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

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 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, 2018 Catalent, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, and Triphase Accelerator Corporation, a company dedicated to acquiring and developing novel therapeutics for the treatment of cancer, reported that Triphase will obtain worldwide rights to further develop Catalent’s proprietary CD22-4AP Antibody-Drug Conjugate (ADC), which has been developed by Catalent’s wholly owned subsidiary, Redwood Bioscience, Inc., using its SMARTagTM technology platform (Press release, Catalent, OCT 4, 2016, https://biologics.catalent.com/index.php/news-events/news/Catalent-Biologics-and-Triphase-Accelerator-Corporation-Announce-License-Agreement-to-Advance-SMARTag-ADC-to-Clinic [SID1234530208]).

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Catalent will receive an upfront payment and has the potential to earn additional development and commercial milestone payments, plus a royalty on product sales. Triphase will also contract with Catalent for development, manufacturing and analytical services to support a fast path to clinic.

CD22-4AP is a novel, site-specific ADC, targeting CD22, a B-cell restricted sialoglycoprotein that is an important modulator of B-cell signaling and survival, which is expressed on 90% of B-cell malignancies. CD22 is a clinically validated ADC target with potential in Non-Hodgkin’s Lymphoma (NHL) and Acute Lymphoid Leukemia (ALL). Catalent’s ADC, CD22-4AP, is a site-specific modified humanized antibody conjugated to a toxin payload using Catalent’s proprietary Hydrazino-Pictet-Spengler (HIPSTM ) chemistry and proprietary 4AP linker.
Pre-clinical data has shown that this optimization of payload placement and linker composition, combined with the stability afforded by HIPS chemistry, leads to better tolerability and expanded therapeutic index.

Dr. Mohit Trikha, Chief Scientific Officer, Executive Vice President and Head of R&D at Triphase, commented, "Given our deep experience in investigating potential treatment for blood cancers and oncology clinical drug development, it is a logical progression for us to explore other approaches for other hematologic tumors. We believe in the potential of Catalent`s SMARTag technology and look forward to advancing CD22-4AP to clinical proof of concept studies.

"Triphase has demonstrated expertise and a track record in advancing pre-clinical oncology candidates to clinical proof of concept," added Mike Riley, Catalent Biologics’ Vice President & General Manager. "We look forward to leveraging Triphase`s expertise in combination with our proprietary SMARTag technology and supporting infrastructure to bring this potentially transformational treatment to patients."

ABOUT THE SMARTAGTM TECHNOLOGY
The proprietary SMARTag site-specific protein-modification and linker technologies were developed by Redwood Bioscience to enable the generation of homogenous bioconjugates engineered to enhance potency, safety and stability. The technology employs natural post-translational modifications found in human cells to create one or more aldehyde tags at designated sites on protein molecules. These chemical "handles" are then stably conjugated to payloads (e.g., cytotoxic or effector) to prevent their systemic release. The SMARTag platform provides precise payload positioning, stable, site-specific conjugation and defined stoichiometry of drug-protein ratios. The control afforded by the technology enables identification of superior drugs from libraries of differentially designed conjugates. Catalent acquired Redwood Bioscience in 2014.

On October 3, 2016, Clovis Oncology, Inc. ("Clovis") and Lonza Ltd ("Lonza") reported that it entered into a Manufacturing Services Agreement (the "Agreement") for the long term manufacture and supply of the active pharmaceutical ingredient ("API") for rucaparib (Press release, Clovis Oncology, OCT 3, 2016, View Source [SID:SID1234515608]). The terms and conditions of the Agreement are contingent upon the approval by the U.S. Food and Drug Administration of the initial New Drug Application for rucaparib, unless triggered earlier by Clovis. Clovis and Lonza are parties to a Development and Manufacturing Agreement, dated February 8, 2013, as amended, under which Lonza has supplied rucaparib API for clinical development.

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The Agreement provides that Lonza will be a non-exclusive manufacturer of the rucaparib API during the term of the Agreement, which expires on December 31, 2025, unless extended by mutual written consent of the parties. Under the Agreement, Lonza will construct, in an existing Lonza facility, a production train that will be exclusively dedicated to the manufacture of the rucaparib API. The dedicated production train will provide manufacturing capacity to meet Clovis’ currently anticipated needs for commercial supply of rucaparib API.

Clovis is obligated to make scheduled capital program fee payments towards capital equipment and other costs associated with the construction of the dedicated production train and, once the facility is operational, Clovis is obligated to pay a fixed facility fee each quarter for the duration of the Agreement.

Pursuant to the terms of the Agreement, Lonza will manufacture and store an advanced intermediate to be used in the subsequent production of the rucaparib API. Clovis will pay fixed fees on a per kilogram basis for quantities of the advanced intermediate and the rucaparib API ordered by Clovis under the Agreement, subject to certain adjustments. Until the dedicated facility is completed and operationally qualified, Lonza will manufacture the rucaparib API in existing Lonza facilities at pricing established in the Agreement.

Either party may terminate the Agreement due to a material breach of the Agreement by the other party, subject to prior written notice and a cure period. Clovis may terminate the Agreement, subject to 90 days’ prior written notice, in the event rucaparib is withdrawn from the market for certain reasons. In the event of such a termination by Clovis, or termination by Lonza due to material breach by Clovis, Clovis is obligated to compensate Lonza for any services rendered, or for which costs have been incurred by Lonza in anticipation of services to be provided to Clovis, and to pay to Lonza the remaining amount of any capital program fees and quarterly fixed facility fees for the remainder of the term of the Agreement. In the event the Agreement is terminated by Clovis due to material breach by Lonza, Lonza is obligated to repay all or a portion of the capital program fees previously paid by Clovis.

The foregoing is only a summary of certain provisions of the Agreement and is qualified in its entirety by the terms of the Agreement, a copy of which will be filed as an exhibit to Clovis’ annual report on Form 10-K for the year ending December 31, 2016. Clovis intends to submit a Confidential Treatment Request to the SEC pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended, requesting confidential treatment of certain portions of the Agreement.