On December 13, 2017 Iovance Biotherapeutics, Inc. (NASDAQ:IOVA), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported that it is hosting an Analyst Day, Wednesday, December 13, 2017, beginning at 9:00am ET, in New York City (Press release, Iovance Biotherapeutics, DEC 13, 2017, View Source;p=RssLanding&cat=news&id=2322493 [SID1234522621]). During the event, the company will provide an update on its lead program in metastatic melanoma, including a presentation of updated data showing partial responses in four out of 10 patients in cohort 2 in the C-144-01 trial. The company will also review its two additional company-sponsored trials in recurrent, metastatic, or persistent cervical cancer and recurrent or metastatic squamous cell carcinoma of the head and neck as well as an expansion of the TIL pipeline into lung cancer. Additionally, the company’s proprietary Generation 2 (Gen 2) manufacturing process has now been selected for all ongoing and future TIL clinical development.

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"Iovance has made substantial progress in 2017 and we are eager to showcase our work during today’s Analyst Day. We have formally selected Gen 2 as the manufacturing process to be used for registration and have switched all the ongoing study protocols over to this process," said Dr. Maria Fardis, PhD, MBA, president and chief executive officer of Iovance Biotherapeutics. "We are also enthusiastic about our expansion into lung cancer. In collaboration with two industry-leading partners, we will explore the potential of TIL therapy alone and in combination with approved systemic agents. The study at Moffitt has been initiated and the Iovance study, with MedImmune, combining TIL and durvalumab will start in the first half of 2018. We also will provide an update regarding data from cohort 2 of the C-144-01 melanoma study confirming partial responses in four out of 10 patients."

Manufacturing Update

Iovance announced today that it has selected its Gen 2 manufacturing process for all three Phase 2 trials and for all future TIL clinical development. The protocols for the company’s three existing studies have all been amended to allow for enrollment of new patients with TIL manufactured with the Gen 2 process. Cohort 1 of the C-144-01 melanoma study will be closed and new patients will be enrolled in cohort 2. The Gen 2 manufacturing process takes 22 days and the final cell product is cryopreserved for ease of scheduling and handling. The decision to use the Gen 2 manufacturing process was based on data recently presented at the SITC (Free SITC Whitepaper) 2017 Annual Meeting in November, the approximately 35 percent reduction in cost of manufacturing as well as the benefits to patients which include minimizing the time a patient has to wait to receive their TIL and flexibility of scheduling the dosing. Iovance has filed multiple provisional patent applications specific to this process, which if granted, could provide exclusive rights through 2038.

Highlights from Three Lead Clinical Programs

Phase 2 trials are ongoing with adoptive cell transfer (ACT) therapies that utilize an autologous TIL manufacturing process in metastatic melanoma, recurrent, metastatic, or persistent cervical cancer and recurrent and/or metastatic squamous cell carcinoma of the head and neck.

C-144-01 is a Phase 2 multicenter study evaluating the safety and efficacy of LN-144, Iovance’s lead product candidate for treatment of patients with metastatic melanoma. The study is currently enrolling. To date, Iovance has 11 active clinical sites in the United States and intends to start enrolling patients at clinical sites in Europe in early 2018. In November 2017, the company reported results from cohort 2 of the C-144-01 study at the SITC (Free SITC Whitepaper) Annual Meeting. The data being presented today show an objective response rate of 40 percent, with four of ten patients showing a partial response. The most common side effects were pyrexia, anemia and decreased neutrophil count. These patients had a high tumor burden despite a median of 3.6 prior therapies including anti-CTLA and PD-1 treatment.

C-145-03 is a Phase 2, multicenter study that will enroll up to 47 patients and will assess the safety and efficacy of LN-145 for the treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck. The trial has met the efficacy threshold for the first stage of the Simon’s two stage design and will therefore continue to enroll patients to the full sample size of 47 per protocol. Iovance has amended the protocol so that newly enrolled patients can be treated using TIL produced from the Gen 2 manufacturing process. Iovance anticipates reporting early data from this study in 2018.

C-145-04 is a Phase 2, multicenter, study that will enroll up to 47 patients and will assess the safety and efficacy of LN-145 for the treatment of patients with recurrent, metastatic, or persistent cervical carcinoma. The study is enrolling patients in the Unites States and is expected to start enrollment of patients in Europe in the first half of 2018. Iovance has amended the protocol so that newly enrolled patients can be treated using TIL produced from the Gen 2 manufacturing process.

