). It was approved first in Japan for treatment of relapsed or refractory CCR4 positive adult T cell lymphoma (ATL) in March 2012 (brand name: POTELIGEO). In addition, mogamulizumab received approvals in Japan for additional indication for relapsed or refractory CCR4-positive peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL) in March 2014 and for chemotherapy-naïve CCR4-positive adult T-cell leukemia-lymphoma (ATL) in December 2014.

About MAVORIC
MAVORIC is a Phase 3 open-label, multi-centre, randomized study of mogamulizumab versus Vorinostat, active comparator in patients with CTCL who have failed at least one prior systemic treatment. The study was the largest comparative trial in patients with CTCL conducted in the US, Europe, Japan and Australia, and randomized 372 patients.

On November 30, 2017 Pfizer Inc. (NYSE:PFE) and Basilea Pharmaceutica Ltd. (SIX:BSLN), an international biopharmaceutical company specializing in the research and development of anti-infective and oncological medicines, reported they have entered into an agreement whereby Pfizer will be granted the exclusive development and commercialization rights in China and several countries in the Asia Pacific region to CRESEMBA (isavuconazole) (Press release, Pfizer, NOV 30, 2017, View Source [SID1234522326]). CRESEMBA is a novel antifungal medicine for the treatment of adult patients with diagnosed invasive aspergillosis and mucormycosis1, two serious infections associated with significant morbidity and mortality among immunocompromised patients, such as those with advanced HIV and those with cancer.

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Under the terms of the agreement, Pfizer will have exclusive rights to develop, distribute and commercialize CRESEMBA in sixteen Asian Pacific countries and China (including Hong Kong and Macao). These rights do not include Japan. In addition, Pfizer will become the marketing authorization holder for the Asia Pacific Region and China. The specific financial terms of the agreement remain confidential. The agreement is subject to customary regulatory approval.

In July 2017, Pfizer completed an agreement with Basilea to obtain the exclusive commercialization rights to CRESEMBA in Europe (with the exception of the Nordic countries). Since that time, Pfizer has assumed responsibility for the commercialization of CRESEMBA in Austria, France, Germany, Italy, and the United Kingdom and successfully launched CRESEMBA in Spain with additional launches expected in 2018 and beyond.

CRESEMBA was developed in response to the urgent medical need for antifungal medicines for the treatment of invasive fungal infections, which are naturally resistant to many antifungal therapies and have become increasingly resistant to other available therapies. Today, invasive aspergillosis is the most frequently reported fungal infection in immunocompromised individuals within the Asian Pacific region.

"We are excited to extend our partnership with Basilea, a company that shares our passion and commitment to confronting the global challenges of infectious disease management," said Suneet Varma, global president of Pfizer APAC, Greater China and Global Brands. "We believe our extensive geographic footprint in APAC and China, together with our expertise in successfully commercializing innovative medicines, will help enable us to continue to address the unmet medical needs of patients, especially in the area of anti-infectives."

"CRESEMBA is a well differentiated drug that addresses a critical medical need in patients with invasive mold infections," said Ronald Scott, chief executive officer of Basilea. "We are very pleased to be expanding our partnership with Pfizer to China and Asia Pacific where it has a strong commercial presence and a proven track record of successfully developing and commercializing hospital antifungals. We have now established partnerships for isavuconazole with leading pharmaceutical companies in all major markets around the world."

About Pfizer Anti-Infectives

Today, Pfizer is a leading global provider of anti-infective medicines, offering patients access to a diverse portfolio of more than 80 products. Since its pioneering work on penicillin in the 1940s, Pfizer has been actively engaged in the research and development of innovative medicines and creation of policies and educational programs to address the evolving needs of patients and physicians in the area of infectious diseases. In December 2016, Pfizer completed the acquisition of AstraZeneca PLC’s small molecule anti-infective business, which includes both marketed agents and clinical development assets primarily outside the United States.

About invasive aspergillosis and mucormycosis

Invasive fungal diseases (IFDs) are an increasingly common complication associated with high morbidity and mortality among immunocompromised patients such as those with advanced HIV infection and those with cancer. Rates of mortality associated with invasive fungal infections depend upon the pathogen, geographic location and underlying patient characteristics and can be as high as 80-90%. Today, there are limited treatment options available for patients diagnosed with invasive aspergillosis and mucormycosis.

