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Neurocrine Biosciences Announces Conference Call and Webcast of Second Quarter 2019 Financial Results

On July 8, 2019 Neurocrine Biosciences, Inc. (NASDAQ: NBIX) reported that it will report second quarter financial results after the Nasdaq market closes on Monday, July 29, 2019 (Press release, Neurocrine Biosciences, JUL 8, 2019, View Source [SID1234537411]). Neurocrine will then host a conference call and webcast to discuss its financial results and provide a Company update that day at 1:30 p.m. Pacific Time (4:30 p.m. Eastern Time).

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Participants can access the live conference call by dialing 866-342-8591 (US) or 203-518-9713 (International) using the conference ID: NBIX. The webcast can also be accessed on Neurocrine’s website under Investors at www.neurocrine.com. A replay of the webcast will be available on the website approximately one hour after the conclusion of the event and will be archived for approximately one month.

Cellectis Publishes New CAR Design to Control CAR T-Cells in Non-Lethal Way

On July 8, 2019 Cellectis (Paris:ALCLS) (NASDAQ:CLLS) (Euronext Growth: ALCLS – Nasdaq: CLLS), a clinical-stage biopharmaceutical company focused on developing immunotherapies based on gene-edited allogeneic CAR T-cells (UCART), reported the publication of a study in BMC Biotechnology, a Springer Nature journal, describing and evaluating the development of the SWIFF-CAR, a CAR construct with an embedded on/off-switch, which enables tight control of the CAR surface presentation and subsequent cytolytic functions using a small molecule drug (Press release, Cellectis, JUL 8, 2019, View Source [SID1234537410]). The reversible control of these engineered T-cells represents a promising approach to further mitigate the potential toxicities that are associated with CAR T-cell administration in clinical settings and to improve the process of CAR T-cell production for specific target antigens.

"Following Cellectis’ previously developed CubiCAR system, an all-in-one CAR architecture with an embedded multi-functional tag for purification, detection and elimination of CAR T-cells, we knew that we needed an additional ‘on/off switch’ to direct T-cells to either be active or inert, without necessarily killing them," said Dr. Alexandre Juillerat, Ph.D., Project Leader and U.S. Laboratory Head, Cellectis. "The SWIFF-CAR system does precisely that, representing a major breakthrough in our ongoing efforts to develop innovative applications to treat a range of diseases, including cancer and autoimmune diseases."

"While suicide gene systems have proven to be an effective way to eliminate transduced CAR T-cells, they also potentially terminate CAR T-cell treatment altogether," added Dr. Philippe Duchateau, Ph.D., Chief Scientific Officer, Cellectis. "The capability to manipulate CAR surface presentation improves the safety of CAR-T therapies and enhances our ability to circumvent hurdles associated with manufacturing. The SWIFF-CAR system addresses both of these factors and is an important next step for Cellectis in treating deadly illnesses that affect patients globally."

Alexandre Juillerat, Ph.D. Project Leader and Senior Scientist, Cellectis

Dr. Alexandre Juillerat, Ph.D., graduated in Chemistry from the University of Lausanne, Switzerland. After receiving his Ph.D. in 2006 in protein engineering from the École Polytechnique Fédérale de Lausanne (EPFL, Switzerland), he moved to the laboratory of Structural Immunology at the Institut Pasteur in Paris, France. In 2010, he joined the R&D department of Cellectis in Paris, France, working on the development and implementation of sequence specific designer nucleases including the transcription activator-like effector nucleases (TALEN). He then joined the Cellectis facility based in New York, NY, USA, leading projects associated with the development of the T-cell chimeric antigen receptor (CAR) technology.

