On June 13, 2018 Nordic Nanovector ASA (OSE: NANO) reported that it has received approval from the Regional Committees for Medical and Health Research Ethics (REK) in Norway with regard to the Clinical Trial Application (CTA) for the Archer-1 Phase 1b trial with Betalutin (177Lu-satetraxetan-lilotomab) in combination with rituximab in second-line follicular lymphoma patients (2L FL) (Press release, Nordic Nanovector, JUN 13, 2018, View Source [SID1234553498]).

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Nordic Nanovector has now received all necessary approvals to begin Archer-1 in Norway and will commence start-up activities immediately. Archer-1 is a Phase 1b clinical trial designed to investigate the safety, tolerability, pharmacokinetic and preliminary efficacy of the Betalutin/rituximab combination in approx. 20 2L FL patients, and the study will initially be conducted in Norway. Further countries are expected to be added later. The first patient is expected to be dosed in the second half of 2018.

On June 13, 2018 Quanterix Corporation (NASDAQ:QTRX), a company digitizing biomarker analysis with the goal of advancing the science of precision health, reported that Kevin Hrusovsky, President, Chairman and CEO of Quanterix, and Founder of Powering Precision Health (PPH), has been named by EY as a finalist for the Entrepreneur Of The Year 2018 Award in the New England program (Press release, Quanterix, JUN 13, 2018, View Source [SID1234527301]). The recognition acknowledges Hrusovsky’s achievements in healthcare technology innovation, Quanterix’ outstanding financial performance, and his personal commitment to improving precision medicine and human health.

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"We are honored to be recognized by EY for this award," said Hrusovsky. "For me, this recognition represents the many people and institutions that we’ve been working with who are driving a precision health vision to eradicate and prevent some of today’s most lethal diseases, namely cancer, Alzheimer’s and infectious disease forward. It’s a privilege for us to be recognized alongside other entrepreneurs and business leaders who are all pioneers in their respective fields."

Hrusovsky has a more than 25 year-long track record commercializing disruptive technologies in the life science industry. His impressive career has been propelled by a unique leadership style marked by transparency, passion, and purpose. Since joining Quanterix less than four years ago, Hrusovsky has transformed the company from one that lacked mission and direction into a successful public entity with industry-leading technology that has the power to transform the way we diagnose and treat disease. The key is his focus on putting science first. With Hrusovsky at the helm, Quanterix now has over 200 peer-reviewed publications backing the abilities of its Simoa technology, a significant industry accomplishment. He’s also expanded the applications for Simoa in the drug development industry, with 18 out of the top 20 pharmaceutical companies having used the technology to date in over 700 clinical trials.

Two years ago, Hrusovsky realized that more needed to be done to drive a true transformation in our healthcare system. As such, he launched PPH as a forum where all key stakeholders, from the world’s leading medical professionals and innovators to patients and patient advocates, could come together to share their latest research and truly revolutionize medicine. Now in its third year, PPH has sparked a true movement, one that puts science before profits and closely examines how we can prevent diseases, not just treat them. Today PPH has more than doubled in size and is considered the leading industry conference focused on advancing precision health.

Hrusovsky also serves on the Board of Directors of several companies shaping the future of precision health, including Quanterix, BioreclamationIVT, Cell Signaling Technology, 908 Devices, SynapDx and Solect Energy. He also serves on the Educational Board of the Massachusetts Biotech Council, the Advisory Committee for the Center for Biomedical Engineering at Brown University, the Association for Laboratory Automation, the JALA Editorial Board, and the Strategy Committee of Children’s Hospital Boston.

Hrusovsky was selected as a finalist by a panel of independent judges. Award winners will be announced at a special gala event on June 28, 2018 at the Westin Boston Waterfront. Now in its 32nd year, the program has expanded to recognize business leaders in more than 145 cities in more than 60 countries throughout the world.

Regional award winners are eligible for consideration for the Entrepreneur Of The Year National competition. Award winners in several national categories, as well as the Entrepreneur Of The Year National Overall Award winner, will be announced at the Entrepreneur Of The Year National Awards gala in Palm Springs, California, on November 10, 2018. The awards are the culminating event of the Strategic Growth Forum, the nation’s most prestigious gathering of high-growth, market-leading companies.

