【4565】そーせいG 446 【ATS International Conference 2018: 5/18-23, 株式分割: 6/30】
■ このスレッドは過去ログ倉庫に格納されています
>>243
あの手法は一文の価値もない屑株を売りつけるってやつだろ 7500円だと上場初値すら超えてないって驚きだわ・・ >>246
アキュセラやブライトバスとかもろにその手法じゃんw
アンジェスやスリーディーも被害者多いんじゃね？ 糞みてえな押さえつけだなおい
成り買いで根性みせろやボケ てめえら威勢だけじゃなく買い板出して根性みせろやボケが そーせい色々やってきているイメージだけどIPOから14年間ホールドしていてもまだマイナスかよ…
こんなんじゃ長期投資する人間がいなくなるのも無理はない
経営者も少しは責任感じて欲しいもんだな ブラパス金曜日より買い少ないな。まじで100円まで逝きそう。 値幅倍になる明後日は寄るやろ
明日377円
明後日217円 ペーターの仕事してます報告だったな
紅茶飲んでるだけじゃねーよと >>257
そんな後付け、言い訳にもならんでしょ。
14年間ホールドしてくれている株主に80万円が9000円になる地獄味わわせておいて今現在75万円なのは事実なんだから。 >>263
お前だって後付けじゃん
初値でだけ買って14年間ホールドしてくれている株主なんて存在がいるかどうか不明だし
時価総額的に見れば当時より遥かに高い 初値があがらなかったら良かったってだけじゃないの？
で、何もしてくれない銘柄を選んで買ったのね
なら文句は自分に言いな。
私は同じでもあがりそうな銘柄を買いましたけど >>266
事実を言ってるだけなのに何をキレているの？
わざわざ難癖付けて絡んでくる理由が謎だわ だから株価を上げなければ下がらないって事だよねえ
経営かばうわけじゃないがくだらないんだよ株価株価って
ホルダーなら中身を見ろよ 政府は日経が騰がりすぎると政権が危うくなるから冷や水ぶっかけるんだよ
庶民は馬鹿だから下がったことしか見ないで政府のせいにするからな
ここにそういうことされちゃ困るんですよ ここ10年で株価600倍になったライザップでも、株価ベースではIPO初値より今の方が下なんだけどねー
263こそ難癖つけてルサンチマンしてるだけに見える 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 will move to a New Research Facility (Steinmetz Building) at Cambridge (Granta Park) in August 2018. Place approximately 130 employees.
Heptares Zurich will be by mid-2018, the biology lab technician will be 70 -100%. Grow a team of protein biochemistry groups from the current 2 FTEs to 5 FTEs by 2020.
Heptares and Imperial College are trying to rapidly advance drug discovery and translation research with emphasis on new and existing multiple GPCR disease targets.
MiNA Therapeutics Step Up to the translation & innovation hub facility at Imperial College London Campus.
・・・
※新春展望Peter Bains：日本に軸足をおいた国際的なバイオ企業、国際的なステージに展開へ。2018年主要テーマ：提携プログラム臨床開発の進捗、3プログラムの臨床入りで自社パイプライン拡大、株主価値の向上。(1/2)
※SOSEI (English) Presentation Material: J.P. Morgan Healthcare Conference: "Strong Cash Position of c.$300m to Drive Global Growth Strategy: Provides Runway of Approx 2-3 Years Based on Organic Business Plan". (1/8)
※個別株情報：みずほ証券レポート発行。開発中の申請・承認などでバイオベンチャー企業が2018年に変曲点を迎える可能性、2018年に期待される進捗：(QVM149：試験結果開示、承認申請) (SO-1105：承認取得)。(1/9)
※個別株情報：メリルリンチ日本証券では当面5年は先行投資負担で営業赤字に陥る年度もあるが2020年代半ば以降に飛躍的な業績拡大を遂げる可能性。18年は複数の新薬カタリストがあり中期成長力が再認識。(1/10)
※個別株情報：ドイツ証券が新規カバレッジ。StaR技術という強み。2018年には第2相臨床試験段階の資産がゼロから4つに増え、開発パイプライン前進と予想。より規模の大きな投資運用会社の関心を引く。(1/22)
※SOSE第3四半期決算：研究開発費3,456百万円(48.4％増加)97.1%は英国活動。中長期的には研究開発から自社製品の販売に至る総合的なバイオテックビジネスモデルを組み入れた企業を目指す。自社PL拡大投資も継続増加。(2/14)
※SOSEI個人投資家説明会：ピーター・ベインズ挨拶、HTL001831の開発(日本)、研究開発パイプライン更新。「研究段階から臨床開発段階へと進行中：今後22ヶ月の間に目標とする第1相及び第2相試験を6件開始予定」(3/14)
※個別株情報：野村は業績予想下方修正。Teva社の戦略変更によるもので化合物への評価に変更はない。自社での臨床試験が必要。HTL0022562を再導出する見込、開発の遅れは見込まず24年3月期発売を予想。(3/14)
※個別株情報：みずほ証券は説明会で今後2年で臨床入りさせる自社パイプラインについて、これまで開示された2つに加え4つのプログラムが明らかになり、ポテンシャル拡大を評価。(3/15)
※個別株情報：いちよしが中長期利益予想を見直し。HTL0022562、しばらく自社で開発を進め、より価値を高めた上で導出するなどの新たなシナリオも考えられるが、現時点では保守的に見る。(3/15)
※四季報：業績予想更新(2018/2/23)。自社パイプライン：他社との提携・導出に加え、自社販売視野に入れた開発候補７品目保有。18年内にレビー小体型認知症薬は2相、神経性疾患薬は1相入り目指す。(3/16更新) ※個別株情報：野村証券では、自社開発重視の方針転換にて自社開発費用増を見込むも新薬創出力の評価は不変とした。未公表パイプラインは他に20近くあり今後も年最大3品目が発表予定と注目。(4/9)
※フィスコ：そーせいグループのフィスコ二期業績予想(4/15更新)。3ヶ月後予想株価9,500円。自社開発重視の方針。18.3期3Q累計は苦戦。3Q売上はほぼロイヤルティー収入。AZD4635試験など進捗は順調。(4/22up)
※個別株情報：クレディ・スイス証券では株価回復の条件は臨床試験結果と開発進ちょく。業績予想を下方修正もパイプラインに対する期待は変わらず。導出開発品は着実に試験が進んでいることを評価。(4/24)
※日本経済新聞：創薬スタートアップ、医薬品候補6種を臨床試験。6種類もの新規化合物を2年の短い期間で臨床試験入りさせるのは極めて珍しい。業界で同社の注目度が改めて高まりそうだ。(5/9)
※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)
・2018/12/31までの9ヶ月間においては、現金収入は65百万米ドルから75百万米ドルの損失の範囲になると予想しています。現時点では、当社グループの財政状況は2019年12月期に改善に向かうものと予測しています。
※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株式分割：基準日(2018/6/30)の株主名簿に記録された株主の所有普通株式1株につき4株の割合をもって分割。効力発生日(2018/7/１）。(5/10) ※SOSEI：決算期変更(事業年度の末日：毎年12/31)。(5/10)
※アイフィス株予報：米系大手証券(シティG)、そーせいのレーティングを強気(1(買い))継続。目標株価11,000円。目標株価コンセンサスは15,644円(アナリスト数8人)。(5/11)
※アイフィス株予報：2018年12月期 業績予想コンセンサス(5/11更新)：売上高3,200百万円、営業利益-6,700百万円、経常利益-7,135百万円、当期利益-5,480百万円。(5/12up)
※SMBC日興証券レーティング：そーせいグループ(4565)「1」目標株価17000円。R＆Dプロジェクト順調に推移、1：4の株式分割発表ポジティブ。(5/14)
※四季報Online：そーせいグループの2018年12月期(変更)及び2019年12月期の業績予想を更新(2018/5/11)。(5/16up)
・18.12予変_売上高6,500百万円、営業利益-1,500百万円、税前利益-1,500百万円、純利益-1,300百万円、1株益_-17.1円
・19.12予___売上高8,000百万円、営業利益＿-500百万円、税前利益_-500百万円、純利益__-400百万円、1株益＿-5.2円
