次なる飛躍へ。着実な進捗と共に更なる成長の黎明期にて振るい育ちゆく相場。控える材料と共に水準訂正。笑。 成長期。予定されていた業績の急成長と共に更なる成長戦略が進展。順調なR&D・PL等の拡充・拡大の加速。笑。 ・・・ ※Sosei Heptares：｢GPCR構造が創薬にもたらすインパクト」最先端のGPCR構造生物学についてのレビューとGPCR薬および臨床試験中の薬剤とどのように相関しているかについてCellに論文を発表。(4/6up) ※Discngine: "Discngine announces that Sosei Heptares will use its 3decision software to create an unprecedented structural GPCR chemogenomics platform." (4/6 Press Release) ※Sosei Heptares：｢Discngine社の3decisionを活用して、これまでに例のないGPCR構造ケモゲノミクスプラットフォームの構築を発表」公開済み構造情報と独自の構造情報を組み合わせ、独自の知見を獲得。(4/6) ※Propeller Health: Propeller Sensor for Breezhaler: "How to Attach Your Sensor for Breezhaler"; "How to Remove Your Sensor for Breezhaler"; "Breezhaler Sensor Technique". (4/9update) ※Sosei Heptares：｢COVID-19に関する新たな研究開発プログラムに構造ベース創薬の専門知識を応用」当社SBDD技術はSARS-CoV-2に対する新規治療薬の創出を目指す、より幅広い共同研究にも貢献。(4/14)
※Clinical Cencer Research May: "Adenosine Signaling is Prognostic for Cancer Outcome and Has Predictive Utility for Immunotherapeutic Response": AZD4635, Landscape of Adenosine Signaling in Cancer. (5/1 Publication) ※ATS International Conference 2020: "QVM149 Asthma P3 Results Presentation (IRIDIUM Study, ARGON Study, Japanese Study)": (5/18 11:15 Cancelled; Presentation Abstracts: Online 5/1up) ※Novartis Spain, Asthma Virtual Assistant Support Tool:"Novartis and the Lovexair Foundation Present MyAVA, the First Virtual Assistant to Control Asthma." (5/5) ※Sosei Heptares：｢Orexia社およびInexia社との協業によるオレキシン受容体作動薬プログラムにおけるさらなる科学的な進展」OX2の構造高解像解析、さらに低分子化合物の結合部位特定に成功。より優れた知見。(5/7) ※Sosei Heptares：｢選択的GPR52作動薬HTL-Aの前臨床における薬力学的および薬物動態学的特性」Support the progression of HTL-A as a safe treatment for cognitive dysfunction in patients with psychotic disorders. (5/7) ※World Journal Gastroenterology: "Radiofrequency Combined with Immunomodulation for Hepatocellular Carcinoma: State of the art and innovations." RFA, checkpoint blockade and MTL-CEBPA. (5/7 Published)
※City of Hope: "Two Groundbreaking Drugs will Combat COVID-19 and its Deadliest Symptoms": MTL-CEBPA, Rossi and Habib Plan to Extend the Liver Cancer Trial to COVID Patients. (5/7) ※JITSUBO：｢Bachemとの独占的ライセンス契約を締結」Molecular Hiving活用。Bachemは商用化に向けて、プロセスの最適化、スケールアップ、生産を行う。対価としてJITSUBOに開発費とロイヤルティを支払。(5/8) ※ASGCT: "Therapeutic saRNAstargeting CEBPA in Myeloid Cells. A Potential Immunomodulatoryswitch for Anticancer Therapy": MTLCEBPA can potentially act as an immuno-modulatory switch. (5/12 Presented) ※Sosei Group「2020年12月期第1四半期決算」2020年12月期の業績見込みは据置。引き続き良好な業績を目指し収益性を追求しますが、COVID-19流行による不確実性の影響を受ける可能性があると認識。(5/13) ※Sosei Group「2020年12月期第1四半期(1月-3月)ビジネスハイライトおよび連結業績」COVID-19の蔓延を押さえるための方針および活動を速やかに実施する一方、大手提携先との収益につながる業務を優先。(5/13) ※Immuno Therapy of Cancer: "Conversion of ATP to Adenosine by CD39 and CD73 in Multiple Myeloma can be Successfully Targeted Together with Adenosine Receptor A2A Blockade." AZD4635. (5/14 Published)
※Biochemistry: How do branched detergents stabilize GPCRs in micelles? Provide a rational foundation on which to develop further variants of detergents that can stabilize even the most unstable membrane proteins. (5/21 Published) ※日本経済新聞：｢そーせい【コスト管理強化】」提携先の製薬大手から得られるマイルストン収入が伸びる見通し。販売実績に応じたロイヤルティー収入も堅調に推移。コスト管理を厳格化しながら効率性の向上。最終黒字の公算。(5/28) ※Respiratory Medicine: "Fixed-Dose Combination of IND/GLY/MF once-daily Versus Sal/Flu twice-daily Plus Tio once-daily in Patients with Uncontrolled Asthma: A Randomised, Phase IIIb, ARGON Study". (5/26 Published) ※MiNA Therapeutics: "MiNA Therapeutics Announces Publication of Phase I Liver Cancer Data in Clinical Cancer Research and Provides Update on Clinical Development and Drug Discovery Programs". (5/27) ※American Association for the Advancement of Science Webinar: "Harnessing Cryo-EM to Investigate GPCR Structure and Discover New Medicines". Stacey Southall, Sosei Heptares. (5/27: Webinar) ※厚生労働省 薬事・食品衛生審議会 医薬品第二部会：｢審議：医薬品エナジア吸入用カプセル(QVM149)中用量及び高用量の製造販売承認の可否」結果：承認を了承しました。日本承認勧告。(5/28開催)
※ミクスOnline：｢薬食審・第二部会 新薬6製品の承認了承、3成分配合喘息薬など」承認の可否を審議し、いずれも承認することを了承。順調にいけば6月に正式承認。喘息適応の3成分配合薬は初となる。(5/29) ※MiNA Therapeutics: "MiNA Therapeutics Presents Top Line Results from Phase Ib Study of MTL-CEBPA in Combination with Sorafenib in Liver Cancer at 2020 ASCO Annual Meeting". (5/29) ※ASCO: "Phase Ib Dose Escalation and Cohort Expansion Study of the Novel Myeloid Differentiating Agent MTL-CEBPA in Combination with Sorafenib in Patients with Advanced HCC". (5/29 Presented) ※ASCO: "Phase I, Preliminary Antitumor Activity of AZD4635 Both as Monotherapy and in Combination in Patients with Advanced Solid Malignancies: Results from Prostate Cancer Patients".(5/29 Presented) ※ASCO 2020 Highlights: Prostate Cancer: "Discussant: Promising Therapeutic Targets in Prostate Cancer". Synergistic Effect of Adenosine Mechanisms and Immunotherapeutic Approaches. (5/31) ※AstraZeneca: Capital Markets Event - Meet AZN Management: ASCO 2020: Data from Across the Portfolio]: Phase I/II New Medicines, Selected: AZD4635 Solid Tumours: "Data at ASCO". (6/1)