Sponsors

Founded and produced by EY, the Entrepreneur Of The Year Awards are nationally sponsored in the US by SAP America, the Kauffman Foundation and Merrill Corporation.

In the New England region, gold sponsors also include Boston Private Bank, fama PR, the Isenberg School of Management at the University of Massachusetts Amherst, Nixon Peabody, True Search, and Woodruff Sawyer. New England silver sponsors include Chatham Financial, Empire Valuation Consultants, Morgan Lewis, Sullivan & Worcester, and T3 Advisors.

On June 13, 2018 Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), reported that the U.S. Food and Drug Administration (FDA) has approved Avastin (bevacizumab) in combination with chemotherapy (carboplatin and paclitaxel), followed by Avastin as a single agent, for the treatment of women with advanced (stage III or IV) ovarian cancer following initial surgical resection (Press release, Genentech, JUN 13, 2018, View Source [SID1234527302]).

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"Today’s approval is an important advance for women newly diagnosed with this type of ovarian cancer," said Sandra Horning, M.D., chief medical officer and head of Global Product Development. "We’re committed to advancing medicines in areas of unmet need and this FDA approval of Avastin plus chemotherapy gives women with advanced ovarian cancer a new treatment option that has been shown to significantly delay disease progression or death."

"This approval represents an important milestone as the first medicine, other than chemotherapy, for women with advanced ovarian cancer after their initial surgery," said Melissa Aucoin, chief executive officer, National Ovarian Cancer Coalition (NOCC). "Ovarian cancer is the fifth leading cause of cancer-related deaths among women in the United States, and this approval underscores Genentech’s dedication to bringing new treatment options to women with gynecological cancers."

The approval for Avastin, in combination with carboplatin and paclitaxel, followed by Avastin as a single agent, for the treatment of women with stage III or stage IV epithelial ovarian, fallopian tube, or primary peritoneal cancer following initial surgical resection, is based on data from the pivotal Phase III GOG-0218 trial. Women who received Avastin in combination with chemotherapy, and continued use of Avastin alone, had a median progression-free survival (PFS) of 18.2 months compared to 12.0 months in women who received chemotherapy alone (HR=0.62; 95% CI 0.52 – 0.75, p<0.0001). This PFS benefit was achieved with a fixed-duration treatment (up to 22 cycles of Avastin total). Avastin has boxed warnings for GI perforation, surgery and wound healing complications and hemorrhage.

Avastin is now approved for ten distinct uses across six different types of cancer in the United States. This indication represents Avastin’s fourth gynecologic oncology indication in four years, including advanced cervical cancer and two different forms of ovarian cancer that recurred after platinum-based chemotherapy.

About the GOG-0218 Study

GOG-0218 (NCT00262847) is a multi-center, randomized, double-blind, placebo-controlled Phase III study in 1,873 women with previously untreated stage III or IV epithelial ovarian, primary peritoneal, or fallopian tube carcinoma who already had surgery to remove as much of the tumor as possible. Participants were randomized into one of three treatment arms: chemotherapy alone (carboplatin and paclitaxel), Avastin (15 mg/kg) plus chemotherapy followed by placebo alone, or Avastin plus chemotherapy followed by Avastin alone for a total of up to 22 cycles. The primary endpoint of the study was investigator-assessed PFS and secondary endpoints included overall survival (OS). The study was conducted by the Gynecologic Oncology Group (GOG) and initial results were previously published in the New England Journal of Medicine.

Grade 3-4 adverse events occurring more often (≥2%) in the Avastin with chemotherapy followed by Avastin alone arm or the Avastin with chemotherapy arm versus the chemotherapy alone arm were fatigue (9%, 6%, 6%, respectively), high blood pressure (10%, 6%, 2%), decreased platelet count (21%, 20%, 15%) and decreased white blood cell count (51%, 53%, 50%).

