On January 27, 2016 Varian Medical Systems (NYSE: VAR) reported non-GAAP net earnings of $0.99 per diluted share and GAAP net earnings of $0.91 per diluted share for the first quarter of fiscal year 2016 (Press release, Varian Medical Systems, JAN 27, 2016, View Source [SID:1234508883]). Varian’s revenues totaled $757 million for the first quarter, up 3 percent from the year-ago quarter and up 7 percent in constant currency. The company ended the quarter with a $3.3 billion backlog, up 7 percent from the end of the first quarter of fiscal year 2015.

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"Company revenues and earnings came in ahead of expectations for the first quarter," said Dow Wilson, CEO of Varian Medical Systems. "Revenue growth was driven by our Oncology Systems and Particle Therapy businesses while the Imaging Components business continued to experience expected pressures on revenues. Our earnings performance was helped by our revenue growth as well as strong SG&A cost controls and an R&D tax credit."

The company finished the first quarter of fiscal year 2016 with $953 million in cash and cash equivalents and $728 million of debt. Cash flow from operations was $77 million for the first quarter. During the quarter, the company spent $192 million to repurchase about 2.4 million shares of common stock.

Oncology Systems

Oncology Systems’ first quarter revenues totaled $589 million, up 5 percent from the same quarter of fiscal year 2015 and up 9 percent in constant currency. First-quarter Oncology gross orders were $533 million, down 5 percent from the year-ago quarter and down 1 percent in constant currency. In the Americas, Oncology gross orders increased by 3 percent in dollars and in constant currency. In EMEA, gross orders were down 14 percent in dollars and down 5 percent in constant currency. In APAC, gross orders declined by 12 percent in dollars and fell 7 percent in constant currency.

"On a constant currency basis, Oncology had strong revenue growth driven by EMEA and APAC while gross orders declined in these regions, reflecting slow market activity during the quarter," Wilson said.

Imaging Components

Imaging Components revenues were $141 million for the first quarter, down 15 percent from the year-ago period. Gross orders were $127 million for the first quarter, down 22 percent from the year-ago period.

"As expected, volumes in all product lines declined in the Imaging Components business," said Wilson. "Beginning in the second half of last fiscal year, this business has been confronted with currency-related pricing pressures, weak market conditions for security and inspection products and the loss of a customer who has insourced panels. Inventory reduction at a major customer contributed to slower tube sales during the quarter. Growth from newly acquired components businesses partially offset the overall decline in Imaging Components."

Other

The company’s Other category, including the Varian Particle Therapy business and the Ginzton Technology Center, recorded revenues of $27 million for the first quarter from ongoing proton therapy installations. "The sales funnel for the Particle Therapy business continues to look promising," Wilson said.

Outlook

"Including the effects of the R&D tax credit re-enactment and the suspension of the medical device excise tax in the U.S., we now believe that for fiscal year 2016 total company non-GAAP earnings will be in the range of $4.55 to $4.65 per diluted share," said Wilson. "We continue to expect that revenues for fiscal year 2016 will increase by about 4 to 5 percent over fiscal year 2015. For the second quarter of fiscal year 2016, we expect revenues to be up one to two percent from the year-ago quarter in dollars. We expect non-GAAP earnings for the second quarter of fiscal year 2016 to be in the range of $1.06 to $1.10 per diluted share."

Please refer to "Discussion of Non-GAAP Financial Measures" below for a description of items excluded from expected non-GAAP earnings.

On January 27, 2016 OncoCyte Corporation (NYSE MKT: OCX), a developer of novel, non-invasive blood based tests for the early detection of cancer, and The Wistar Institute, an international biomedical research leader in cancer, immunology and infectious diseases, have entered into a definitive global licensing agreement for a simple, non-invasive, blood test to aid physicians in the early detection of lung cancer(Press release, BioTime, JAN 27, 2016, View Source;p=RssLanding&cat=news&id=2132555 [SID:1234508871]). The agreement provides OncoCyte the exclusive rights to commercialize this lung cancer diagnostic test.

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Since 2013, OncoCyte and Wistar have been collaborating on product development of the lung cancer diagnostic test. In 2015, positive interim clinical results demonstrating the high level of observed sensitivity and specificity in the assayed samples of a prototype blood test for lung cancer were presented at the American Thoracic Society International Conference. Now, both parties are finalizing this assay, which is intended to serve as a confirmatory test for patients who are at risk for lung cancer (based on a patient’s positive or suspicious results identified by low dose computed tomography (LDCT) screening). If successful scientific and technical results are achieved, OncoCyte will proceed to the test’s final validation with the goal of completing work in 2016 to enable its commercial launch.