Modulation of Chimeric Antigen Receptor surface expression by a small molecule switch

Alexandre Juillerat1, Diane Tkach1, Brian W. Busser1, Sonal Temburni1, Julien Valton1, Aymeric Duclert2, Laurent Poirot2, Stéphane Depil2 and Philippe Duchateau2

1Cellectis Inc, 430E 29th street, NYC, NY 10016, USA
2Cellectis, 8 rue de la croix Jarry, 75013 Paris, France

OncoSenX Raises $3 Million to Advance New Class of Cancer Therapeutics

On July 8, 2019 OncoSenX, Inc., a late preclinical-stage company developing therapeutics to kill cancer cells based on their genetics, reported it has raised $3 million in pre-seed funding to advance its pipeline (Press release, OncoSenX, JUL 8, 2019, View Source [SID1234537409]).

"These funds will allow us to accelerate the preclinical research necessary for us to begin phase 1 clinical development"

"These funds will allow us to accelerate the preclinical research necessary for us to begin phase 1 clinical development," said Matthew Scholz, chief executive officer of OncoSenX. "We believe our non-viral gene therapy for solid tumors represents the first in a new class of cancer therapeutics. The OncoSenX team is diligently working to bring this new approach into the clinic for the benefit of a global oncology community clearly in need of new options."

OncoSenX is developing a highly selective tumor-killing platform with two main components: a proprietary lipid nanoparticle (LNP) for cellular delivery and a highly selective DNA payload. The LNP is designed to deliver its non-integrating DNA payload to solid tumors, while an engineered promoter drives expression of a potent, inducible death protein only in the target cell population. The goal is to precisely target cell populations based on their genetic activity without harming nearby cells. The platform can be effectively programmed to implement logic gates (IF/OR/AND) to provide selectivity to any target cell based on its genetics.

"Our preclinical studies suggest the OncoSenX approach has the potential to precisely kill cancer cells based on the mutations they harbor," said John Lewis, Ph.D., chief science officer of OncoSenX. "If substantiated in the clinic, the platform could deliver reduced toxicity and improved tolerability over conventional chemotherapy, with the potential for superior targeting over biologics or even CAR-T therapy."

OncoSenX is currently preparing for its regulatory interactions and will then perform pivotal toxicology studies in anticipation of filing to begin human trials.

XPOVIO™ (selinexor) Available for Order at Biologics by McKesson

On July 8, 2019 McKesson, an independent specialty pharmacy for oncology and other complex therapeutic areas, reported that it has been selected by Karyopharm Therapeutics, Inc. to be in the limited distribution network for XPOVIO (selinexor) (Press release, McKesson, JUL 8, 2019, View Source [SID1234537408]).

XPOVIO is the first and only nuclear export inhibitor that blocks XPO1 and is indicated in combination with dexamethasone for the treatment of adult patients with relapsed refractory multiple myeloma (RRMM) who have received at least five prior therapies and whose disease is refractory or intolerant to at least two proteasome inhibitors (PI), at least two immunomodulatory agents (IMiD), and an anti-CD38 monoclonal antibody (mAb).1,2 Approved on July 3, XPOVIO was previously granted both Orphan Drug designation and Fast Track designation by the FDA.

"We are excited that Biologics is included in the limited network distribution for XPOVIO," said Ann Steagall, director of Clinical Policy at Biologics. "We are pleased to be included in the distribution of a first in class XPO inhibitor. Patients who have exhausted the current standard of care therapies now have another option. It is important to us as a premier oncology pharmacy to offer patients and prescribers the newest therapies available."

Biologics is committed to and recognized for its high level of customer service as well as its innovative, high-touch and multidisciplinary patient-centric approach. Each team includes a pharmacist with in-depth knowledge of disease states and oncology therapies available, an experienced oncology nurse and a financial counselor who is familiar with various financial assistance programs and organizations that help cancer patients. This highly-skilled care team works together to develop individualized care plans that address each patient’s unique clinical, financial and emotional needs and streamlines communication back to the treating provider, enabling high-quality care and differentiated outcomes. In addition, the Biologics team works closely with payers to ensure patients can access the specialty medications they need.

Physicians may submit prescriptions to Biologics via phone (800.850.4306), fax (800.823.4506) or eScribe. For electronic prescribing systems, physicians may search for Biologics within their EMR system.

