https://blog-imgs-34-origin.fc2.com/d/o/u/doubutuburogu/201001061738130de.jpg0609山師さん@トレード中 (ワッチョイ 4b37-9nzk [202.124.48.126 [上級国民]])2018/07/26(木) 22:00:15.48ID:w1bODsA/0 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。 Heptares is based the New Research Facility (Steinmetz Building) of Granta Park (Cambridge) from August 2018. ・・・ ※SOSEI 2018年3月期決算:研究開発費4,818百万円(54%増加)97%は英国活動。毎年3つの新薬候補を発見するPresentingことができるプラットフォーム構築。当社独自の化合物関連パイプラインが大幅に進展。自社開発品拡充。(5/10) ※SOSEI決算説明会:「戦略プランを着実に実行し2017年度は著しい進捗を達成」。事業は堅調に進捗。ビジネスモデル3つの柱:リスク低減及び収益機会の拡大。PLへの投資を継続。新たに6つの臨床試験予定:投与開始タイミング。(5/10) ※SOSEI:「A2A拮抗薬の将来性」- BioCenturyがAZD4635の記事(3/26)を掲載。新規併用療法の後期第I相/第II相試験(NCT03381274)データは2021年になる見込み。固形がんに対する第I相試験(NCT02740985)を併せて実施中。(5/16) ※SOSEI :ニューヨークで開催のUBS Global Healthcare Conferenceにて発表。Presentation "Sosei Group Corporation": Global operations and aspirations - aiming to build Japan’s first global biotech champion: Drive Global Growth Strategy. (5/21Presented, 5/22up) ※SOSEI:PAR2 標的に対して高い親和性と選択性を有するペプチド・アンタゴニストを同定。わずか2カ月未満で同定することができました。ペプチドリーム社とのコラボレーションが順調に進展。現在は、臨床開発への進展を目指し、さらに本ペプチドの特性分析と最適化。(5/24) ※タイヨウ・パシフィック・パートナーズ:そーせいグループの発行済株式総数の5%超を取得し、実質調査ベースで第2位の株主になったと発表。「そーせいの経営陣と協働し、継続的な成長をサポートできることを楽しみにしています。」(6/3) ※SOSEI:MiNA Therapeuticsが進行肝がん患者を対象とする MTL-CEBPA の初めてのヒト試験の初期結果を発表:正常肝機能および肝機能障害のある患者において良好な忍容性がみられた。血液検体の解析によりRNA活性機序を実証。薬効標的への作用を確認。(6/5) ※Heptares: Download Corporate Presentation: "2018.06.08 Corporate Presentation (Sosei Group Corporation Corporate Presentation June 2018)". (6/8up) ※ClinicalTrials(NCT03379233): Ultibro(Phase 3): "Concept2 Inhaler: Digital Adherence System": A Randomized Study to Evaluate the Effect of Reminder Notifications and Motivational/Adaptive Messaging. Change Study Start: "2018/7/16" (6/13update) ※ClinicalTrials(NCT03316898): Phase 1b, FDG-PET Study of AGN-242071 Added to Standard-of-Care (Donepezil±Memantine) for the Treatment of Participants with Mild to Moderate AD. Change Start: "2018/7/30", Add: United States, California, Study Research Sites. (6/14update) ※SOSEI定時株主総会:「当社事業の飛躍的な拡大」:COPDフランチャイズ売上は順調推移・複数の共同開発プログラム保有・自社PLの迅速な拡充。日本から世界へ:新たなグローバルブランドへ統一:2018年内に運用開始。(6/22) ※個人投資家説明会(名古屋・大阪:6/25) ※JITSUBO_HPリニュアル更新:「高品質で低コストなペプチド医薬品の提供を通じ、世界の健康文化の向上に貢献します。」:受託合成サービス(ペプチド合成に関する受託業務)紹介。(6/25) ※City of Hope: Researchers Use Nanoparticles to Test Treatment for Liver Disease. Promising Results: Promising Results: In the study, saRNAs were encapsulated in SMARTICLES nanoparticles to deliver a treatment called MTL-CEBPA in multiple liver disease models. (6/25) 0610山師さん@トレード中 (ワッチョイ 4b37-9nzk [202.124.48.126 [上級国民]])2018/07/26(木) 22:00:39.32ID:w1bODsA/0 ※Trial Profile: A randomized, double-blind, placebo controlled, dose ranging study to assess the safety, tolerability, and efficacy of HTL0018318 in patients with dementia with Lewy bodies: JapicCTI-183989(ja):(予定試験期間:2018/6/1〜2020/7/31、被験者募集状況:募集前、日本). (6/28update) ※医薬品原料国際展in-Pharma Japan (JITSUBO出展6/27~6/29)・技術セミナーも開催「新規ペプチド原薬製造法の開発」:液相、固相合成法に続く第3世代のペプチド合成技術Molecular Hivingの創薬研究および原薬製造への適用と、更なる進化への取り組み紹介。