※BioRxiv: New Results: "Short chain fatty acids enhance expression and activity of the umami taste receptor in enteroendocrine cells via a Gαi/o pathway": Imperial College London & Sosei Heptares, (6/1 Posted) ※Sosei Heptares：｢AstraZeneca社がAZD4635の単剤、およびPD-L1抗体デュルバルマブ(Imfinzi)を併用した第1a相試験における新しい臨床データを2020 ASCO Virtual Scientific Programで発表」(6/4up) ※Novartis: "Novartis Phase IIIb ARGON Study Meets Primary Endpoint in a Comparison of Enerzair Breezhaler (QVM149) Versus a Free Combination of Two Existing Inhaled Treatments in Uncontrolled Asthma". (6/5) ※Sosei Heptares：｢コントロール不良な喘息患者を対象とした Enerzair Breezhaler(QVM149)の第Ⅲb 相臨床試験(ARGON試験)において主要評価項目を達成」Respiratory Medicineにオンライン掲載で発表。(6/5) ※Xtalks Life Science Webinars: "Exploring Changes of Myeloid Cells with Chromogenic Multiplex IHC in Advanced Liver Cancer. MTL-CEBPA": Nagy Habib, MiNA Therapeutics. (6/8:Webinar) ※厚生労働省：｢薬事・食品衛生審議会 薬事分科会 (6/25 15:00-17:00: Web会議) 開催のお知らせ」報告事項：医薬品エナジア吸入用カプセル(QVM149)の中用量及び高用量の製造販売承認。(6/11)
※ClinicalTrials(NCT04089735): " Phase 2, A Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of APP13007 to Treat Inflammation and Pain After Cataract Surgery". ("Completed", 6/11update) ※Journal of Chemical Information and Modeling: "Accurate Prediction of GPCR Ligand Binding Affinity with Free Energy Perturbation". (6/15 Published) ※Angewandte Chemie: Research Article: "X-Ray Crystallography and Free Energy Calculations Reveal the Binding Mechanism of A2A Adenosine Receptor Antagonists." (6/16 Published) ※Nature: "Molecular basis of β-arrestin coupling to formoterol-bound β1-adrenoceptor". Researchers from Chris Tate’s group have solved the first high-resolution structure of a GPCR-arrestin complex. (6/17 Published) ※Journal of Medicinal Chemistry: Article: "Structure-Based Drug Discovery of HTL22562: a Calcitonin Gene-Related Peptide (CGRP) Receptor Antagonist For Acute Treatment of Migraine" (6/19 Publication) ※Sosei Heptares：｢そーせいグループ創立30周年を迎えて」日本に軸足を持つ世界的なバイオ医薬品企業になるための堅牢な基盤を作り上げることができたと確信。将来の更なる可能性に大いに期待しています。(6/22)
※PNAS: "A Combined Activation Mechanism for the Glucagon Receptor". he mechanism found here is consistent with electron cryo-microscopy structural data and might be general for class B GPCRs. (6/22 published) ※AACR 2020 Virtual MeetingⅡ: "Clinical Pharmacology of AZD4635: Integration of PK Data from Cancer Patients and Healthy Volunteer Clinical Trials to Provide Dosing Recommendations" (6/22 Presented) ※Sosei Heptares：｢HTL22562の構造ベース創薬：片頭痛の急性期治療woCGRP受容体拮抗薬」Teva Pharmaceuticalsの研究者とともに、Journal of Medicinal Chemistryに論文を掲載。(6/23) ※AACR 2020 Virtual MeetingⅡ: "Targeting A2aR (AZD4635) in Mouse Pten-Deficient Prostate Cancer" (6/23 Presented) ※AstraZeneca: General presentation for investors and analysts June 2020: Oncology: Solid pipeline moving forward: PhaseII "AZD4635" A2aR inhibitor prostate cancer. (6/23up) ※Uppsala University: "Molecular Simulations Show How Drugs Block Key Receptors". Jointly with the Sosei-Heptares. "Our calculation methods are now having a major breakthrough in structure-based drug design". (6/24 Press Release)
※Sosei Heptares：｢アッヴィと炎症性疾患を標的とした新規創薬提携」契約一時金と初期マイルストン合計で最大約34億円を受領する権利、拡大オプションにて総額約1,065億円を超える取引額となる可能性。(6/25) ※厚生労働省 薬事・食品衛生審議会 薬事分科会：｢報告：医薬品エナジア吸入用カプセル(QVM149)中用量及び高用量の製造販売承認」(6/25開催) ※四季報更新：【改善】的絞った研究開発費等の増加抑制も効き営業黒字定着。【前進】3剤配合ぜんそく薬は7月にも欧州委員会が承認の可能性。新型コロナ下で開発は提携案件優先。(6/26) ※Sosei Heptares：｢自由エネルギー摂動によるGPCRリガンド結合親和性の正確な予測」Janssenとライデン大学の研究者とともにJournal of Chemical Information and Modelingにこの度論文を発表。(6/26up) ※Sosei Heptares HP Update：(6/28 update) ※Novartis: "Novartis receives simultaneous approval for five new products from Japanese Ministry of Health, Labour and Welfare, offering Japanese patients a broad range of novel treatment options". (6/29 Press Release)
※USC (University of Santiago de Compostela): "At the Forefront of Developing a New Generation of Cancer Drugs". USC scientists in collaboration with the Swedish University of Uppsala and pharmacist Sosei Heptares. (7/6 Press Release) ※EC: Commission Implementing Decision: "Granting Marketing Authorisation for Enerzair Breezhaler". (7/3); "Union Register of medicinal products for human use: Enerzair Breezhaler, EC Medicinal Products Register up". (7/6) ※Sosei Heptares：｢EUにてエナジア ブリーズヘラー承認取得」EU加盟国全27ヵ国および英国、アイスランド、ノルウェー、リヒテンシュタインに適用。日本およびカナダで承認済。デジタルデバイスも欧州委員会による承認。(7/7) ※Novartis: "Novartis receives EC approval for Enerzair Breezhaler, including the first digital companion (sensor and app) that can be prescribed alongside a treatment for uncontrolled asthma in the EU". (7/7 Press Release) ※Sosei Heptares：｢EUにてEnerzair Breezhaler承認取得」約5.38億円のマイルストンを受領する。EU加盟国全27ヵ国および英国･アイスランド･ノルウェー･リヒテンシュタインに適用。日本･カナダで承認済。(7/7) ※Propeller Health: " Propeller Health sensor to be co-packaged with recently approved Enerzair Breezhaler asthma medication in Europe." First asthma medication to be co-packaged and co-prescribed with a digital health platform. (7/7 Press Release)
※Vectura: "Enerzair Breezhaler Rceives Rgulatory Aproval". Enerzair Breezhaler receives regulatory approval in Europe and Japan, triggering $6.25 million in milestone payments to Vectura. (7/7 Press Release) ※Bachem: Webinar "Cost-Efficient and Green Manufacturing of Peptides Thanks to Molecular Hiving Technology". Guide you through the individual steps for synthesis of peptides applying Molecular HivingTM technology. (7/7 Presented) ※ClinicalTrials(NCT04462263; HTL0014242-103): Phase 1, "Study to Investigate the Receptor Occupancy of HTL0014242 Using [18F] FPEB in Healthy Male Subjects". (New Trials Record, Recruiting, 7/8 First Posted) ※Sosei Heptares：｢進行性前立腺癌患者を対象としたAZD4635単剤療法およびPD-L1抗体デュルバルマブとの併用の第1a相試験の結果と健康な治験者を対象とした臨床薬理学研究における新しい臨床データをAACR 2020で発表」(7/9up) ※The Lancet Respiratory Medicine: "Once-daily, single-inhaler mometasone-indacaterol-glycopyrronium versus mometasone-indacaterol or twice-daily fluticasone-salmeterol in patients with inadequately controlled asthma (IRIDIUM)". (7/9 Published) ※Novartis: "Novartis Phase III IRIDIUM data in Lancet Respiratory Medicine show benefit of Enerzair Breezhaler (QVM149), the first-in-class inhaled LABA/LAMA/ICS combination in uncontrolled asthma". (7/10 Press Release)