AmerisourceBergen Announces Long-Term Strategic Relationship with OneOncology

On July 8, 2019 AmerisourceBergen, a global healthcare solutions leader, reported that it has entered a long-term strategic relationship with OneOncology, the national partnership of community oncologists driving the future of cancer care in the U.S. OneOncology has selected ION Solutions and Oncology Supply to provide a suite of services and solutions to community oncology practices across the nation. ION Solutions has been selected for GPO contracting and Oncology Supply for the distribution of chemotherapy and supportive care products to OneOncology members (Press release, AmerisourceBergen, JUL 8, 2019, View Source [SID1234537407]).

OneOncology partners with the nation’s top community oncology practices and their physicians to support delivery of comprehensive cancer care to patients, close to home. Since its public launch in September 2018, the organization is now comprised of four large practices across the U.S., representing nearly 250 physicians practicing at more than 70 sites of care.

"At ION Solutions and AmerisourceBergen, we’re dedicated to supporting community-based care. This commitment aligns nicely with OneOncology’s mission to drive the future of cancer care through a physician-led, data-driven, technology-powered and patient-centric model and we’re excited to have them in our network," said Brian Ansay, President, Physician Group Purchasing Organizations, AmerisourceBergen. "We look forward to supporting OneOncology with the full power of our ION GPO and AmerisourceBergen’s integrated service offerings, and we’ll continue to enhance value, provide more efficiencies and offer more clinical-decision support to all of our esteemed GPO members and customers."

OneOncology partners will have dedicated account teams that act as an extension of the practice and actively consult on inventory and creating operational efficiencies. OneOncology members will have access to Oncology Supply’s robust inventory of specialty and full-line oral, infusible and injectable products. AmerisourceBergen will provide OneOncology practices with tools and resources, practice management technologies, analytics and reports for better insight and education, and consultants, business coaches, and advisors who will assist with maximizing operating efficiencies.

"We look forward to a collaborative relationship with AmerisourceBergen that delivers value to all of our stakeholders," said Dr. Jeffrey Patton, President of Physician Services at OneOncology and CEO Of Tennessee Oncology, a OneOncology practice. "We believe this strategic partnership will help to optimize clinical and financial efficiencies for all of our partners during an era of unprecedented innovation in oncology."

To support the shift to value-based care, ION Solutions’ network members can leverage technology, analytics and informatics solutions to drive higher-quality and lower-cost care in every community. Tools like InfoDive, a web-based business intelligence solution, allows practices to quickly and easily analyze internal and comparative data in the areas of coding, productivity, marketing, revenue collection and more. ION is supporting the standardization of treatment protocols. For example, network members have full access to a centralized library of precision medicine testing recommendations and resources through the Precision Medicine Center.

Through the power of the ION GPO and AmerisourceBergen’s relationships with pharmaceutical manufacturers, members have access to the newest therapies entering the market. ION also advocates for community practices and their access to new research opportunities. Through solutions like AdvanceIQ, ION Solutions can help match independent community oncology practices with national clinical trials and research opportunities.

OneOncology partners will also have access to ION’s ongoing educational conference series. ION hosts nine annual conferences for its members; these events are designed to facilitate peer-to-peer learning and networking and strengthen the community of independent oncologists. Each conference features expert speakers, clinical reviews and best practices for business operations.

About ION Solutions & Oncology Supply

ION Solutions, a part of AmerisourceBergen Corporation, is the largest physician service organization and GPO specializing in the support of community oncology. ION provides GPO procurement services, technologies, advocacy resources and expertise to more than half of the community-based oncology practices in the nation to help improve their clinical and operational management. For more information, go to www.iononline.com. For over 35 years, Oncology Supply has been a trusted partner and supplier of chemotherapy and supportive care products to independent oncology practices nationwide from our office/distribution center in Dothan, AL. For more information about Oncology Supply, www.oncologysupply.com/OSCHome.