TIL Pipeline Expansion into Lung Cancer

The company announced today that patient enrollment has begun in a study in collaboration with researchers at H. Lee Moffitt Cancer Center and Research Institute (Moffitt), Stand Up to Cancer, and other collaborators. Patients with advanced non-small cell lung cancer (NSCLC) will be enrolled in a study combining TIL and nivolumab in patients who have progressed on nivolumab.

The company also announced that a Phase 2 study in PD-1 and PD-L1 naïve NSCLC patients, sponsored by Iovance, in collaboration with MedImmune, the global biologics research and development arm of AstraZeneca, will initiate in the first half of 2018. The study with MedImmune will allow for enrollment with LN-145 alone or in combination with durvalumab.

MD Anderson Collaboration Update

Iovance provided an update on its collaboration with the MD Anderson Cancer Center (MDA). Under the collaboration, MDA will initiate two basket studies in sarcoma and platinum resistant ovarian cancer. One study will utilize TIL manufactured by Iovance and for the second study, TIL will be manufactured by MDA. Under the agreement with MDA, Iovance also retains the rights to MDA preclinical research in expanding the understanding of TIL and certain intellectual property related to the MDA TIL manufacturing process.

Today’s Guest Speakers

Key Opinion Leaders will discuss current treatment options and the role of TIL in melanoma, head and neck, lung and cervical cancers. Invited guest speakers include:

Sylvia Lee, MD, University of Washington, Fred Hutch Cancer Research Center
Jason Chesney, MD, PhD, University of Louisville, Brown Cancer Center
Emese Zsiros, MD, PhD, Roswell Park Cancer Institute
Webcast Information
A live webcast of today’s presentation can be accessed on the investor page of Iovance Biotherapeutics’ website at View Source A replay of the webcast will be archived on Iovance Biotherapeutics’ website for 30 days following the presentation.

On December 13, 2017 Sanofi reported that it will host an analyst meeting in Paris today to discuss the company’s Research and Development strategy, development pipeline and milestones for 2018 (Press release, Sanofi, DEC 13, 2017, View Source [SID1234522611]). The company will highlight the progress it has made against "Sustaining Innovation", a key pillar of its 2020 strategic roadmap, and advancing a differentiated portfolio addressing unmet needs.

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The company’s pipeline spans 71 R&D projects, which includes 37 new molecular entities and novel vaccines. At least 10 pivotal phase 3 studies are expected to start over the next 12 months and will evaluate new treatments for:
chronic obstructive pulmonary disease and eosinophilic esophagitis (dupilumab[1]);
autosomal dominant polycystic kidney disease (ADPKD), a rare kidney disease (venglustat);
type 2 diabetes (efpeglenatide, a once-weekly GLP-1 agonist);
obesity (a GLP-1/GCG dual agonist);
primary progressive multiple sclerosis (alemtuzumab), and;
first line NSCLC[2] (cemiplimab).

Regulatory filings expected in the next 12 months include two investigational cancer drugs (cemiplimab and isatuximab), a novel therapy for type 1 diabetes (sotagliflozin) and a potential treatment for uncontrolled, persistent asthma (dupilumab).

"We have seen significant advancement on our ambition to sustain innovation in R&D, with the development of leading technology platforms and proof of concept demonstrated in multiple high-potential projects in late stage trials. We are confident this portfolio will be the foundation for Sanofi’s future long-term growth," said Olivier Brandicourt, MD, Chief Executive Officer at Sanofi.

As a key pillar of the 2020 Roadmap, the new Sanofi R&D model is based on three key strategic shifts:
From small molecules to biologics;
From mono-targeting to multi-targeting compounds; and
From licensing to proprietary assets.

The company has continuously adapted its R&D model in recent years to deliver greater efficiency and excellence in development, resulting in a major uplift in productivity. Since 2016, consistent with the three key strategic shifts outlined above, Sanofi has placed increasing emphasis on developing proprietary technology platforms, including multi-specific antibodies (bi- & tri-specific), siRNA, trigonal peptides, dual and triple agonists, and PRR-Antibody conjugates. It has also leveraged external expertise in targeted platforms such as mRNA mixtures and Nanobodies.

