July 9, 2013, French Competent Authority (ANSM), June 18, 2013, the local Ethic Committee (CPP) cleared a new amendment of DRIIM trial for up to 2 dose expansion cohorts at the recommended dose as a results of good tolerance and safety, as well as the observed tumor responses correlated with systemic exposure of DT01.
March 26, 2013, DNA Therapeutics was awarded "the Best Biotech Company" at the Biovision Investor Conference 2013 for its breakthrough innovation in overcoming cancer resistance to treatments based on a paradigm-shift concept siDNA.
December 27, 2012, French Competent Authority (ANSM) and the local Ethic Committee (CPP) cleared the amendment of DRIIM trial for up to 2 additional doses.
December 21, 2012, DRIIM trial completed its initially planned 4 dose escalations (16 mg, 32 mg, 48 mg and 64 mg DT01) without safety and tolerance issues. Dose-dependent tumor responses were observed.January 10, 2012, US Patent and Trademark Office (USPTO) has notified its decision to grant the 3rd Dbait patent for its standalone treatment (monotherapy) in cancer. This approval greatly strengthens the company's IP assets, and further secures the development of its lead product.
November 25, 2011, The State Intellectual Property Office of the People's Republic of China issued the allowance of Dbait patent. The princeps patent of Dbait has been granted so far in major pharmaceutical territories including USA, Europe, Japan, China, Australia & Eurasia.
August 22, 2011, French Competent Authority (AFSSAPS) issued its Clinical Trial Authorization (CTA) for DNA Therapeutics' First-in-Human trial. There was no any question on the safety, quality of the investigational medicinal product - DT01, and trial protocol.
Together with local Ethic Committee's agreement issued on July 20, 2011, DNA Therapeutics has cleared the regulatory path to initiate the DRIIM (Dna Repair Inhibition & Irradiation on Melanoma) trial to evaluate the safety, tolerability, pharmacokinetics, preliminary anti-tumor activity and pharmacodynamic effect (including biomarkers) of locally administered DT01 in combination with radiotherapy in patients with metastatic melanoma with relapsed cutaneous tumors including melanoma-in-transit.
June 29, 2011, DNA Therapeutics has submitted its application for Clinical Trial Authorization (CTA) to French Competent Authority (AFSSAPS), and to local Ethic Committee.
May 17, 2011, the existing investors and all shareholders agreed to proceed a convertible bridge loan of 2 million € in order to start DNA Therapeutics' first clinical development.
April 4, 2011, Japanese Patent Office notified its decision to grant the 1st Dbait patent in Japan. So far, the princeps patent of Dbait has been granted in the major pharmaceutical territories, such as USA, Europe, Japan and Australia.
March 31, 2011, DNA Therapeutics has successfully completed regulatory toxicology studies in rat and in monkey. The draft study reports showed excellent safety properties of DT01: absence of any significant toxicities, no Central Nervous System (CNS) or Central Vascular System (CVS) disorder.
October 8, 2010, French National Ageny for Research (ANR) notified its decision to provide a grant of €772.504 to support the project of early stage clinical development of DT01 presented by DNA Therapeutics.
August 26, 2010, French National Agency for Innovation (Oséo) notified its decision to provide a loan of €562.000 to DNA Therapeutics for the regulatory preclinical development program of DT01.
June 21, 2010, Scientific Advise meeting (eq. pre-IND meeting) with French Competent Authority (AFSSAPS). DNA Therapeutics presented its 1st clinical trial synopsis and the relevant regulatory preclinical program and obtained AFSSAPS' agreement.
March 17, 2010, Australian Patent Office notified its decision to grant the 1st Dbait patent in Australia.
February 26, 2010, European Patent Office (EPO) has notified its decision to grant DNA Therapeutics' first European patent of Dbait. This approval greatly strengthens the company's IP assets, and further secures the development of its lead product.
January 12, 2010, US Patent and Trademark Office (USPTO) has notified its decision to grant DNA Therapeutics' second Dbait patent.
October 23, 2009, Dr.Marie Dutreix, co-inventor of siDNA technology and co-founder of DNA Therapeutics, received an award of the Antony Bernard Foundation against Cancer in union with the General Council of the Department Oise, the Municipality of Beauvais and the Committee of the Oise League against Cancer.
July 21, 2009, the article entitled "Hyperactivation of DNA-PK by double-strand break mimicking molecules disorganizes DNA damage response" was published in PLoS ONE, 4:e6298. This paper describes the molecular and cellular mechanisme of action of Dbait molecules.
July 17, 2009, French innovation promotion agency "Oséo" provided a €550 000 loan to DNA Therapeutics for the CMC (Chemistry-Manufacturing-Control) development, part of the regulatory preclinical development program of Dbait.
