On July 11, 2019 The Ivy Brain Tumor Center at the Barrow Neurological Institute has reported a partnership with Karyopharm Therapeutics (Nasdaq:KPTI) to accelerate the treatment of brain cancer (Press release, The Ivy Brain Tumor Center, JUL 11, 2019, View Source [SID1234537485]). The Ivy Brain Tumor Center will employ Karyopharm’s first-in-class oral Selective Inhibitor of Nuclear Export (SINE) compound, selinexor, in combination with other new-in-class drugs, as a dual-drug experimental therapy for adult glioblastoma.

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"We are highly motivated to study novel drug combination strategies with selinexor to potentially advance the available treatment options for patients with glioblastoma, one of the most aggressive forms of brain cancer"

This academic-private partnership will begin with a preclinical study targeting the protein XP01 in glioblastoma patients and testing several new drug cocktails involving selinexor. Based on detailed pharmacodynamic and pharmacokinetic analyses, the lead drug cocktail will then be pursued as a combined-drug trial within the Ivy Brain Tumor Center’s Phase 0 clinical trial portfolio. This unique trial format will enable researchers to understand if the experimental therapy is impacting an individual patient’s brain tumor in as little as seven days, therefore saving valuable patient time.

Drug development for glioblastoma has remained stagnant for decades, with the latest FDA-approved therapy associated with a survival benefit occurring in 1999. The Ivy Brain Tumor Center, a nonprofit clinical trials program funded by the largest grant in the history of brain tumor research, is challenging the status quo of conventional drug development by streamlining early-phase identification of promising agents through tissue-based Phase 0 trialing.

"Selinexor exploits a compelling target in glioblastoma patients, which is why we have selected it as the backbone of a new experimental drug cocktail," said Dr. Nader Sanai, director of the Ivy Brain Tumor Center. "Our scientific partnership with Karyopharm Therapeutics will arrive at a new therapeutic strategy that can be accelerated into the clinic and patients in need."

Developed by Karyopharm Therapeutics, selinexor is the first in a new family of investigational therapies known as Selective Inhibitor of Nuclear Export (SINE) compounds and is currently being evaluated in Phase 2 and 3 clinical trials for multiple myeloma, diffuse large B-cell lymphoma (DLBCL), and a variety of solid tumors. It functions by blocking the nuclear export protein XPO1, forcing accumulation and activation of tumor suppressor proteins.

"We are highly motivated to study novel drug combination strategies with selinexor to potentially advance the available treatment options for patients with glioblastoma, one of the most aggressive forms of brain cancer," said Sharon Shacham, PhD, MBA, president and chief scientific officer of Karyopharm. "We share the Ivy Brain Tumor Center’s sense of urgency and commitment to pursuing future breakthroughs in glioblastoma treatment and look forward to our partnership in this important and innovative research endeavor."

On July 11, 2019 Sengenics, the functional proteomics company, reported that it has joined the Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium (Press release, Sengenics, JUL 11, 2019, View Source [SID1234537486]). As a member of the consortium, Sengenics aims to further accelerate the identification and commercialisation of autoantibody biomarkers for early diagnosis of cancer and autoimmune diseases as well as development of new companion diagnostics tests.

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The FNIH Biomarkers Consortium was co-founded by the U.S. National Institutes of Health (NIH), the U.S. Food and Drug Administration (FDA), the Pharmaceutical Research and Manufacturers of America (PhRMA), the Centers for Medicare & Medicaid Services (CMS) and BIO. It counts amongst its list of contributing members, major pharmaceutical companies such as Novartis, GSK and Merck; as well as not-for-profit organisations such as the Alzheimer’s Drug Discovery Foundation and the American Heart Association.

Sengenics will work with the FNIH Biomarkers Consortium to provide expertise about the discovery of autoantibodies for diagnostics, companion diagnostics and therapeutics applications, particularly through its proprietary KREX technology. As KREX-based protein arrays use antigens that are correctly folded and functional, autoantibodies are detected with very high specificity and sensitivity. The technology has already been applied to discover autoantibody biomarkers with both diagnostic and protective potential for cancers, autoimmune diseases and neurodegenerative disorders. KREX protein arrays have also been used for stratification of patients into responders, non-responders and those exhibiting immune-related adverse events (irAEs). This has been achieved with very high positive predictive values (PPV) and negative predictive values (NPV) for patients on autoimmune or immune checkpoint inhibitor drugs.