※Sosei Heptares：｢喘息患者を対象としたエナジア ブリーズヘラー(QVM149)の第Ⅲ相臨床試験(IRIDIUM試験)における有効性成績がThe Lancet Respiratory Medicine誌に掲載」その他の国でもQVM149の承認審査が進められている。(7/10) ※Worldwide PDB (Protein Data Bank): Structure Validation Report (Stacey Southall, Sosei Heptares): "6ZHO; 6ZIS: Crystal structure of a CGRP receptor ectodomain heterodimer with bound high affinity inhibitor". (7/15 Release, up) ※Sosei Heptares Official Blog：｢日経バイオテクにCEOロングインタビュー掲載中」(5連載7/13-7/17) 創業30年を迎え、CEO田村が創業から現在に至る長い足取りを振り返り、数々のエピソードを交えながら語っています。(7/16) ※Sosei Heptares：｢海外募集による新株式の発行及び2025年満期ユーロ円建転換社債型新株予約権付社債の発行に係る払込完了」総額210億5510万3680円の払込みが完了。戦略的成長投資に資金を充当予定。(7/16) ※Scrip: "Sosei Heptares Seeks Acquisitions After $200m Boost". Looking To Add $50-100m In Revenues Per Year. Conducting a Search to Find "a Potentially Transformative Acquisition". (7/16) ※Duke University School of Medicine: New funding awards - June: "Daniel George" has received an award from AstraZeneca for a project entitled "An Phase II Combination Study of AZD4635 Prostate Cancer." Total funding will be $488,210. (7/20)
※ClinicalTrials (NCT04478513): "A Study to Assess the Effect of Fluvoxamine and Smoking on Pharmacokinetics ( the Movement of Drugs Within the Body) of AZD4635 in Healthy Volunteers". ("New Trial Record", 7/20 First Posted) ※EMA EPAR: Enerzair Breezhaler: "Medicine Overview", "Risk-Management-Plan Summary", "Product Information", "Public Assessment Report". (First Publication 7/21) ※Novartis Q2 2020 Results: "Ultibro Group": (USD 149m, -10%, -7% cc) Sales Declined Due to Competitive Pressures in All Regions. Medicines Approvals: "Enerzair Breezhaler Asthma: (EU - July), (JP - June)." (7/21) ※キャピタル・リサーチ・アンド・マネージメント・カンパニー：[変更報告書]：報告義務発生日(2020/07/15)、共同保有割合7.92％(1.07増加）、筆頭提出者保有割合：1.80％(0.77増加）。(7/22提出) ※X-Chem: "X-Chem Announces Achievement of Milestone In Orexia Collaboration". met a key development milestone in its collaboration with Orexia Limited. (7/22 Press Release) ※Sosei Heptares Twitter: we are seeking an experienced CryoEM microscopy scientist and Bioinformatician to join the Biomolecular Structure Group, as well as a Biophysicist to join the Biophysics group." (7/24) ・・・
※Drug Profile: "Research programme: small molecule therapeutics - Unknown company/X-Chem". (7/27update) ・Latest Information Update: 27 Jul 2020. At a glance: ・Originator: X-Chem ・Class: Sleep disorder therapies; Small molecules ・Mechanism of Action: Orexin receptor type 2 agonists ・Orphan Drug Status: No ・New Molecular Entity: Yes ・Highest Development Phases: "Preclinical: Narcolepsy" Most Recent Events: ・23 Jul 2020, "Orexia exercises its option to license orexin receptor type 2 programme from X-Chem." ・23 Jul 2020, "Orexia plans clinical trials for Narcolepsy." ・20 Dec 2017, Orexia and X-Chem collaborate to develop small molecule therapeutics.
Funded PhD Project up ・・・ ※Imperial College London: PhD Research Project: "Understanding nutrient derived small molecule signalling in the Gastrointestinal Tract". (7/28up) ・Supervisors: Imperial College London, Prof G Frost, Dr A Hanyaloglu. ・Funded PhD Project (European/UK Students Only). ・The closing date: Sunday August 16, 2020. About the Project: Hundreds of small molecules are present in the intestinal space either derived from digestion or the intestinal microbiota. G protein-coupled receptors (GPCRs) represent one of the main host receptor mechanisms whereby small molecules generated by the gut microbiome affect host physiology, for example the release of gut hormones from enteroendocrine cells. Dysregulated signaling through one or more of these metabolite-sensing GPCRs can influence a range of physiological processes including intestinal barrier function, immune homeostasis and hormone production. A major challenge is to understand this complex array of potential signal generating molecules and multiple receptors. Current work has identified a profile of molecules in the intestinal space. We know wish to explore the metabolite receptor interaction to understand how this complex environment influences the release of GLP-2 (a hormone that is critically important in maintaining gastrointestinal function). The person appointed to this studentship will gain experience in metabolomic analysis, GPCR receptor biology,cell and organoid culture and imaging. Based on the likely complex mixtures of metabolites in the GI tract, a key aspect of this work is to evaluate whether synergistic or additive effects can be demonstrated with specific metabolite pairings. Combination approaches may be applied using metabolite ligand pools. Funding Notes: This studentship is part of fully funded Enterprise DTP PhD Studentships to start in October 2020, with a stipend of EURO 18,000 p/a. As part of this support, funding is provided at the end of three years for a 6 month writing up period. The studentship is tied to a specific Collaborative Award in Science and Engineering (CASE) project. The student will benefit from additional training through the CASE commercial partner, Sosei Heptares, in specific areas such as ligand receptor interaction.