※アイフィス株予報：日系大手証券(みずほ証券)、そーせいのレーティング強気継続。目標株価21,600円。目標株価コンセンサスは15,044円(アナリスト数8人)。(5/18 18:01)
※アイフィス株予報：2018年12月期 業績予想コンセンサス(5/18更新)：売上高2,976百万円、営業利益-7,512百万円、経常利益-8,140百万円、当期利益-6,190百万円。(5/19up)
※Reuters：SOSEI 2019-2022業績予想コンセンサス。(5/19update) ※CHEST: Conference Coverage: "Most COPD patients on triple therapy can withdraw steroids" (5/20)
Reporting from ATS 2018: (Source: Chapman K et al. ATS 2018 Abstract A1009 "Withdrawal of Inhaled Corticosteroids from COPD Patients Inhaling Long-Term Triple Therapy: The SUNSET Study": 5/20 Presented)
・Key clinical point: Switching from triple therapy to indacaterol/glycopyrronium (IND/GLY) is effective in COPD patients and avoids long-term exposure to inhaled corticosteroids.
・Major finding: ICS withdrawal led to a mean reduction in trough FEV1 of -26 mL, which exceeded the noninferiority margin.
・Study details: A randomized trial of COPD patients in which 527 were randomized to IND/GLY and 526 to triple therapy.
・Disclosures: SUNSET was sponsored by Novartis.
※JPモルガン・アセット・マネジメント そーせいグループ株に係る変更報告書を提出。(5/21 10:29)
・2018年5月21日、JPモルガン・アセット・マネジメント（東京都千代田区）ら計4名は、そーせいグループの保有株式に関して変更報告書を提出した。
・報告書によると、報告義務発生日(2018年5月15日)における提出者・共同保有者合計の保有割合は5.86％(0.23ポイントの減少）、筆頭提出者の保有割合は4.83％(0.01ポイントの減少)であった。
・保有目的は「投資一任契約および投資信託による純投資を目的として保有している」としている。
※個別株情報：そーせい - みずほが目標株価引き下げ、「提携型」から「自社創薬型」へ。(5/21 11:12)
・そーせいグループがもみ合い。みずほ証券では、「提携型」から「自社創薬型」へビジネスモデルの転換点と判断。投資判断「買い」を継続も、目標株価は26400円(2017/5/26)→21600円(5/18)と引き下げた。
・大手製薬企業にパイプラインを導出する「提携型」から、自社での医薬品開発を中心とした「自社創薬型」へと、同社のビジネスモデルの主軸が転換期を迎えている。
・短・中期的には、売上高減少と研究開発投資を中心とした費用増により、従来の黒字から一転、当面は赤字が継続するとみられるが、自社品の上市が期待できる24.12期以降の成長スピードは、むしろ加速するとの見方を示した。
※SOSEI：ニューヨークで開催のUBS Global Healthcare Conferenceに参加。(5/21 15:30)
・当社代表執行役社長CEOピーター・ベインズは、2018年5月21日からニューヨークで開催されるUBS Global Healthcare Conferenceにて発表いたします。
・発表は21日午前10時半より、グランドハイアットホテルのBallroomIIにて行われます。発表資料はイベント終了後、当社ホームページ上で公開いたします。
（英文のみとなります。新規の情報は含まれておりませんのであらかじめご了承いただきますようお願い申し上げます） ・・・
※四季報(2018年3集夏号)：6月15日(金)発売。(四季報先取り新興株50 そーせいグループ：6月上旬配信予定)。
※SOSEI 第28回定時株主総会：(6月22日)
・・・
※SOSEIの成長相場の動向：[株式4分割：基準日2018/6/30・効力発生日2018/7/１]。
2014/_4/25 (終値_2058) 売残高36200 買残高 1053200 ・(2014/4/22最安値_1854)※[成長回収期の入口]ステージへ
2015/_2/20 (終値_3780) 売残高14200 買残高 1530800 ・(2015/3/16最安値_2851)※Heptares [成功の序章ステージ]
2015/10/30 (終値_4320) 売残高11400 買残高 2217900 ・(2015/9/24安値_3550)※米国承認[次なる飛躍ステージへ]
2015/11/27 (終値_6360) 売残高 14800 買残高 2552500 ・(2015/11/30終値_6060: Pfizer)※[上抜け圏へ]
2016/_4/25 (終値23230) 売残高39800 買残高 3404900 ・(2016/5/9最高値26180)※Allergan[強気相場]
2016/_6/24 (終値14720) 売残高10500 買残高 2486100 ・(2016/6/24安値12960)※[強気相場解除]→※[時間軸での調整局面へ]
2017/_1/_6 (終値14030) 売残高__300 買残高 2907100 ・(2017/2/13安値12400)※[強気相場解除後の時間軸調整は順調に推移]
2017/_3/31 (終値10880) 売残高_5600 買残高 2621800 ・(2017/4/4安値10280)※[振るい場・拾い場へ]
2017/_9/_8 (終値_8700) 売残高_1900 買残高 2037800 ・(2017/9/6最安値_8590)※[拾い場も順調に推移]
2018/_1/26 (終値12210) 売残高__900 買残高 1429100 ・(1/22安値10960)※[振るいも順調に推移]
2018/_4/27 (終値_7580) 売残高17700 買残高 2113400 ・(4/23安値_7210)※[再びの拾い場へ]
2018/_5/11 (終値_7040) 売残高21200 買残高 2099200 ・(5/11最安値_6660)※[年初来安値]※空売り価格規制トリガー抵触
2018/_5/18 (終値_7600) 5日線乖離(+2.84%) 25日線乖離(+1.38％) 75日線乖離(-14.73％) 200日線乖離(-22.71％) (安値_7540) ・(5/14安値_6980)
2018/_5/21 (終値_7520) 5日線乖離(+0.37%) 25日線乖離(+0.58％) 75日線乖離(-15.08％) 200日線乖離(-23.35％) (安値_7500)
更なる成長の黎明期にて、強気相場解除後の時間軸での調整の終盤(拾い場)は、上抜け圏で順調に推移。笑。
中長期成長戦略(R&D・PL等の拡充・進捗)も順調・着実な進展で、次なる展開・進捗が楽しみです。笑。
予定通りの拾い場は順調推移。笑。決算発表通過・株式分割、今回も面白くなりましたね。笑。 今日そーせい仕込めなかったやつはセンスねーなww
引けで上がってっから、明日から分割まで上がり続けるのは確定してるかんなww
分割直後に利確してメシウマだぜ楽勝楽勝ww 今日そーせい仕込めなかったやつはセンスねーなww
引けで上がってっから、明日から分割まで上がり続けるのは確定してるかんなww
分割直後に利確してメシウマだぜ楽勝楽勝ww 分割後に利確とかセンスねーな
持たざるリスクに備えないと ・・・
↓
※アイフィス株予報：日系中堅証券、レーティング強気継続。目標株価13,000円。(5/21 18:01)
・日系中堅証券(いちよし)が5月21日、そーせいグループのレーティングを強気(A)に据え置いた。また、目標株価は(3/14: 15,000円→)13,000円としている。
・因みに前日(5月18日)時点のレーティングコンセンサスは5(アナリスト数8人)で「強気」の水準、目標株価コンセンサスは15,044円(アナリスト数8人)となっている。
※アイフィス株予報：2018年12月期 業績予想コンセンサス(5/21更新)：売上高2,807百万円、営業利益-7,484百万円、経常利益-7, 955百万円、当期利益-6,243百万円。(5/21up)
・・・ 分割すれば他のしょーもないバイオを握ってる輩も
アホらしくてそーせい に乗り換えるだろ
本当に中身のペラいバイオだらけだからな 目標株価、いちよし３月に17000→15000と下げたばかりなのに、15000→13000ともう下方修正か 地合いが良くても下落で地合いが悪化したら暴落する
本当に糞すぎる
この上昇相場で何の恩恵も受けていない だから空売り外資に勝てるわけないやろ
諦めろ
3桁に絶対にするからな コソコソ買っては損切りからの悪罵（笑）
ルサンチメンズｗ これは完全に暴落待ちだわ
地合いが悪化するのを糞空売り外資は待っているかもな >>297
お前マジでそんな事を言ってんのか？