"We aim to advance multi-targeting therapeutic approaches for core disease pathways that have the potential to attack more than one disease at a time or bring improved risk benefit in the treatment of a single disease," said Elias Zerhouni, MD, Global Head of R&D at Sanofi. "2018 will be an important year as we expect multiple milestones for Sanofi’s late-stage pipeline, made possible through the prioritization principles we have consistently applied to our early-stage research programs."

Building a competitive position in Specialty Care

Immunology

Sanofi is strengthening its specialty care portfolio and has executed launches in its fast-growing immunology franchise. Dupilumab, which we are developing in collaboration with Regeneron, has potential across multiple indications. Phase 3 trials for uncontrolled, persistent asthma recently demonstrated a potentially clinically important profile among biologic treatments. Submission in this important indication is expected before the end of 2017. Clinical development is underway in nasal polyposis, eosinophilic esophagitis, food allergies and in pediatric populations in most of these indications. Additionally, phase 3 development for dupilumab is now planned in chronic obstructive pulmonary disease (COPD). Sanofi, in collaboration with Regeneron, also expects to bring SAR440340, an anti-IL-33 antibody, which has the potential for a broader spectrum of immune modulation, into phase 2 in atopic dermatitis, asthma and COPD in 2018, alone or in combination with dupilumab.

Oncology

Sanofi is committed to re-building its position in oncology and has made major progress in the past two years. This strategy is starting to deliver and we anticipate 14 new proof-of-concept studies to be initiated, four potential proof-of-concept readouts, six phase one starts and three BLA/ MAA submissions in 2018. Cemiplimab is an investigational PD-1 checkpoint inhibitor and the backbone of our checkpoint immuno-oncology strategy with our partner Regeneron. It is being studied in cutaneous squamous cell carcinoma (CSCC), for which it was granted "Breakthrough Therapy" designation by the U.S. Food and Drug Administration (FDA), with an expected regulatory submission in Q1 2018. The development program also includes large or untapped opportunities in immuno-oncology, such as basal cell carcinoma, cervical cancer, and first line lung cancer.

Isatuximab is a Sanofi investigational antiCD38 monoclonal antibody with a first regulatory submission expected in 2018 for relapsed refractory multiple myeloma (RRMM). Beyond multiple myeloma, and building on the emerging evidence that CD38 inhibition may reverse resistance to PD-L1, isatuximab will be studied in combination with cemiplimab or other immuno-oncology agents. Sanofi will also present early research programs for its Selective Estrogen Receptor Degrader (SERD) and TGF-beta program to overcome PD-1 resistance.

Multiple Sclerosis

In multiple sclerosis (MS), Sanofi plans to build on the proven long-term clinical profile of Lemtrada (alemtuzumab) by initiating a Phase 3 study in 2018 for alemtuzumab in patients with primary progressive multiple sclerosis (PPMS). Consistent with Sanofi’s rigorous prioritization methodology, the company will deprioritize GLD-52 in this indication in favor of alemtuzumab. In addition, Sanofi, in collaboration with Principia, will be developing a novel Bruton’s tyrosine kinase (BTK) inhibitor, designed to access the brain and spinal cord by crossing the blood-brain barrier and impact immune cell and brain cell signaling. It is currently being studied in MS with potential applications in other central nervous system diseases[3].

Sustaining leadership in Rare Disease, Diabetes & Cardiovascular and Vaccines
Rare Disease

Sanofi’s Rare Disease pipeline is structured with the goal of sustaining innovation in lysosomal storage disorders, while also expanding strategically into related conditions. Clinical development programs include venglustat, an oral inhibitor of glucosylceramide synthase, in Fabry Disease, Gaucher Disease Type 3, GBA Parkinson’s Disease and autosomal dominant polycystic kidney disease (ADKPD). Late-stage/pivotal programs include olipudase, a first-in-class enzyme replacement therapy (ERT) for the non-neurological manifestations of acid sphingomyelinase deficiency (ASMD), and avalglucosidase alfa, a novel ERT for Pompe disease. Finally, through a strategic collaboration with Alnylam, we are advancing the development of patisiran for hATTR[4] amyloidosis and fitusiran for hemophilia A and B, with and without inhibitors.

