Drugs / suratadenoturev
suratadenoturev
Trials 8
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials · 1 met primary | ||||||
| Phase 1 | NCT04391049 | Dec 2021 → Oct 2024 overdue | esophageal adenocarcinoma, gastroesophageal adenocarcinoma, gastroesophageal junction adenocarcinoma, squamous cell carcinoma | NRG Oncology | Active not recruiting | Met primary |
| Phase 1 | NCT03172819 | Oct 2017 → Apr 2021 | neoplasm | Toshihiko Doi | Completed | No outcome recorded |
| Phase 1 | NCT03213054 | Jul 2017 → Mar 2019 | esophageal cancer | Oncolys BioPharma Inc | Unknown | No outcome recorded |
| Phase 1 | NCT02293850 | Oct 2014 → Apr 2019 | hepatocellular carcinoma | Oncolys BioPharma Inc | Unknown | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT06340711 | Apr 2024 → Apr 2028 expected | esophageal adenocarcinoma, gastric adenocarcinoma, gastroesophageal junction adenocarcinoma | Weill Medical College of Cornell University | Recruiting | No outcome recorded |
| Phase 2 | NCT04685499 | May 2021 → Mar 2022 | head and neck squamous cell carcinoma | Weill Medical College of Cornell University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03921021 | May 2019 → Jun 2023 | gastroesophageal adenocarcinoma | Weill Medical College of Cornell University | Completed | No outcome recorded |
| Phase 2 | NCT03190824 | Dec 2016 → Jun 2021 | melanoma | Syneos Health | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 70
| Date | Issuer | Release |
|---|---|---|
| 2026-08-12 | Oncolys BioPharma Inc | Regulatory 腫瘍溶解ウイルス テロメライシン ®注の oncolys.com ↗ |
| 2026-08-05 | Oncolys BioPharma Inc | Regulatory 腫瘍溶解ウイルス テロメライシン ®注の oncolys.com ↗ |
| 2026-06-30 | Oncolys BioPharma Inc | Results 腫瘍溶解ウイルス OBP-301 の論文発表に関するお知らせ oncolys.com ↗ |
| 2026-06-24 | Oncolys BioPharma Inc | Regulatory 再生医療等製品テロメライシンの oncolys.com ↗ |
| 2026-06-08 | Oncolys BioPharma Inc | Regulatory Oncolys BioPharma Announces Full Marketing Approval in Japan for Telomelysin for the Treatment of Esophageal Cancer oncolys.com ↗
The approval was granted as a full marketing approval, rather than conditional or time-limited approval, following MHLW review of data from Oncolys’ pivotal clinical study conducted at 17 sites in Japan. |
| 2026-06-08 | Oncolys BioPharma Inc | Regulatory 腫瘍溶解ウイルス テロメライシン注の oncolys.com ↗ |
| 2026-06-03 | Oncolys BioPharma Inc | Regulatory 腫瘍溶解ウイルス OBP-301 の oncolys.com ↗ |
| 2026-05-11 | Oncolys BioPharma Inc | Results お問い合わせへの回答に関するお知らせ oncolys.com ↗ |
| 2026-04-30 | Oncolys BioPharma Inc | Results 腫瘍溶解ウイルス OBP-301 の oncolys.com ↗
今回の発表では、5年全生存率は13％であることが報告されました。 |
| 2026-04-23 | Oncolys BioPharma Inc | Regulatory 腫瘍溶解ウイルス OBP-301 の oncolys.com ↗ |
| 2026-01-28 | Oncolys BioPharma Inc | Regulatory 腫瘍溶解ウイルス OBP-301 に関する oncolys.com ↗ |
| 2025-12-26 | Oncolys BioPharma Inc | Regulatory 腫瘍溶解ウイルス OBP-301 に関する oncolys.com ↗ |
| 2025-12-15 | Oncolys BioPharma Inc | Regulatory 腫瘍溶解ウイルス OBP-301 の oncolys.com ↗
当社は、本日、食道がん治療再生医療等製品として開発を進めています腫瘍溶解ウイルス OBP-301の製造販売承認申請を行いましたので、お知らせします。 |
| 2025-12-12 | Oncolys BioPharma Inc | Regulatory 腫瘍溶解ウイルス OBP-301 の oncolys.com ↗ |
| 2025-12-12 | Oncolys BioPharma Inc | Regulatory 腫瘍溶解ウイルス OBP-301 の oncolys.com ↗ |
| 2025-11-25 | Oncolys BioPharma Inc | Regulatory 腫瘍溶解ウイルス OBP-301 の oncolys.com ↗ |
| 2025-11-21 | Oncolys BioPharma Inc | Regulatory 腫瘍溶解ウイルス OBP-301 の oncolys.com ↗ |