"This global licensing agreement is an important milestone as we move toward commercializing our blood test for lung cancer," said William Annett, OncoCyte’s chief executive officer. "OncoCyte now has exclusive access to patented and unpatented technology developed at Wistar, including its scientific and technical lung cancer diagnostic expertise. This will be critical as we conclude our clinical studies, conduct the test’s validation study, and, if that work is successful, commercialize the new cancer diagnostic test. Our lung cancer test addresses a large unmet need for the estimated 10 million high risk patients in the U.S. who require annual testing. Today’s standard of care, LDCT screening, has a high false positive rate, so our lung cancer test is intended to improve patient outcomes and reduce costs to the healthcare system through the early and accurate detection of cancer."

"The signing of this licensing agreement is an additional milestone in what has been a particularly successful partnership between Wistar and OncoCyte and another step forward in realizing our common goal to develop new applications that will benefit populations that are at risk for developing lung cancer," said Louise Showe, Ph.D, professor in the Molecular and Cellular Oncogenesis Program, associate director of the Center for System’s and Computational Biology, and scientific director of the Bioinformatics Facility and the Genomics Facility at The Wistar Institute.

OncoCyte/Wistar Collaboration

This licensing agreement builds on existing collaborations between OncoCyte and Wistar including previously announced sponsored research agreements entered into to develop and test potential lung cancer biomarkers identified by Dr. Louise Showe. In August 2015, Wistar and OncoCyte announced an expanded agreement to continue their collaboration.

On January 27, 2016 BIND Therapeutics, Inc. (NASDAQ:BIND), a clinical-stage nanomedicine company developing targeted and programmable therapeutics called ACCURINS, reported that the iNSITE 1 trial in non-small cell lung cancer (NSCLC) with squamous histology is fully enrolled and data is expected to be available by the end of the first quarter of 2016 (Press release, BIND Therapeutics, JAN 27, 2016, View Source [SID:1234508870]). In addition, the Company reported that the iNSITE 2 trial in patients with advanced cervical cancer and head and neck cancer has completed enrollment of at least 20 patients in each cohort in the first stage of the trial. A decision is expected on whether to advance to the second stage of the study for head and neck cancer by the end of the first quarter of 2016 and early in the second quarter of 2016 for the cervical cancer cohort. Lastly, the Company announced that enrollment is being discontinued in the cholangiocarcinoma and bladder cancer cohorts in the iNSITE 2 trial due to slower than anticipated enrollment.

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Additional information on the iNSITE 1 and iNSITE 2 studies can be found at: View Source

On January 27, 2016 Kancera reported the approval of their patent covering small molecule inhibitors of PFKFB3 in the United States (Press release, Kancera, JAN 27, 2016, View Source;releaseID=1097861 [SID:1234508869]). Further, a patent application covering new chemical series in the HDAC6 project has been filed according to plan. In the ROR project, the company intends in the near future to further strengthen the patent portfolio with new highly potent ROR inhibitors.

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The PFKFB3 project: To complement the patent approved in the United States (patent number US9233946), Kancera intends during the spring to file a divisional application for the use of anti-cancer PFKFB3 inhibitors by counteracting the ability of cancer cells to repair their DNA.

The HDAC6 project: As previously reported, Kancera filed a patent application in 2014 covering new inhibitors which in laboratory studies kill both cancer cells and helper cells in tumors. In December 2014, Kancera reported that the HDAC6 inhibitors also act by an additional unique mechanism ("Target 2"), which may contribute to decrease the survival of cancer cells. Kancera has now filed a patent application (EP15201841.2) covering new potent series of compounds that only inhibit HDAC6. In order to facilitate the filing of the new patent application Kancera has, as previously announced, decided to use the opportunity to postpone the publication of the first patent application for one year.

The ROR project: In February 2015, Kancera reported that a patent application (EP15153394.0) was filed which included ca 100 examples of small-molecule ROR inhibitors, including the drug candidate KAN0439834. This patent application is now entering the international phase and Kancera will now strengthen the application by adding examples of ca 300 substances. The application will then cover substances showing more than 20 times higher potency than KAN0439834 against cancer cells from CLL patients.

About the PFKFB3 project
By blocking mechanisms which enable the cancer cells to adapt to periods of oxygen deprivation, possibilities open for new treatment strategies. Kancera’s project is based on a specific inhibition of the enzyme PFKFB3 resulting in a decreased metabolism in cancer cells, and decreased cell growth. In addition, research shows that PFKFB3 is involved in the regulation of both angiogenesis and division of cells, two critical processes that contribute to tumor growth. PFKFB3 is more common in oxygen-deficient tumor tissue compared to healthy tissue, which makes a targeted effect therapy with fewer side effects than traditional chemotherapy possible. Inhibition of PFKFB3 is expected to starve and weaken the tumor cells by reducing their glycolysis and cell division. This is a way to overcome the current problems of tumor resistance to radiation and chemotherapy. Kancera’s PFKFB3 inhibitors have also been shown to prevent DNA repair in cancer cells following e.g. radiation treatment.

