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Exosome Diagnostics Presented the Highest Sensitivity Liquid Biopsy Test for Lung Cancer

On December 21, 2016 Exosome Diagnostics, Inc. reported data that sets a new standard for EGFR-T790M resistance mutation detection in lung cancer, with the highest sensitivity reported to date (Press release, Exosome Diagnostics, DEC 21, 2016, View Source [SID1234517160]). This test is being developed to improve care and outcomes for the large population of patients who can benefit from second line EGFR Tyrosine Kinase Inhibitor (TKI) therapy but are missed with currently available tissue and liquid biopsy tests. Clinical validation data from a cohort of 160 patients, the largest of its kind in this patient population, was presented in plenary session during the recent AACR (Free AACR Whitepaper)-EORTC-NCI meeting in Munich, Germany. ExoDx Lung(T790M) has been optimally designed for ExosomeDx’s high throughput biomarker testing platform that is being deployed in 2017.

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Twenty percent of non-small cell lung cancer (NSCLC) patients test positive for an EGFR driver mutation (approximately 45,000 patients in the U.S. alone) and receive EGFR TKI therapy. Unfortunately, most will develop a resistance to EGFR TKI therapy. Tissue biopsies are the current standard for identifying T790M resistance. If a patient tests positive, they are eligible for treatment with a second line EGFR TKI therapy. Unfortunately, a tissue biopsy is not always a viable option for a large percentage of these patients.

Non-invasive liquid biopsies have emerged as a viable alternative for patients unable to have tissue biopsy procedure. Clinical studies have demonstrated that the FDA approved cobas test for liquid biopsy, only identifies 59% of patients who will respond to a second line EGFR TKI therapy. This is a direct result of lack of sensitivity and inability to test challenging intrathoracic disease. By analyzing exosomal RNA (exoRNA) and cell free tumor DNA (ctDNA) from the same sample Exosome Dx addresses current limitations by identifying 96% of the T790M positive population, with no loss of sensitivity in patients with intrathoracic disease.

"EGFR T790M mutations have previously been challenging for liquid biopsy assays. In this clinical study, we show that ExoDx Lung(T790M) has a higher clinical sensitivity and specificity than what has been reported to date for the FDA cleared test distributed by Roche. This study further demonstrates the power of our ExoLution Plus platform that combines exoRNA plus ctDNA. This result was not surprising since we have shown superior performance to ctDNA across several disease states in blinded head to head studies. Clinical samples are precious so we are thrilled to be able to offer a more sensitive test that take both exoRNA and ctDNA into consideration,"stated Dr. Johan Skog, Chief Scientific Officer at Exosome Diagnostics.
The test is the latest in a series of biofluids based diagnostic and companion diagnostic biomarker tests being developed by Exosome Diagnostics to potentially aid in therapy selection and patient monitoring in oncology and other diseases.

To assure future access to the company’s novel biomarker tests worldwide, Exosome Diagnostics also announced that it has developed a high throughput version of its proprietary ExoLution Plus system to prepare samples that can be analyzed with exoRNA and cfDNA analysis test kits. This system utilizes Exosome Diagnostics’ patented technology and has been developed with high throughput capability to be integrated with leading clinical laboratory analytical systems including those marketed by Roche and Thermo Fisher

"This data illustrates one of the many indications for which Exosome Diagnostics can leverage its extremely sensitive liquid biopsy technology to improve patients’ lives by guiding therapy, where other technologies could not in a reliable fashion" stated John Boyce, President and CEO of Exosome Diagnostics. "Exosome Diagnostics has proven that its technology is extremely robust and can scale on a variety of existing commercial platforms in diagnostic laboratories," Boyce continued.

Astellas Completes Acquisition of Ganymed Pharmaceuticals

On December 21, 2016 Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, "Astellas" ) reported that it has completed the acquisition of Ganymed Pharmaceuticals AG ("Ganymed"), a biopharmaceutical company located in Mainz, Germany, and Ganymed has become a wholly owned subsidiary of Astellas as of CET December 20, 2016 (Press release, Astellas, DEC 21, 2016, View Source [SID1234517149]).