| 2025-10-14 | Oncolys BioPharma Inc | Results 欧州臨床腫瘍学会における oncolys.com ↗ |
| 2025-09-30 | Oncolys BioPharma Inc | Regulatory 腫瘍溶解ウイルス OBP-301 の oncolys.com ↗ |
| 2025-06-24 | Oncolys BioPharma Inc | Regulatory 腫瘍溶解ウイルス OBP-301 の先駆け総合評価相談の oncolys.com ↗ |
| 2025-03-26 | Oncolys BioPharma Inc | Regulatory 腫瘍溶解ウイルス OBP-301の投与方法に関する oncolys.com ↗ |
| 2025-03-18 | Oncolys BioPharma Inc | Regulatory 腫瘍溶解ウイルス OBP-301 の oncolys.com ↗ |
| 2025-01-30 | Oncolys BioPharma Inc | Results Disclosure document additions, revisions oncolys.com ↗
登録患者15名全例で安全性を評価しました。 |
| 2025-01-27 | Oncolys BioPharma Inc | Results (Delayed) Announcement of Final Safety and Clinical Complete Response Data Presentation of Phase I Clinical Trial for OBP-301-CRT at ASCO GI 2025 oncolys.com ↗
Fourteen out of 15 patients (93%) received all planned OBP-301 injections and radiation therapy. |
| 2025-01-24 | Oncolys BioPharma Inc | Results 米国臨床腫瘍学会消化器がんシンポジウムでの oncolys.com ↗ |
| 2024-11-06 | Oncolys BioPharma Inc | Regulatory 腫瘍溶解ウイルスOBP-301 の製造委託先の oncolys.com ↗ |
| 2024-04-09 | Oncolys BioPharma Inc | Results お問い合わせへの回答に関するお知らせ oncolys.com ↗ |
| 2023-11-07 | Oncolys BioPharma Inc | Results SITC 2023 ANNOUNCEMENT_Phase II study of Telomelysin (OBP-301) in combination with pembrolizumab in gastroesophageal (GEA) adenocarcinoma oncolys.com ↗
Study results showed 2 patients with a partial response and 1 patient with a complete response out of 16 evaluable patients, thereby meeting the Simon two-stage threshold. |
| 2023-11-07 | Oncolys BioPharma Inc | Results Society for Immunotherapy of Cancer (SITC) 2023 でのテロメライシン（OBP-301） oncolys.com ↗ |
| 2023-10-16 | Oncolys BioPharma Inc | Results Achievement of Primary Endpoint for Efficacy in the Phase2 Clinical Trial for Telomelysin-Radiation Combination Therapy oncolys.com ↗
As a result, the primary endpoint L-CR rate assessed by the Central Review Board for Endoscopic Findings (CRBEF), was 41.7%, which confers to exceed the predefined threshold of 30.2% derived from a historical data in the study protocol. |
| 2023-10-16 | Oncolys BioPharma Inc | Results テロメライシンの局所進行性食道がんに対する oncolys.com ↗ |
| 2023-08-10 | Oncolys BioPharma Inc | Results Meeting of Safety Endpoint in the Initial Safety Cohort of the Phase I Clinical Trial for Telomelysin Chemoradiation Combination Therapy oncolys.com ↗ |
| 2023-08-10 | Oncolys BioPharma Inc | Results 食道がん及び胃食道接合部がんへのテロメライシン（OBP-301）と oncolys.com ↗ |
| 2023-06-09 | Oncolys BioPharma Inc | Results お問い合わせへの回答に関するお知らせ oncolys.com ↗ |
| 2023-06-06 | Oncolys BioPharma Inc | Results ASCO 2023 ANNOUNCEMENT: Encouraging Preliminary Data of OBP-301 with Pembrolizumab in refractory gastroesophageal adenocarcinoma oncolys.com ↗
The investigators observed clinical responses in 3 patients (ORR 19%). |
| 2023-06-06 | Oncolys BioPharma Inc | Results 2023 年米国臨床腫瘍学会（ASCO）でのテロメライシン（OBP-301）と oncolys.com ↗ |
| 2023-04-17 | Oncolys BioPharma Inc | Results テロメライシン（OBP-301）肝細胞がん Phase1 臨床試験の oncolys.com ↗ |
| 2023-03-22 | Oncolys BioPharma Inc | Results AACR ANNUAL MEETING 2023でのテロメライシンⓇ（OBP-301）と oncolys.com ↗ |
| 2022-12-19 | Oncolys BioPharma Inc | Results テロメライシン（OBP-301）の開発状況及びビジネス活動 oncolys.com ↗ |
| 2022-11-01 | Oncolys BioPharma Inc | Results 熊本大学とオンコリスバイオファーマ 共同発表論文 oncolys.com ↗ |
| 2022-08-25 | Oncolys BioPharma Inc | Regulatory テロメライシン（OBP-301）の oncolys.com ↗ |