(6/29) ※ClinicalTrials(NCT03381274): Phase 1b/2, Oleclumab(MEDI9447) EGFRm NSCLC Novel Combination Study. (MEDI9447 with Osimertinib or AZD4635, AZD4635 with MEDI9447). Research Site Status Change: Korea Seoul (03080): "Recruiting". (6/29update) ※大阪大学大学院医学系研究科:「認知症プレシジョン医療開発学」寄附講座開講(寄附講座教授:森原剛史)。発症メカニズムの分子レベルの解明とバイオマーカーの開発、認知症サブグループに対する効率的な治療法開発を目指す。臨床と分子生物学の両分野に強い阪大精神科の強みを活かす。(7/1) ※日本国特許庁(公開商標公報):【商標】MATILDA 【商品及び役務】バイオ技術・薬剤・科学に関する試験・研究・開発・指導・助言並びにこれらに関する情報の提供及びコンサルティング等【出願人】ヘプタレス【出願番号】商願2018-79942【出願日】2018/6/18【公開日】2018/7/3。(7/3公開) ※MiNA Therapeutics_HP: Renewal. "Development Programs" update. (7/3up) ※MiNA Therapeutics: Exited to launch our new website. Head minatx.com to learn more about small activating RNA medicines. (7/6) ※Heptares: We are now seeking to appoint an enthusiastic and motivated “IT Support Technician” working in our expanding IT team. (7/9up, 7/30Closing) ※ClinicalTrials(NCT02740985): A Phase 1 (Ph1b Expansion Cohorts) Clinical Study of AZD4635 and Durvalumab in Patients With Advanced Solid Malignancies. Enrollment: 156→"206”(Change), Secondary Outcome Measures (Change), Eligibility (Change), Study Research Site (Add). (7/16update) ※ClinicalTrials(NCT02571777): Phase 3, Study to Compare the Efficacy and Safety of QVM149 With QMF149 in Patients with Asthma. Study Locations: (Research Site update, Research Site Status update). (7/16update) ※Novartis Q2 2018 Results: Continued Strong Growth of Ultibro (USD 116 million, +11% cc). QVM149 Asthma: First planned submissions: "2019", Expected Launches: "2020". News update: "QVM149 IRIDIUM study enrollment completed end of April". (7/18) ※SOSEI:「シーブリおよびウルティブロ」の2018年第2四半期(4月〜6月)の業績。ウルティブロは当四半期において、FLAME, CLAIM studyの良好な結果、2018年版GOLDレポート、さらにSUNSET studyに後押しされ、売上は二桁の伸び。シーブリの売上は、ほぼ横ばい。(7/18) ※米国特許出願(MiNA):"Albumin Production and Cell Proliferation". (7/19公開) 0611山師さん@トレード中 (ワッチョイ 4b37-9nzk [202.124.48.126 [上級国民]])2018/07/26(木) 22:01:30.33ID:w1bODsA/0 ※ClinicalTrials(NCT03592862: HTL0018318-203): Phase 2, A Study to Assess Safety, Tolerability, and Efficacy of HTL0018318 in Patients With Dementia With Lewy Bodies (DLB). Study Start: "August 2018". Primary Completion: "July 2020", Study Completion: "January 2021". (7/19up, "New Trial Record".) ※ClinicalTrials(NCT03456349: HTL0018318-202): Phase 1b, Multi-center Study to Determine the Safety and Tolerability of HTL0018318 in Subjects With Alzheimer's Disease Receiving Standard-of-care. Actual Study Completion: "2018/7/16" (7/20update, "Completed".) ※トレーダーズ・ウェブ:そーせい大幅続伸。著名投資家が株買い増し。23日公表の大量保有報告書で、同社の筆頭株主でもある五味大輔氏が19日時点で保有株比率を従来の6.13%から7.16%へと引き上げたことが判明し、投資妙味があるとの期待から買いが集中。(7/24) ※米国特許(Heptares):"Piperidin-1-yl and azepin-1-yl carboxylates as muscarinic M4 receptor agonists". (7/24公開) ※米国特許(Heptares):"Muscarinic receptor agonists". (7/24公開) ※ClinicalTrials(NCT03100825): Phase 3, A Long-term Safety Study of QVM149 in Japanese Patients With Asthma. Study Start: "2017/4/13 [Actual]", Primary Completion: 2018/9/18, Study Completion: "2019/4/8, Study Enrollment: "94 participants [Actual]". (7/24update) ※メルトレ:そーせいグループHTL18318の国内フェーズ2試験が8月に開始。