Under the agreement executed between Astellas and Ganymed’s shareholders, Astellas paid EUR 422 million to acquire 100% of the equity in Ganymed. In addition, Ganymed’s shareholders will become eligible to receive up to EUR 860 million in further contingent payments based on progress in the development of IMAB362, Ganymed’s most advanced clinical program.

Through the acquisition, Astellas will expand its oncology pipeline with antibody program in the late-stage to build upon its leading oncology franchise as a platform for sustainable growth.

Astellas is still reviewing the impact of the completion of the acquisition on its financial results for the fiscal year ending March 31, 2017.

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Can-Fite Receives $500,000 Payment as Part of $3 Million Distribution Deal for Liver Cancer Drug Namodenoson (CF102) in South Korea

On December 21, 2016 Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE:CFBI), a biotechnology company with a pipeline of proprietary small molecule drugs being developed to treat inflammatory and liver diseases, cancer, and sexual dysfunction, reported it has received its first payment of $500,000 from Chong Kun Dang Pharmaceuticals (CKD) (Korean Stock Exchange: 185750.KS) (Filing, 6-K, Can-Fite BioPharma, DEC 21, 2016, View Source [SID1234517146]). Can-Fite recently announced entering a distribution agreement with CKD for the exclusive right to distribute Namodenoson (CF102) for the treatment of liver cancer in South Korea, upon receipt of regulatory approvals, for up to $3,000,000 in upfront and milestone payments, plus royalties on net sales of 23%.

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"We are pleased to receive this upfront payment of $500,000 from CKD and look towards future potential milestone payments as we advance Namodenoson through completion of our current Phase II trial as a second line treatment for hepatocellular carcinoma and into Phase III," stated Can-Fite CEO Dr. Pnina Fishman.

Per the terms of the distribution agreement, Can-Fite will deliver finished product to CKD and CKD has a right of first refusal to distribute Namodenoson for other indications for which Can-Fite develops Namodenoson.

Can-Fite is currently conducting a global Phase II double-blind, placebo controlled study evaluating the efficacy of Namodenoson as a second-line treatment for advanced HCC. The primary endpoint is overall survival. In the coming quarters, Can-Fite intends to initiate a Phase II study of Namodenoson in the treatment of non-alcoholic fatty liver disease (NAFLD), the precursor to non-alcoholic steatohepatitis (NASH).

About Namodenoson (CF102)

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug. In Can-Fite’s pre-clinical and clinical studies, Namodenoson has demonstrated a robust anti-tumor effect via deregulation of the Wnt signaling pathway, resulting in apoptosis of liver cancer cells. Based on preclinical data showing Namodenoson has strong liver protective properties, Can-Fite intends to initiate a Phase II study in NASH. Can-Fite has received Orphan Drug Designation for Namodenoson in Europe and the U.S., as well as Fast Track Status in the U.S. as a second line treatment for hepatocellular carcinoma.

BeiGene Announces First Patient Dosing in China with Investigational PARP Inhibitor BGB-290

On December 21, 2016 BeiGene, Ltd. (NASDAQ:BGNE), a clinical-stage biopharmaceutical company developing molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported the dosing of the first patient in a Phase I clinical trial of BGB-290, a potent and selective PARP inhibitor, in Chinese patients with advanced solid tumors (Press release, BeiGene, DEC 21, 2016, View Source [SID1234517156]).

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"We are pleased to announce the start of clinical development for BGB-290 in China, and we look forward to its rapid development following this Phase I study. BGB-290 entered clinical evaluation in Australia in July 2014, and proof of principle data were presented at the AACR (Free AACR Whitepaper)-NCI-EORTC meeting in 2015. We look forward to developing BGB-290 for patients in China, where this class of agents is still not available," commented John V. Oyler, Founder, Chief Executive Officer, and Chairman.