時価総額が150億円しかないゴミ以下の一本足糞バイオの影響なんてねえよ
今日はぺプチ4％も上がってんだぞ
糞ゴミ外資が買わないと上がらない典型的なゴミ株化している 資料きてんな
研究者向けというよりは投資家を募るような内容だがそういう会なのか？ 小生には理解できない資料きてんね
今がチャンスだ！ http://kabumatome.doorblog.jp/archives/65919446.html
運勝ちで成り上がったひともわずか15年でこれだけ消える 👀
Rock54: Caution(BBR-MD5:f2c519fe5384e767e1c9e99abdcfc293) だから空売り外資に勝てるわけないやろ
諦めろ
3桁に絶対にするからな 外資の買いが入ってると言ってるのと同じやん
アホは死ぬまでだな 発表した結果マイナスってつまり評価されてないってことでしょ？ 今夜は久しぶりにビールと刺身で一息つけますね。笑。 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 will move to a New Research Facility (Steinmetz Building) at Cambridge (Granta Park) in August 2018. Place approximately 130 employees.
Heptares Zurich will be by mid-2018, the biology lab technician will be 70 -100%. Grow a team of protein biochemistry groups from the current 2 FTEs to 5 FTEs by 2020.
Heptares and Imperial College are trying to rapidly advance drug discovery and translation research with emphasis on new and existing multiple GPCR disease targets.
MiNA Therapeutics Step Up to the translation & innovation hub facility at Imperial College London Campus.
・・・
※新春展望Peter Bains：日本に軸足をおいた国際的なバイオ企業、国際的なステージに展開へ。2018年主要テーマ：提携プログラム臨床開発の進捗、3プログラムの臨床入りで自社パイプライン拡大、株主価値の向上。(1/2)
※SOSEI (English) Presentation Material: J.P. Morgan Healthcare Conference: "Strong Cash Position of c.$300m to Drive Global Growth Strategy: Provides Runway of Approx 2-3 Years Based on Organic Business Plan". (1/8)
※SOSEI：AstraZenecaとのがん免疫療法分野の共同開発プログラムが順調に進行。進行性固形がんを対象とした経口投与可能な低分子の新規選択的アデノシンA2A受容体拮抗薬の第I相臨床試験において主要評価項目をほぼ達成。(2/8)
※SOSE第3四半期決算：研究開発費3,456百万円(48.4％増加)97.1%は英国活動。中長期的には研究開発から自社製品の販売に至る総合的なバイオテックビジネスモデルを組み入れた企業を目指す。自社PL拡大投資も継続増加。(2/14)
※SOSEI個人投資家説明会：ピーター・ベインズ挨拶、HTL001831の開発(日本)、研究開発パイプライン更新。「研究段階から臨床開発段階へと進行中：今後22ヶ月の間に目標とする第1相及び第2相試験を6件開始予定」(3/14)
※四季報：業績予想更新(2018/2/23)。自社パイプライン：他社との提携・導出に加え、自社販売視野に入れた開発候補７品目保有。18年内にレビー小体型認知症薬は2相、神経性疾患薬は1相入り目指す。(3/16更新)
※AstraZeneca IMED Biotech Unit, 2017 - A Year in Review: Early Clinical Development Highlights: "We delivered Phase II Start AZD4635 (Oncology Pipeline: Phase II, A2aR) in Solid Tumours". (4/10up)
※SOSEI：新規A2A受容体拮抗薬｢AZD4635｣、免疫応答性の回復および抗腫瘍効果の可能性を確認。2018年米国癌学会年次総会にて新たな前臨床データ結果データを発表。標的分子への作用については引き続き研究を進めていく。(4/18)
※Novartis Q1 2018: Ultibro Continued to Grow, Driven by Positive FLAME, FLASH, and CLAIM Study Results as well as the GOLD Global Strategy for the Diagnosis, Management, and Prevention of COPD 2018 Report. (4/19)
※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。新たに6つの臨床試験予定：投与開始タイミング。(5/10) ※アイフィス株予報：米系大手証券(シティG)、そーせいのレーティングを強気(1(買い))継続。目標株価11,000円。目標株価コンセンサスは15,644円(アナリスト数8人)。(5/11)
※SMBC日興証券レーティング：そーせいグループ(4565)「1」目標株価17000円。R＆Dプロジェクト順調に推移、1：4の株式分割発表ポジティブ。(5/14)
※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相試験を併せて実施中。(5/16)
※Sunovion: Present eight posters featuring data from treatments for COPD at ATS 2018. New Data analyses include three posters reporting effects of Seebri and Utibron on lung function and patient-reported outcomes. (5/16)
※Novartis Investor Presentation: Full pipeline of late-stage assets with blockbuster potential: QVM149 Asthma, "Planned filings: 2019", "Expected launches: 2020". Expected launches leverage existing infrastructure. (5/16)
※アイフィス株予報：日系大手証券(みずほ証券)、そーせいのレーティング強気(買い)継続。目標株価21,600円。目標株価コンセンサスは15,044円(アナリスト数8人)。(5/18)
※AstraZeneca Clinical Trials Appendix, Q1 2018 Results update: AZD4635 (A2aR inhibitor solid tumours): Cancer: Phase 1: "Data Anticipated: 2018". (5/18)
※CHEST Conference Coverage (ATS 2018 Report): Switching from Triple Therapy to Indacaterol/Glycopyrronium is Effective in COPD Patients and Avoids Long-Term Exposure to Inhaled Corticosteroids: "SUNSET Study" (5/20)
※個別株情報：みずほ証券は「提携型」から「自社創薬型」へビジネスモデルの転換点と判断。自社品上市が期待できる24.12期以降の成長スピードは、むしろ加速するとの見方。(5/21)
※SOSEI：ニューヨークで開催のUBS Global Healthcare Conferenceに当社代表執行役社長CEOピーター・ベインズ参加。発表資料(英文)はイベント終了後、当社ホームページ上で公開。(5/21)
※アイフィス株予報：日系中堅証券(いちよし)、そーせいのレーティング強気(A)継続。目標株価13,000円。目標株価コンセンサスは14,794円(アナリスト数8人)。(5/21) ※SOSEI：UBS Global Healthcare Conference 発表資料(英文のみ)。"Sosei Group Corporation, UBS Global Healthcare Conference, 21 May 2018" (5/22 10:20)
[A Japan-listed biotech with a difference]:
・Global operations and aspirations – aiming to build Japan’s first global biotech champion.