「HTL18318 セールスピーク800億円予想」。国内大手証券バイオセクターアナリストは、「重要な進捗でプラスな印象」とコメント。今回の試験期間は2018年8月〜2021年1月の予定、患者数172人、有効性の観察期間は12週間。(7/25) ※Heptares: "All set for our study of HTL0018318 in Patients with Dementia with Lewy Bodies (DLB)". (7/25) ※JITSUBO:日本プロセス化学会2018サマーシンポジウムにて発表(7/27 14:40〜16:20):「疎水性タグを用いたIcatibant Acetateの合成」久保大輔 (JITSUBO)。(7/25)
※AstraZeneca H1 and Q2 2018 Results: Clinical Trials Appendix Q2 2018 results update. (7/26) ・Movement since Q1 2018 update: New to Phase I (Additional indications): "oleclumab+AZD4635 (CD73 mAb + A2aR inhibitor EGFRm NSCLC)" ・Q2 2018 New Molecular Entity (NME) Pipeline: Phase I: "Small molecule: AZD4635 (A2aR inhibitor solid tumours)" ・Q2 2018 Lifecycle Management (LCM) Pipeline: Phase I (Oncology Combinations): "oleclumab + AZD4635 (CD73+A2aR EGFRm NSCLC)" ※Allergan Q2 2018 Results: (7/26) ・・・ 0612山師さん@トレード中 (ワッチョイ 4b37-9nzk [202.124.48.126 [上級国民]])2018/07/26(木) 22:02:15.28ID:w1bODsA/0 Pluristem: ・・・ ※Pluristem 2Q Report: "Our Expectations; Sosei CVC"; "Pluristem is working hard to negotiate the best possible terms for a Japanese JV and will provide an update upon reaching an agreement." (2/7) ※Pluristem 3Q Report: "The proposed joint venture, with Sosei CVC for the clinical development and commercialization in Japan, the plan to enter into definitive agreements and the timing of entering into such agreements." (5/9) ※Pluristem: Announced that the top-line results of the company’s multinational Phase II clinical trial of PLX-PAD cells in the treatment of Intermittent Claudication (IC) will be released on June 12, 2018. (6/4) ※Pluristem Reports: Positive Top-Line Results from Its Multinational Phase II Intermittent Claudication Study: PLX-PAD treatment reduced risk of revascularization and improved patients’ mobility. (6/12) ※Pluristem: "These study results are highly encouraging and suggest that PLX-PAD cells may be the answer for both PAD patients and physicians seeking effective medical solutions". (6/12) ※Reuters: Israel's Pluristem sees positive results from leg pain study: The study’s results also validate the design of Pluralism’s advanced Phase III trial for CLI, the company said. (6/12) ※Pluristem: Pluristem to Open Weekly Market Trading at TASE Following Positive Study Results. (6/14) ※Pluristem: U.S. Department of Defense to Study Pluristem’s PLX-R18 for the Treatment of Mustard Gas Injuries Studies to be funded by the U.S. NIH Marks the second project for DOD with PLX-R18 cell therapy product. (6/19) ※Seeking Alpha: Pluristem's PLX-PAD Cell Therapy Promising As A Non-Invasive Treatment For Peripheral Artery Disease. (6/19) ※Pluristem: and Fukushima University Report Positive Data: PLX-R18 Increases Survival Rates and Mitigates Severe Intestinal Damage after Acute Radiation Exposure. (6/25) ※Pluristem: A Glimpse from