※Sosei Heptares：｢欧州連合においてコントロール不十分な喘息の治療剤としてエナジア ブリーズヘラー承認取得」約5億3800万円のマイルストンを受領する。(7/7) ※Sosei Heptares Official Blog：｢日経バイオテクにCEOロングインタビュー掲載中(5連載7/13-7/17)」創業30年を迎え、CEO田村が創業から現在に至る長い足取りを振り返り、数々のエピソードを交えながら語っています。(7/16up) ※Sosei Heptares：｢海外募集による新株式の発行及び2025年満期ユーロ円建転換社債型新株予約権付社債の発行に係る払込完了」総額210億5510万3680円の払込みが完了。戦略的成長投資に資金を充当予定。(7/16) ・長期的な収益成長を確保するための転機となる可能性を持った企業買収、創薬プラットフォームを補完・拡充する新規技術へ、創薬及び初期開発の新規ターゲットへの拡大、国内市場向けの後期臨床開発段階にあるアセットの導入。 ※Scrip: "Sosei Heptares Seeks Acquisitions After $200m Boost". Looking To Add $50-100m In Revenues Per Year. Conducting a Search to Find "a Potentially Transformative Acquisition". (7/16) ※X-Chem: "X-Chem Announces Achievement of Milestone In Orexia Collaboration". Orexia exercised an option to exclusively license the OX2R program from X-Chem, which comprises multiple novel orexin positive modulators. (7/22) ・・・ ※Sosei Group 2020年12月期第2四半期決算発表・中間決算説明会 (8/13) ・・・
※Clinical Cencer Research: "Adenosine Signaling is Prognostic for Cancer Outcome and Has Predictive Utility for Immunotherapeutic Response": AZD4635, Landscape of Adenosine Signaling in Cancer. (5/1 Publication) ※Immuno Therapy of Cancer: "Conversion of ATP to Adenosine by CD39 and CD73 in Multiple Myeloma can be Successfully Targeted Together with Adenosine Receptor A2A Blockade." AZD4635. (5/14 Published) ※ASCO: "Phase I, Preliminary Antitumor Activity of AZD4635 Both as Monotherapy and in Combination in Patients with Advanced Solid Malignancies: Results from Prostate Cancer Patients".(5/29 Presented) ※ASCO 2020 Highlights: Prostate Cancer: "Discussant: Promising Therapeutic Targets in Prostate Cancer". Synergistic Effect of Adenosine Mechanisms and Immunotherapeutic Approaches. (5/31) ※AstraZeneca: Capital Markets Event - Meet AZN Management: ASCO 2020: Data from Across the Portfolio]: Phase I/II New Medicines, Selected: AZD4635 Solid Tumours: "Data at ASCO". (6/1) ※Sosei Heptares：｢AstraZeneca社がAZD4635の単剤、およびPD-L1抗体デュルバルマブ(Imfinzi)を併用した第1a相試験における新しい臨床データを2020 ASCO Virtual Scientific Programで発表」(6/4up)
※AACR 2020 Virtual MeetingⅡ: "Clinical Pharmacology of AZD4635: Integration of PK Data from Cancer Patients and Healthy Volunteer Clinical Trials to Provide Dosing Recommendations" (6/22 Presented) ※AACR 2020 Virtual MeetingⅡ: "Targeting A2aR (AZD4635) in Mouse Pten-Deficient Prostate Cancer" (6/23 Presented) ※AstraZeneca: General presentation for investors and analysts June 2020: Oncology: Solid pipeline moving forward: PhaseII "AZD4635" A2aR inhibitor prostate cancer. (6/23up) ※Sosei Heptares：｢進行性前立腺癌患者を対象としたAZD4635単剤療法およびPD-L1抗体デュルバルマブとの併用の第1a相試験の結果と健康な治験者を対象とした臨床薬理学研究における新しい臨床データをAACR 2020で発表」(7/9up) ※Duke University School of Medicine: New funding awards - June: "Daniel George" has received an award from AstraZeneca for a project entitled "An Phase II Combination Study of AZD4635 Prostate Cancer." Total funding will be $488,210. (7/20) ※ClinicalTrials (NCT04478513): Phase I, "A Study to Assess the Effect of Fluvoxamine and Smoking on Pharmacokinetics ( the Movement of Drugs Within the Body) of AZD4635 in Healthy Volunteers". ("New Trial Record", 7/20 First Posted) ↓ ※AstraZeneca Q2 2020 Results (7/30) ・・・
※Sosei Heptares：｢HTL22562の構造ベース創薬：片頭痛の急性期治療woCGRP受容体拮抗薬」Teva Pharmaceuticalsの研究者とともに、Journal of Medicinal Chemistryに論文を掲載。(6/23) ※Sosei Heptares：｢アッヴィと炎症性疾患を標的とした新規創薬提携」契約一時金と初期マイルストン合計で最大約34億円を受領する権利、拡大オプションにて総額約1,065億円を超える取引額となる可能性。(6/25) ※Sosei Heptares：｢自由エネルギー摂動によるGPCRリガンド結合親和性の正確な予測」Janssenとライデン大学の研究者とともにJournal of Chemical Information and Modelingにこの度論文を発表。(6/26up) ※Sosei Heptares：｢本邦において世界初のLABA/LAMA/ICS配合喘息治療剤「エナジア」が製造販売承認を取得」第3四半期に約1億3400万円のマイルストン受領。新たなデジタルデバイスが日本で初めて提供。(6/29) ※Sosei Heptares：｢海外募集による新株式の発行及び2025年満期ユーロ円建転換社債型新株予約権付社債の発行による資金(209億円)調達」発行価格(募集価格)1,595円、引受人払込金額1,531.2円、払込期日7/16。(6/30) ※Sosei Heptares HP：｢ファクトシート(更新) 2020年7月」https://www.soseiheptares.com/uploads/financial_presentations/2020.07.01%20JP_Sosei%20Heptares_Factsheet%20(Jul-20).pdf (7/1update)
AZD4635 Publication up: ・・・ ※Journal for ImmunoTherapy of Cancer: "Small molecule AZD4635 inhibitor of A2AR signaling rescues immune cell function including CD103+ dendritic cells enhancing anti-tumor immunity". (7/29 Published) ・First published July 29, 2020. [Abstract]: Accumulation of extracellular adenosine within the microenvironment is a strategy exploited by tumors to escape detection by the immune system. Adenosine signaling through the adenosine 2A receptor (A2AR) on immune cells elicits a range of immunosuppressive effects which promote tumor growth and limit the efficacy of immune checkpoint inhibitors. Preclinical data with A2AR inhibitors have demonstrated tumor regressions in mouse models by rescuing T cell function; however, the mechanism and role on other immune cells has not been fully elucidated. [Methods]: We report here the development of a small molecule A2AR inhibitor including characterization of binding and inhibition of A2AR function with varying amounts of a stable version of adenosine. Functional activity was tested in both mouse and human T cells and dendritic cells (DCs) in in vitro assays to understand the intrinsic role on each cell type. The role of adenosine and A2AR inhibition was tested in DC differentiation assays as well as co-culture assays to access the cross-priming function of DCs. Syngeneic models were used to assess tumor growth alone and in combination with alphaprogrammed death-ligand 1 (αPD-L1). Immunophenotyping by flow cytometry was performed to examine global immune cell changes upon A2AR inhibition.