| 2021-02-18 | Oncolys BioPharma Inc | Regulatory Announcement of International Nonproprietary Name for Telomelysin (OBP-301) oncolys.com ↗
Oncolys BioPharma Inc. (hereafter, “Oncolys”) today announced that the World Health Organization selected the recommended International Nonproprietary Name (INN) for "Telomelysin (OBP-301)", oncolytic viral immunotherapy. |
| 2020-07-01 | Oncolys BioPharma Inc | Results Oncolys Announces Completion of Phase 1 study for Telomelysin of Hepatocellular Carcinoma oncolys.com ↗
the eighteen patients that can be evaluated for safety were confirmed to have tolerability. |
| 2020-07-01 | Oncolys BioPharma Inc | Results 肝細胞がん Phase１企業治験の完了に関するお知らせ oncolys.com ↗ |
| 2020-06-04 | Oncolys BioPharma Inc | Regulatory [Delayed]Orphan-Drug Designation of Telomelysin for Treatment of Esophageal Cancer oncolys.com ↗ |
| 2020-06-03 | Oncolys BioPharma Inc | Regulatory 米国FDA によるテロメライシンの oncolys.com ↗ |
| 2019-10-16 | Chugai Pharmaceutical | Regulatory Change in Designated Applicant under SAKIGAKE Designation System Concerning “Telomelysin (OBP-301),” Oncolytic Viral Immunotherapy chugai-pharm.co.jp ↗ |
| 2019-10-16 | Oncolys BioPharma Inc | Regulatory Change in Designated Applicant under SAKIGAKE Designation System Concerning “Telomelysin (OBP-301),” Oncolytic Viral Immunotherapy oncolys.com ↗ |
| 2019-10-16 | Oncolys BioPharma Inc | Regulatory （TEL 03-5472-1578） oncolys.com ↗ |
| 2019-09-24 | Oncolys BioPharma Inc | Results Oncolys Announces Completion of DSMB Review of Phase I Study for Telomelysin-Radiation Combination Therapy in Esophageal Cancer oncolys.com ↗
Six patients in total have been administered Telomelysin and the results show that there has been no adverse event observed which requires withdrawal of the drug. |
| 2019-09-24 | Oncolys BioPharma Inc | Results 放射線併用食道がん Phase１企業治験 oncolys.com ↗ |
| 2019-04-08 | Oncolys BioPharma Inc | Regulatory 「先駆け審査指定制度」の対象品目に oncolys.com ↗ |
| 2019-01-07 | Oncolys BioPharma Inc | Regulatory 米コーネル大学とのテロメライシン®・抗 PD-1 抗体ペムブロリズマブ併用 oncolys.com ↗ |
| 2018-07-19 | Oncolys BioPharma Inc | Results TelomelysinR-Radiation Combination Therapy Clinical Study Data Presented at the 2018 Annual Meeting of JSMO oncolys.com ↗
The responses included 8 complete response (CR) and 3 partial responses (PR) out of 13 patients enrolled in the study, which altogether accounts for 84.6% of patients responded to the treatment. |
| 2018-03-26 | Oncolys BioPharma Inc | Results 財務 担当 小林 直樹 oncolys.com ↗ |
| 2017-06-27 | Oncolys BioPharma Inc | Regulatory 経営 管 理 担 当 oncolys.com ↗ |
| 2017-06-27 | Oncolys BioPharma Inc | Regulatory CTN submitted for an Investigator-Initiated Clinical Trial for Telomelysin (OBP-301) - pembrolizumab combination therapy oncolys.com ↗
CTN submitted for an Investigator-Initiated Clinical Trial for Telomelysin® (OBP-301) - pembrolizumab combination therapy |
| 2017-05-24 | Oncolys BioPharma Inc | Regulatory Oncolys' First Telomelysin Phase I Clinical Trial in Japan Received IRB Approval oncolys.com ↗
Oncolys BioPharma (“Oncolys”) is pleased to announce that the Institutional Review Board (IRB) of Okayama University Hospital, has approved the Phase I clinical trial protocol of Telomelysin® (OBP-301) for esophageal cancer and patient enrollment for the study at Okayama University Hospital. |
| 2017-03-14 | Oncolys BioPharma Inc | Regulatory 常 務 取 締 役 oncolys.com ↗ |
