Physicians’ Education Resource® Releases Agenda for 20th Annual International Lung Cancer Congress®

On June 18, 2019 Physicians’ Education Resource (PER), a worldwide leading resource for continuing medical education, reported the full agenda for the 20th Annual International Lung Cancer Congress (Press release, Physicians’ Education Resource, JUN 18, 2019, View Source [SID1234537144]). The congress will be held July 25-27 at the Hyatt Regency Huntington Beach in California.

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"We are so proud to be celebrating 20 years of educational excellence at this year’s congress," said Phil Talamo, president of PER. "This is a major milestone for PER, and we wouldn’t be able to become one of the most comprehensive and detailed educational lung cancer meetings in the world without the support of our national and international faculty members and participants who attend our International Lung Cancer Congress every year."

The 20th Annual International Lung Cancer Congress is a three-day program for surgical, medical and radiation oncologists interested in the treatment of patients with lung cancer. During this meeting, the activity co-chairs—Drs. David R. Gandara and Roy S. Herbst—will be joined by renowned international and national experts who will present a series of cutting-edge lectures, case-based panel and interactive discussions, a molecular tumor board and several Medical Crossfire programs on how oncologists can incorporate the latest data on targeted agents, immunotherapy, surgery and radiation oncology in the clinic. Additionally, Gandara and Herbst will present the 12th annual Bonnie J. Addario Lung Cancer Foundation keynote lecture and award at this year’s congress.

Magellan Rx Management Pioneers Novel Drug Wastage Program, Savings Exceed $46 Million in First Year, While Promoting High Quality Care for Members

On June 18, 2019 Magellan Rx Management, the pharmacy benefit management (PBM) division of Magellan Health, Inc. (NASDAQ: MGLN), reported that it has launched an innovative solution to control spend for high-cost infusible drugs, while promoting high quality care for members (Press release, Magellan Health Services, JUN 18, 2019, View Source [SID1234537143]). Payers are often faced with challenges like limited vial size options and availability that can lead to excessive spend in categories such as oncology and autoimmune conditions. The Magellan Rx drug wastage program leverages prior authorization and dosing protocols, in collaboration with providers, to identify clinically-appropriate opportunities to reduce waste.

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Since the drug wastage program launched in early 2018, participating health plans have saved over $46 million and savings continue to grow. This reduction in waste is also critical to improving the efficiency of healthcare throughout the United States and is a key component to providing high quality care.

Effective Strategies to Combat Expensive Drug Wastage

When a portion of a medication is unused and discarded due to vial size limitations, payers are billed for product that wasn’t actually administered to the patient. Depending on the drug, this can equate to tens of thousands of dollars wasted per patient over the course of treatment. Drug wastage is an established problem, especially in oncology where research has estimated that nearly $3 billion is wasted annually in cancer medicines that are discarded.1 High-cost medications used to treat autoimmune conditions such as rheumatoid arthritis can also contribute to substantial drug wastage. Given the top five Commercial medical benefit drugs by spend fall within the oncology, oncology support, or autoimmune categories2, there is an opportunity to leverage drug wastage strategies to combat rising drug spend.

"It is imperative for payers and patients to be aware of these market dynamics and medical benefit drug spend and trend—which, historically, has gone unmanaged—in order to implement timely strategies that will mitigate escalating drug costs," said Steve Cutts, senior vice president and general manager, specialty. "At Magellan Rx, we equip our customers with the knowledge to make better decisions and provide clinically-appropriate interventions for their members directed at reducing drug waste, resulting in significant dollars saved for the plan as well as downstream reductions in member cost share."

Clinical pharmacists at Magellan Rx teamed up with expert key opinion leaders and health plan customers to develop and implement a program that identifies opportunities to reduce drug wastage, targeting high-cost medications. Once identified, providers are given the option to prescribe a clinically-equivalent dose that would minimize the amount of drug waste. Provider validation has been excellent to date, with nearly 50 percent of providers agreeing to the use of more efficient vials.

For over 14 years, Magellan Rx has delivered cost-effective and leading-edge strategies for medical benefit drug management, offering flexible solutions that can also operate outside of the traditional payer-PBM relationship. Health plans can plug in to the extensive clinical expertise and experience at Magellan Rx by delegating specialty and medical drug management services while retaining a separate PBM. Through innovative, targeted initiatives like the drug wastage program, combined with other clinical solutions such as utilization management, site of service, and biosimilar management, Magellan Rx helps customers reduce their drug spend for highly complex and costly medical benefit drugs while promoting high quality care for their members.