Joseph P. Menetski, Ph.D., Associate Vice President for Research Partnerships, FNIH said, "Autoantibodies are fundamental biomarkers for cancer and autoimmune disease diagnostics. We believe that Sengenics’ expertise will be complementary to the FNIH Biomarker Consortium’s key focus areas in terms of the rapid identification, development and qualification of potential high-impact biomarkers for improvements in drug development, clinical care and regulatory decision-making. We are looking forward to Sengenics making a positive contribution in terms of advancing medical diagnostics and research within the consortium."

Speaking on the collaboration, Chief Scientific Officer of Sengenics, Jonathan Blackburn, D.Phil., said, "We are delighted to join the FNIH Biomarkers Consortium. We see this as an important vehicle to collaborate with industry experts and partners across the biomarker discovery and commercialisation chain. In the last year, we have seen our technology becoming established as the benchmark for high specificity and sensitivity autoantibody detection by both the pharmaceutical industry as well as leading academic institutions. Our fundamental aim going forward is to apply our technology to patient-centric, autoantibody-based, translational diagnostics tests for both precision medicine and early disease detection applications."

On July 11, 2019 Physicians’ Education Resource, LLC (PER), a worldwide leading resource for continuing medical education, reported that it has released the agenda for the 37th Annual Chemotherapy Foundation Symposium: Innovative Cancer Therapy for Tomorrow (Press release, Physicians’ Education Resource, JUL 11, 2019, View Source [SID1234537487]). The conference will take place Nov. 6-8 at the New York Marriott Marquis in New York City.

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"This fall we look forward to having oncology professionals from around the world attend our three-day marquee oncology CME conference in New York City," said Phil Talamo, president of PER. "Oncology data is evolving at an unprecedented rate, and the opportunities to share clinical experience across tumors, particularly with novel targeted agents and immunotherapies, are needed for the cancer team to provide state-of-the-art treatments. This year’s meeting will focus on the cutting edge of medicine, and how new treatments are trailblazing contemporary oncology care."

Each year, the Chemotherapy Foundation Symposium: Innovative Cancer Therapy for Tomorrow brings together more than 1,000 health care professionals for three days to network with the top minds in oncology. At this year’s meeting, activity co-chairs — Drs. Adam M. Brufsky, Benjamin P. Levy and William K. Oh — will be joined by 100 internationally world-renowned experts who will provide attendees with expert insights on the latest developments in cancer therapeutics, offering an unparalleled opportunity to learn how innovative approaches fit into existing treatment paradigms to optimize care and outcomes for their patients with cancer.

Additionally, the PER Educator of the Year award, which highlights the accomplishments of oncology leaders and honors their contributions and efforts to propel the field of medical oncology through innovative and collaborative education will also be presented at this year’s conference.

For more information and to view the agenda or register, click here.

On July 11, 2019, Gritstone Oncology, Inc. (the "Company") reported that entered into a First Amendment to License Agreement (the "Amendment"), dated as of July 11, 2019, with MIL 21E, LLC (the "Licensor"), amending that certain License Agreement, dated as of September 6, 2018, by and between the Company and the Licensor (the "License Agreement" and the License Agreement as amended by the Amendment, the "Amended License Agreement") (Filing, 8-K, Gritstone Oncology, JUL 11, 2019, View Source [SID1234550632]). Pursuant to the Amended License Agreement, effective as of September 1, 2019 (the "Effective Date"), the Licensor granted the Company a non-transferable, non-assignable license to use an aggregate total of 14,683 square feet of office and laboratory space located at 21 Erie Street, Cambridge, Massachusetts 02139.

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The term of the original License Agreement commenced on September 1, 2018. The Amended License Agreement will expire on August 31, 2021, unless earlier terminated. Beginning six months after the Effective Date, the Company shall have the right to early terminate the Amended License Agreement upon six months’ prior written notice. In addition, the Licensor may terminate the Amended License Agreement for cause by giving written notice to the Company (subject to a 10 day cure period, except under certain circumstances).