[GPCRs/StaR]:
Why do we target G-Protein-Coupled Receptors (GPCRs)?
・Huge opportunity to create new drugs or improve existing drugs.
StaR is Revolutionary for GPCR Structure-Based Drug Design:
・Unique, scalable and sustainable platform, delivering differentiated pipeline candidates.
[Business Model]:
Leveraging unique GPCR technology to deliver differentiated drug candidates:
・Risk-balanced business model creates and captures optimal value.
[Partnered GPCR Pipeline]:
Advancing a Partnered GPCR pipeline in multiple therapeutic areas, Balanced and diversified:
Muscarinic M1 Agonist Program for Alzheimer’s disease, A novel approach for symptomatic treatment of AD:
・Selective muscarinic M1 receptor agonism offers a potential first-in-class therapy for AD patients.
HTL0018318 is a potential first-in-class therapy for Alzheimer’s disease, Highly selective M1 receptor agonist derived from StaR and SBDD:
・Receptor subtype selectivity is crucial. HTL0018318 has a differentiated mechanism of action with the potential to optimise symptomatic benefits in AD patients.
AZD4635 has emerged as a potential next-generation I/O therapy, First A2a R antagonist structurally derived from StaR and SBDD:
・Checkpoint inhibitors are highly effective against certain types of tumors (e.g. lung, skin, and renal).
・Next-gen I/O may enhance efficacy of approved checkpoint inhibitors across more tumor types.
AZD4635 has emerged as a potential next-generation I/O therapy First A2a R antagonist structurally derived from StaR and SBDD: [Proprietary GPCR Pipeline]:
Proprietary pipeline now led by M1 DLB opportunity in Japan, Focus on selected rare/orphan and specialty indications or markets:
・Investment in StaR technology driving Proprietary GPCR pipeline progress – average of 3 novel drug candidates into clinical development every year commencing CY2018.
HTL0018318 for DLB in Japan, Great potential for M1 agonist treatment for DLB in Japan:
HTL0018318 for DLB in Japan, Summary of clinical program to date:
・Clinical progress to date encouraging.
・Advancing preparation to commence Phase 2 PoC study in DLB in Japan in Q3 CY18.
[Strategic Investment]:
・Strategic investment in saRNA technology, Exclusive option to move from 25.6% to 100% ownership at pre-determined economics: MiNA Therapeutics.
[Financials]:
Balance sheet strengthened to scale and progress the business, Allergan upfront milestone in FY2016 drives P&L variance:
・Successful ~$200m raise in November 2017 via a Global Offering of shares to international investors.
・Current cash balance of ~$260m provides runway of ~2 years based on organic business plan.
Substantial economic returns secured from lead compounds, Provides potential source of non-dilutive finance for proprietary pipeline:
・$5bn plus in potential development, regulatory and commercial milestones to come, in addition to royalties on sales.
[Global operations and aspirations - aiming to build Japan’s first global biotech champion]:
・World-leader in GPCR-focused drug design based on unique IP protected StaR GPCR technology & enabled SBDD platform.
・Partnered clinical-stage pipeline in neurology, immuno-oncology, CNS & other diseases, with $5bn plus in potential economics.
・Proprietary pipeline led by dementia with Lewy bodies (DLB) Phase 2 program in Japan, plus multiple novel candidates in development.
・Strategic investment in saRNA therapeutics with lead candidate in Phase 1/2a for liver cancer, an orphan indication.
・Robust royalties from legacy respiratory products provide source non-dilutive cash flows.