About CRESEMBA (isavuconazole)

CRESEMBA is an intravenous (IV) and oral azole antifungal and the active agent of the prodrug isavuconazonium sulfate. It was approved in March 2015 by the United States Food and Drug Administration (FDA) for patients 18 years of age and older in the treatment of invasive aspergillosis and invasive mucormycosis. The European centralized marketing authorization was granted in October 2015 to isavuconazole for the treatment of adult patients with invasive aspergillosis and for the treatment of adult patients with mucormycosis for whom amphotericin B is inappropriate. Isavuconazole has orphan drug designation for the approved indications in Europe and the US. The drug is commercialized in the US by Astellas Pharma US. Outside the US and the EU, isavuconazole is not approved for commercial use. Pfizer does not have commercialization rights to CRESEMBA in the United States.

On November 30, 2017 Oncolytics Biotech Inc. (TSX: ONC) (OTCQX: ONCYF) (Oncolytics or the Company), a biotech company developing REOLYSIN, also known as pelareorep, an intravenously delivered immuno-oncolytic virus that activates the innate and adaptive immune systems to turn ‘cold’ tumors ‘hot’, reported the establishment of its Scientific Advisory Board (SAB) (Press release, Oncolytics Biotech, NOV 30, 2017, View Source [SID1234522318]). The SAB will provide Oncolytics with significant clinical expertise and experience in breast cancer drug development in both the U.S. and Europe with the following initial members:

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Dr. Mattine Piccart, M.D., Ph.D., Professor of Oncology, Université Libre de Bruxelles, Director of the Medicine Department, TRANSBIG and Jules Bordet Institute, Brussels, Belgium, Member, BCRF Scientific Advisory Board
Dr. Aleix Prat, M.D., Ph.D., Head, Medical Oncology Department, Hospital Clinic of Barcelona & Associate Professor, University of Barcelona, SOLTI – Breast Cancer Research Group
Dr. Padmanee Sharma, M.D., Ph.D., Professor, Department of Genitourinary Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX
"As we continue to expand our collaborative third-party expertise to build on the momentum of our phase 3 program in metastatic breast cancer, we are delighted to introduce a strong Scientific Advisory Board comprised of world-renowned clinical and medical oncologists," said Dr. Matt Coffey, President and CEO of Oncolytics Biotech. "Drs. Piccart, Prat and Sharma will provide crucial guidance based on their specializations in breast cancer drug development and cancer immunotherapy, which parallel the development plan we have established for REOLYSIN."

Dr. Mattine Piccart is a Professor of Oncology at the Université Libre de Bruxelles and a member of the Breast Cancer Research Foundation (BCRF) SAB. She is a member of the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Magnitude of Clinical Benefit Scale Working Group and co-founder and Chair of the Breast International Group (BIG), an international group that includes more than 56 cooperative groups, more than 10,000 experts and links more than 3,000 hospitals. Dr. Piccart was President of ESMO (Free ESMO Whitepaper) from 2012 to 2013 and the European Cancer Organization (ECCO) from 2014 to 2015. She is a former president of the European Organisation for Research and Treatment of Cancer (EORTC) and served on the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Board. Author or co-author of more than 470 peer-reviewed publications, she has received numerous prestigious awards, including the Jill Rose Award, the William L. McGuire Award, the Umberto Veronesi Award for the Future Fight against Cancer, and 2013 David A. Karnofsky Memorial Award, Dr. Piccart obtained both her M.D. and Ph.D. degrees from the Université Libre de Bruxelles.

Dr. Aleix Prat is the Head of Medical Oncology of the Hospital Clinic of Barcelona, Associate Professor of the University of Barcelona and the Head of the Translational Genomics and Targeted Therapeutics in Solid Tumors Group at August Pi i Sunyer Biomedical Research Institute (IDIBAPS). Dr. Prat designs and leads clinical trials for novel drugs and approaches, and has a particular interest in the clinical implications of different subtypes of breast cancer. He is currently the scientific coordinator of SOLTI, a Spanish breast cancer cooperative group, and was recently named as a Member of the Executive Committee of BIG. In 2008, Dr. Prat became a postdoctoral research associate at the Lineberger Comprehensive Cancer Center (University of North Carolina), and in 2012, returned to Barcelona as the Head of the Translational Genomics Group at Vall d´Hebron Institute of Oncology (VHIO). Dr. Prat obtained his M.D. degree in 2003 from the University of Barcelona and completed a medical oncology fellowship in 2008 at VHIO.