About the HDAC6 project
Histone deacetylases (HDACs) are primarily involved in removing acetyl groups from the so-called histones and thereby affect how our genes are stored and activated in the cell nucleus. Some HDACs also affect the cell function outside the cell nucleus. HDAC6 belongs to this group of HDACs with a major biological role in the regulation of the cancer cell´s ability to migrate and to form metastases. The use of HDAC inhibitors in the treatment of cancer patients has so far yielded promising results, but has been limited due to severe side effects. For this reason, the pharmaceutical industry is now looking for more selective inhibitors of individual HDAC enzymes. Kancera´s discovery of selective HDAC6 inhibitors may provide a solution on how health care could take advantage of the anti-cancer effects of HDAC inhibitors without causing the patient severe side effects.

About the ROR project
ROR is a family of receptors, ROR1 and ROR2. The ROR receptors mediate signals for growth and survival. Originally ROR was linked to fetal development, but it is now known that they also contribute to cancer cell development and proliferation. Professor Håkan Mellstedt, Kancera´s co-founder and professor at the Karolinska Institute, and his colleagues have shown that Kancera´s ROR inhibitors have the ability to kill cells from tumors in pancreas and leukemia cells. Professor Mellstedt and his colleagues as well as independent researchers have shown that ROR is also active as a target in prostate, breast, skin and lung cancer.

Because ROR primarily generates a survival and growth signal to tumor cells but is inactive in healthy cells in adults, there are good prospects that a drug directed against ROR hit the tumor much harder than the surrounding healthy cells. Kancera and Professor Mellstedt have shown that inhibition of ROR leads to that cancer

On January 27, 2016 Cancer Research Technology (CRT) – the development and commercialisation arm of Cancer Research UK – reported to have entered into a license agreement with MSD, known as Merck in the US and Canada, to develop inhibitors of protein arginine methyltransferase 5 (PRMT5) (Press release, Cancer Research Technology, 27 27, 2016, View Source [SID1234523188]). These promising new drugs, which potentially have clinical applications in both cancer and non-cancer blood disorders, have been developed by the Australian Cooperative Research Centre (CRC) for Cancer Therapeutics (CTx) with support from the Wellcome Trust and CRT.​

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CRT has licensed rights to MSD on behalf of CTx – a Melbourne based CRC focused on the discovery and development of novel therapies for cancer. The programme is the result of initial research by Professor Stephen Jane at Monash University and collaboration between the CTx academic partners.

The PRMT5 protein is involved in many cellular processes including the epigenetic control of genes such as p53 – a gene that protects the cell against cancer-causing mutations and is faulty in nine out of ten cancers. High levels of PRMT5 protein are found in mantle cell lymphoma (MCL), chronic lymphocytic leukaemia (CLL), melanoma, lung and breast cancers and are linked to poor survival.

In addition to applications for cancer, PRMT5 inhibitors switch on important genes in the development of blood, which could provide disease-modifying treatment options for patients with blood disorders like sickle cell disease and beta thalassemia.

Dr Ian Street, CTx chief scientific officer, said: "We are delighted to be working with CRT and MSD to progress the PRMT5 programme to the clinic. This is why CTx was established, to leverage cutting edge research developed by Australian scientists and ensure that this knowledge is translated for the benefit of patients."

Under the terms of the license, MSD will be responsible for research and development, including clinical development, and for worldwide commercialisation of products. As part of the research and development activities, MSD has entered into a research collaboration with CTx focusing on blood disorders, which MSD will fund.

CRT will receive an upfront payment of US$15 million (around £10.5 million) and is eligible to receive potential payments of up to US$0.5 billion (around £0.35 billion) for achievement of development, regulatory and commercialisation milestones. In addition, the agreement provides for royalties on sales. All payments will be shared between CRT, CTx and the Wellcome Trust with the majority being returned to CTx and its Australian research partners.

Dr Phil L’Huillier, Cancer Research Technology’s director of business development, said: "We’re delighted to have brought together the multiple parties involved in the discovery and optimisation of this multi-purpose target and to have established this major license agreement. The deal provides potentially significant financial returns, which CRT will invest into life-saving cancer research, and most importantly will hopefully bring promising new drugs to cancer patients as well as those suffering from blood disorders where there are no effective treatment options available."

Dr Warwick Tong, CTx chief executive, said: "This is a great result for Australian science and the CRC Programme as a whole and further demonstrates what can be achieved when science and commercialisation capabilities unite."

Dr Richard Seabrook, head of business development at the Wellcome Trust, said: "We’re excited to see that the support from our Seeding Drug Discovery Award is playing a key role in moving the project forward. We hope that in time the collaboration will lead to the development of effective new treatments for haemoglobin disorders such as sickle cell and beta thalassemia, both of which are associated with significant illness and early mortality."