・Strong cash position of ~$260m to drive global growth strategy. ※個別株情報：いちよしがフェアバリュー引き下げ、新薬候補創出力に対する評価は変わらず。(5/22 13:41)
・そーせいグループが3日続落。いちよし経済研究所では、今18.12期に3つの開発品の臨床試験を自社で開始する予定と注目。レーティング「A」を継続も、フェアバリューは15000円→13000円と引き下げた。
・導出品のマイルストン獲得時期の見直しや研究開発費の増額等で中長期の利益予想を修正し、フェアバリューを引き下げたとしたが、導出品からの収入獲得への期待や、同社の新薬候補創出力に対する評価は変わらないとした。
・自社での臨床試験も計画している。今18.12期中にレビー小体型認知症治療薬の日本での第2相臨床試験開始、他の2つの開発品（神経性疾患治療薬など）の第1相臨床試験開始を予定。 ・・・
※Heptares: We now seek to recruit a analytical chemist to join the analytical and compound purification team within our medicinal chemistry department. "Analytical/Seperation Scientist". (5/24Closing)
※KeMoMo-QSAR 2018 Symposium: "3D-e-Chem: Structural-based keminformatic workflows in computer drug design": Marton Vass, Chris de Graaf (VU Amsterdam, Heptares Therapeutics UK). (5/25 10:15)
※ICCS: "Using FEP (Free Energy Perturbation) Calculations to estimate relative binding affinities and selectivity for GPCR targets": Francesca Deflorian, Heptares Therapeutics. (5/28 15:00)
※ICCS: "HELM-driven Integration of Peptides into Structure-Based Drug Design and Cheminformatics": Conor Scully, Heptares Therapeutics. (5/29 15:00)
※ICCS: "3D-e-Chem: Structural Cheminformatics Workflows for Computer-Aided Drug Discovery": Chris de Graaf, Heptares Therapeutics. (5/29 15:00)
※ASCO 2018: "Preliminary results of a first-in-human, first-in-class phase I study of MTL-CEBPA, a small activating RNA (saRNA) targeting the transcription factor C/EBP-α in patients with advanced liver cancer": MiNA Therapeutics. (6/4)
※NovAlix Biophysics in Drug Discovery 2018: "Structural Insight into Allosteric Modulation of GPCRs": Miles Congreve, Heptares. (6/14 15:10)
※四季報(2018年3集夏号)：6月15日(金)発売。(四季報先取り新興株50 そーせいグループ：6月上旬配信予定)。
※EHA: "MTL-CEBPA, a Small Activating RNA for Intravenous Administration to Enhance C/EBPΑ Expression in Patients with Liver Cancer Shows Potential Use in Neutropenia": Choon Ping Tan, MiNA Therapeutics. (6/16 17:30)
※Biotech Outsourcing Strategies 2018: Attending-Companies: Heptares Therapeutics, CMC Projects Manager. (6/19-20)
※SOSEI 第28回定時株主総会：(6月22日)
※LSX CEO Forum (formerly Biotech and Money CEO Forum): Case Studies and Peer Review: "Sosei - AZ immune-oncology collaboration" - Malcolm Weir, Chief R&D officer, Sosei (CEO Heptares) (Invited). (6/28 14:15)
※Adrenoreceptors 2018, Receptor Structure Changes the Pharmacology Paradigm: "Structural insight driving commercial drug discovery": Rob Cooke, Heptares. (6/28)
※World Congress of Basic and Clinical Pharmacology (WCP2018) Kyoto: "Biased apelin receptor agonists for cardiovascular disease" :Anthony P. Davenport, University of Cambridge, UK, (Heptares ORBIT Projects). (7/6 10:20)
※Early Career Scientist Forum on GPCR Signal Transduction (ECSF-GPCR): Ali Jazayeri, Heptares. (7/11-14)
※Medicinal Chemistry GRC: "Novel Adenosine 2A Receptor Antagonist AZD4635: From the Brain to the Tumor Microenvironment": Michelle Lamb, AstraZeneca USA. (8/6 9:45)
※SCI/RSC Symposium on GPCRs in Medicinal Chemistry: "Keynote: Application of structure-based drug design to peptidergic GPCRs": Miles Congreve, Heptares. (9/11 9:30)
※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 9:00)
※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」Heptares寄附講座教授 森悦郎 (9/19 14:10-14:50)
・・・ ※SOSEIの成長相場の動向：[株式4分割：基準日2018/6/30・効力発生日2018/7/１]。
2010/12/30 (終値_1350) ・(2010/10/15※最安値_650、2010/12/27最高値_1748)
2011/12/30 (終値_1271) ・(2011/3/15※最安値__693、2011/6/30最高値_1680)
2012/12/28 (終値_2087) ・(2012/6/6※最安値__950、2012/9/7最高値_2967)
2013/12/30 (終値_4315) ・(2013/1/4※最安値_2050、2013/5/7最高値_6100)
2014/_4/25 (終値_2058) 売残高36200 買残高 1053200 ・(2014/4/22最安値_1854)※[成長回収期の入口]ステージへ
2015/_2/20 (終値_3780) 売残高14200 買残高 1530800 ・(2015/3/16最安値_2851)※Heptares [成功の序章ステージ]
2015/10/30 (終値_4320) 売残高11400 買残高 2217900 ・(2015/9/24安値_3550)※米国承認[次なる飛躍ステージへ]
2015/11/27 (終値_6360) 売残高 14800 買残高 2552500 ・(2015/11/30終値_6060: Pfizer)※[上抜け圏へ]
2016/_4/25 (終値23230) 売残高39800 買残高 3404900 ・(2016/5/9最高値26180)※Allergan[強気相場]
2016/_6/24 (終値14720) 売残高10500 買残高 2486100 ・(2016/6/24安値12960)※[強気相場解除]→※[時間軸での調整局面へ]
2017/_1/_6 (終値14030) 売残高__300 買残高 2907100 ・(2017/2/13安値12400)※[強気相場解除後の時間軸調整は順調に推移]
2017/_3/31 (終値10880) 売残高_5600 買残高 2621800 ・(2017/4/4安値10280)※[振るい場・拾い場へ]
2017/_9/_8 (終値_8700) 売残高_1900 買残高 2037800 ・(2017/9/6最安値_8590)※[拾い場も順調に推移]
2018/_1/26 (終値12210) 売残高__900 買残高 1429100 ・(1/22安値10960)※[振るいも順調に推移]
2018/_2/_2 (終値11650) 売残高__300 買残高 1482300(_+53200) ・(1/31安値11440) 2018/_2/_9 (終値10330) 売残高12500 買残高 1524700(_+42400) ・(2/6安値_9700)
2018/_2/16 (終値_9920) 売残高11800 買残高 1591200(_+66500) ・(2/14安値_9700)
2018/_2/23 (終値_9620) 売残高_9800 買残高 1773800(+182600) ・(2/22安値_9460)
2018/_3/_2 (終値_9380) 売残高10500 買残高 1854600(_+80800) ・(3/2安値_9270)
2018/_3/_9 (終値_9510) 売残高10500 買残高 1794400(_-60200) ・(3/5安値_8780)※[悪地合いにて再びの拾い場へ]
2018/_3/16 (終値_9070) 売残高13500 買残高 2019900(+225500) ・(3/16安値_9070)
2018/_3/23 (終値_8590) 売残高14100 買残高 2046500(_+26600) ・(3/23安値_8580)
2018/_3/30 (終値_8820) 売残高14400 買残高 2028000(_-18500) ・(3/26安値_8320)
2018/_4/_6 (終値_8810) 売残高17000 買残高 1981500(_-46500) ・(4/3安値_8550)
2018/_4/13 (終値_7840) 売残高15400 買残高 2080200(_+98700) ・(4/13安値_7770)
2018/_4/20 (終値_7280) 売残高15100 買残高 2115200(_+35000) ・(4/20安値_7260)
2018/_4/27 (終値_7580) 売残高17700 買残高 2113400(__-1800) ・(4/23安値_7210)
2018/_5/11 (終値_7040) 売残高21200 買残高 2099200(_-14200) ・(5/11最安値_6660)※[年初来安値]※空売り価格規制トリガー抵触
2018/_5/18 (終値_7600) 売残高19700 買残高 2047200(_-52000)※5/22up ・(5/14安値_6980)
2018/_5/21 (終値_7520) 5日線乖離(+0.37%) 25日線乖離(+0.58％) 75日線乖離(-15.08％) 200日線乖離(-23.35％) (安値_7500)
2018/_5/22 (終値_7550) 5日線乖離(+0.24%) 25日線乖離(+1.13％) 75日線乖離(-14.20％) 200日線乖離(-22.88％) (安値_7430) ※Technical Analysis Charts (Week)：
ttps://www.zonebourse.com/zbcache/charts/ObjectChart.aspx?Name=6814799&Type=Custom&Intraday=1&Width=980&Height=650&Cycle=WEEK1&Duration=9999&TopMargin=10&Render=Candle&ShowName=0&Company=4Traders_us
※Technical Analysis Charts (Day)：
ttp://www.4-traders.com/SOSEI-GROUP-CORPORATION-6814799/charts/&applet_mode=statique
更なる成長の黎明期にて、強気相場解除後の時間軸での調整の終盤(拾い場)は、上抜け圏で順調に推移。笑。
中長期成長戦略(R&D・PL等の拡充・進捗)も順調・着実な進展で、次なる展開・進捗が楽しみです。笑。
予定通りの拾い場は順調推移。笑。決算発表通過・株式分割、今回も面白くなりましたね。笑。 そーせいクレスイ再インきてんね
空売りオールスターズ再結成きてんね
上がるはず無いね。
3桁までやられるだろうね Granta Park:
※Site 5 Granta Park Cambridge, Design & Access Statement September 2016: Client: Heptares. (2016/9/26)
・Heptares currently occupy accommodation in BioPark, Hertfordshire but their lease is shortly to expire and the company wish to re-locate to Granta Park, Cambridge and take the opportunity
to improve their research and operational facilities within the re-modelled Flowers Building (Site 5 Building).
