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Grant
Agency: Cordis | Branch: H2020 | Program: RIA | Phase: PHC-09-2015 | Award Amount: 28.14M | Year: 2016

Many HIV vaccine concepts and several efficacy trials have been conducted in the prophylactic and therapeutic fields with limited success. There is an urgent need to develop better vaccines and tools predictive of immunogenicity and of correlates of protection at early stage of vaccine development to mitigate the risks of failure. To address these complex and challenging scientific issues, the European HIV Vaccine Alliance (EHVA) program will develop a Multidisciplinary Vaccine Platform (MVP) in the fields of prophylactic and therapeutic HIV vaccines. The Specific Objectives of the MVP are to build up: 1.Discovery Platform with the goal of generating novel vaccine candidates inducing potent neutralizing and non-neutralizing antibody responses and T-cell responses, 2. Immune Profiling Platform with the goal of ranking novel and existing (benchmark) vaccine candidates on the basis of the immune profile, 3. Data Management/Integration/Down-Selection Platform, with the goal of providing statistical tools for the analysis and interpretation of complex data and algorithms for the efficient selection of vaccines, and 4. Clinical Trials Platform with the goal of accelerating the clinical development of novel vaccines and the early prediction of vaccine failure. EHVA project has developed a global and innovative strategy which includes: a) the multidisciplinary expertise involving immunologists, virologists, structural biology experts, statisticians and computational scientists and clinicians; b) the most innovative technologies to profile immune response and virus reservoir; c) the access to large cohort studies bringing together top European clinical scientists/centres in the fields of prophylactic and therapeutic vaccines, d) the access to a panel of experimental HIV vaccines under clinical development that will be used as benchmark, and e) the liaison to a number of African leading scientists/programs which will foster the testing of future EHVA vaccines through EDCTP


Grant
Agency: Cordis | Branch: FP7 | Program: CP-IP | Phase: HEALTH-2009-2.3.2-4 | Award Amount: 15.44M | Year: 2010

Despite significant effort over the past decade to design and implement new vaccines strategies against HIV, no one has met its promise to prevent infection and/or to reduce viral load until reaching eradication of the HIV reservoir. To reach this goal, a translational research is critical to propose innovative approaches for an HIV vaccine enhancing broadly cross-reactive mucosal, humoral and cellular immune responses specific to HIV antigens. Composed by 13 partners from 5 European countries and 2 International Cooperation countries, the CUTHIVAC consortium gathers knowledges and cutting-edge technologies in vaccinology and HIV diseases to raise the challenge of developing a new HIV strategy. The CUTHIVAC approach is based on innovative transcutaneous and/or mucosal needle-free vaccination methods in a perspective that new vaccine candidates will redirect immune response toward cytotoxic CD8 and mucosal humoral responses. The trust of the project derives from the proof-of-concept that combination of routes of immunization and delivery systems will shape the immune responses towards its protective arms against HIV. Clinical trials will be implemented with last cutting-edge generation of HIV DNA-GTU candidate applied by transcutaneous, intradermal routes and/or mucosal administration of HIV-envelop protein-based vaccine. Large efforts will be positioned on the new genetic design of HIV antigens and delivery systems for developed and developing countries. These new vaccines will be tested in innovative preclinical approaches with a special highlight on routes of vaccination that will be translated into 2nd round of clinical trials in a perspective that could help to prevent and eradicate HIV. Through its integrative and multidisciplinary approach, CUTHIVAC will therefore provide the basis for a novel approach in vaccination with a view to wide its application to other infectious diseases such as malaria and tuberculosis.


News Article | February 13, 2017
Site: globenewswire.com

EXCHANGE NOTICE, FEBRUARY 13, 2017 SHARES FIT BIOTECH LTD: SHARES SUBSCRIBED WITH CONVERTIBLE LOAN A total of 351,885 K-shares will be traded as old K-shares as of February 14, 2017. Identifiers of FIT Biotech Ltd's K-share: Trading code: FITBIO ISIN code: FI4000148606 Orderbook id: 109536 Number of shares: 45,687,598 Nasdaq Helsinki Oy, Issuer Surveillance, survo@nasdaq.com, +358 9 6166 7260 TIEDOTE, 13. HELMIKUUTA 2017 OSAKKEET FIT BIOTECH OY: VAIHDETTAVALLA PÄÄOMALAINALLA MERKITYT OSAKKEET Yhteensä 351 885 K-osaketta otetaan kaupankäynnin kohteeksi yhdessä vanhojen K-osakkeiden kanssa 14. helmikuuta 2017. FIT Biotech Oy:n K-osakkeen perustiedot: Kaupankäyntitunnus: FITBIO ISIN-koodi: FI4000148606 id: 109536 Osakemäärä: 45 687 598 Nasdaq Helsinki Oy, Issuer Surveillance, survo@nasdaq.com, +358 9 6166 7260