the Media: Study shows placenta treatment effective against radiation sickness. Pluristem has been working with researchers in Fukushima, the site of nuclear meltdowns in 2011, to treat acute radiation syndrome. (6/27up) ※World Congress of Basic and Clinical Pharmacology, Kyoto: "PLX-R18- Placenta-derived Mesenchymal-like Stromal Cells are efficacious in reducing lethality in Gastrointestinal Acute Radiation Syndrome (GI-ARS) Mouse Model": Yoshiyuki Soeda, Fukushima Medical University. (7/3 Presented) ※Pluristem: Signs Collaboration Agreement With Thermo Fisher Scientific: Advance fundamental knowledge of cell therapy industrialization and to improve quality control of the end-to-end supply chain. "A potential to advance the industry significantly". (7/9) ※Pluristem: Company Presentation July 2018. (7/23update) ・Critical Limb Ischemia (CLI): PLX-PAD: Single pivotal study (Japan: Via PMDA’s Accelerated Regulatory Pathway for Regenerative Therapies). ・Collaboration with Fukushima Medical University: Evaluating PLX-R18 cells as a treatment for radiation damage to the gastrointestinal (GI) tract and bone marrow. 50% Increase in survival rate. Suggesting PLX-R18 potential as a multi-organ therapy for radiation exposure. ↓ 0613山師さん@トレード中 (ワッチョイ 4b37-9nzk [202.124.48.126 [上級国民]])2018/07/26(木) 22:03:06.17ID:w1bODsA/0 ※Pluristem 2時間前:"New patent in Japan- covers PLX-R18’s protection of the gastrointestinal (GI) tract from radiation exposure". (7/26)
※Pluristem: Granted Key Patent in Japan for Treatment of GI Following Acute Radiation Exposure. (7/26) ・Patent covers PLX-R18’s protection of the gastrointestinal (GI) tract from radiation exposure ・Recent data from Fukushima University shows PLX-R18 cells significantly increased survival and enhanced the recovery of the GI tract after radiation exposure HAIFA, Israel, July 26, 2018 - Pluristem Therapeutics Inc., a leading developer of placenta-based cell therapy products, announced today that the Japan Patent Office has granted Pluristem a patent for the treatment of Acute Radiation Syndrome (ARS) and its impact on the gastrointestinal tract. The patent titled “Methods for Treating Radiation or Chemical Injury” relates to intramuscular (IM) administration of adherent stromal cells, cultured under three-dimensional culturing conditions, for mitigating intestinal damage in patients that have been exposed to radiation or chemotherapy. “The patent is a particularly meaningful asset for our Company in Japan, due to recently published findings from pre-clinical studies conducted at Fukushima Medical University, showing that following radiation exposure PLX-R18 cells significantly increase survival rates, preserve GI stem cell activity, enhance the recovery of the GI system and prevent severe damage to the intestinal lining,” stated Pluristem Chairman and Co-CEO Zami Aberman. “We believe PLX-R18 is the optimal therapy available today for acute radiation injury. ARS includes injury to multiple