2004

MAR.2004

Incorporated Oncolys BioPharma Inc. in Minato-ku, Tokyo for the research and development of oncolytic viruses and molecular targeted anti-cancer drugs

2005

MAY.2005

Obtained a grant from NEDO (New Energy and Industrial Technology Development Organization) for research on OBP-401 (TelomeScan) entitled "Molecule Imaging Device Research and Development Project/Malignant Tumor Treatment Support Molecule Imaging Device Research and Development Project"

2006

MAR.2006

Filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for OBP-301 (Telomelysin)

JUN.2006

Concluded a worldwide Exclusive License Agreement with Yale University (U.S.A.) on a new HIV drug, OBP-601(Censavudine) and started research and development on it

OCT.2006

Established Kyoto Research Center in Kyoto-city, Kyoto Japan Patent 3867968 of OBP-301 (Telomelysin) was issued.

OCT.2006

Started Phase 1 clinical trial in the U.S. for Telomelysin

2007

SEP.2007

Received the Grand Prix of the 5th Japan Bio-Venture Award (sponsored by FujiSankei Business i)

NOV.2007

Moved Kyoto Research Center to Kobe-city, Kobe, and named Kobe Research Center

2008

MAR.2008

Concluded a Strategic Alliance Agreement with Medigen Biotechnology Corp. (Taiwan) for OBP-301 (Telomelysin) Filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for OBP-601(Censavudine)

MAY.2008

Started Phase 1a clinical trial in the U.S. for OBP-601(Censavudine)

AUG.2008

Filed an application to start Phase 1b/2a clinical trial with French National Agency for the Safety of Health Products (AFSSAPS) for OBP-601(Censavudine)

2009

JAN.2009

Started Phase 1b/2a clinical trial in France for OBP-601(Censavudine)

SEP.2009

U.S. Patent 7,589,078 of OBP-601(Censavudine) was issued.

OCT.2009

Concluded a worldwide exclusive license agreement with Astellas Pharma Inc. on a novel molecular targeting anti-cancer drug, and started research and development of OBP-801

2010

JUL.2010

Obtained a grant from NEDO for OBP-401 (TelomeScan) as Innovation Promotion Program for fiscal 2010

2011

APR.2011

Concluded an exclusive worldwide license agreement with National Institute of Biomedical Innovation for OBP-1101 (TelomeScan F35) and started research and development of OBP-1101 (TelomeScan F35)

2012

MAR.2012

Started Phase 2b clinical trial of OBP-601(Censavudine) in 94 institutions in 17 countries

APR.2012

U.S. Patent 8,163,892 of OBP-301 (Telomelysin) was issued.

AUG.2012

Concluded a collaboration research agreement with Juntendo University regarding OBP-401 (TelomeScan)

SEP.2012

Concluded a collaboration research agreement with National Hospital Organization Kure Medical Center and Chugoku Cancer Center regarding OBP-401 (TelomeScan)

NOV.2012

Obtained a grant from JST (Japan Science and Technology Agency) as Feasibility Study (FS) Stage, Seeds Validation Type in Adaptable and Seamless Technology Transfer Program through Target-Driven R&D (A-Step) for OBP-401 (TelomeScan)

2013

FEB.2013

Concluded a worldwide exclusive license agreement with Geron Corporation for licensing patents concerning human telomerase specific reverse transcriptase (hTERT) promoter for diagnostic use in cancer

MAY.2013

Obtained a grant from NEDO for OBP-801 as Innovation Promotion Program of Venture Support for fiscal 2010

DEC.2013

Oncolys BioPharma was listed on the Tokyo Stock Exchange Mothers.

2014

NOV.2014

Started Phase 1/2 clinical trial in the Korea & Taiwan for Telomelysin

NOV.2014

Filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for OBP-801

2015

MAY.2015

Started Phase 1 clinical trial in the U.S. for OBP-801

AUG.2015

Started research and development of OBP-702 & OBP-405

2016

Jul.2016

Concluded a joint research agreement with Graduate School of Medicine, Nagoya University, for Telomelysin (OBP-301) combined with checkpoint inhibitor.

Aug.2016

Concluded an investigator-initiated trial agreement with National Cancer Center Hospital East for Telomelysin (OBP-301) combined with other therapies.

Aug.2016

Concluded a collaboration research agreement with Kyoto Prefectural University of Medicine for OBP-801 for glaucoma surgery

Aug.2016

Submitted a protocol of Telomelysin (OBP-301) to the Food and Drug Administration (FDA), for a Phase 2 clinical trial in the United States, for melanoma

Sep.2016

Established Oncolys USA Inc.

2017

MAR.2017

Submitted CTN for Phase 1 clinical trial in combination with radiotherapy for esophageal cancer to PMDA（Pharmaceuticals and Medical Devices Agency）

JUL.2017

Initiated Phase 1 clinical trial for OBP-301 (Telomelysin) in combination with radiotherapy for esophageal cancer in Japan

DEC.2017

Started investigator-initiated clinical trial for OBP-301 (Telomelysin) in combination with pembrolizumab, an anti-PD-1 antibody in Japan

2019

APR.2019

Received "SAKIGAKE designation" on OBP-301 (Telomelysin) by Ministry of Health, Labour and Welfare

2020

MAR.2020

Initiated Phase 2 clinical trial for OBP-301 (Telomelysin) in combination with radiotherapy for esophageal cancer in Japan

JUN.2020

Received Orphan Drug Designation from the US FDA for OBP-301 as a treatment for esophageal cancer

JUN.2020

Concluded a worldwide Exclusive License Agreement with Transposon Therapeutics, Inc (U.S.A.) on the nucleoside reverse transcriptase inhibitor (NRTI) OBP-601 (censavudine)

2021

FEB. 2021

Been selected “suratanodeturev” for OBP-301 (Telomelysin) by International Nonproprietary Names (INN) Expert Committee of the WHO

2022

DEC.2022

Achieved the last patient enrollment in Phase 2 pivotal clinical trial for OBP-301 (Telomelysin) in combination with radiotherapy for esophageal cancer in Japan

2023

JUN.2023

Made an announcement of the results from an investigator-initiated phase 2 clinical trial for OBP-301 (Telomelysin) in combination with pembrolizumab in advanced gastric and gastroesophageal junction (GEA) adenocarcinoma at ASCO 2023