On October 4, 2016 EUSA Pharma (EUSA), a specialty pharmaceutical company with a focus on oncology and oncology supportive care, reported the acquisition of exclusive global commercialization rights to the oncology product dinutuximab beta from Apeiron Biologics (Press release, EUSA Pharma, OCT 4, 2016, View Source [SID1234527664]). Dinutuximab beta is currently used as part of the regimen for the treatment of high risk neuroblastoma in Europe and is available under a managed access program. The immunotherapy has orphan drug designation in the US and EU and is currently under review for marketing authorization by the EMA. EUSA expects to file the product for registration in the US and Japan in 2017.

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Under the terms of the agreement, EUSA Pharma will pay Apeiron an upfront fee, with a portion contingent on EU approval. EUSA will also pay regulatory milestone payments in other key territories and royalties on future product sales.

Neuroblastoma is an orphan oncology indication with significant unmet medical need. It accounts for up to 10% of childhood tumors and affects approximately 1,200 children in the EU5 and US each year. Consequently, EUSA Pharma intends to continue dinutuximab beta’s managed access program, and once approved in Europe will promote the immunotherapy to oncologists through its specialty sales team. In the United States, the company plans to submit a regulatory filing in 2017, and once approved will commercialize the product directly through its established US infrastructure. In other territories, including Japan, EUSA plans to bring the product to market through its international network of partners.

"We are delighted to acquire the global rights to dinutuximab beta, which is a perfect fit with our strategic focus in the specialty oncology field and will allow us to leverage our commercial infrastructure in the EU and expand our presence in the US," said Lee Morley, EUSA Pharma’s Chief Executive Officer. "Dinutuximab beta is already used extensively across Europe, where it is included in a number of treatment protocols, and we look forward to bringing this life saving therapy to patients around the world. As a rapidly growing specialty pharma company we have made great progress since our launch 18 months ago, and we plan to continue this through further product acquisition and in- licensing."

"EUSA Pharma is the ideal partner to bring dinutuximab beta to market, with its strong focus on oncology and specialty commercial expertise in Europe, the US and further afield," said Dr. Hans Loibner, Apeiron Biologic’s Chief Executive Officer. "Dinutuximab beta is an important treatment in an area of significant unmet need, which we have developed together with our academic partners, in particular with the cooperative group SIOPEN, and we look forward to working with EUSA to make this product available around the world."

On October 4 , 2016 – Affimed N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company focused on discovering and developing highly targe ted cancer immunotherapies, announced today the presentation of preclinical data on the Company’s lead candidate AFM13 , a bispecific NK – cell – engaging TandAb targeting CD30/CD16A , at the 16th Annual Meeting of the Society for Natural Immunity in Taormina, Italy (Press release, Affimed, OCT 4, 2016, View Source [SID1234515989]).

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The data, generated in Affimed’s collaboration with the Innate Immunity Group of Dr. Adelheid Cerwenka at the German Cancer Research Center (DKFZ) in Heidelberg, Germany, were presented in a poster ti tled " The bispecific CD3 0/CD16A TandAb AFM13 amplifies the cytolytic and proliferative potential of NK – cells " yesterday, October 3, 2016 .

In this preclinical study, the specific phenotype and functionality of human NK – cells when redirected to AFM13 – coated tumor cells, as well as their responsiveness to cytokines , were analyzed. The results show that AFM13 improves NK – cell cytotoxicity against CD30+ tumor cells that are resistant to naïve NK – cells. Using CFSE – labelled NK – cells, the researchers demonstrated that AFM13 amplifies cytokine – mediated NK – cell proliferation and expansion by enhancing the NK – cells’ sensitivity to IL – 2 and IL – 15. These data indicate that cytokine administration in combination with AFM13 might potentially enhance NK – cell activity in the tumor microenvironment.

AFM13 is a tetravalent bispecific TandAb antibody that binds bivalently to both CD30 on tumor cells and CD16A on NK – cells. The molecule has been shown to engage NK – cells through CD16A with high affinity and specificity, resulting in strong NK – cell – mediated cytotoxicity. AFM13 is currently being tested in Hodgkin lymphoma patients as a monotherapy (Phase 2) and in combination with Merck’s Keytruda (Phase 1b).

On October 4, 2016 Myriad Genetics, Inc. (NASDAQ:MYGN) and The US Oncology Network (The Network) reported that The Network has selected Myriad Genetic Laboratories as its preferred provider laboratory for hereditary cancer testing (Press release, Myriad Genetics, OCT 4, 2016, View Source [SID:SID1234515587]). The US Oncology Network is one of the nation’s largest networks of integrated, community-based, and independent physician practices dedicated to advancing high-quality, evidence-based cancer care. With more than 1,000 affiliated physicians in 19 states, providers in The Network treat over 800,000 patients every year.

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As part of the collaboration, Myriad and The US Oncology Network will work together to perform hereditary cancer research through the Genetic Risk Evaluation and Testing (GREAT) program within The Network affiliated practices. Under this program, the two organizations will collaborate to create a database that links patient outcomes with genetic test results. Principal among the research aims of this program is to better understand the genotype-phenotype correlation, gene prevalence, and research related to improving patient counselling and access to testing. The scale achieved by combining the largest hereditary cancer testing laboratory in the world with the more than 350 sites of care affiliated with The US Oncology Network will lead to unprecedented insights into the field of oncology.