organs, with its lethality stemming from radiation-induced damage mainly to the bone marrow and GI tract. The Fukushima University studies demonstrate PLX-R18’s potential ability to treat multiple organs affected by ARS,” Aberman added. Pluristem’s PLX-R18 cells are in late-stage development as a treatment for ARS in a program conducted and funded by the U.S. National Institutes of Health (NIH) and are also being studied by the U.S. Department of Defense (DOD) and Fukushima University. A PLX-R18 investigational new drug (IND) application for ARS was recently cleared by the U.S. Food and Drug Administration (FDA), allowing Pluristem to treat victims who may have been acutely exposed to high dose radiation due to nuclear attack or accident. Pluristem’s PLX-R18 ARS program has also received an orphan drug designation by the FDA. 0614山師さん@トレード中 (アウアウオーT Saba-x//5 [119.104.111.177])2018/07/26(木) 22:21:04.32ID:42R7b5Mia >602 7/19に改訂しているから、少なくとも19日までには募集しているはず。 大体1か月くらいだと思うので、お盆明け位には何等かアナウンスあるのでは? 0615山師さん@トレード中 (ワッチョイ 4b37-9nzk [202.124.48.126 [上級国民]])2018/07/26(木) 22:30:57.53ID:w1bODsA/0 ・・・ ※日本プロセス化学会2018サマーシンポジウム:「疎水性タグを用いたIcatibant Acetateの合成」久保大輔(JITSUBO) (7/27 14:40-16:20) ※大日本住友製薬2019年3月期 第1四半期決算発表:(7/27) ※第一三共 平成31年3月期第1四半期決算発表:(7/31) ※Pfizer Quarterly Corporate Performance - Second Quarter 2018: (7/31) ※Imperial Innovations: "Incubator 18 Month Review and Graduation Ceremony of MiNA Therapeutics." (7/31 18:00-20:30) ※MorphoSys Publication of Half-Year Report 2018: (8/1) ※あすか製薬 平成31年3月期第1四半期決算発表:(8/6) ※Medicinal Chemistry GRC: "Novel Adenosine 2A Receptor Antagonist AZD4635: From the Brain to the Tumor Microenvironment": Michelle Lamb, AstraZeneca USA. (8/6 9:45) ※SOSEI 2018年12月期第1四半期決算発表:(8/9) ※ペプチドリーム 平成30年6月期決算発表: (8/9) ※ACS National Meeting - GPCR Symposium: "SBDD for GPCRs & Other Difficult Targets": Session Organizers, Presiders (8/21 13:30); "Navigating structural GPCR-ligand interaction space for crafted computer-aided drug design": Chris de Graaf, Heptares. (8/21 14:50) ※EFMC International Symposium on Medicinal Chemistry: Chris de Graaf, Heptares. (9/2-6) ※EFMC International Symposium on Medicinal Chemistry: Breakthroughs in Polypharmacology Towards Neurological Disorders(ACS Session): "In silico Polypolpharmacology": Giovanni Bottegoni, Heptares. Invited Speakers. (9/4 14:50) ※Annual CCPBioSim Meeting: Molecular Simulations in Drug Discovery and Development: (Invited Speakers): Chris de Graaf, Heptares. (9/5-7) ※SCI/RSC Symposium on GPCRs in Medicinal Chemistry: "Keynote: Application of structure-based drug design to peptidergic GPCRs": Miles Congreve, Heptares. (9/10 14:50) ※Pluristem FY 2018 Earnings Release: (9/10 Projected) ※SCI/RSC Symposium on GPCRs in Medicinal Chemistry: "Mining structural GPCR-ligand interaction maps to navigate medicinal chemistry space": Chris de Graaf, Heptares.