The Phase I open-label, multi-center dose escalation and expansion study of BGB-290 is designed to investigate the safety, pharmacokinetics, and antitumor activity of BGB-290 in Chinese patients with advanced solid tumors and to determine the recommended Phase II dose in these patients. Professor Binghe Xu from The Chinese Academy of Medical Sciences Cancer Hospital is the principal investigator of the study.

About BGB-290

BGB-290 is a potent and highly selective inhibitor of PARP1 and PARP2. BGB-290 is being developed as a monotherapy and in combination with other therapies for the treatment of several cancers including ovarian cancer, prostate cancer, breast cancer, glioblastoma multiforme, small cell lung cancer, and gastric cancer.

Incyte and Merus Announce Global Strategic Research Collaboration to Discover and Develop Bispecific Antibodies

On December 21, 2016 Incyte Corporation (NASDAQ:INCY) and Merus N.V. (NASDAQ:MRUS) reported that they have entered into a global, strategic collaboration agreement focused on the research, discovery and development of bispecific antibodies utilizing Merus’ proprietary Biclonics technology platform (Press release, Incyte, DEC 21, 2016, View Source [SID1234517155]). The Collaboration and License Agreement grants Incyte the exclusive rights for up to eleven bispecific antibody research programs, including two of Merus’ current preclinical immuno-oncology discovery programs.

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Biclonics retain the IgG format of antibodies that are produced naturally by the immune system and, by binding to two targets, enable multiple modes of action that cannot otherwise be obtained with conventional monoclonal antibodies.

"By virtue of a unique ability to simultaneously engage multiple protein targets, we believe bispecific antibodies have the potential to play an important role in the future of biotherapeutics," said Reid Huber, Ph.D., Incyte’s Chief Scientific Officer. "This collaboration with Merus expands our large molecule discovery capabilities into an innovation-rich area of research, creating additional opportunities for us to deliver on our commitment to improving and extending the lives of patients with cancer and other serious diseases."

"This transformative, global collaboration further underscores the potential of Merus’ Biclonics technology platform and establishes a strong relationship with Incyte, a leader in innovative drug development," said Ton Logtenberg, Ph.D., Chief Executive Officer of Merus. "We look forward to expanding our pipeline under this agreement, as we efficiently exploit our preclinical discovery engine and progress our most advanced, proprietary assets in the clinic."

Terms of the Collaboration
Under the terms of the collaboration, Incyte has agreed to pay Merus an upfront payment of $120 million. In addition, Incyte has agreed to purchase 3.2 million shares of Merus stock at $25 per share, for a total equity investment of $80 million.

The parties have agreed to collaborate on the development and commercialization of up to 11 bispecific antibody programs. For one current preclinical program, Merus will retain all rights to develop and commercialize approved products in the United States, and Incyte will develop and commercialize approved products arising from the program outside the United States. Following any regulatory approval of a product candidate for this particular pre-clinical program, each company has agreed to pay the other tiered royalties ranging from 6 to 10 percent on net sales of products in their respective territories.

Merus also has the option to co-fund development of product candidates arising from two other programs. For any program for which Merus exercises its co-development option, Merus would be responsible for 35 percent of global development costs in exchange for a 50 percent share of U.S. profits and losses and tiered royalties ranging from 6 to 10 percent on ex-U.S. sales by Incyte for these programs. Merus also has the right to elect to provide up to 50 percent of detailing activities for product candidates arising from one of these programs in the United States.

For each of the other eight programs, Incyte has agreed to independently fund all development and commercialization activities. For these programs, Merus will be eligible to receive potential development, regulatory and sales milestone payments of up to $350 million per program, which could result in an aggregate milestone opportunity of approximately $2.8 billion if all development, regulatory and sales milestones are achieved across all such eight other programs in all territories. Merus will also be eligible to receive tiered royalties ranging from 6 to 10 percent on global sales of any approved products under these eight programs.

Merus will retain rights to both of its clinical candidates and MCLA-158, as well as its technology platform and future programs emerging from Merus’ platform that are outside the scope of this agreement.

The transaction is expected to close in the first quarter of 2017, subject to the early termination or expiration of any applicable waiting periods under the Hart-Scott Rodino Act and customary closing conditions.