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Affimed Presents Preclinical Data on Lead Candidate AFM13 at the Annual Meeting of the Society for Natural Immunity

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).

The US Oncology Network Selects Myriad Genetics as Preferred Provider for Hereditary Cancer Testing

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.

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."

Cascadian Therapeutics Announces Proposal for Reverse Stock Split

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]).

"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.

Corvus Pharmaceuticals to Present Data on Lead Oral Checkpoint Inhibitor CPI-444 at ESMO 2016 Congress

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]).

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

Asana BioSciences Announces Acceptance of Its Third IND Application in Oncology

Asana BioSciences, LLC, an oncology-focused, clinical stage biopharmaceutical company, reported that the FDA has accepted the IND application for ASN003, a selective RAF/PI3K inhibitor (Press release, Asana BioSciences, OCT 4, 2016, View Source [SID:SID1234515590]).

"We are extremely pleased with the execution of our strategy to work on clinically validated targets and develop drugs that are clearly differentiated from the competition," said Sandeep Gupta, PhD, Founder, President and Chief Executive Officer at Asana BioSciences. Using a unique, virtual and efficient operating model, Asana is focused on the development of ‘best-in-class’ drugs that are expected to offer significant benefit over the existing standards of care and address unmet medical needs. "To the best of our knowledge, ASN003 is the only molecule in development that selectively targets both RAF and PI3 kinase pathways. This program represents Asana’s 3rd successful IND in oncology in less than two years, and several other lead molecules from our pipeline are positioned to enter clinical development in the near future," stated Dr. Gupta.

The Phase I, open-label, dose-finding and cohort expansion study will evaluate safety and tolerability of ASN003 as well as preliminary efficacy in patients with advanced solid tumors with RAF or PI3K pathway alterations. The RAS-RAF-MEK and PI3K pathways are two major signaling pathways involved in abnormal cell growth and are frequently mutated in melanoma and other cancers, such as colon and lung cancer. Dual targeting of RAF and PI3K pathways with ASN003 has the potential to overcome and/or delay acquired resistance to selective RAF inhibitors and may thus result in improved activity against cancers driven by both pathways.

Asana’s other lead candidates, ASN001 and ASN002, are in Phase I/II clinical development. ASN001, a novel and highly selective CYP17 inhibitor that does not require prednisone co-administration, targets metastatic castration resistant prostate cancer. ASN002 is a novel oral inhibitor of spleen tyrosine kinase (SYK) and Janus kinase (JAK), which is currently in Phase I/II studies in patients with non-Hodgkin’s lymphoma and solid tumors. Evaluation of ASN002 in autoimmune disease indications is also being planned. Both these programs are approaching the end of dose-finding phase of the trials, and Asana expects to announce initial safety and efficacy results early next year. ASN004 is an antibody drug conjugate (ADC) targeting 5T4-oncofetal antigen that selectively and efficiently delivers a cytotoxic agent into tumor cells, resulting in potent, selective anti-proliferative activity and complete tumor regression in multiple tumor models including breast, lung and colon. ASN007 is a novel ERK inhibitor that shows potent activity against multiple KRAS mutant driven tumor models. These programs will enter clinical development in 2H 2017.