On the Effective Date, the Company prepaid the monthly license fees under the Amended License Agreement through August 31, 2020, as well as certain other fees and deposits totaling $3.5 million in the aggregate, and thereafter shall pay a monthly fee of approximately $279,000. Prior to the Effective Date, the Company paid an aggregate of $1.6 million under the terms of the original License Agreement.

The foregoing descriptions of the License Agreement and the Amendment do not purport to be complete and are subject to, and qualified in their entirety by reference to, the full terms of the License Agreement and the Amendment, copies of which will be filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the fiscal quarter ending September 30, 2019.

On July 11, 2019 Median Technologies, The Imaging Phenomics Company (Paris: ALMDT), reported preliminary and unaudited financial results for the first half of 2019 (Press release, MEDIAN Technologies, JUL 11, 2019, View Source [SID1234537488]).

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For the first half of 2019, Median Technologies’ revenues reached €4m, an increase of 19.6% compared to the first half of 2018 (€3.4m). Company revenues were entirely generated by the iCRO1 business; the iBiopsy business unit is not generating revenues at this stage, as it currently only includes Research and Development activities.

As of June 30, 2019, net new booking totaled €11m and contributed to an order backlog of €30.7m, a €7m increase compared to the backlog as of December 31, 2018. During the first half of 2019, new business growth for the iCRO was strengthened by increased business in China, along with several new Phase III contracts signed with Top 5 pharma sponsors in the US and in Europe. H1 2019 business activity validates the reorganization and strategic refocus, which was put into action in 2018. The iCRO order booking enables Median to be confident about 2019 revenues and beyond. As of June 30, 2019, the iCRO business unit is operationally at its break-even point.

As of June 30, 2019, the Company’s cash and cash equivalents are expected to be approximatively €7.9m. This amount doesn’t include the €1.5m Research Tax Credit payment, which will occur during the second semester. The burn rate was significantly reduced in H1 2019 and reached €4.8m, compared to €9.8m during the same period in 2018. In the second half of 2019, the company’s cash should be increased by the release of the first €15m tranche of the European Investment Bank (EIB) financing loan for which negotiations are now in the final stages. As a reminder, the loan will enable Median Technologies to accelerate its investment in the iBiopsy imaging phenomics platform innovation program for the coming years. The ongoing negotiations for this loan have been published on May 15th, 2019.

During the first half of the year, along with Dr. Nozha Boujemaa taking office as Median’s Chief Science and Innovation Officer, Median has continued its R&D investments in iBiopsy, the imaging phenomics platform. The iBiopsy Business Unit has been reorganized and its scientific team notably strengthened, with new talents and expertise in Artificial Intelligence and Data Sciences. These changes consolidate Median’s leadership in the field of imaging phenomics. In parallel, Median’s iCRO Business pursued development in China with a China-based structure to run projects and operations locally, leading to a significant increase of order booking in the first half of the year. Regarding the US and EU markets, first semester booking exceeded the booking forecasts for the full 2019.

"During the semester, we harvested the first results of the reorganization and strategic refocus we conducted in 2018," said Fredrik Brag, co-founder and CEO of Median Technologies. "Our current results go beyond our expectations for the semester. The iCRO Business Unit is already break-even operationally, which was initially expected by the end of 2019 only. With new recruitments in the iBiopsy team, we master the most advanced AI and data science technologies which allows us to move forward quickly and increase our technological differentiators. We expect this positive momentum to continue during the second part of the year", he added.

The Company expects to announce Half Year 2019 financial results on October 3, 2019, after market close.

The preliminary results set forth above are based on management’s initial review of the Company’s operations for the year ended December 31, 2018 and are subject to revision based upon the Company’s year-end closing procedures and upon the completion and external audit of the Company’s year-end financial statements. Actual results may differ materially from these preliminary results as a result of the completion of year-end closing procedures, final adjustments and other developments arising between now and the time that the Company’s financial results are finalized, and such changes could be material. In addition, these preliminary results are not a comprehensive statement of the Company’s financial results for the fourth quarter or full year ended December 31, 2018, should not be viewed as a substitute for full, audited financial statements prepared in accordance with generally accepted accounting principles, and are not necessarily indicative of the Company’s results for any future period.