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 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 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."

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 26, 2016 Inivata Limited, a clinical cancer genomics company employing the precision of circulating tumour DNA ("ctDNA") analysis to improve personalized healthcare in oncology, reported the completion of a Series A fundraising of £31.5 Million ($45M) (Press release, Cancer Research Technology, JAN 26, 2016, View Source [SID1234523507]). Existing investors Imperial Innovations, Cambridge Innovation Capital, and Johnson & Johnson Innovation – JJDC, Inc. all participated in the round, as did new investor Woodford Patient Capital Trust.

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"Since Inivata’s seed funding sixteen months ago, the market has seen an explosion of interest and funding in liquid biopsy research. With our early presence in Cambridge, UK and our imminent presence in the USA, we are well-placed to be forerunners in the practical application of liquid biopsy for clinical oncologists," said Michael Stocum, Chief Executive Officer of Inivata. "We are grateful to our existing investors for their continued strong support of Inivata and very pleased to welcome Woodford Patient Capital Trust to augment what is already a very strong investor base. Our mission is to partner with oncologists to revolutionize cancer treatments and outcomes for their patients – part of a new landscape of personalized healthcare."

The new funds will be used to accelerate clinical studies to validate Inivata’s technology platform based on enhanced TAm-Seq, and commercialize the company’s first products. Inivata’s platform will initially be applied across a spectrum of solid tumors, including lung, breast and colon cancer to demonstrate the integration of genomic information with clinically actionable decision-making, thereby defining a personalized approach to cancer care.

"Inivata has advanced significantly since inception and is poised to become a leader in the rapidly-growing field of ctDNA analysis," said Rob Woodman, Director of Healthcare Investments at Imperial Innovations. "This fundraising reflects the great progress the company has made in developing innovative molecular profiling and monitoring products that will have real impact on patient care, and will help strengthen the platform for the company to roll these products out."

Inivata’s proprietary technology represents a new generation of non-invasive molecular profiling from a simple blood draw that is poised to impact the major aspects of a patient’s care including diagnosis, prognosis, treatment stratification and response monitoring. The test, which allows precise analysis of cancer-related mutations present in ctDNA, is designed to provide oncologists with clinically actionable genomic information to guide therapy selection, monitor treatment progress and, importantly, detect new mutations as they emerge. The genomic analysis of ctDNA has the potential to transform cancer care and resolve many of the limitations inherent in current tissue-based testing protocols that are highly invasive and are not amenable to serial monitoring in routine practice. Inivata’s platform is based on pioneering research from the Rosenfeld Lab at the Cancer Research UK Cambridge Institute (CRUK-CI) and to date, Inivata has demonstrated putative clinical utility of enhanced TAm-Seq through published clinical work presented at multiple cancer conferences in the fall of 2015.

"We have been impressed with the results thus far from Inivata’s initial clinical studies that highlight the sensitivity and accuracy of the Company’s ctDNA platform. Inivata is already working with a strong network of clinicians in both Europe and the United States and this new funding will allow the company to accelerate its clinical validation and commercialization efforts," said Robert Tansley of Cambridge Innovation Capital.