Diabetes & Cardiovascular

Sanofi is committed to sustaining a leadership position in diabetes and expanding into adjacent co-morbidities. Its late-stage diabetes pipeline includes sotagliflozin, an investigational SGLT-1/2 inhibitor being developed in collaboration with Lexicon, and efpeglenatide, a once-weekly GLP-1 being developed in collaboration with Hanmi, both of which potentially offer unique patient advantages. Additionally, Sanofi is leveraging its novel peptide incretin platform to develop breakthrough assets for diabetes, obesity and non-alcoholic steatohepatitis (NASH). The lead compound is a dual agonist of GLP-1/GCG which has shown highly competitive weight loss in the clinic and is expected to enter phase 3 in obesity in 2018. A phase 2 study in NASH is also due to start in 2018.
In cardiovascular, Sanofi continues to work in collaboration with Myokardia on therapeutic options for genetic forms of cardiomyopathy. The lead compound is mavacamten, an oral modulator of cardiac myosin, which is in phase 2 for HCM[5] and is expected to start a registrational phase 2b/3 study in 2018.
Vaccines

Sanofi has six key vaccine projects currently in development, and priority disease areas include influenza, meningitis and respiratory syncytial virus (RSV). RSV is the leading cause of infant viral mortality and represents a new potential category for Sanofi. The company is taking a complementary dual approach to RSV with a monoclonal antibody in phase 2, in collaboration with MedImmune, and a vaccine in phase 1.

Webcast details

The event will be webcast live on Sanofi’s website at 8:30 am CET/2:30 am EST. The webcast details and full presentation will be made available on Sanofi’s Investor Relations webpage and an Appendix compiling all Sanofi studies registered on clinicaltrials.gov will also be published.
[1] Partnered products: cemiplimab, dupilumab, anti-IL33 mAb (Regeneron); sotagliflozin (Lexicon); efpeglenatide (Hanmi); fitusiran, patisiran (Alnylam); mavacamten, MYK-491 (Myokardia).
[2] Non-Small Cell Lung Cancer
[3] The Principia transaction remains subject to customary regulatory approvals and has not yet closed.
[4] hATTR = Hereditary Transthyretin-Mediated Amyloidosis
[5] HCM= Hypertrophic cardiomyopathy

On December 13, 2017 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported updates related to its collaboration programs with Sanofi, which were highlighted during Sanofi’s Sustaining Innovation Analyst Day in Paris, France (Press release, Regeneron, DEC 13, 2017, View Source [SID1234522610]).

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In a separate release today the companies also shared positive topline results for PD-1 antibody cemiplimab in advanced cutaneous squamous cell carcinoma (CSCC).

Immunology and Inflammation: Dupixent (dupilumab) and IL-33 antibody

A supplemental Biologics License Application (sBLA) for dupilumab in persistent, uncontrolled asthma is expected to be submitted in the fourth quarter of 2017.
In 2018, a Dupixent (dupilumab) sBLA submission is planned for atopic dermatitis in adolescents ages 12 to 17, and in 2019, a second sBLA is planned for children ages 6 to 12.
In 2019, an sBLA is planned for dupilumab in adults with nasal polyposis.
Pivotal Phase 3 studies are planned for 2018 evaluating the use of dupilumab in chronic obstructive pulmonary disease (COPD), a condition for which there are no approved biologic therapies.
A pivotal Phase 3 study is planned for 2018 evaluating the use of dupilumab in eosinophilic esophagitis (EoE), a condition for which there are no approved therapies in the U.S.
Phase 2 studies investigating the use of dupilumab as an adjunctive therapy to immunotherapies for the treatment of peanut and grass allergy are planned for 2018.
Dupilumab studies are planned for 2018 to evaluate patients with comorbid allergic inflammatory conditions.
REGN3500, an antibody to IL-33, is currently being investigated in Phase 1b studies in adult patients with moderate asthma and mild allergic asthma both as monotherapy and in combination with dupilumab.
In 2018, the companies plan to initiate Phase 2 proof-of-concept studies for REGN3500 in asthma and COPD, and a Phase 2b study in atopic dermatitis.
Immunology and Inflammation: Kevzara (sarilumab)

