On December 19, 2018 MiNA Therapeutics, the pioneer in RNA activation therapeutics, reported that enrolment of the first patients treated with MTL-CEBPA in combination with Sorafenib in OUTREACH, the multi-centre Phase 1b clinical trial in patients with advanced liver cancer (Press release, MiNA Therapeutics, DEC 19, 2018, View Source [SID1234532155]). The study is designed to assess the safety, tolerability and clinical activity of MTL-CEBPA in combination with Sorafenib. OUTREACH is currently being conducted at multiple clinical trials sites in the United Kingdom, Singapore and Taiwan.

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Evaluation of MTL-CEBPA in combination with Sorafenib follows the evaluation of MTL-CEBPA as a single agent in 38 patients with advanced liver cancer. Preliminary clinical results of MTL-CEBPA as a single agent presented in June 2018 at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting showed encouraging safety, pharmacology and clinical activity. Furthermore in September 2018 at the International Liver Cancer Association (ILCA) Conference, investigators reported complete tumour responses in patients off-study when subsequently administered Sorafenib. Sorafenib is the standard of care for first line treatment of advanced liver cancer.

Robert Habib, CEO of MiNA Therapeutics, commented, "We are encouraged by our initial clinical evaluation of MTL-CEBPA as a single agent and are excited about its potential in combination with approved therapies that on their own have demonstrated only modest benefit to patients. We look forward to continue to collaborate with our clinical investigators and evaluating the combination of MTL-CEBPA and Sorafenib into the expansion of the OUTREACH trial."

MTL-CEBPA consists of a double stranded RNA formulated in a liposomal nanoparticle and is designed to activate the CEBPA gene. The CEBPA gene encodes CCAAT/enhancer binding protein alpha (C/EBP-α), a transcription factor that acts as a master regulator of cell lineage determination and differentiation in several tissues including myeloid cells, liver cells and adipose tissue. In cancer, C/EBP-α plays important roles in regulating both tumour growth and the tumour immune microenvironment.

On December 19, 2018 Genomic Health, Inc. (NASDAQ: GHDX) reported that the National Institute for Health and Care Excellence (NICE) in the United Kingdom has issued its updated guidance again recommending the Oncotype DX Breast Recurrence Score test for use in clinical practice to guide adjuvant chemotherapy treatment decisions for certain patients with early-stage breast cancer (Press release, Genomic Health, DEC 19, 2018, View Source [SID1234532154]). Further, NICE expanded its recommendation to include patients with micrometastases, indicating that some cancer cells have spread to the lymph nodes.

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"Oncotype DX is the only test that provides specific information about an individual patient’s response to chemotherapy, correctly identifying the important minority of patients who will receive substantial treatment benefit and the majority of patients who will not benefit from chemotherapy," said Simon D H Holt, Honorary Consultant Surgical Oncologist, Peony Breast Care Unit at Prince Philip Hospital in Llanelli, UK. "This test allows us to target treatment much more effectively and should be routinely used for all eligible patients."

The recommendation of the Oncotype DX Breast Recurrence Score test in NICE’s updated guidance is based on the test’s unique ability to predict who will benefit from chemotherapy and who will not. Importantly, NICE acknowledges Oncotype DX as the only test that reduces the overall number of patients who receive chemotherapy, as well as the only test supported by long-term patient outcomes evidence, including the recently published landmark TAILORx study. Further, NICE also found the Oncotype DX test to be the most cost-effective tool in guiding chemotherapy treatment.

"We believe this positive endorsement from NICE reflects the growing global recognition of the unique value Oncotype DX provides," said Torsten Hoof, senior vice president, international, Genomic Health. "As we continue to experience an increasing impact of the TAILORx study results on clinical practice, we believe we are one step closer to broadening Oncotype DX access through increased reimbursement in Western Europe and around the world."

The predictive value of the Oncotype DX Breast Recurrence Score test was also recently acknowledged by Germany’s health technology assessment body, the Institute for Quality and Efficiency in Health Care (IQWiG), which concluded that only the Oncotype DX test has sufficient evidence to guide breast cancer adjuvant chemotherapy decisions based on the TAILORx study results.