[Results]: We provide the first report of AZD4635, a novel small molecule A2AR antagonist which inhibits downstream signaling and increases T cell function as well as a novel mechanism of enhancing antigen presentation by CD103+ DCs. The role of antigen presentation by DCs, particularly CD103+ DCs, is critical to drive antitumor immunity providing rational to combine a priming agent AZD4635 with check point blockade. We find adenosine impairs the maturation and antigen presentation function of CD103+ DCs. We show in multiple syngeneic mouse tumor models that treatment of AZD4635 alone and in combination with αPD-L1 led to decreased tumor volume correlating with enhanced CD103+ function and T cell response. We extend these studies into human DCs to show that adenosine promotes a tolerogenic phenotype that can be reversed with AZD4635 restoring antigen-specific T cell activation. Our results support the novel role of adenosine signaling as an intrinsic negative regulator of CD103+ DCs maturation and priming. We show that potent inhibition of A2AR with AZD4635 reduces tumor burden and enhances antitumor immunity. This unique mechanism of action in CD103+ DCs may contribute to clinical responses as AZD4635 is being evaluated in clinical trials with IMFINZI (durvalumab, αPD-L1) in patients with solid malignancies. [Conclusion]: We provide evidence implicating suppression of adaptive and innate immunity by adenosine as a mechanism for immune evasion by tumors. Inhibition of adenosine signaling through selective small molecule inhibition of A2AR using AZD4635 restores T cell function via an internal mechanism as well as tumor antigen cross-presentation by CD103+ DCs resulting in antitumor immunity.
Sosei Heptares: Job Portal update: ・・・ ※Sosei Heptares: Job Portal: "Biophysicist". (7/24up) ※Sosei Heptares: Job Portal: "Bioinformatician". (7/24up) ※Sosei Heptares: Job Portal: "Cryo-Electron Microscopy Scientist". (7/24up) ↓ ※Sosei Heptares Twitter 1時間前：(7/31) "Sosei Heptares Job Opportunities - We are seeking an experienced protein crystallographer to join the Crystallography group and an experienced molecular biologist to join the ProteinEngineering group, to work on GPCR structure determination."
※Sosei Heptares: Job Portal: "Crystallographer". (7/31up) Position: We are currently seeking an experienced protein crystallographer to join the crystallography group working on GPCR structure determination to enable drug discovery efforts. This is an exceptional opportunity to participate in pioneering science with an Industry-leading Drug Discovery company. The successful candidate is expected to work independently and: ・Express and purify GPCRs for structural and biophysical methods ・Set up and optimise vapour diffusion and LCP crystallisation experiments ・Collect X-ray diffraction data at synchrotron sources ・Solve and refine structures ・Present results (written and oral) to internal and external audiences. The closing date for applications is 4th September 2020.
※Sosei Heptares: Job Portal: "Molecular Biologist". (7/31up) Position: We are currently seeking an experienced molecular biologist to join the Protein Engineering group working on GPCR structure determination to enable drug discovery efforts. The successful candidate will be expected to work independently, and the role will include the following responsibilities: ・Cloning of plasmid constructs for expression; ・Expression of GPCRs in insect, yeast and human cells; ・Characterization of GPCRs in membrane and in solubilised form using radioligand and fluorescent binding assays; ・Setting up and optimising thermal stability assays; ・Mutant library generation and directed evolution of proteins; ・Screening for stabilising mutations using our proprietary platform to create StaR proteins; ・Construct engineering to optimise expression; ・Purification and biochemical characterisation of GPCRs using a range of techniques such as size exclusion chromatography ・Careful documentation of experimental work; and, ・Work closely with molecular biologists, protein expression scientists, crystallographers and pharmacologists to help advance the project. This is an exceptional opportunity to participate in pioneering science with an Industry-leading Drug Discovery company The closing date for applications is 4th September 2020.
ちなみに AZD4635 Publication up: ・・・ ※Journal for ImmunoTherapy of Cancer: "Small molecule AZD4635 inhibitor of A2AR signaling rescues immune cell function including CD103+ dendritic cells enhancing anti-tumor immunity". (7/29 Publication) https://jitc.bmj.com/content/jitc/8/2/e000417.full.pdf ↓ ※Journal for ImmunoTherapy of Cancer Twitter 16時間前：(7/31) "New JITC article: Small molecule AZD4635 inhibitor of A2AR signaling rescues immune cell function including CD103 dendritic cells enhancing anti-tumor immunity" ・・・
AZD4635 update: ・・・ ※AstraZeneca Q1 2020 Results: Q1 NME (Prostate Cancer, Phase II): AZD4635, Imfinzi+AZD4635, Oleclumab+AZD4635. Oncology ’What’s Next’: Solid Pipeline Moving Forward: "Phase I/II New Medicines, Selected: AZD4635". (4/29) ※Clinical Cencer Research: "Adenosine Signaling is Prognostic for Cancer Outcome and Has Predictive Utility for Immunotherapeutic Response": AZD4635, Landscape of Adenosine Signaling in Cancer. (5/1 Publication) ※Immuno Therapy of Cancer: "Conversion of ATP to Adenosine by CD39 and CD73 in Multiple Myeloma can be Successfully Targeted Together with Adenosine Receptor A2A Blockade." AZD4635. (5/14 Published) ※ASCO: "Phase I, Preliminary Antitumor Activity of AZD4635 Both as Monotherapy and in Combination in Patients with Advanced Solid Malignancies: Results from Prostate Cancer Patients".(5/29 Presented) ※ASCO 2020 Highlights: Prostate Cancer: "Discussant: Promising Therapeutic Targets in Prostate Cancer". Synergistic Effect of Adenosine Mechanisms and Immunotherapeutic Approaches. (5/31)
※AstraZeneca: Capital Markets Event - Meet AZN Management: ASCO 2020: Data from Across the Portfolio]: Phase I/II New Medicines, Selected: AZD4635 Solid Tumours: "Data at ASCO". (6/1) ※Sosei Heptares：｢AstraZeneca社がAZD4635の単剤、およびPD-L1抗体デュルバルマブ(Imfinzi)を併用した第1a相試験における新しい臨床データを2020 ASCO Virtual Scientific Programで発表」(6/4up) ※AACR 2020 Virtual MeetingⅡ: "Clinical Pharmacology of AZD4635: Integration of PK Data from Cancer Patients and Healthy Volunteer Clinical Trials to Provide Dosing Recommendations" (6/22 Presented) ※AACR 2020 Virtual MeetingⅡ: "Targeting A2aR (AZD4635) in Mouse Pten-Deficient Prostate Cancer" (6/23 Presented) ※AstraZeneca: General presentation for investors and analysts June 2020: Oncology: Solid pipeline moving forward: PhaseII "AZD4635" A2aR inhibitor prostate cancer. (6/23up) ※Sosei Heptares：｢進行性前立腺癌患者を対象としたAZD4635単剤療法およびPD-L1抗体デュルバルマブとの併用の第1a相試験の結果と健康な治験者を対象とした臨床薬理学研究における新しい臨床データをAACR 2020で発表」(7/9up)
※Duke University School of Medicine: New funding awards - June: "Daniel George" has received an award from AstraZeneca for a project entitled "An Phase II Combination Study of AZD4635 Prostate Cancer." Total funding will be $488,210. (7/20) ※ClinicalTrials (NCT04478513): Phase I, "A Study to Assess the Effect of Fluvoxamine and Smoking on Pharmacokinetics ( the Movement of Drugs Within the Body) of AZD4635 in Healthy Volunteers". ("New Trial Record", 7/20 First Posted) ※Journal for ImmunoTherapy of Cancer: "Small molecule AZD4635 inhibitor of A2AR signaling rescues immune cell function including CD103+ dendritic cells enhancing anti-tumor immunity". (7/29 Publication) ※ClinicalTrials (NCT04478513): Phase I, "A Study to Assess the Effect of Fluvoxamine and Smoking on Pharmacokinetics ( the Movement of Drugs Within the Body) of AZD4635 in Healthy Volunteers". ("Recruiting", 7/30update) ※AstraZeneca H1 2020 Results: Q2 NME (Prostate Cancer, Phase II): AZD4635, Imfinzi+AZD4635, Oleclumab+AZD4635. Oncology ’What’s Next’: Solid Pipeline Moving Forward: "Phase I/II New Medicines, Selected: AZD4635". (7/30) ・What’s Next’: Next Key Milestone by Project: Oncology "AZD4635 (A2AR, Phase II, Solid Tumours): Phase II Data".