"We are focused on reducing cost of care while maintaining a high quality of care for our members," said Scott McClelland, vice president of commercial and specialty pharmacy programs at Florida Blue. "That’s why we collaborate with Magellan Rx to find solutions, like the drug waste prevention program, that help curb rising specialty spend on the medical benefit. The success of this partnership has helped us save money for our members while ensuring they get the care they need."

For more on trends in medical drug management, get the latest updates from the Magellan Rx Report Spring 2019 Edition.

1. Harris, Gardiner. "Waste in Cancer Drugs Costs $3 Billion a Year, a Study Says." The New York Times 1 Mar. 2016. Web. 16 April 2019.

2. 2018 Magellan Rx Management Medical Pharmacy Trend ReportTM, ©2019.

Moderna to Present at BMO 2019 Prescriptions for Success Healthcare Conference

On June 18, 2019 Moderna, Inc., (Nasdaq: MRNA) a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, reported that Pamela Cohen, M.D., Head, Clinical Oncology Development, will present at the BMO 2019 Prescriptions for Success Healthcare Conference on Tuesday, June 25, 2019 at 3:20 p.m. ET (Press release, Moderna Therapeutics, JUN 18, 2019, View Source [SID1234537142]).

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A live webcast of the presentation will be available under "Events and Presentations" in the Investors section of the Moderna website at View Source A replay of the webcast will be archived on Moderna’s website for 30 days following the presentation.

BeiGene and SpringWorks Therapeutics Announce the Formation of MapKure to Develop BGB-3245, an Investigational, Selective Next-Generation RAF Kinase Inhibitor

On June 18, 2019 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biotechnology company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, and SpringWorks Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, reported the formation of MapKure, LLC, a newly created entity that is jointly owned by BeiGene and SpringWorks (Press release, BeiGene, JUN 18, 2019, View Source [SID1234537141]). MapKure intends to develop BGB-3245, an investigational, oral, selective small molecule inhibitor of monomer and dimer forms of activating B-RAF mutations including V600 BRAF mutations, non-V600 B-RAF mutations, and RAF fusions. These mutations and fusions have been identified in a number of solid tumors to be drivers of cancer growth, including in non-small cell lung cancer, colorectal cancer, thyroid cancer, and brain tumors.

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BGB-3245 was discovered by BeiGene scientists and is currently in preclinical development. Under the terms of the agreements, SpringWorks has made an equity investment into MapKure and BeiGene has contributed an exclusive royalty and milestone-bearing license to develop and commercialize BGB-3245 outside of Asia, but including rights to Japan, in exchange for a majority ownership position in MapKure. MapKure will form a joint steering committee that will oversee clinical development and operations for BGB-3245, as well as a Board of Directors. Both the joint steering committee and the Board will include members from BeiGene, SpringWorks and MapKure’s CEO. Further terms of the agreements were not disclosed.

Neal Rosen, M.D., Ph.D., Director of the Center for Mechanism-Based Therapeutics and the incumbent of the Enid A. Haupt Chair in Medical Oncology at Memorial Sloan-Kettering Cancer Center, is the founding member of the MapKure Scientific Advisory Board.

"Preclinical data demonstrate that BGB-3245 could potentially address a significant unmet medical need for patients with non-V600 B-RAF mutations or RAF fusions that are presently unaddressed with approved B-RAF-directed therapies. In addition, BGB-3245’s preclinical activity in cancer models driven by V600 B-RAF mutations demonstrate that it could provide an additional therapeutic option for these patients with the potential to reduce dimer-driven resistances," said Dr. Rosen. "I look forward to being part of this endeavor to evaluate the therapeutic potential of BGB-3245."

BeiGene and SpringWorks plan for MapKure to initiate an adaptive Phase 1 dose-escalation and expansion study of BGB-3245 in solid tumor patients harboring specific B-RAF driver mutations and RAF fusions, as well as in patients who have developed resistance to first-generation BRAF inhibitors. MapKure intends to enter into service agreements with both BeiGene and SpringWorks to enable the execution of this study and to perform other activities to support MapKure operations. Subsequent clinical development efforts with BGB-3245 may also include rational combination therapies, including with MEK inhibitors such as PD-0325901, which is being developed by SpringWorks.

