【4565】そーせいG 508【薬事･食品衛生審議会医薬品第二部会(5/28)】

[過去ﾛｸﾞ] 【4565】そーせいG 508【薬事･食品衛生審議会医薬品第二部会(5/28)】 (664ﾚｽ)
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次ｽﾚ検索歴削→次ｽﾚ栞削→次ｽﾚ過去ﾛｸﾞﾒﾆｭｰ

361: 2020/05/29(金)15:02 ID:kpWhJiVR0NIKU(1/12) AAS
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の成長相場の動向：今回の下押しでの調整相場(2/17:新年最高値2217、3/13最安値1051)は順調に推移しました。笑。
2020/_2/14 (終値2012) 売残高__3000 買残高_6410500 ・(2/14安値1972) ※2/13:決算
2020/_2/21 (終値2030) 売残高_26400 買残高_6176400 ・(2/21安値2004) ※2/17:決算説明会※(2/17:新年最高値2217)
2020/_2/28 (終値1645) 売残高_12800 買残高_5606500 ・(2/28:安値1590)
2020/_3/_6 (終値1538) 売残高__3800 買残高_5568200 ・(3/_6安値1526) ※3/3:MTL-CEBPA TIMEPOINT Study Initiation.

362: 2020/05/29(金)15:03 ID:kpWhJiVR0NIKU(2/12) AAS
2020/_3/13 (終値1165) 売残高_12000 買残高_4196500 ・(3/13最安値1051)
2020/_3/19 (終値1062) 売残高__2100 買残高_3760700 ・(3/19安値1058)
2020/_3/27 (終値1288) 売残高_12600 買残高_3487900 ・(3/23安値1063) ※3/25:株主総会
2020/_4/_3 (終値1225) 売残高_11600 買残高_3401500 ・(4/_3安値1211)
2020/_4/10 (終値1327) 売残高_14000 買残高_3361900 ・(4/_6安値1212) ※4/6:Discngine 3decision Selected. ※5日･25日線再GC(4/9)
2020/_4/17 (終値1419) 売残高_13200 買残高_3519700 ・(4/13安値1325)

363: 2020/05/29(金)15:03 ID:kpWhJiVR0NIKU(3/12) AAS
2020/_4/24 (終値1417) 売残高_13600 買残高_3325000 ・(4/22安値1345)
2020/_5/_1 (終値1577) 売残高_20300 買残高_3389600 ・(4/28安値1436) ※4/30: QVM149欧州承認勧告
2020/_5/15 (終値1687) 売残高_17500 買残高_3234400 ・(5/8; 5/11安値1500) ※5/7:Orexia&Inexia進捗 ※一目均衡表3役好転(5/15)
2020/_5/22 (終値1794) 売残高_14300 買残高_3362800 ・(5/18安値1722) ※5日･75日線再GC(5/18) ※9週･13週線再GC(5/19)
2020/_5/29 (終値1818) 25日線1629.84 (+11.54％) ・(5/28安値1726) ※25日･75日線再GC(5/26) ※5/28: QVM149日本承認勧告

364: 2020/05/29(金)15:03 ID:kpWhJiVR0NIKU(4/12) AAS
更なる成長の黎明期、今回はコロナショックにて、信用需給が大きく改善し、振るいは順調に推移しましたね。笑。
新型コロナの感染拡大も収束中。笑。成長戦略は着実に進捗。笑。次なる成長ステージが楽しみですね。笑。

365: 2020/05/29(金)15:30 ID:kpWhJiVR0NIKU(5/12) AAS
※日本経済新聞電子版：「そーせいグループ、コスト管理強化」(5/28 20:35)
【コスト管理強化】
新薬の臨床試験の進行に伴い、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する。
コスト管理を厳格化しながら研究開発に資金を充当するほか、ITシステムの刷新など効率性の向上に努める。
最終黒字の公算。

374: 2020/05/29(金)19:01 ID:kpWhJiVR0NIKU(6/12) AAS
MiNA Therapeutics update:
・・・
※MiNA Therapeutics: "Announces Research Collaboration with AstraZeneca in Metabolic Diseases". Completion of these studies, AstraZeneca will have the option to negotiate a license agreement to further develop saRNA molecules. (1/7)
※MiNA Therapeutics: "Announces Initiation of Phase I Clinical Study of MTL-CEBPA in Combination with anti-PD1 Checkpoint Inhibitor in Patients with Advanced Solid Tumours". TIMEPOINT Study. (3/3)
※Advanced Therapies 2020: "Small activating RNAs as a novel approach for immunotherapy": David Blakey, MiNA Therapeutics. (4/1 Presented)
※Clinical Cencer Research: "MTL-CEBPA, a small activating RNA therapeutic up-regulating C/EBP-α, in patients with advanced liver cancer: a first-in-human, multi-centre, open-label, phase I trial". Results.(5/1 Published)
※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)
※ASGCT: "Therapeutic saRNAstargeting CEBPA in Myeloid Cells. A Potential Immunomodulatoryswitch for Anticancer Therapy": MTL-CEBPA can potentially act as an immuno-modulatory switch. (5/12 Presented)