News Article | December 15, 2016
Site: globenewswire.com

The Board of Directors of FIT Biotech Oy ("Company") has resolved on December 14, 2016, by virtue of the authorization of General Meeting on April 8, 2016, to issue 213,763 new K-shares as a directed share issue. FIT Biotech Oy carries out the directed share issue to Translink Corporate Finance Oy ("Translink") as a reward for Translink's provided services as per the advisor agreement that was in force between Company and Translink. There are weighty financial reasons for the share issue since the purpose of the issue is to strengthen the Company's capital structure and cash funds. New shares represent 0.52 % of Company's outstanding shares before the issue of the new shares. Translink has earlier acted as Company's Certified Advisor. The shares are issued with the following terms and conditions: 1.The Shares and Subscription Rights The Company issues 213,763 new K-shares. The shares are offered to Translink Corporate Finance Oy ("Translink") deviating from the pre-emptive rights of shareholders referred to in Chapter 9 Section 3 of Finnish Companies Act. There are weighty financial reasons for the share issue since the purpose of the issue is to strengthen the Company's capital structure and cash funds. 2. Subscription Price The subscription price totals EUR 41,450 being ca EUR 0.19391 per share. The subscription price for the shares is based on share price in FIRST NORTH trading before the share issue, which shall be considered the fair value of the shares. The subscription price is paid fully with receivable of EUR 41,450 of Translink from the Company. The Subscription Price shall be recorded in its entirety into the equity capital. 3. Subscription Period and Time of Payment The Shares are regarded as subscribed after the resolution of the Board of Directors. The shares are considered to be paid when subscribed. 4. Right to Dividend and Other Rights The new shares will entitle their holders to shareholder rights, including the right to receive full dividends declared by the Company, if any, after the shares have been registered with the Trade Register. 5. Book Entry System and Trading of Shares The Shares will be issued in book-entry form in the Finnish book-entry securities system operated by Euroclear Finland Ltd after their registration with the Trade Register. The Company shall apply the listing of the new shares together with the other shares in the Company on the NASDAQ FIRST NORTH List. 6. Other Issues The Board of Directors of the Company will decide on other matters related to the share issue and practical arrangements resulting therefrom. For further information: Chairman of the Board of Directors Juha Vapaavuori E-mail: juha.vapaavuori@fitbiotech.com Tel: +358 50 372 0824 About FIT Biotech FIT Biotech Oy is a biotechnology company established in 1995. The company develops and licenses its patented GTU® (Gene Transport Unit) vector technology for new-generation medical treatments. GTU® is a gene transport technology that meets an important medical challenge in the usability of gene therapy and DNA vaccines. FIT Biotech applies GTU® technology in its drug development programmes. Application areas include cancer (gene therapy) and infectious diseases such as HIV and tuberculosis, as well as animal vaccines. FIT Biotech shares are listed on the First North Finland marketplace maintained by Nasdaq Helsinki Oy.


News Article | February 17, 2017
Site: globenewswire.com

Related to Convertible Note and Warrant Programmes established on September 26, 2016 between the Fit Biotech Oy ("Company") and Bracknor Investment ("Bracknor") the Company's board of directors has today resolved to approve Bracknor's request relating to the funding programme to convert EUR 60,000 worth of Convertible Notes into the Company's K shares. Due to the conversion of the Convertible Notes, the Company issues 748,549 new K shares in the Company to Bracknor with the conversion price of EUR 0.080155 per share. As a result of the issue of the new K shares in the Company, the total number of shares in the Company will increase to 47,715,727 shares, and the share capital of the Company will be increased by EUR 59,999.95. After the issue of the new K shares in the Company, the Company's shares will be divided in share series as follows: 47,645,263 K shares, 5,229 A shares and 65,235 D shares. The increase of the share capital and new K shares in the Company will be registered in the Trade Register on or about February 20, 2017 and the new K shares will be admitted to trading on First North Finland on or about February 22, 2017. For further information: Chairman of the Board of Directors Juha Vapaavuori E-mail: juha.vapaavuori@fitbiotech.com Tel: +358 50 372 0824 About FIT Biotech FIT Biotech Oy is a biotechnology company established in 1995. The company develops and licenses its patented GTU® (Gene Transport Unit) vector technology for new-generation medical treatments. GTU® is a gene transport technology that meets an important medical challenge in the usability of gene therapy and DNA vaccines. FIT Biotech applies GTU® technology in its drug development programmes. Application areas include cancer (gene therapy) and infectious diseases such as HIV and tuberculosis, as well as animal vaccines. FIT Biotech shares are listed on the First North Finland marketplace maintained by Nasdaq Helsinki Oy.