・The Flowers Building is currently occupied by Gilead who will be moving in mid 2017 into their new purpose built facility on the adjacent Site 6, designed by Aukett Swanke.
※Site 5 Granta Park Cambridge, Full Planning: Planning Applications. (Registration Date: 2016/10/19 - Decision Date: 2017/2/7)
※Cambridge Enjoys Strong Office Take-Up: Deals of this nature include Heptares taking 30,000 sq ft at Granta Park. (2016/12/20)
※Aukett Swanke Group Final Results: " The £20m Biomed Realty building at Granta Park pre let to Heptares and a further phase on the iconic Adelphi building off the Strand." (2017/1/12)
※Heptares: Heptares Plans Relocation to Cambridge, UK. Company to create a state-of-art R&D facility on Granta Park to support growth strategy. (2017/6/20)
※Business Weekly Cambridge: Japanese owned biotech joins march into Cambridge cluster. (2017/6/20)
・Owned by Sosei Corporation, Heptares is creating a state-of-the-art R & D facility at Granta Park to support an international growth strategy.
・It will be extensively remodelling the facility being vacated by US company Gilead Sciences Inc which is expanding into a new £28 million research hub at Granta.
・Its relocation to Granta Park from the BioPark in Welwyn also caps a brilliant couple of years for BioMed Realty, Granta’s US owner and developer, following multimillion investment in flagship facilities announced by Illumina and Gilead.
※SOSEI：Heptares、研究施設を英国ケンブリッジへ移転することを発表。更なる成長戦略の推進にむけて、Granta Parkに最先端研究開発施設を開設。The Steinmetz Buildingと呼ばれる予定。2018 年後半をめどに新拠点へ移転します。(2017/6/20)
・新施設への移転はHeptares社の近年の急成長に基づく、土地面積35,000平方フィートの新拠点には英国におけるHeptares社の全研究開発チームが活動する場となり、スイス・チューリッヒを拠点とした事業活動の成長と一体となったものです。
・本移転までに、GPCRターゲットとした構造ベースドラッグデザインを中心とする固有の基盤技術から生み出された新規低分子化合物や生物製剤の研究並びに臨床開発を専門とする高度な技術を持った研究者らを世界中から130名以上雇用する予定。
・世界最高水準の研究施設が多く並ぶケンブリッジ市に拠点を移す予定ですが、ロンドンやオックスフォードにある最高水準のバイオ医薬品研究の機関との繋がりも保つことにより、当社はこれからも世界屈指の地位を維持することができる。」 ※Heptares: The company is currently based in Welwyn Garden City and will be relocating to the Cambridge area in "July 2018". It has approximately 100 employees. (2017/9/6up)
※Business Weekly Cambridge: "Rapidly Advance Drug Discovery. Heptares is set to relocate to a new 35,000 sq ft facility at Granta Park, Cambridge in-mid 2018 by which time local headcount should be up to 130." (1/16)
※Heptares: Approximately 100 Employees. →Changed to "Heptares has approximately 130 employees who will all be based in this new research facility". (2/5update)
※Aukett Swanke Annual Report: BioMed Realty, Granta Park: Following our initial option studies the client engaged in tenancy negotiations with Heptares improve their laboratory and technical research facilities. will be completed in July 2018. (3/1)
※Business Weekly Cambridge: Granta Park’s owner BioMed Realty: "The next move for Granta Park will be to welcome life science company Heptares in the summer". (3/2)
※Metrion Biosciences (Granta Park): Announced it has appointed "Dr Barry Kenny (Non-Executive Director.)" to its Board of Directors. "Dr Kenny is Chief Business Officer of Heptares, now part of Sosei Group." (3/5)
※Heptares Zurich: By mid-2018, we are seeking for our site in Schlieren/Zurich (Switzerland) an enthusiastic and motivated laboratory technician (70-100%). (3/15up)
※Heptares Zurich: Protein Biochemistry Group, Grow the team from currently 2 FTEs to 5 FTEs by 2020. Close interaction with protein biochemistry group in the UK. (4/3up)
※Labiotech.eu: The 10 Biotech Companies in London to Keep an Eye on in 2018. "Golden Triangle”: London, Oxford and Cambridge. Worth keeping an eye on. "Heptares". (4/16)
※GOV.UK [Notice]: "CB21 6GT, Heptares Therapeutics Limited (Steinmetz Building, Granta Park: Radioactive substances activity) environmental permit application advertisement." (4/5)
※Heptares: Heptares will move to a New Research Facility (Steinmetz Building) in Cambridge (Granta Park) in July 2018.→ Changed to "August 2018". (5/3update)
※Heptares: We are seeking to appoint "Logistics Assistant", working in our expanding Operations team, with an opportunity to contribute to the setting up of our exciting new facility in Cambridge. (5/20 Closed)
※HeptaresTL 32分前: We are currently looking to recruit a Senior Scientist to join our Molecular Pharmacology team GPCR. (5/22) ※Senior Scientist - Molecular Pharmacology: Heptares Therapeutics United Kingdom. (5/22)
Company Description:
Heptares Therapeutics is an established UK biotech company with world-class technology in structure-based drug design applied to discovery of novel small molecules acting through GPCRs.
The company is developing its own pipeline of proprietary molecules and works in collaboration with major global pharmaceutical companies on both small molecule and antibody discovery programmes.
The most advanced of these are now in clinical studies with others moving towards clinical development.
The company is currently based in Welwyn Garden City but will be moving to a brand-new research facility at Granta Park (Cambridge) in August 2018.