"We are excited to work with Myriad as they have been a pioneer in personalized medicine for more than 25 years and have an unmatched reputation for diagnostic accuracy and customer service," said Michael Seiden, MD, PhD, chief medical officer of The US Oncology Network. "Additionally, Myriad’s expertise and scientific leadership, having authored or co-authored over 50 peer-reviewed publications in the last three years, makes them an ideal research collaborator for The US Oncology Network."

"We are exceptionally pleased to work with The US Oncology Network, and are honored by their recognition of Myriad as a preferred provider laboratory," said Johnathan M. Lancaster, MD, PhD, chief medical officer of Myriad Genetic Laboratories, Inc. "We share with The Network an absolute commitment to the highest possible quality of clinical care. We will continue to invest in both research and customer service, which set Myriad apart as the industry gold-standard for hereditary cancer testing."

On October 4, 2016 Cascadian Therapeutics (NASDAQ:CASC), a clinical-stage biopharmaceutical company, reported that its board of directors has approved a plan for a reverse split of the Company’s common stock to increase its share price and reduce the number of authorized and outstanding shares (Press release, Cascadian Therapeutics, OCT 4, 2016, View Source [SID:SID1234515581]).

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"The board and management have worked diligently on several facets of the Company this year to position it for the future, including bringing in new management, and solidifying our product development and regulatory strategies. With this action, we are helping ensure that the necessary financial structure is in place to execute our plans," said Scott Myers, President and CEO of Cascadian Therapeutics. "We believe this proposed change will make our stock accessible to a wider range of institutional investors, benefiting all stockholders."

Cascadian is advancing tucatinib (ONT-380), its lead product candidate in Phase 2 development for HER2+ metastatic breast cancer patients, with and without brain metastases. The Company plans to report updated clinical data from its Phase 1b tucatinib combination study with capecitabine and trastuzumab at the San Antonio Breast Cancer Symposium in December. It also expects to provide an update during the fourth quarter on its regulatory strategy for tucatinib.

Cascadian plans to hold a special meeting on November 18, 2016 at the Company’s headquarters to obtain stockholder approval of the reverse split, proposed at a ratio of not less than 1-for-4 and not greater than 1-for-10, and to reduce the total authorized shares of the Company’s common stock by a ratio of two times (2x) the reverse split ratio. The Company believes these proposals will provide shares to operate and fund the Company’s programs. The Cascadian board of directors will set the exact range and timing of the reverse split and share reduction of authorized common stock at its discretion following approval by stockholders and before December 31, 2016. The Company filed a preliminary proxy statement regarding the special meeting with the U.S. Securities and Exchange Commission. The preliminary proxy statement and the Company’s 2015 annual report can be accessed for free at www.sec.gov. The Company’s 2015 annual report can also be accessed for free on SEDAR in Canada. Investors are encouraged to read the preliminary proxy statement because it includes important information regarding the special meeting.

Our board of directors is soliciting proxies in connection with this special meeting. Directors and executive officers of Cascadian have no substantial interests, directly or indirectly, in the matters to be voted upon at the special meeting, except to the extent of their ownership of shares of Cascadian’s common stock and securities convertible to or exercisable for common stock.

On October 4, 2016 Corvus Pharmaceuticals, Inc. (NASDAQ:CRVS), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel immuno-oncology therapies, reported that it will present preclinical data and preliminary biomarker data from its ongoing Phase 1/1b study of CPI-444 as a single agent, and in combination with Genentech’s TECENTRIQ (atezolizumab), in poster presentation sessions at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2016 Congress, which is taking place October 7-11 at the Bella Center in Copenhagen, Denmark (Press release, Corvus Pharmaceuticals, OCT 4, 2016, View Source;p=RssLanding&cat=news&id=2209051 [SID:SID1234515572]).

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The ESMO (Free ESMO Whitepaper) abstracts are now available at www.esmo.org. Following are details for each poster presentation.

SUNDAY, OCTOBER 9
ABSTRACT #: 1068P
ABSTRACT TITLE: Adenosine A2A receptor antagonist, CPI-444, blocks adenosine-mediated T cell suppression and exhibits anti-tumor activity alone and in combination with anti-PD-1 and anti-PD-L1
POSTER PRESENTER: Stephen Willingham, Ph.D., Senior Scientist, Corvus
POSTER PRESENTATION TIME: 13:00-14:00 CEST
POSTER DISPLAY LOCATION: Hall E

ABSTRACT #: 1105TIP
ABSTRACT TITLE: Phase 1/1b multicenter trial of the adenosine A2a receptor antagonist (A2aR) CPI-444 as single agent and in combination with atezolizumab (ATZ) in patients (Pts) with advanced cancers
POSTER PRESENTER: Ginna G. Laport, M.D., Vice President, Clinical Development, Corvus
POSTER PRESENTATION TIME: 13:00-14:00 CEST
POSTER DISPLAY LOCATION: Hall E

MONDAY, OCTOBER 10
ABSTRACT #: 389P
ABSTRACT TITLE: Biomarker and clinical activity of CPI-444, a novel small molecule inhibitor of A2A receptor (A2AR), in a Phase 1b study in advanced cancers
POSTER PRESENTER: Ian McCaffery, Ph.D., Vice President, Translational Sciences, Corvus
POSTER PRESENTATION TIME: 13:00-14:00 CEST
POSTER DISPLAY LOCATION: Hall E