"This effort, once again, shows our commitment to developing innovative medicines for cancer patients with few or no treatment options. We are pleased to expand our collaboration with SpringWorks to take this potentially first-in-class product candidate into human trials," said John V. Oyler, Co-Founder, Chief Executive Officer and Chairman of BeiGene.

"SpringWorks is committed to identifying and advancing medicines for underserved patient populations. We are delighted to be working again with BeiGene, as well as with several leaders in the targeted oncology field who have been invited to join the MapKure Scientific Advisory Board," said Saqib Islam, Chief Executive Officer of SpringWorks Therapeutics and member of the MapKure Board of Directors.

Lusong Luo, Ph.D., Senior Vice President of External Innovation at BeiGene, will be Acting CEO of MapKure and a member of the MapKure Board of Directors.

"BGB-3245 has demonstrated antitumor activity in a variety of preclinical cancer models, including those driven by mutations for which there are currently no approved therapies," said Dr. Luo. "I look forward to advancing BGB-3245 into human trials in hopes of providing a treatment for these patients."

In September 2018, BeiGene and SpringWorks announced a global clinical collaboration agreement to evaluate the safety, tolerability, and preliminary efficacy of combining BeiGene’s investigational RAF dimer inhibitor, lifirafenib (BGB-283) and SpringWorks’ investigational MEK inhibitor, PD-0325901, in patients with advanced solid tumors. Under the collaboration, BeiGene recently began a Phase 1b clinical trial to evaluate this combination in patients with advanced or refractory solid tumors that harbor RAS mutations, RAF mutations, and other MAPK pathway aberrations.

About MapKure

MapKure is a research-stage company that was created in 2019 to develop precision medicines to help patients with life-threatening diseases, with an initial focus on cancer. By focusing on genetically defined disease drivers, MapKure is positioned to provide transformative medicines to patients whose unmet medical needs are largely unaddressed. Jointly owned by BeiGene, Ltd. and SpringWorks Therapeutics, Inc., MapKure is currently developing BGB-3245, a preclinical oral, small molecule inhibitor of specific BRAF mutations, including B-RAF non-V600 mutations and RAF fusions, which have been identified in numerous solid tumor indications to be drivers of tumor growth. In addition to its intended use as a monotherapy in several genetically defined solid tumor types, BGB-3245 also has the potential to be used in rational combination therapies in the future.

Alligator Bioscience applies to start clinical trials for ATOR-1017

On June 18, 2019 Alligator Bioscience (Nasdaq Stockholm: ATORX), reported that the company has submitted an application (Clinical Trial Authorization, CTA) for permission to start a clinical phase I study for the wholly-owned 4-1BB antibody ATOR-1017 , which is being developed for the treatment of spread cancer (Press release, Alligator Bioscience, JUN 18, 2019, View Source [SID1234537140]).

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ATOR-1017 is an immune-activating antibody (IgG4) that activates tumor-specific T cells and NK cells via the co-stimulatory receptor 4-1BB. T cells and NK cells are capable of detecting and killing tumor cells, making 4-1BB an extremely attractive target for cancer immunotherapy.

ATOR-1017 has a unique profile, among other things, because the immune-activating effect is enhanced in environments where there are many immune cells, which is particularly prevalent in tumors. This creates opportunities for a powerful, tumor-localized immune activation that can reduce the side effects of the patient.

The upcoming Phase I study is a dose determination study in patients with spread cancer, and this is the first time that ATOR-1017 has been evaluated in humans. The study will be conducted at three different clinics in Sweden and cover up to 50 patients. The primary objective of the study is to investigate the safety and tolerability of ATOR-1017 and to establish a recommended dose for subsequent phase II studies.

"We look forward to starting the patient recruitment as soon as the application for ATOR-1017 is approved by the authorities. Our data show that the antibody has the potential to provide a powerful and long-lasting immune response, and even immunity to cancer, while minimizing the side effects by tumor-directed immune activation. This will be our third drug candidate to initiate clinical development and a significant milestone in our work to develop the next generation of immunotherapies against cancer, "says Per Norlén, CEO of Alligator Bioscience.

For further information, please contact:
Cecilia Hofvander, Director Investor Relations & Communications
Phone: +46 46 540 82 06
E-mail: [email protected]

The information was submitted, through the agency of the above contact person, for publication on June 18, 2019, at 16:15.