| 2017-03-14 | Oncolys BioPharma Inc | Regulatory Oncolys Submitted CTN of the First Sponsor-Initiated Clinical Trial for Telomelysin (OBP-301) in Japan oncolys.com ↗ |
| 2016-08-31 | Oncolys BioPharma Inc | Regulatory 常 務 取 締 役 oncolys.com ↗ |
| 2016-08-31 | Oncolys BioPharma Inc | Regulatory Protocol Submission of OBP-301 (Telomelysin) for Phase II Clinical Trial in the United States oncolys.com ↗
Oncolys BioPharma (“Oncolys”) is pleased to announce that today it submitted a protocol of OBP-301 (Telomelysin®) to the Food and Drug Administration (FDA), for a Phase II clinical trial in the United States. |
| 2016-05-26 | Oncolys BioPharma Inc | Results 常 務 取 締 役 oncolys.com ↗ |
| 2016-03-26 | Oncolys BioPharma Inc | Results Completion of Highest Single-Dose Level Clinical Trial of OBP-301 (Telomelysin) Phase I/II in Taiwan and Korea oncolys.com ↗
In DSMB’s view, the results from Cohort 3 showed the safety of OBP-301 administered intrahepatically and there was no adverse effects which can be regarded as an issue to proceed to the next stage of the clinical trial, while the exploratory efficacy of OBP-301 continues to be under review. |
| 2014-01-22 | Medigen Vaccine Biologics Corp. | Regulatory 【公告】基亞肝癌新藥OBP-301獲韓國核准臨床試驗 com.tw ↗
基亞生技與日本Oncolys生技公司(東京證交所上市公司)共同開發的肝癌新藥 OBP-301，甫接獲韓國MFDS (FDA等同單位)通知，同意進行第一/第二期人體臨床試驗。 |
| 2014-01-22 | Oncolys BioPharma Inc | Regulatory 兼 経 理 部 長 六反田 靖 oncolys.com ↗ |
| 2013-12-17 | Oncolys BioPharma Inc | Regulatory 兼 経 理 部 長 六反田 靖 oncolys.com ↗ |
| 2013-12-06 | Oncolys BioPharma Inc | Results Other oncolys.com ↗ |
| 2008-05-29 | Oncolys BioPharma Inc | Results ONCOLYS BIOPHARMA DISCLOSED THE INTERIM CLINICAL RESULT OF A PHASE I CLINICAL TRIAL OF TELOMELYSIN™ (OBP-301) AT ASCO 2008 (AMERICAN SOCIETY OF CLINICAL ONCOLOGY) IN CHICAGO oncolys.com ↗
All adverse events reported categorized as mild to moderate se verity. |
| 2006-08-25 | Oncolys BioPharma Inc | Regulatory Japan's First Anti-cancer Adenovirus Is Now GO for Clinical Studies in US oncolys.com ↗ |
All press releases naming this drug 133 releases
| Date | Issuer | Release |
|---|---|---|
| Show all 133 releases opens the full record — a long page | ||
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 9 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | suratadenoturev | “This is a phase II study of suratadenoturev (OBP-301) with pembrolizumab in advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma that has...” NCT06340711 ↗ |
| Known as | OBP 301 | “Telomerase-specific Type 5 Adenovirus. OBP-301 OBP 301 will be injected intratumorally into tumor lesions.” NCT04685499 ↗ |
| Known as | Telomelysin | “The goal of this study is to learn about of the research study drug, telomelysin (OBP-301), in combination with pembrolizumab in advanced or metastatic gastric or...” NCT06340711 ↗3“This is a phase 1 study to evaluate safety and tolerability of Telomelysin (OBP-301) in combination with radiation therapy in patient with esophageal cancer who are not...” NCT03213054 ↗ “Y.U. is the president and CEO of Oncolys BioPharma, Inc., the manufacturer of OBP-301 (Telomelysin).” PMID 37060176 ↗ Apr 2023 |
| Action | Deplete | “modified to replicate within cancer cells and lyse them” PMID 37060176 ↗ Apr 2023 |
| Route | Other | “single intra-tumoral injection” NCT02293850 ↗ |