Phase 3 studies of sarilumab in giant cell arteritis and polymyalgia rheumatica are expected to be initiated in 2018.
A Phase 2 study of sarilumab in systemic juvenile arthritis is also expected to begin in 2018.
Immuno-Oncology

In the first quarter of 2018, the companies plan to submit a BLA to the FDA for cemiplimab (REGN2810, PD-1 antibody) for the lead indication of locally advanced and unresectable or metastatic CSCC.
Further development plans for cemiplimab include ongoing studies in basal cell carcinoma and cervical cancer.
Three Phase 3 studies are either planned or underway in first-line non-small cell lung cancer (NSCLC):
Cemiplimab vs. platinum doublet in patients with PD-L1 expression greater than or equal to 50 percent (ongoing).
Cemiplimab in combination with ipilimumab or chemotherapy vs. platinum doublet in patients with PD-L1 expression less than 50 percent (initiated).
Cemiplimab in combination with ipilimumab or chemotherapy in patients with PD-L1 expression greater than or equal to 50 percent (planned).
A second-line study of cemiplimab in NSCLC is also planned.
Regeneron is also advancing REGN3767, a LAG3 antibody, for cancer both as monotherapy and in combination with cemiplimab, as well as other preclinical immuno-oncology bispecific and monoclonal antibody therapies.
Cardiovascular Disease: Praluent (alirocumab)

Data from the ODYSSEY OUTCOMES trial evaluating PRALUENT (alirocumab) are expected in the first quarter of 2018.
The median duration of treatment in the ODYSSEY OUTCOMES study is 33 months, with some patients treated for up to five years.
Based on data from ODYSSEY OUTCOMES, the companies anticipate submitting an sBLA to the FDA by the third quarter of 2018. (Press release, Regeneron, DEC 13, 2017, View Source [SID1234522610])

On December 13, 2017 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo), reported results from the Hokusai-VTE CANCER study evaluating oral edoxaban (known by the brand names LIXIANA outside the U.S. and SAVAYSA in the U.S.), and found that edoxaban is non-inferior to subcutaneous injectable LMWH dalteparin for the treatment of cancer-associated VTE and major bleeding (Press release, Daiichi Sankyo, DEC 13, 2017, View Source [SID1234522607]). The results of the study were simultaneously published in the New England Journal of Medicine (NEJM) and presented during the late-breaker session at the 59th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in Atlanta, Georgia.

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Hokusai-VTE CANCER is the first study with a direct oral anticoagulant (DOAC), edoxaban, to meet pre-specified non-inferiority criteria versus the standard of care dalteparin in this patient population.2,3 The study met the primary objective of non-inferiority of edoxaban for the composite outcome of first recurrent VTE or ISTH-defined major bleeding during a 12-month study period, which occurred in 67 of 522 patients (12.8%) in the edoxaban group compared with 71 of 524 patients (13.5%) in the dalteparin group (hazard ratio with edoxaban, 0.97; 95% CI, 0.70 to 1.36; P = 0.006 for non-inferiority) for a risk difference (edoxaban minus dalteparin) of -0.7% (95% CI, -4.8 to 3.4).2,3 The difference in risk for recurrent VTE was -3.4% (95% CI, -7.0 to 0.2) whereas the corresponding difference in risk for major bleeding was 2.9% (95% CI, 0.1 to 5.6).3 The frequencies of severe major bleeding events at presentation (categories 3 and 4) were similar during treatment with edoxaban or dalteparin (12 patients in each group, respectively).2,3 There was no fatal bleed in the edoxaban group versus two fatal bleedings in the dalteparin arm.3

The study also met the secondary outcome of event-free survival (free of recurrent VTE, major bleeds or death) at 12 months, and rates were similar between edoxaban and dalteparin (55.0% and 56.5%, respectively).2,3 The trial was a PROBE design study and included a broad spectrum of patients (n=1,050) with primarily active cancer (98%): 53% of which had metastatic cancer and 72% of which were receiving cancer therapy at randomisation.2,3 This is the largest prospectively randomised clinical trial to have studied the benefit risk of DOACs in cancer patients versus the current injectable standard of care, dalteparin. Hokusai-VTE CANCER is the first study to demonstrate that a DOAC, edoxaban, is non-inferior to the standard of care, injectable LMWH (dalteparin), in this population.2,3

"Cancer patients have a significantly increased risk of VTE, and are a high-risk population since 82% of patients have one or more pre-specified bleeding risk factors," said co-principal study investigator Professor Harry Büller, from the Department of Vascular Medicine at Academic Medical Center, Amsterdam, The Netherlands. "We saw a lower rate of recurrent VTE with edoxaban compared to dalteparin over the one-year study period. In addition, in the edoxaban arm, we saw no bleeding fatalities and similar severity of clinical presentation of major bleeding events compared to dalteparin. The risk for VTE persists beyond six months for cancer patients, therefore, the study duration of 12 months enabled the evaluation of edoxaban over a longer time period."