1 Relative to the control arm; stratified hazard ratio

2 Two-sided p-value based on re-randomization test

3 Final overall survival analysis

About Ovarian Cancer

Ovarian cancer causes more deaths among women than any other gynecologic cancer in the United States. In 2018, more than 22,000 women will be diagnosed with ovarian cancer in the U.S. and about 14,000 will die from the disease. About 80% of ovarian cancer cases are found at an advanced stage, when the cancer has spread beyond the ovaries. Early ovarian cancer often does not have any symptoms and when symptoms, such as abdominal swelling, bloating, abdominal pain, difficulty eating or feeling full quickly and/or frequent urination, are present, they can be associated with other less serious conditions. Five-year survival rates worsen dramatically based on stage of diagnosis.

On June 13, 2018 Cytokinetics, Inc. (Nasdaq:CYTK) reported that Robert I. Blum, President and Chief Executive Officer, is scheduled to present a corporate update at the JMP Securities Life Sciences Conference on Wednesday, June 20, 2018 at 11:00 AM EDT at the St. Regis Hotel in New York (Press release, Cytokinetics, JUN 13, 2018, View Source [SID1234527303]).

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Interested parties may access the live webcast of this presentation by visiting the Investors & Media section of the Cytokinetics website at www.cytokinetics.com. The webcast replay of the presentation will be archived on the Presentations page within the Investors & Media section of Cytokinetics’ website for 90 days following the conclusion of the event.

On June 13, 2018 BridgeBio Pharma reported the launch of CoA Therapeutics, a biopharmaceutical company developing novel small-molecules designed to increase Coenzyme-A (CoA) levels in genetic disorders where CoA deficiency is implicated (Press release, BridgeBio, JUN 13, 2018, https://investor.bridgebio.com/news-releases/news-release-details/bridgebio-pharma-launches-coa-therapeutics-target-coenzyme-rare [SID1234576279]). BridgeBio has committed funding to drive the program toward clinical studies. CoA Therapeutics’ lead compound will be entering the clinic in 2019 with a planned initial focus on pantothenate kinase-associated neurodegeneration, or PKAN.

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PKAN is an autosomal recessive genetic disorder caused by mutations in the pantothenate kinase 2 (PANK2) gene. The PANK2 enzyme plays a critical role in the synthesis of CoA, which is crucial in energy metabolism and implicated in a large number of developmental disorders. Patients with PKAN either have a complete absence or a significant deficiency of the PANK2 enzyme, which may lead to reduced CoA levels in the brain. There are currently no treatments approved for PKAN.

The CoA Therapeutics’ lead compounds, which were obtained under a license from St. Jude Children’s Research Hospital, were discovered and developed by St. Jude investigators Suzanne Jackowski, Ph.D., Charles Rock, Ph.D., Richard Lee, Ph.D., and Stephen White, Ph.D.

The prevalence of PKAN is estimated to be three in every 1,000,000 people. In the typical form of PKAN, symptoms present before the age of 10, and patients may rapidly experience neuronal degeneration, causing problems with movement, speech and vision.

"PKAN is a progressive, debilitating disease with no current approved therapy, and patients and their families currently rely on supportive treatments, which partially address the symptoms but not the root cause," said Shafique Virani, M.D., CEO of CoA. "We believe that our novel approach, using a highly brain-penetrant compound to directly target enzyme activity in neurons, can safely increase CoA levels, ease patients’ symptoms and make a meaningful difference in their quality of life. Our novel approach also holds promise for other diseases with defects in CoA metabolism, including the organic acidemias."

Joining Dr. Virani is Adam Shaywitz, M.D., Ph.D., who will serve as chief medical officer at CoA as well as CMO-in-residence at BridgeBio. Shaywitz was most recently executive director in clinical sciences at BioMarin Pharmaceuticals where he was involved in the design and planning of a number of clinical studies in rare disease including serving as program lead for the natural history and clinical treatment studies in Sanfilippo Syndrome B (MPS IIIB).

"We are privileged to be working with Drs. Jackowski, Rock, Lee and White, who have been at the forefront of CoA metabolism research in health and disease," said Neil Kumar, Ph.D., CEO of BridgeBio. "Their novel approach, which relies on increasing activity of the PANK enzyme family, is a great example of an allosteric agonist approach to potentially treat patients who have very few options."