April 27, 2009, the French Business Angels in Health awarded the Prize of Innovative Enterpreneur in Health 2008 to the co-founder, Chairman & CEO of DNA Therapeutics, Prof. Jian-Sheng SUN.
February 15, 2009, the article entitled "Small-molecular drugs mimicking DNA damage (Dbait): a new strategy for sensitizing tumors to radiotherapy" was published in Clinical Cancer Research, 2009, 15: 1308. This paper describes the Dbait molecules, their mechanisms of action and proofs of concept in several human radio-resistant tumors xenografted on nude mice. http://clincancerres.aacrjournals.org/cgi/content/abstract/15/4/1308
January 29, 2009, successful closing of DNA Therapeutics' Series A equity investment round. The investor syndicate led by SGAM SEFTI with two of the previous seed investors, Blue Medical Investments and G1J-Ile de France, is committed to invest 2.2 million EUR based on certain milestones to be met. Since June 2008, DNA Therapeutics has raised 3 million EUR (US$4 million) through this Series A and the previous seed round led by Inserm-Transfert Initiative, with BMI, G1J and a group of international business angels. Clic for PDF of the Press Release.
January 13, 2009, US Patent and Trademark Office (USPTO) issued DNA Therapeutics' core siDNA patent. This first approval among the company's IP portfolio greatly strengthens its assets, and secures the development of its lead product Dbait.
September 12, 2008, US Patent and Trademark Office (USPTO) has notified its decision to grant DNA Therapeutics' core siDNA patent. This first approval among the company's IP portfolio greatly strengthens its assets, and secures the development of its lead product Dbait.
September 8, 2008, Inserm Transfer Initiative and G1J-Ile de France announced the execution of the seed financing of DNA Therapeutics specialized in developing innovative medicines in oncology. The syndicate of investors, led by Inserm Transfer Initiative, brings together G1J-Ile de France, Blue Medical Investment Group and International Business Angels, and invests 800k€. Clic for PDF of the Press Release. Following up the seed investment, Bernard Davitian was named vice chairman, Louis Jammayrac, Frédéric Zampatti and Anne-Catherine Jouanneau were named directors. Jian-Sheng Sun continues to serve as Chairman & CEO.
July 15, 2008, a six private-academic partner consortium led by DNA Therapeutics has been selected by the BiotecS 2008 program of the French National Agency for Research (ANR). It is eligible to €1.3 million (US$1.9 million) funding to a 3 year R&D reserach project aimed at developing new therapeutic strategy in glioblastoma combining DNA repair inhibitor (Dbait) and stereotactic irradiation ("GlioTherap").
December 10, 2007, DNA Therapeutics has been assigned SME status by the European Medicines Agency (EMEA) and is now eligible to benefit from the provisions for administrative and financial assistance laid down in Regulation (EC) No 2049/2005.
July 13, 2007, DNA Therapeutics announced that Dr. François Thomas, MD, MBA, has been appointed to the board of directors. Dr. Thomas currently heads the Healthcare Practice at Bryan, Garnier & Co. Prior thereto, he was a life science partner at Atlas Venture, held various positions in pharmaceutical companies, and practiced medical oncology at the Institut Gustave Roussy.
Genetic Engineering & biotechnology News reported on siDNA and DNA Therapeutics: http://www.genengnews.com/articles/chitem.aspx?aid=2129
DNA Therapeutics reports a novel mechanism of action and a biomarker of its lead molecule Dbait that open an innovative pathway-targeting in molecular cancer therapy.
April 12th, 2007. Clic for PDF of the Press Release, or check for the Biospace site: http://www.biospace.com/news_story.aspx?StoryID=52038&full=1
DNA Therapeutics was granted the status of "Jeune Entreprise Innovante” (Young Innovative Company status) by the French Ministry of research & Technology and the French “IRS” which gives a 7 years tax saving benefit, on February 26th, 2007.
DNA Therapeutics announces highly significant efficacy against xenografted tumors in animals thanks to its molecule Dbait, in association with standard radiotherapy.
November 7th, 2006. Clic for PDF of the Press Release, or check for the Biospace site: http://www.biospace.com/news_story.aspx?StoryID=36244&full=1
DNA Therapeutics won the trophy of Life Scientice at the "concours Tremplin Entreprises" organized by French Senate
French Senate, July, 2006
DNA Therapeutics : l'appât anti-cancer
Paris Developpement, May, 2006
Une entreprise défie les resistances du cancer
Journal CNRS, March, 2006
DNA Therapeutics received a grant from French national agency for research (ANR) for the maturation of siDNA technology
DNA Therapeutics: comment neutraliser un mécanisme de réparation cellulaire
Pharmaceutiques, July, 2005
DNA Therapeutics won the 2nd special prize of “concours national d’aide à la creation d’entreprises de technologies innovantes”