News Article | February 21, 2017
Site: globenewswire.com

Related to Convertible Note and Warrant Programmes established on September 26, 2016 between the Fit Biotech Oy ("Company") and Suomen itsenäisyyden juhlarahasto Sitra ("Sitra") the Company's board of directors has today resolved to approve Sitra's request relating to the funding programme to convert EUR 50,000 worth of Convertible Notes into the Company's K shares. Due to the conversion of the Convertible Notes, the Company issues 668,449 new K shares in the Company to Sitra with the conversion price of EUR 0.0748 per share. As a result of the issue of the new K shares in the Company, the total number of shares in the Company will increase to 48,384,176 shares, and the share capital of the Company will be increased by EUR 49,999.99. After the issue of the new K shares in the Company, the Company's shares will be divided in share series as follows: 48,313,712 K shares, 5,229 A shares and 65,235 D shares. The increase of the share capital and new K shares in the Company will be registered in the Trade Register on or about February 22, 2017 and the new K shares will be admitted to trading on First North Finland on or about February 23, 2017. For further information: Chairman of the Board of Directors Juha Vapaavuori E-mail: juha.vapaavuori@fitbiotech.com Tel: +358 50 372 0824 About FIT Biotech FIT Biotech Oy is a biotechnology company established in 1995. The company develops and licenses its patented GTU® (Gene Transport Unit) vector technology for new-generation medical treatments. GTU® is a gene transport technology that meets an important medical challenge in the usability of gene therapy and DNA vaccines. FIT Biotech applies GTU® technology in its drug development programmes. Application areas include cancer (gene therapy) and infectious diseases such as HIV and tuberculosis, as well as animal vaccines. FIT Biotech shares are listed on the First North Finland marketplace maintained by Nasdaq Helsinki Oy.


FIT Biotech Oy's Board of Directors has decided on the issue of Convertible Notes and Warrants On September 26, 2016, the Board of Directors of FIT Biotech Oy (hereinafter also the "Company") decided to establish Convertible Note and Warrant Programmes in order to implement the Convertible Notes with Warrants Funding Programme of up to EUR 12,480,000 between the Company and Bracknor Investment. The Company's Board of Directors has decided to withdraw a fourth tranche of EUR 250,000 included in the Programme and to issue to Bracknor a total of 250 Convertible Notes and 2,890,173 Warrants, which entitle to subscribe for the Company's K shares in accordance with the Terms and Conditions of the Convertible Notes and the Warrants. For further information: Chairman of the Board of Directors Juha Vapaavuori E-mail: juha.vapaavuori@fitbiotech.com Tel: +358 50 372 0824 About FIT Biotech FIT Biotech Oy is a biotechnology company established in 1995. The company develops and licenses its patented GTU® (Gene Transport Unit) vector technology for new-generation medical treatments. GTU® is a gene transport technology that meets an important medical challenge in the usability of gene therapy and DNA vaccines. FIT Biotech applies GTU® technology in its drug development programmes. Application areas include cancer (gene therapy) and infectious diseases such as HIV and tuberculosis, as well as animal vaccines. FIT Biotech shares are listed on the First North Finland marketplace maintained by Nasdaq Helsinki Oy.


Patent
FIT Biotech | Date: 2014-01-13

A method for treating an HIV disease in a subject in need of said treatment, comprising administering to the subject a therapeutically effective amount of a DNA vaccine comprising an expression vector and a pharmaceutically acceptable excipient, where the expression vector comprises: (a) a heterologous promoter operatively linked to a DNA sequence encoding a nuclear-anchoring protein, where the nuclear-anchoring protein comprises: (i) a DNA binding domain which binds to a specific DNA binding sequence, and (ii) a functional domain of the Bovine Papilloma Virus Type 1 E2 protein, where the functional domain binds to a nuclear component; (b) a multimerized DNA sequence that forms a binding site for the nuclear anchoring protein; and (c) at least one expression cassette comprising a DNA sequence encoding a protein or peptide that stimulates an immune response specific to the protein or peptide; where the expression vector lacks an origin of replication functional in mammalian cells.


The present invention relates to a novel selection system, which is based on the use of an araD gene, a mutated form of an araD gene, a complementary sequence thereof, or a catalytically active fragment thereof as a selection marker and to the use of a bacterial strain deficient of the araD gene. The present invention further relates to novel vectors containing an araD gene, a mutated form of an araD gene, a complementary sequence thereof, or a catalytically active fragment thereof and to novel bacterial strains deficient of the araD gene. The present invention additionally relates to a method of selecting the cells transformed with a plasmid, which contains the gene of interest.


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