375: 2020/05/29(金)19:02 ID:kpWhJiVR0NIKU(7/12) AAS
↓
※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)
Announced today the publication of data from its Phase I liver cancer trial, OUTREACH, in Clinical Cancer Research. It is the first publication in which a small activating RNA treatment (MTL-CEBPA) demonstrated clinical benefit.
Publication and OUTREACH Study Update:
The publication in Clinical Cancer Research summarizes the results from MiNA’s Phase I, open-label, dose escalation and dose expansion trial of MTL-CEBPA, OUTREACH, in adults with advanced Hepatocellular Carcinoma (HCC).
Overall, MTL-CEBPA was well-tolerated and demonstrated pharmacodynamic target engagement, meeting the primary endpoint of the study.
Furthermore, a reduction of suppressive immune cells in the tumour microenvironment as well as initial signs of potential synergistic efficacy when combined with standard of care tyrosine kinase inhibitors in HCC could be observed.
These encouraging Phase I data validate the targeting of C/EBP-α as a novel therapeutic strategy in cancer and prompted a Phase Ib study further evaluating MTL-CEBPA in combination with sorafenib in HCC.
Enrolment for the Phase Ib part of the OUTREACH trial was completed in Q1 2020 and initial results will be presented during a poster session at the forthcoming American Society of Clinical Oncology (ASCO) on Friday, May 29, 2020.
The framework for a subsequent Phase II clinical trial is currently being designed with the objective of initiating this next stage of clinical development in the second half of 2020.

376: 2020/05/29(金)19:02 ID:kpWhJiVR0NIKU(8/12) AAS
↓
MiNA Therapeutics Press Release (5/29)

"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".
--Observed clinical activity, including durable and complete tumour responses, suggests that MTL‑CEBPA may increase the effectiveness of sorafenib standard of care--
--Results confirm safety and tolerability of MTL-CEBPA and sorafenib combination and support continued development in liver cancer--
May 29, 2020.
LONDON--MiNA Therapeutics, the pioneer in RNA activation therapeutics, announced today top line results from the Phase Ib dose escalation and cohort expansion study,
OUTREACH, of lead candidate MTL-CEBPA in combination with sorafenib standard of care in patients with advanced hepatocellular carcinoma (HCC or liver cancer).
The study met its primary endpoints of safety and tolerability for MTL‑CEBPA administered either concomitantly or sequentially with sorafenib.
In addition, five patients experienced objective tumour responses, including two complete responses during the combination treatment.
省1

377: 2020/05/29(金)19:03 ID:kpWhJiVR0NIKU(9/12) AAS
“We are delighted to have confirmed objective tumour responses in a Phase Ib study in advanced liver cancer patients who are poorly served by existing treatments,” commented Robert Habib, CEO of MiNA Therapeutics.
“Combined with previous positive results, these data suggest that by reducing immune suppression in the tumour microenvironment, MTL‑CEBPA may increase the effectiveness of sorafenib standard of care.”
At the data cut-off of February 1, 2020, 36 patients with advanced HCC had been treated with MTL‑CEBPA in combination with sorafenib in the Phase Ib study.
22 patients received MTL‑CEBPA and sorafenib concomitantly, and 14 patients received the two agents sequentially.
Both concomitant and sequential treatment regimens were generally very well tolerated, and no maximum tolerated dose was determined.
The profile of adverse events was consistent with the known safety profile of each agent and the underlying disease.
In addition, concomitant sorafenib treatment did not alter the pharmacokinetics of MTL‑CEBPA.
Five patients who were naïve to prior tyrosine kinase inhibitor (TKI) treatment experienced objective tumour responses, including two patients who experienced complete remission.
Tumour responses were most pronounced in those TKI naïve patients with viral aetiology, where four out of nine evaluable patients experienced objective responses.

378: 2020/05/29(金)19:04 ID:kpWhJiVR0NIKU(10/12) AAS
Treatment was associated with a reduction in both the number of immature immune suppressor cells as well as genetic markers of immune suppression in patient samples.
These biomarker data validate the mechanism of action of MTL‑CEBPA in reducing immune suppression, which has been identified as a resistance mechanism of solid tumours to cancer treatment, including sorafenib.
These encouraging Phase Ib data add to the previously published positive Phase I results in which four out of five patients experienced a durable, objective response to off-study sorafenib treatment after discontinuation of MTL‑CEBPA.
As a single agent treatment, sorafenib is associated with a very low objective response rate.
In a recent Phase III study, complete responses were observed in 1% of patients and partial responses were observed in 6% of patients based on RECIST 1.1 criteria in 372 patients1.
The poster will be made available on the “Publications” page of MiNA’s website.
ASCO Presentation information:
Title: Phase Ib dose escalation and cohort expansion study of the novel myeloid differentiating agent MTL-CEBPA in combination with sorafenib in patients with advanced hepatocellular carcinoma (HCC)
Abstract no: 4601
Session: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary
省1

379: 2020/05/29(金)19:06 ID:kpWhJiVR0NIKU(11/12) AAS
↓
※MiNA Therapeutics Publications:
(ASCO Presentation Poster: 5/29up)
外部ﾘﾝｸ[pdf]:minatx.com

※ASCO 2020 Virtual Scientific Program Meeting (5/29 Today 8:00)
Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary: Poster Session:
[Abstract #:4601]
"Phase Ib dose escalation and cohort expansion study of the novel myeloid differentiating agent MTL-CEBPA in combination with sorafenib in patients with advanced hepatocellular carcinoma (HCC)."
Conclusions:
MTL-CEBPA + sorafenib is well tolerated with an acceptable safety profile.
省3

380: 2020/05/29(金)19:08 ID:kpWhJiVR0NIKU(12/12) AAS
MiNA Therapeutics Next Presentations:
・・・
※TIDES 2020: "Small Activating RNA to CEBPa in Patients with Hepatocellular Carcinoma": Nagy Habib, MiNA Therapeutics. (9/18 12:00 Presenting)
※Keystone Symposium: Myeloid Cells and Innate Immunity in Solid Tumors: "MTL-CEBPA - Next Generation Immunotherapy Targeting Myeloid Cell Differentiation": Nagy Habib. (9/24 17:00 Presenting)
・・・

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