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.

On June 18, 2019 Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, reported that it has initiated dosing in the Phase 2 EMERGE clinical trial of its lead product candidate, vopratelimab, in combination with ipilimumab in patients with non-small cell lung cancer (NSCLC) or urothelial cancer who have progressed on or after PD-1/PD-L1 inhibitor therapies (Press release, Jounce Therapeutics, JUN 18, 2019, View Source [SID1234537158]). These patient populations represent a rapidly growing area of unmet need as PD-1 inhibitors move into earlier lines of therapy, with few options and no established standard of care for patients who progress after a PD-1/PD-L1 inhibitor.

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"The Phase 2 EMERGE clinical trial of vopratelimab and ipilimumab builds upon the original science from our founders as well as the reverse translational subset analysis from patients who benefitted in our ICONIC trial versus those who did not. Vopratelimab treatment resulted in the emergence of ICOS hi CD4 T effector cells in the peripheral blood and emergence of these cells was associated with response and improvements in progression free survival and overall survival, as presented at the 2019 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting," said Beth Trehu, M.D., chief medical officer of Jounce Therapeutics. "Ipilimumab is known to induce a population of ICOS hi CD4 T cells, making it a scientifically logical combination partner for vopratelimab in the EMERGE study, as we have shown vopratelimab stimulates, expands and sustains ICOS hi CD4 T cells. We are pleased to have begun enrollment in the EMERGE clinical trial and expect to report preliminary efficacy data in 2020."

About the Phase 2 EMERGE Clinical Trial
The Phase 2 EMERGE clinical trial is an open-label, multi-center study to evaluate the efficacy of vopratelimab in combination with ipilimumab. In the initial stage, Jounce expects to enroll approximately 40 patients with NSCLC and approximately 40 patients with urothelial cancer. The primary endpoint is overall response rate (ORR) and secondary endpoints include safety, duration of response, progression free survival (PFS) and overall survival (OS). Additional important assessments will include close monitoring of ICOS hi CD4 T cell emergence, and a range of other biomarkers, including exploratory assessment of potential predictive biomarkers. Jounce expects to report preliminary efficacy and biomarker relationships to clinical outcomes on up to 80 patients in 2020.

Patients and physicians interested in the Phase 2 EMERGE trial can contact [email protected]. For more information on this trial, please visit View Source (Identifier: NCT03989362).

About Vopratelimab
Jounce’s lead product candidate, vopratelimab (formerly JTX-2011), is a clinical-stage monoclonal antibody that binds to and activates ICOS, the Inducible T cell CO­Stimulator, a protein on the surface of certain T cells commonly found in many solid tumors. Vopratelimab was assessed in a Phase 1/2 clinical trial that we refer to as ICONIC. In the initial Phase 1/2 portion of ICONIC, vopratelimab was found to be safe and well-tolerated, both alone and in combination with nivolumab, an anti-PD-1 antibody. At the June 2018 annual meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), we reported Response Evaluation Criteria in Solid Tumors, or RECIST, responses and other tumor reductions as determined by investigator assessment that were associated with an ICOS pharmacodynamic biomarker. We subsequently reported that these responses were durable, lasting six or more months and that all responders, as determined by investigator assessments, remained on study for more than one year. ICONIC also included dose-escalation Phase 1 portions to assess vopratelimab in combination with pembrolizumab, an anti-PD-1 antibody, and in combination with ipilimumab, an antibody that binds to CTLA-4 on certain T cells. This Phase 1 portion established the safety of vopratelimab in combination with each of ipilimumab and pembrolizumab.

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.

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.

On June 18, 2019 Vivoryon Therapeutics AG, (Euronext Amsterdam: currently PBD, to be changed to VVY, ISIN: DE0007921835), a clinical stage precision medicine company focused on bringing first-in-class therapies to patients suffering from age-related diseases, and goetzpartners, an independent advisory firm for strategy, M&A and transformation, reported their collaboration to explore the expansion of Vivoryon’s proprietary platform based on its Glutaminyl-peptide cyclotransferase-like protein (QPCTL) technology into the field of immuno-oncology (Press release, Vivoryon Therapeutics, JUN 18, 2019, View Source [SID1234537421]). In this context goetzpartners has been mandated as the exclusive strategic business development advisor of Vivoryon Therapeutics.

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Vivoryon’s lead molecule, PQ912, is currently in clinical stage development for Alzheimer’s Disease (AD) and is a first-in-class, highly specific and potent inhibitor of Glutaminyl cyclases (QPCT and QPCTL). New research has shown that small molecule Glutaminyl cyclase inhibitors could also represent an attractive approach for myeloid immune checkpoint control.

Consequently, Vivoryon’s next platform project focuses on immune checkpoint inhibition and the Glutaminyl-peptide cyclotransferase-like protein (QPCTL). QPCTL is a posttranslational modifying enzyme that is essential for the pyroglutamate formation on CD47, a crucial signaling protein in immune response to cancer. Inhibitors of QPCTL, like PQ912 and other small molecule compounds protected under Vivoryon’s patents, have been shown to silence the checkpoint signal from the CD47/SIRPa axis, and thus are offering a novel strategy to augment the efficacy of anti-tumor antibody therapies. Based on Vivoryon’s data, PQ912 could readily be advanced into clinical Phase I studies in cancer. In addition, Vivoryon Therapeutics owns a broader set of highly promising QPCTL inhibitor compounds in advanced preclinical stages of development.

"When weighing our options on how to move forward our QPCTL technology into the field of immuno-oncology, we wanted to make sure we did everything possible to bring scientific excellence for the benefit of patients to other indications. Understanding this responsibility, we decided to seek out industry leaders in business development consulting who understood our strategic needs and could provide us with the support necessary to unlock the full potential of our platform by partnering with major pharma players. For this reason, we look forward to working with goetzpartners, who have robust business experience and the expertise to guide us through this process" said Dr. Ulrich Dauer, CEO of Vivoryon Therapeutics.

"We are proud to have been selected by Vivoryon Therapeutics as their strategic advisors," said Ulrich Kinzel, Managing Director at goetzpartners, "The Company is a technology leader with their patented proprietary Glutaminyl Cyclase inhibition platform, and it is an exciting opportunity for us to connect them with the right partner to explore its full potential."

For more information, please contact:

Vivoryon Therapeutics AG
Dr. Ulrich Dauer, CEO
Email: [email protected]

goetzpartners Corporate Finance GmbH
Ulrich Kinzel
Tel: +49 (0) 89 29 07 25 125

MC Services AG
Anne Hennecke, Susanne Kutter
Tel: +49 (0) 211 529 252 27
Email: [email protected]