↓ AZD4635 New Trial Record up: (7/31up) ※ClinicalTrials(NCT04495179): Phase 2, "A Study of AZD4635 With Durvalumab and With Cabazitaxel and Durvalumab in Patients With mCRPC. (AARDVARC)". ("New Trial Record", 7/31 First Posted) [Official Title]: "A Phase II, Open-label, Study to Assess the Efficacy, Safety, and Tolerability of AZD4635 in Combination With Durvalumab and in Combination With Cabazitaxel and Durvalumab in Patients Who Have Progressive Metastatic Castrate-Resistant Prostate Cancer (AARDVARC)" ・Sponsor: AstraZeneca. ・Collaborator: Parexel. ・Research Site Locations: United States, Belgium, Denmark, France, Germany, Italy, Korea, Spain, United Kingdom. ・Estimated Enrollment: "160 participants". ・Estimated Study Start Date: "July 24, 2020" ・Estimated Primary Completion Date: "September 16, 2022". ・Estimated Study Completion Date: "September 16, 2022". ・First Posted: July 31, 2020.
[Brief Summary]: This is a Phase II, international, open-label, two-arm, non-randomised study of AZD4635 in participants with metastatic castration-resistant prostate cancer (mCRPC). Condition or disease: Progressive Metastatic Castrate-Resistant Prostate Cancer. [Detailed Description]: This is a Phase II, international, open-label, two-arm, non-randomised study of AZD4635 in participants with mCRPC. Participants in each arm will be stratified by the presence of measurable soft tissue metastasis (per Response Evaluation Criteria in Solid Tumours [RECIST v1.1]) or bone-only metastasis (per Prostate Cancer Working Group 3 [PCWG3 criteria]). There will be no formal comparisons between treatment arms. AZD4635 plus durvalumab (Arm A) will consist of 80 participants with mCRPC previously treated with one or more approved new hormonal agent(s) (NHAs) and one or more taxanes or participants who are taxane ineligible. AZD4635 plus durvalumab plus cabazitaxel (Arm B) will consist of 80 participants mCRPC previously treated with docetaxel and one prior NHA. ・・・
※Sosei Heptares：｢海外募集による新株式の発行及び2025年満期ユーロ円建転換社債型新株予約権付社債の発行による資金調達を決定」本海外募集による手取金概算額合計約209億円、戦略的成長投資等に充当する予定。(6/30) ・事業戦略を背景として、経営基盤の強化を目的とした今後の買収や事業投資、当社の既存事業と補完性のある技術の獲得に対応するとともに、調達コストの抑制及び調達手段の多様化を図るために、資金調達を行うことを決定。 ※Sosei Heptares：｢欧州連合においてコントロール不十分な喘息の治療剤としてエナジア ブリーズヘラー承認取得」約5億3400万円のマイルストンを受領する。デジタルデバイスも承認に含まれる。日本･カナダで承認済。(7/7) ※Sosei Heptares：｢海外募集による新株式発行及び2025年満期ユーロ円建転換社債型新株予約権付社債発行に係る払込完了」総額210億5510万3680円。新たな転機となる可能性を持つ企業買収を中心とした戦略的成長投資に。(7/16) ・長期的な収益成長を確保するための転機となる可能性を持った企業買収。創薬プラットフォームを補完・拡充する新規技術へ。創薬及び初期開発の新規ターゲットへの拡大。国内市場向けの後期臨床開発段階にあるアセットの導入。 ※Scrip: "Sosei Heptares Seeks Acquisitions After $200m Boost". Looking To Add $50-100m In Revenues Per Year. Conducting a Search to Find "a Potentially Transformative Acquisition". (7/16)
※Sosei Heptares：｢海外募集による新株式の発行及び2025年満期ユーロ円建転換社債型新株予約権付社債の発行に係る払込完了」(7/16) ・総額210億5510万3680円の払込みが完了。新たな転機となる可能性を持つ企業買収を中心とした戦略的成長投資に資金を充当予定。 ・長期的な収益成長を確保するための転機となる可能性を持った企業買収、創薬プラットフォームを補完・拡充する新規技術へ、創薬及び初期開発の新規ターゲットへの拡大、国内市場向けの後期臨床開発段階にあるアセットの導入。 ※Scrip: "Sosei Heptares Seeks Acquisitions After $200m Boost". Looking To Add $50-100m In Revenues Per Year. (7/16) ・The Japanese firm with R&D operations in the UK is conducting a search to find "a potentially transformative acquisition," helped by a significant financing round. ・・・ ※Sosei Group 2020年12月期第2四半期決算発表(8/13) ・・・
※Sosei Heptares：｢HTL22562の構造ベース創薬：片頭痛の急性期治療woCGRP受容体拮抗薬」Teva Pharmaceuticalsの研究者とともに、Journal of Medicinal Chemistryに論文を掲載。(6/23) ※Sosei Heptares：｢アッヴィと炎症性疾患を標的とした新規創薬提携」契約一時金と初期マイルストン合計で最大約34億円を受領する権利、拡大オプションにて総額約1,065億円を超える取引額となる可能性。(6/25) ※Sosei Heptares：｢自由エネルギー摂動によるGPCRリガンド結合親和性の正確な予測」Janssenとライデン大学の研究者とともにJournal of Chemical Information and Modelingにこの度論文を発表。(6/26up) ※Sosei Heptares：｢本邦において世界初のLABA/LAMA/ICS配合喘息治療剤「エナジア」が製造販売承認を取得」第3四半期に約1億3400万円のマイルストン受領。新たなデジタルデバイスが日本で初めて提供。(6/29) ※Sosei Heptares：｢海外募集による新株式の発行及び2025年満期ユーロ円建転換社債型新株予約権付社債の発行による資金(209億円)調達」発行価格(募集価格)1,595円、引受人払込金額1,531.2円、払込期日7/16。(6/30) ※Sosei Heptares：｢EUにてエナジア ブリーズヘラー承認取得」約5億3800万円のマイルストンを受領する。EU加盟国全27ヵ国および英国、アイスランド、ノルウェー、リヒテンシュタインに適用。日本およびカナダで承認済。(7/7)
Voyager Therapeutics (NASDAQ:VYGR) announces the termination of its tau and alpha-synuclein vectorized antibody collaborations with AbbVie (NYSE:ABBV) thereby regaining all rights to the vectorization technology and certain novel vectorized antibodies developed under the partnership.