At the University of Texas MD Anderson Cancer Center, Dr. Padmanee Sharma is a Professor at the Department of Genitourinary Medical Oncology, the Co-Director of the Parker Institute for Cancer Immunotherapy and Scientific Director of the Immunotherapy Platform at the Department of Immunology. She has participated in 54 research outputs since 1996, focusing primarily on immunotherapy, and is principal investigator of several immunotherapy clinical trials that study immune and anti-tumor responses in cancer patients. Dr. Sharma has served as a member of the BMS Immuno-Oncology Network, a Member of the SAB at Kite Pharma, Inc. and also recently became a member of Constellation Pharmaceuticals, Inc.’s SAB. Dr. Sharma holds a Ph.D. in immunology and an M.D. from Pennsylvania State University.

On November 30, 2017 MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) and I-Mab reported that they have entered into an exclusive regional licensing agreement to develop and commercialize MOR202 in China, Taiwan, Hong Kong and Macao (Press release, MorphoSys, NOV 30, 2017, View Source [SID1234522310]). MOR202 is MorphoSys’s proprietary investigational antibody against CD38, for which recruitment of a European Phase 1/2a clinical study in relapsed/refractory multiple myeloma has been concluded.

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Under the terms of the agreement, I-Mab Biopharma will assume exclusive responsibility for all subsequent development and commercialization of MOR202 in the agreed territory. MorphoSys receives an immediate upfront payment of USD 20 million. MorphoSys will be entitled to receive additional success-based clinical and commercial milestone payments from I-Mab of up to approximately USD 100 million, as well as tiered double-digit royalties on net sales of MOR202 in the territory.

In connection with the license agreement with I-Mab, MorphoSys has increased its financial guidance. For the year 2017, MorphoSys now expects revenues in the range from EUR 63 to 66 million (up from previously EUR 46 to 51 million) and earnings before interest and taxes (EBIT) of EUR -66 to -71 million (up from previously EUR -75 to -85 million). Guidance for revenues and EBIT includes royalty income on Tremfya(R) sales in Q3 2017, but does not include any royalty income on Tremfya(R) sales in Q4 2017. Following the partnering of MOR202, proprietary R&D expenses will be in the range from EUR 96 to 100 million (previously EUR 85 to 95 million).

I-Mab Biopharma intends to start clinical development of MOR202 to treat patients with multiple myeloma in China next year.

"Our deal with I-Mab is the first step in our plan to secure the development and commercialization of MOR202. In I-Mab, we have found an ideal partner with a highly dedicated and experienced team who are committed to developing MOR202 as fast as possible for the Chinese market", commented Dr. Simon Moroney, Chief Executive Officer of MorphoSys AG.

"We are very excited to partner with MorphoSys to develop this highly differentiated investigational oncology medicine for unmet needs in China. This partnership marks a latest addition to our China portfolio of clinical stage assets, which parallels with our global immuno-oncology portfolio of innovative biologics", said Jingwu Zang, founder and CEO of I-Mab Biopharma.

About MOR202 and the ongoing phase 1/2a study in multiple myeloma
The investigational drug MOR202 is a human HuCAL antibody directed against CD38, a highly expressed and validated target in multiple myeloma. Preclinical findings also support an anti-CD38 approach in other therapeutic fields beyond multiple myeloma including solid tumors and autoimmune diseases. MOR202 is currently in a phase 1/2a, open-label, multi-center, dose-escalation clinical study conducted in several sites in Germany and Austria. The study is evaluating the safety and preliminary efficacy of MOR202 with low dose dexamethasone and in combination with the immunomodulatory drugs (IMiDs) pomalidomide (POM) and lenalidomide (LEN) plus DEX in patients with relapsed/refractory multiple myeloma. The primary endpoints of the trial are the safety, tolerability and recommended dose of MOR202 with DEX and in combination with the IMiDs. Secondary outcome measures are pharmacokinetics and preliminary efficacy based on overall response rate, duration of response, time-to-progression, and progression-free survival.