Additionally, the U.S. National Comprehensive Cancer Network (NCCN) categorized Oncotype DX as the only "preferred" test for chemotherapy treatment decision-making for node-negative, early-stage breast cancer patients in its 2018 updated treatment guidelines.

About Oncotype DX

The Oncotype DX portfolio of breast, colon and prostate cancer tests applies advanced genomic science to reveal the unique biology of a tumor in order to optimize cancer treatment decisions. The company’s flagship product, the Oncotype DX Breast Recurrence Score test, is the only test that has been shown to predict the likelihood of chemotherapy benefit as well as recurrence in invasive breast cancer. Additionally, the Oncotype DX Breast DCIS Score test predicts the likelihood of recurrence in a pre-invasive form of breast cancer called DCIS. In prostate cancer, the Oncotype DX Genomic Prostate Score test predicts disease aggressiveness and further clarifies the current and future risk of the cancer prior to treatment intervention. With more than 950,000 patients tested in more than 90 countries, the Oncotype DX tests have redefined personalized medicine by making genomics a critical part of cancer diagnosis and treatment. To learn more about Oncotype DX tests, visit www.OncotypeIQ.com, www.MyBreastCancerTreatment.org or www.MyProstateCancerTreatment.org.

On December 19, 2018 Aurinia Pharmaceuticals Inc., (NASDAQ:AUPH)(TSX:AUP) reported its Chairman and Chief Executive Officer, Richard M. Glickman, will present a company overview at the 37th Annual J.P. Morgan Healthcare Conference in San Francisco, CA on Thursday, January 10, 2019 at 10:00am PST, 1pm EST (Press release, Aurinia Pharmaceuticals, DEC 19, 2018, View Source [SID1234532153]).

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The presentation will be webcast live and can be accessed via the investor section of the Aurinia website, www.auriniapharma.com. A replay of will also be archived on the site following the event.

On December 19, 2018 Seattle Genetics, Inc. (NASDAQ:SGEN) reported that management will present at the 37th Annual J.P. Morgan Healthcare Conference on Monday, January 7, 2019 at 2:30 p.m. Pacific Time (Press release, Seattle Genetics, DEC 19, 2018, View Source [SID1234532152]). Both the presentation and question and answer session that follows at 3:00 p.m. will be webcast live and available for replay from Seattle Genetics’ website at www.seattlegenetics.com in the Investors section.

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On December 19, 2018 Sutro Biopharma, Inc. (NASDAQ: STRO), reported that the company earned $10 million in a milestone payment from Celgene triggered by the successful development of a dry powder XtractCFTM formulation, using spray drying technology, which is well established in the pharmaceutical industry (Press release, Sutro Biopharma, DEC 19, 2018, View Source [SID1234532149]). Dried XtractCFTM is a significant advancement, facilitating the commercial-scale manufacturing of protein therapeutics, using Sutro’s proprietary cell-free XpressCFTM technology for its fully owned and partnered programs.

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"We highly value the collaborative nature of our partnership with Celgene and continue to deliver on important milestones," said Sutro CEO Bill Newell. "This advancement is yet another validation of our expertise in the field and adds to our successes in developing novel antibody-drug conjugates for the treatment of cancer patients."

This collaboration was originally signed in September 2014 and amended in August 2017. According to the terms of the agreement, Celgene acquired worldwide rights to one collaboration program to reach IND status and maintains an option to obtain worldwide rights to a second collaboration program. Sutro will retain U.S. development and commercialization rights and Celgene will retain ex-U.S. rights for the remaining collaboration programs. Sutro is entitled to development and regulatory milestone payments and royalties from Celgene.

About Spray Drying Technology

Sutro’s spray drying technology is used to produce dry powders from liquids and intends to use this technology to support the company’s industrial-scale manufacturing of XtractCFTM, a proprietary cell-free extract used to produce novel protein therapeutics. Developing XtractCFTM in the form of a dry powder significantly improves manufacturing efficiency, enabling global supply chains to produce commercial-scale protein therapeutics using Sutro’s proprietary XpressCFTM technology.