The tau agreement was inked in 2018 followed by the alpha-synuclein deal in 2019. 
※Sosei Heptares：｢欧州連合においてコントロール不十分な喘息の治療剤としてエナジア ブリーズヘラー承認取得」約5億3800万円のマイルストンを受領する。(7/7) ※Sosei Heptares Official Blog：｢日経バイオテクにCEOロングインタビュー掲載中(5連載7/13-7/17)」創業30年を迎え、CEO田村が創業から現在に至る長い足取りを振り返り、数々のエピソードを交えながら語っています。(7/16up) ※Sosei Heptares：｢海外募集による新株式の発行及び2025年満期ユーロ円建転換社債型新株予約権付社債の発行に係る払込完了」総額210億5510万3680円の払込みが完了。戦略的成長投資に資金を充当予定。(7/16) ・長期的な収益成長を確保するための転機となる可能性を持った企業買収、創薬プラットフォームを補完・拡充する新規技術へ、創薬及び初期開発の新規ターゲットへの拡大、国内市場向けの後期臨床開発段階にあるアセットの導入。 ※Scrip: "Sosei Heptares Seeks Acquisitions After $200m Boost". Looking To Add $50-100m In Revenues Per Year. Conducting a Search to Find "a Potentially Transformative Acquisition". (7/16) ※X-Chem: "X-Chem Announces Achievement of Milestone In Orexia Collaboration". Orexia exercised an option to exclusively license the OX2R program from X-Chem, which comprises multiple novel orexin positive modulators. (7/22) ※AstraZeneca H1 2020 Results: Q2 NME (Prostate Cancer, Phase II): AZD4635, Imfinzi+AZD4635, Oleclumab+AZD4635. What’s Next’: Next Key Milestone by Project: "AZD4635 (A2AR, Phase II, Solid Tumours): Phase II Data". (7/30) ・・・ ※Sosei Group 2020年12月期第2四半期決算発表(8/13) ・・・
※Sosei Heptares：｢海外募集による新株式の発行及び2025年満期ユーロ円建転換社債型新株予約権付社債の発行による資金調達を決定」本海外募集による手取金概算額合計約209億円、戦略的成長投資等に充当する予定。(6/30) ・事業戦略を背景として、経営基盤の強化を目的とした今後の買収や事業投資、当社の既存事業と補完性のある技術の獲得に対応するとともに、調達コストの抑制及び調達手段の多様化を図るために、資金調達を行うことを決定。 ※Sosei Heptares：｢欧州連合においてコントロール不十分な喘息の治療剤としてエナジア ブリーズヘラー承認取得」約5億3400万円のマイルストンを受領する。デジタルデバイスも承認に含まれる。日本･カナダで承認済。(7/7) ※Sosei Heptares：｢海外募集による新株式発行及び2025年満期ユーロ円建転換社債型新株予約権付社債発行に係る払込完了」総額210億5510万3680円。新たな転機となる可能性を持つ企業買収を中心とした戦略的成長投資に。(7/16) ・長期的な収益成長を確保するための転機となる可能性を持った企業買収。創薬プラットフォームを補完・拡充する新規技術へ。創薬及び初期開発の新規ターゲットへの拡大。国内市場向けの後期臨床開発段階にあるアセットの導入。 ※Scrip: "Sosei Heptares Seeks Acquisitions After $200m Boost". Looking To Add $50-100m In Revenues Per Year. Conducting a Search to Find "a Potentially Transformative Acquisition". (7/16)
※Sosei Heptares: Job Portal: "Biochemist". (8/6up) Position: We are now seeking an experienced membrane protein biochemist to join the Protein Expression and Biochemistry group at our research facility on Granta Park, Cambridge, UK, working on membrane protein biochemical characterisation to enable drug discovery efforts. At Sosei Heptares we are equipped with state-of-the-art protein expression, purification, SPR, mass-spec, crystallisation and cryoEM facilities. Applicants should be proficient in the expression and purification of challenging membrane proteins destined for biochemical, biophysical and structural studies. A proven track record of publications related to the expression, purification, and biochemical characterisation of difficult membrane protein targets in peer-reviewed journals is highly desirable. This is an exceptional opportunity to participate in pioneering science with an Industry-leading Drug Discovery company. The successful candidate is expected to: ・Express and purify challenging membrane proteins. ・Perform appropriate quality control analyses and biochemically and biophysically characterise purified membrane proteins. ・Keep up to date, propose, develop, implement and optimise new techniques in the fields of membrane protein expression, purification and biochemical characterisation. ・Collaborate with other Sosei Heptares scientists on research projects, working closely with molecular biologists, biophysicists and structural biologists. ・Prepare and effectively present results (written and oral) to program teams. Have strong interpersonal skills and interact effectively with collaborators across a wide range of disciplines. The closing date for applications is 4th September 2020.
※Sosei Heptares: Job Portal: "Tissue Culture Scientist". (8/6up) Position: We are seeking an experienced and enthusiastic scientist to provide cell culture expertise and to support our protein production facility. The candidate will be part of the Protein Expression and Biochemistry group which supports our drug discovery platform. The ideal candidate will have the following experience: ・Sterile cell culture techniques. ・Handling of adherent and suspension mammalian and insect cell cultures. ・Experience with transient transfection methods and baculovirus mediated protein expression protocols. ・Performing expression quality control (QC) experiments using methods such as Western Blot, fluorescence size exclusion chromatography, FACS and ligand binding assays. ・Protein purification skills. ・Comprehensive and accurate record keeping and reporting. ・Organisation skills such as maintaining lab consumable stocks, ordering materials and expression logistics. ・Molecular biology skills such as cloning, plasmid extraction, bacmid generation. The closing date for applications is 4th September 2020.