VTE includes both deep vein thrombosis (DVT) and pulmonary embolism (PE) and is the second leading cause of death in cancer patients receiving chemotherapy.4 Current guidelines recommend LMWH for at least six months as the standard of care in cancer patients,5,6,7 and currently there is poor adherence to VTE cancer treatment guidelines due to the requirement for daily injections. The treatment of cancer-associated VTE is challenging because these patients are at increased risk of both recurrent VTE and major bleeding.2 The occurrence of VTE increases the risk of death 2-6-fold in cancer patients4 and can interrupt cancer treatment.8

"The use of an oral anticoagulant that alleviates the burdens associated with a daily injectable drug, without loss of clinical benefit, would represent an advance for cancer patients with VTE," said Hans J. Lanz, MD, Vice President, Global Medical Affairs, Daiichi Sankyo. "The data will continue to add to the growing body of knowledge in the Edoxaban Clinical Research Programme, which provides key insights into the potential effects of edoxaban in VTE and AF patients."

About the Hokusai-VTE CANCER study
Hokusai-VTE CANCER is a multinational, prospective, randomised, open-label, blinded endpoint evaluation (PROBE) study, evaluating the efficacy and safety of once-daily edoxaban compared to dalteparin for the treatment of VTE associated with cancer.1,2,3 The purpose of the study was to evaluate edoxaban in comparison with dalteparin in preventing the combined outcome of VTE recurrence or major bleeding in patients with VTE associated with cancer.1,2,3 Other objectives include assessing the effects of treatment on VTE recurrence, clinically relevant bleeding and event-free survival, defined as the proportion of subjects over time free of recurrent VTE, major bleeding events and death.1,2,3 The study enrolled 1,050 patients across 13 countries in North America, Europe, Australia and New Zealand.2,3 Patients were randomised to receive edoxaban 60 mg once-daily (reduced to 30 mg edoxaban for patients with creatinine clearance [CrCL] 30-50 mL/min, body weight ≤ 60 kg, or concomitant use of P-glycoprotein [P-gp] inhibitors), following treatment with LMWH for at least five days; or dalteparin SC 200 IU/kg once-daily for 30 days, then 150 IU/kg once-daily for the remainder of the 12-month study.1,2,3

For more information please visit: View Source

About Venous Thromboembolism
Venous thromboembolism (VTE) is an umbrella term for two conditions, deep vein thrombosis (DVT) and pulmonary embolism (PE). DVT is a disease caused by a blood clot found in deep veins, usually within the lower leg, thigh or pelvis, although they can occur in other parts of the body as well.10 PE occurs when part of a clot detaches and lodges in the pulmonary arteries, causing a potentially fatal condition.11

About VTE and Cancer
VTE is a major cause of morbidity and mortality in patients with cancer, with an annual incidence that can be as high as 20 percent depending on the cancer type, background risk and time since diagnosis.12,13 Patients with cancer have multiple risk factors for VTE and the risk of VTE events increases in patients with cancer receiving chemotherapy.14 In addition, patients with cancer and VTE have a lower survival rate than those without VTE.14

About Edoxaban
Edoxaban is an oral, once-daily, direct factor Xa (pronounced "Ten A") inhibitor. Factor Xa is one of the key components responsible for blood clotting, so inhibiting this makes the blood thin and less prone to clotting. Edoxaban is currently marketed by Daiichi Sankyo and its partners in more than 20 countries around the world.