Heptares has been operating for over ten years and has approximately 130 employees who will all be based in this new research facility.
The size of the company ensures a transparent linkage between all activities from early discovery through to clinical development.
Position:
Heptares is currently looking to strengthen and expand its capabilities in the immunology/inflammation therapeutic areas.
As a result, we now seek to recruit a highly motivated laboratory-based in vitro pharmacologist to join our Molecular Pharmacology team.
The Molecular Pharmacology team is responsible for both new drug target validation and supporting all drug discovery phases up to pre-clinical candidate (PCC) selection including assay development,
provision of routine small/large molecule screening and more detailed mechanism of action studies.
Requirements:
Ideally, candidates should have experience in the field of immunology, as demonstrated through a post-doctoral academic / industry background and prior experience of GPCRs.
The candidate must have a thorough knowledge of experimental design, and a high level of technical laboratory skill.
Preferable techniques include, cell culture/immune cell isolation, GPCR signaling, qPCR technology platforms, flow cytometry and assay automation techniques.
Candidates should possess a PhD/postgraduate degree in immunology, pharmacology, biochemistry or similar biological sciences.
Candidates must be highly motivated, flexible scientists with the ability to multi-task.
Good interpersonal skills are also essential as you will be working closely with other members of key drug discovery programmes and with scientists from other disciplines in support of our research projects.
The closing date for applications is 21st June 2018.
・・・
※Heptares: We now seek to recruit a analytical chemist to join the analytical and compound purification team within our medicinal chemistry department. "Analytical/Seperation Scientist". (5/24Closing)
・・・ Patent:
・・・
※米国特許(Heptares)：CGRP Receptor Antagonists. (2017/11/7公開)
※米国特許出願(MiNA)：Albumin Production and Cell Proliferation. (2017/11/9公開)
※国際特許出願(AstraZeneca)：Inhibitors of Protease-Activated Receptor-2. (Inventors: AstraZeneca R&D & Heptares). (2017/11/16公開)
※中国特許出願(Jitsubo)：ペプチド合成法(2017/11/28公開)
※日本特許(Heptares)：アッセイ(2017/12/20公開)
※日本特許(Heptares)：安定したタンパク質(2017/12/20公開)
※日本特許出願(Jitsubo)：ペプチド合成法 (2017/12/21再公開)
※米国特許(Heptares)：Orexin Receptor Antagonists. (2017/12/26公開)
※欧州特許(Heptares)：Stable Proteins. (2017/12/27公開)
※欧州特許出願(Jitsubo)：Peptide Synthesis Method. (1/10公開)
※英国特許出願(Heptares)：Novel GLP-1 Receptor Agonist Peptides. (1/10公開)
※米国特許出願(Heptares)：CGRP Receptor Antagonists. (1/11公開)
※米国特許出願(Heptares)：CGRP Receptor Antagonists. (1/18公開)
※欧州特許出願(Heptares)：Spirocyclic Compounds as Agonists of the Muscarinic M1 Receptor and/or M4 Receptor. (1/24公開)
※米国特許出願(Heptares)：Muscarinic Agonists. (1/25公開)
※米国特許(MiNA)：Methods of Inducing Insulin Production. (2/6公開)
※日本特許出願(Heptares)：ムスカリンM１受容体作動薬としての二環式アザ化合物 (2/8公開)
※欧州特許出願(MiNA)：Sarna Compositions and Methods of Use. (2/28公開)
※欧州特許出願(MiNA)：C/EBP Alpha Sarna Compositions and Methods of Use. (2/28公開) ※米国特許(Heptares)：Muscarinic M1 Receptor Agonists. (3/6公開)
※米国特許出願(Heptares)：Spirocyclic Compounds as Agonists of the Muscarinic M1 Receptor and/or M4 Receptor. (3/15公開)
※米国特許(Heptares)：CGRP Receptor Antagonists. (3/27公開)
※米国特許(Heptares)：Bicyclic AZA Compounds as Muscarinic M1 Receptor and/or M4 Receptor Agonists. (3/27公開)
※日本特許出願(Heptares)：ムスカリンM1受容体及び/またはM4受容体のアゴニストとしてのスピロ環状化合物 (3/29公開)
※米国特許出願(Heptares)：Mutant G-Protein Coupled Receptors and Methods for Selecting Them. (3/29公開)
※米国特許(MiNA)：Albumin production and cell proliferation. (4/17公開)
※欧州特許(Heptares)：Assays. (4/18公開）
※米国特許出願(Heptares)：Pharmaceutical Compounds. (4/19公開)
※国際特許出願(Heptares)：Heterocyclic Compounds Having Activity as Modulators of Muscarinic M1 and/or M4 Receptors in the Treatment of CNS Diseases and Pains. (4/19公開)
※米国特許出願(MiNA)： Methods of Inducing Insulin Production. (4/26公開)
↓
※米国特許(Heptares)："Bicyclic AZA compounds as muscarinic M1 receptor antagonists." (5/22公開)
・Document Type and Number: United States Patent 9975890 B2
・Publication Date: 2018/5/22
・Assignee: Heptares Therapeutics Limited.
Abstract:
・This invention relates to compounds (Formula (1)) that are agonists of the muscarinic M1 receptor and which are useful in the treatment of muscarinic M1 receptor mediated diseases.
・Also provided are pharmaceutical compositions containing the compounds and the therapeutic uses of the compounds.
・Compounds provided are of formula where R1-R5, X1, X2 and p are as defined herein.
http://www.freepatentsonline.com/9975890.pdf ※Pluristem: From THE MEDIA, a Glimpse from the Media: "Pluristem Breakthrough Brings Global Hope for Radiation Treatment" - Bloomberg, May 22, 2018. (5/22up)
※Bloomberg: Pluristem Breakthrough Brings Global Hope for Radiation Treatment.
The human placenta’s role in sustaining life is no longer known to be confined to pregnancy,
after a scientific breakthrough has identified the organ’s vital capability in treating radiation therapy patients and victims of radiation exposure from nuclear power plant accidents, such as those at Chernobyl and Fukushima.
The U.S. Food and Drug Administration (FDA) has cleared an Investigational New Drug (IND) application
by the pioneering Israeli biotech company Pluristem Therapeutics for the use of its PLX-R18 placenta-based cell therapy product in the treatment of acute radiation syndrome (ARS).
Pluristem, a world leader in cell therapies, has developed PLX-R18 primarily for use in bone marrow deficiencies and alleviating the side effects of chemotherapy and radiotherapy suffered by millions of cancer patients.
The company is also at an advanced stage of deploying its placenta-based products to boost muscle regeneration among hip fracture surgery patients, and in treatments of sever Ischemic conditions such as in critical limb ischemia.
The company has attracted major funding from the American and Israeli governments and from the European Union.
The success of its technology could have major implications for the cost of healthcare, particularly in treating aging populations around the world.