Propeller Health update: ・・・ ※Propeller Health: Propeller Sensor for Breezhaler: "How to Attach Your Sensor for Breezhaler"; "How to Remove Your Sensor for Breezhaler"; "Breezhaler Sensor Technique". (4/9update) ※Propeller Health: " Propeller Health sensor to be co-packaged with recently approved Enerzair Breezhaler asthma medication in Europe." First asthma medication to be co-packaged and co-prescribed with a digital health platform. (7/7 Press Release) ↓ ※ResMed Q4 2020 Earnings Call, Aug 05, 2020. (8/5) (Mick Farrell -- Chief Executive Officer): ・・・ Our recently announced commercial partnership with Novartis, which I will describe in more detail later during the call, is a great example of this progress with propeller. During the last 12 months, we have improved 16 million lives by providing a person with a device or complete mask system to help them breathe. Importantly, the ability to help these patients on their individual journey to better sleep and better breathing is powered by the over 6.5 billion nights of medical data in our ecosystem. These data form a significant competitive advantage as they enable us to perform sophisticated analytics and drive actionable insights to benefit all of our customer groups, including the patients most importantly, but also improving workflows for physicians, for providers, for payers and for full healthcare systems. Fundamentally, we believe the future of healthcare delivery is outside the hospital. That's where ResMed competes today, and that's where we win today. Globally, there are 936 million people with sleep apnea. There are over 380 million people who suffer from COPD, and there are over 340 million people living with asthma. They all need our help, and they all want that help at home, definitely not in a hospital. Our SaaS business is 100% focused on out-of-hospital care, leveraging the global trend for seniors to age in place. We think this trend will accelerate in a post COVID world. ResMed can provide seamless care for our portfolio of out-of-hospital care settings, including home medical equipment, skilled nursing facilities, senior living, life plan communities, home health, hospice, as well as home care services.
・・・ We accelerated the delivery of this technology for clear and urgent needs during the pandemic. However, this enhanced AirView capability, providing insights across European ventilation patient populations will provide differentiation for ResMed through the clinical value for physicians and better outcome for patients in perpetuity. In terms of execution in our third key disease state of asthma, ResMed has partnered with Novartis to co-package the propeller solution and digital platform with the new triple-action asthma medication in a brand called Enerzair Breezhaler. This novel combination has been cleared by the European Commission for launch. The propeller sensor attaches to the new inhaler from Novartis and its new medication where it can collect medication usage data. The app works both as an adherence measure that gives the patient reminders to take their medication, but also as a means of collecting information about the patient's medical condition to help their physician provide even better care to the patient. This is a breakthrough innovation as it is the first time a respiratory medicine has been co-packaged with a digital health platform and co-prescribed. The benefits of this combination are tremendous for the patient. It's a simple and convenient way to have a fully integrated experience to allow them to better live with their chronic disease, to better live with asthma with no incremental cost to the patient. This brand-new approval is a new-to-the-world technology that will accelerate the adoption of digital health in the respiratory medicine space and will help us identify other innovative opportunities to combine our propeller tech with medicine delivery. This new Novartis partnership follows our announcement in May that the propeller sensor and an app gained 510(k) US 510(k) clearance for use with the SYMBICORT inhaler for both asthma and COPD patients from AstraZeneca. This sensor is built to fit various inhalers and their generic equivalents. Propeller's cloud-based system tracks medication usage of the SYMBICORT from these inhalers through a smartphone app, which patients can use to paint a clearer picture of their disease control for their clinicians. These new partnerships with both Novartis and AstraZeneca and previously announced collaborations with Orion, as well as Boehringer Ingelheim expand the potential reach of propeller's technology to around 90% of inhaled medicines for both asthma and COPD in the United States. We believe that this represents a significant upside opportunity for the expansion of the propeller platform in the US market, but also around the world as the benefits of digital health grow and move around the world. ・・・
※国際特許出願(Heptares)："Orexin 1 Receptor Antagonists". (8/6公開) ・Document Type and Number: WIPO Patent Application WO/2020/15747 A1. ・Publication Date: 2020/08/06. ・Application Number: GB2020/050182. ・Filing Date: 2020/01/28. ・Inventors: Heptares & Sygnature Discovery. ・Assignee: Heptares Therapeutics Limited. Abstract: The disclosures herein relate to novel compounds of formula (1) and salts thereof, wherein V; W; X; Y; Z; R1; R2; R3; R4 and R5 are defined herein, and their use in treating, preventing, ameliorating, controlling or reducing the risk of neurological or psychiatric disorders associated with orexin receptors. http://www.freepatentsonline.com/WO2020157474A1.pdf
※Sosei Heptares：｢HTL22562の構造ベース創薬：片頭痛の急性期治療CGRP受容体拮抗薬」Teva Pharmaceuticalsの研究者とともに、Journal of Medicinal Chemistryに論文を掲載。(6/23) ※Sosei Heptares：｢アッヴィと炎症性疾患を標的とした新規創薬提携」契約一時金と初期マイルストン合計で最大約34億円を受領する権利、拡大オプションにて総額約1,065億円を超える取引額となる可能性。(6/25) ※Sosei Heptares：｢自由エネルギー摂動によるGPCRリガンド結合親和性の正確な予測」Janssenとライデン大学の研究者とともにJournal of Chemical Information and Modelingにこの度論文を発表。(6/26up) ※Sosei Heptares：｢本邦において世界初のLABA/LAMA/ICS配合喘息治療剤「エナジア」が製造販売承認を取得」第3四半期に約1億3400万円のマイルストン受領。新たなデジタルデバイスが日本で初めて提供。(6/29) ※Sosei Heptares：｢海外募集による新株式の発行及び2025年満期ユーロ円建転換社債型新株予約権付社債の発行による資金(209億円)調達」発行価格(募集価格)1,595円、引受人払込金額1,531.2円、払込期日7/16。(6/30)
※ClinicalTrials (NCT04478513): Phase 1, "A Study to Assess the Effect of Fluvoxamine and Smoking on Pharmacokinetics ( the Movement of Drugs Within the Body) of AZD4635 in Healthy Volunteers". ("New Trial Record", 7/20up) ※X-Chem: "X-Chem Announces Achievement of Milestone In Orexia Collaboration". Orexia exercised an option to exclusively license the OX2R program from X-Chem, which comprises multiple novel orexin positive modulators. (7/22) ※Journal for ImmunoTherapy of Cancer: "Small molecule AZD4635 inhibitor of A2AR signaling rescues immune cell function including CD103+ dendritic cells enhancing anti-tumor immunity". (7/29 Publication) ※AstraZeneca H1 2020 Results: Q2 NME (Prostate Cancer, Phase II): AZD4635, Imfinzi+AZD4635, Oleclumab+AZD4635. What’s Next’: Next Key Milestone by Project: "AZD4635 (A2AR, Phase II, Solid Tumours): Phase II Data". (7/30) ※ClinicalTrials(NCT04495179): Phase 2, "A Study of AZD4635 With Durvalumab and With Cabazitaxel and Durvalumab in Patients With mCRPC. (AARDVARC)". ("New Trial Record", 7/31up) ・・・ ※Sosei Group 2020年12月期第2四半期決算発表 (8/13) ・・・
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