(9/11 10:20). ※SCI/RSC Symposium on GPCRs in Medicinal Chemistry: "Keynote: Shedding light on G protein bias: structures of GPCRs coupled to G proteins determined by cryo-EM and X-ray crystallography": Chris Tate, MRC LMB. (9/12 9:30) ※European Symposium on Quantitative Structure-Activity Relationships (EuroQSAR) 2018: Jon Mason, Heptares. (9/16-20) ※千里ライフサイエンスセミナー「アルツハイマー病研究の最前線」:「アルツハイマー病というcomplex diseaseをどう攻めるか:A mouse-to-human translational research」大阪大学大学院 医学系研究科 医学部講師 (寄附講座教授) 森原剛史 (9/19 11:00) ※千里ライフサイエンスセミナー「アルツハイマー病研究の最前線」:「アルツハイマー病の治療戦略に対する洞察:対症療法や他の認知症性疾患の臨床試験をモデルとして」行動神経学・神経精神医学(Heptares)寄附講座教授 森悦郎 (9/19 14:10) ※OTS(Oligonucleotide Therapeutics Society) Annual Meeting 2018, Seattle, WA, USA: MiNA Therapeutics. (9/30-10/3) ※Fragment-based Lead Discovery Conference 2018: (Plenary speakers): Miles Congreve, Heptares. (10/7-10) ※ELRIG Drug Discovery 2018, London: Kirstie Bennett, Heptares. (10/9-10) ※AASLD Liver Meeting 2018, San Francisco: MiNA Therapeutics. (11/9-13) ※PCT (Partnerships in Clinical Trials) Europe: "Use of molecular and functional Imaging in early clinical development: From target engagement to proof of concept": Pradeep Nathan, Heptares. (11/29 15:00) ※PREP UK 2018: Organising Committee: Kerry O'Hare (Lead Analytical and Purification Chemist, Heptares). (11/29-30) ・・・ 0616山師さん@トレード中 (ワッチョイ 4b37-9nzk [202.124.48.126 [上級国民]])2018/07/26(木) 22:32:03.64ID:w1bODsA/0 ※SOSEIの成長相場の動向:[株式4分割:(6/27)分割比率修正済] 2010/12/30 (終値_338) ・(2010/10/15※最安値_163、2010/12/27最高値_437) 2011/12/30 (終値_318) ・(2011/_3/15※最安値_173、2011/_6/30最高値_420) 2012/12/28 (終値_522) ・(2012/_6/_6※最安値_238、2012/_9/_7最高値_742) 2013/12/30 (終値1079) ・(2013/_1/_4※最安値_513、2013/_5/_7最高値1525) 2014/_4/25 (終値_515) 売残高144800 買残高_4212800 ・(2014/_4/22最安値_464)※[成長回収期の入口]ステージへ 2015/_2/20 (終値_945) 売残高_56800 買残高_6123200 ・(2015/_3/16最安値_713)※Heptares [成功の序章ステージ] 2015/10/30 (終値1080) 売残高_45600 買残高_8871600 ・(2015/_9/24安値_888)※米国承認[次なる飛躍ステージへ]※[上抜け圏へ] 2016/_4/25 (終値5808) 売残高159200 買残高13619600 ・(2016_5/_9最高値6545)※Allergan[強気相場] 2016/_6/24 (終値3680) 売残高_42000 買残高_9944400 ・(2016/_6/24安値3240)※[強気相場解除]※[時間軸での調整局面へ] 2017/_3/31 (終値2720) 売残高_22400 買残高10487200 ・(2017/_4/_4安値2570)※[時間軸調整は順調に推移]※[振るい場・拾い場へ] 2017/_9/_8 (終値2175) 売残高__7600 買残高_8151200 ・(2017/_9/_6最安値2147)※[拾い場も順調に推移] 2018/_1/26 (終値3053) 売残高__3600 買残高_5716400 ・(1/22安値2740)※[振るいも順調に推移] 2018/_3/_9 (終値2378) 売残高_42000 買残高_7177600 ・(3/_5安値2195)※[悪地合いにて再びの拾い場へ] 2018/_6/29 (終値1784) 売残高_____0 買残高_7931600 ・(6/26安値1663)※空売り価格規制トリガー抵触(5/11安値1665, 6/5安値1695) 2018/_7/_6 (終値1387) 売残高__7300 買残高_7728300 ・(7/5最安値1304[※年初来安])※空売り価格規制トリガー抵触(7/2安値1584, 7/3安値1414) 2018/_7/13 (終値1412) 売残高__6800 買残高_7479600(-248700) ・(7/11安値1342) 2018/_7/20 (終値1329) 売残高_10700 買残高_7489500(__+9900)※7/24up ・(7/20安値1308) 2018/_7/23 (終値1331) 5日線乖離(-1.68%) 25日線乖離(-12.86%) 75日線乖離(-24.04%) 200日線乖離(-41.55%) (安値1325) 2018/_7/24 (終値1435) 5日線乖離(+5.08%) 25日線乖離(_-5.40%) 75日線乖離(-17.61%) 200日線乖離(-36.86%) (安値1355) 2018/_7/25 (終値1416) 5日線乖離(+3.21%) 25日線乖離(_-6.10%) 75日線乖離(-18.19%) 200日線乖離(-37.57%) (安値1406) 2018/_7/26 (終値1390) 5日線乖離(+0.71%) 25日線乖離(_-7.12%) 75日線乖離(-19.19%) 200日線乖離(-38.58%) (安値1371)