In clinical trials conducted and funded by the U.S. National Institute of Allergy and Infectious Diseases (NIAID) under the FDA Animal Rule pathway,
Pluristem’s placenta-based therapy was shown to increase bone marrow’s ability to produce blood cells,
leading to statistically significant increases in survival rates (85 percent compared to 50 percent of a placebo-treated control group) among non-human primates exposed to radiation.
Following FDA approval of its IND application, PLX-R18 will proceed to a pivotal clinical study later this year, ahead of Pluristem’s submission of its FDA biologics license application (BLA) soon afterward.
Final FDA approval will allow Pluristem to market its product to governments around the world wishing to stockpile doses of PLX-R18 to guard against the effects of future nuclear catastrophes,
including “dirty bomb” terror incidents, nuclear missile attacks and damage to nuclear facilities caused by earthquakes and other natural disasters.
“The FDA are giving us the green light to treat patients exposed to acute radiation syndrome,” says Yaky Yanay, Pluristem’s President and Co-CEO.
“We were searching for the ideal source for cell therapy. For 40 years everyone was doing [cell therapy with] bone marrow as the source of cells. In the last 20 years people started to use fat cells.
I think the Placenta is rising and shining as the ideal source; it’s young and has very fresh and potent cells, with no ethical or religious issues.”
The Haifa, Israel-based company is currently in position to produce 150,000 doses a year, although demand is expected to quickly increase.
“If they are going to request a significantly larger amount, we will prepare ourselves and scale up,” says Yanay. The potential of the placenta for use in cell therapy is only now becoming better understood. Pluristem, founded in 2003, first began working with the organ toward the end of 2005.
“It’s a good time for us to start to discuss with governments their need to start stockpiling in their countries,” Yanay explains.
“We are telling them, if you want to make sure we are keeping an inventory for you, go ahead and place an order for this product.”
From each placenta, Pluristem is able to generate 20,000 treatments.
The full-term placentas, which once would have been discarded as medical waste, are collected by partner hospitals with the consent of mothers, who Yanay says have been overwhelmingly supportive of the project.
“The placenta comes from a unique situation in nature: pregnancy,” he says.
“You have the mother and the baby living together in the body of the mother.
It’s marvelous-you don’t have any other similar condition in nature where you have two immune systems that can live together without rejection.”
It is this allogeneic compatibility that sets apart placenta-based cell therapy from allogeneic stem cell treatments, which require genetic matching.
It means that products such as PLX-R18 and PLX-PAD-which is being developed to replenish muscles after hip operations,
and to treat the artery disease critical limb ischemia (CLI)-can be mass-produced and administered by a simple intramuscular injection.
Once injected, the placenta-based cell-therapy products start to interact with the patient’s body and release soluble biomolecules such as cytokines, chemokines and growth factors,
which have the ability to heal damaged tissue, reduce inflammation, stimulate growth of collateral blood vessels and regeneration of damaged bone marrow.
Yanay notes that the U.S. National Institutes of Health recently launched the Human Placenta Project at the National Institute of Child Health and Human Development.
“We are seeing more and more interest in the placenta, which has been identified as an organ with huge and undiscovered potential,” he says. Horizon 2020, the EU’s research and innovation program, has provided$27 million to fund Pluristem’s work, with a $8.7 million grant designed to support its muscle regeneration project,
which aims to give patients greater mobility and reduce hospital stays.
The U.S. government has entirely funded the radiation trials of PLX-R18 to date, to the tune of more than $20 million.
The Israeli government has also provided around $20 million for Pluristem’s work, the only funding that the company must eventually repay.
Yanay says governments can greatly benefit from Pluristem’s success. “We are seeing significant aging of populations all over the world, and significant increases in healthcare spending in all countries.
One thing that is very clear is that we will not be able to continue to treat our elderly patients in the way we treat them today.”
Yanay warns that governments will go “bankrupt” unless they found ways to exploit innovations and reduce costs.
“This advanced technology will bring a much better quality of life for millions of patients, and will save billions in healthcare spending,” he says.
“This is the motivation for governments, and this is their ROI.”
The funding has coincided with a “major change” in the regulatory environment around the world, reflecting the hunger for the emergence of more efficient technology-based health solutions.
“Today we are hospitalizing patients for too many days, and the procedures and treatments and drugs they are consuming are for too long and too expensive,” says Yanay.
“At Pluristem we are talking about regeneration, with less hospitalization and less consumption of drugs.” The company has started recruiting 240 patients in a multinational Phase III pivotal study in the treatment of critical limb ischemia,
caused by fatty deposits in leg arteries that obstruct blood flow due to smoking, diabetes, heavy weight and cardiovascular problems.
The company is also expecting to publish in June top line data from a large Phase II study in intermittent claudication, an earlier stage of the disease.
The company also recently received a green light from the FDA to begin a Phase III trial of PLX-PAD this year,
in which it will test 240 hip-joint surgery patients to see whether their mobility and balance improve 26 days after treatment with the product.
The Phase I/II trials showed muscle volume increases of 300 percent six months after surgery, compared to a control group taking a placebo.
Yanay claims that PLX-R18 represents a significant improvement over existing “slow and extremely expensive” treatments for radiation exposure.
“This is a game-changing product in the industry that will allow real massive catastrophe treatment in a very simple manner,” he says.
Critically, the NIAID trials showed that PLX-R18 causes no harmful side effects to individuals who have not experienced irradiation,
meaning it could be used in emergency situations with no need to determine the level of exposure prior to treatment.
“In a massive catastrophe it would be almost impossible to measure to what level people were exposed, if at all,” says Yanay.
“One guy can be in the basement and another can be on the 15th floor, and they will be exposed to different levels, so we provide an agent that can be easily administered-just an injection into the muscle.” In parallel to the FDA program, the U.S. Department of Defense is doing its own research on PLX-R18 to measure its potential use in protecting the American armed forces from ARS, both prior to exposure and for 24 hours afterward.
Yanay says it is likely that members of the armed forces would be the first responders to a nuclear disaster:
“The armed forces will be on the inside of the danger zone, so we are interested to see if these cells can protect these soldiers in a prophylactic manner.”
Pluristem has also partnered with Japan’s Fukushima Medical University in testing PLX-R18 to potentially offer protection against ARS to workers involved in decommissioning nuclear reactors.
After more than a decade of research and trials of its groundbreaking placenta-based regenerative medicine, Pluristem is ready to move to the next level.
“I’m preparing our company toward marketing,” says Yanay.
The company has a “three-leg strategy” for its commercialization.
Its products for muscle regeneration and treating CLI, once approved, will be distributed under license and partnership agreements with large pharmaceutical companies,
and its radiation exposure treatments will be sold directly to governments.
The third leg, based on Pluristem’s hematological and oncology division, will develop its own premium products and marketing capability.
“We are one of the very few companies in the world that control our entire process,” Yanay says.
“We decided to invest in infrastructure and technology in order to be able to manage the entire spectrum, from the placenta to the patient’s bed, and hopefully become one of the major players in the industry.”
This is the start of an exciting journey that has the very real possibility of being a fundamental, game-changing breakthrough in healthcare. ■ このスレッドは過去ログ倉庫に格納されています