About Multiple Myeloma:
Multiple myeloma (MM), a cancer derived from plasma cells, ranks second among hematological malignancies in many countries. In China, there would be an estimated 27,800 new cases each year and a total of 200,000 cases. With the acceleration of the aging process in China, it is predicted that MM, with a rapid growth in incidence, will become one of the more significant diseases that affect people’s health. Patients who are refractory to the existing treatments have a very poor prognosis. MOR202 could be a highly differentiated innovative medicine for the treatment of multiple myeloma.

On November 30, 2017 GT Biopharma, Inc. (OTCQB: GTBP and Euronext Paris GTBP.PA) ("GT Biopharma" or the "Company") reported that Dr. Jeffrey Miller, Deputy Director of the Masonic Cancer Center, University of Minnesota, will be presenting data on its second-generation anti-CD16-IL-15-anti-CD33 TriKE (OXS-C3550); another first of its kind, single-chain, tri-specific NK cell engager (TriKE) (Press release, GT Biopharma , NOV 30, 2017, View Source [SID1234539536]).

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The TriKE platform technology, developed by Dr. Miller and his colleagues at the University of Minnesota, is designed to enhance the activity of Natural Killer (NK) cells. NK cells are a type of white blood cell which are an important component of the innate immune system and play a major role in the rejection of tumor and virally infected cells.

The original anti-CD16-IL-15-anti-CD33 TriKE (OXS-3550) utilizes the inclusion of a modified Interleukin-15 (IL-15), a peptide that activates NK cells, while the "engager" further increases NK cancer-cell killing capabilities and improves their function in the tumor microenvironment (Vallera et al, 2016). OXS-3550 is expected to enter human clinical trials in 2018. OXS-C3550, the second-generation anti-CD16-IL-15-anti-CD33 TriKE, utilizes a modified anti-CD16 component while incorporating the wild-type IL-15.

The OXS-C3550 TriKE was developed following continued research with the TriKE platform at the University of Minnesota Masonic Cancer Center. As demonstrated in non-clinical models, this targeted immunotherapy directs immune cells to kill cancer cells while diminishing drug-related toxicity.

The TriKE platform technology can be viewed as a protein version of CAR-T; but unlike traditional CAR-T platforms, it is anticipated that TriKEs could service a much larger part of the cancer population at a fraction of the cost. TriKEs are an antibody platform that could be tailored to treat any form of cancer, liquid or solid tumors.

OXS-C3550 will focus on acute myeloid leukemia (AML), the most common form of adult leukemia with 43,000 new cases each year. These patients will require frontline therapy, usually chemotherapy including cytarabine and an anthracycline, a therapy that has not changed in over 40 years. Also, about half of these patients are likely to have relapses and require alternative therapies. In addition, OXS-C3550 could be used to treat myelodysplastic syndrome (MDS), which has about 20,000 new cases diagnosed each year with minimal current treatment options (Siegel et al, 2014). At a minimum, OXS-3550 is expected to serve as a relatively safe, inexpensive, and easy to use therapy for resistant or relapsing AML. From a biologic standpoint, it could also be combined with chemotherapy as frontline therapy.

GT Biopharma Chief Medical officer (CMO) Dr. Raymond Urbanski said, "The data on our second-generation TriKE, which will be presented at the upcoming ASH (Free ASH Whitepaper) meeting, will be noticed by investigators in the field and will set the tone for all future discussions on the use of NK cells in the treatment of cancer. We believe the distinctions and potential benefits relative to other immunotherapies, including CAR-T, will become apparent."

GT Biopharma Chief Executive Officer (CEO) Dr. Kathleen Clarence-Smith said, "In collaboration with the experts from the University of Minnesota Masonic Cancer Center, GT Biopharma continues to advance the search for next generation anti-cancer treatments, especially on novel ways to enhance the cancer-killing capabilities of NK cells. In my view, the potential for the success of this immunotherapy approach is substantial and the possibility of extending it to solid tumors gives us even added hope."

GT Biopharma Executive Chairman Anthony J. Cataldo said, "This is another milestone achievement for the company as we continue to close out a very productive 2017."