About Edoxaban Clinical Research Programme (ECRP)
Daiichi Sankyo is committed to expanding scientific knowledge about edoxaban, as demonstrated through our research programmes evaluating its use in a broad range of cardiovascular conditions, patient types and clinical settings in AF and VTE. The edoxaban clinical research programme includes multiple RCTs (randomised, controlled trials), registries and non-interventional studies, with the goal of generating new clinical and real-world-data regarding its use in AF and VTE populations. Daiichi Sankyo expects that more than 100,000 patients will participate in the edoxaban clinical research programme, including completed, ongoing, and future research.

The RCTs include:
− ENSURE-AF (EdoxabaN vs. warfarin in subjectS UndeRgoing cardiovErsion of Atrial Fibrillation), in AF patients undergoing electrical cardioversion
− ENTRUST-AF PCI (EdoxabaN TReatment versUS VKA in paTients with AF undergoing PCI), in AF patients undergoing percutaneous coronary intervention
− Hokusai-VTE CANCER (Edoxaban in Venous Thromboembolism Associated with Cancer), in patients with cancer and an acute VTE event
− ELDERCARE-AF (Edoxaban Low-Dose for EldeR CARE AF patients), in elderly AF patients in Japan
− ELIMINATE-AF (EvaLuatIon of edoxaban coMpared with VKA IN subjects undergoing cAThEter ablation of non-valvular Atrial Fibrillation)
− ENVISAGE-TAVI AF (EdoxabaN Versus standard of care and theIr effectS on clinical outcomes in pAtients havinG undergonE Transcatheter Aortic Valve Implantation (TAVI) – Atrial Fibrillation)

In addition, global and regional registry studies will provide important real-world data about the use of edoxaban and other oral anticoagulants in everyday practice, and include:
− ETNA-AF (Edoxaban Treatment in routiNe clinical prActice in patients with non valvular Atrial Fibrillation)
− ETNA-VTE (Edoxaban Treatment in routiNe clinical prActice in patients with Venous ThromboEmbolism)
− EMIT-AF/VTE (Edoxaban Management In diagnostic and Therapeutic procedures-AF/VTE);
− Prolongation PREFER in AF (PREvention oF thromboembolic events – European Registry) in patients with AF
− ANAFIE (All Nippon AF In Elderly) Registry in Japan
− Cancer-VTE Registry in Japan

We are committed to adding to the scientific body of knowledge around edoxaban in a variety of AF and VTE patients, including those who are vulnerable.

On December 12, 2017 Cyclenium reported the signing of a drug discovery collaboration agreement with Ono Pharmaceutical Co., Ltd., a leading Japanese pharmaceutical research and development company (Press release, Cyclenium, DEC 12, 2017, View Source [SID1234635926]). The collaboration will exploit Cyclenium’s proprietary QUEST Library of next generation synthetic small-molecule macrocycles and associated optimization expertise to identify clinical candidates effective against multiple pharmacological targets selected by Ono in their therapeutic focus areas.

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While Cyclenium will be responsible for all medicinal chemistry efforts, starting from hit validation, to generate new macrocyclic compounds by employing its CMRTTM Technology, Ono will utilize its internal resources for the characterization of biological and pharmacological properties of these new macrocycles, as well as having full rights and responsibility for development and commercialization of the resulting drug candidates worldwide. In return, Cyclenium will receive an upfront payment and research funding from Ono, as well as development milestones and royalties on marketed products.

"We are very excited about entering this collaboration with Ono, our second with a major, globallyoperating, Japanese pharmaceutical partner," stated Helmut Thomas, Ph.D., President, Chief Executive Officer & Chief Scientific Officer of Cyclenium. "We are confident that our CMRT Technology and proven success in the macrocycle area combined with the excellent research team at Ono will provide new insight into the modulation of their difficult targets and enable the discovery of novel macrocyclic therapeutic agents."

"We highly appreciate Cyclenium’s expertise in the macrocycle area and their technology platform to generate new drug candidates for high priority targets in our portfolio," said Hiromu Habashita, Ph.D., Corporate Officer and Executive Director, Discovery and Research of Ono. "We are very pleased to work with Cyclenium on identifying and developing the next generation of innovative drugs and we believe novel macrocyclic drugs to be generated through this collaboration will fulfill unmet medical needs."

Cyclenium has translated its over 18 years of pioneering experience, extensive knowledge base and unparalleled expertise in small molecule macrocyclic chemistry into the next generation CMRT ("smart") drug discovery technology that addresses the shortcomings of earlier efforts in this increasingly important domain.