- TGT, an industrial group from Barcelona, Spain, has facilitated the exit of the financial investor pool and will inject up to 15M€ over the next four years to help RUTI® to reach the market in its first indications.
- In a phase II clinical trial in South Africa RUTI® showed a bell-shaped immunological response to structural and secreted antigens of M. tuberculosis, with optimal safety, tolerability and immunogenicity responses at a single dose in combination with antibiotic therapy both in HIV- and in HIV+ individuals with latent tuberculosis infection.
- The company will start phase III in 2013, aiming to reduce the incidence of active tuberculosis in HIV+ individuals with latent tuberculosis infection treated with standard chemotherapy. If successful, the therapeutic vaccine has the potential to become the first to reach the market almost 100 years after the first BCG treatment, the only immunological approach currently available in tuberculosis.
Barcelona, January 15, 2012. After the corporate operation, TGT and Archivel Technologies will each own 49,2% of the company, with Laboratorios Reig Jofre from Barcelona retaining the remaining participation as industrial partner. The new CEO of the company will be Mrs. Olga Rue, who retains her previous CFO role, whereas former interim CEO Luis Ruiz-Avila (from Janus Developments) will stay as VP of Business Development. Prof. Pere Joan-Cardona, one of the inventors of RUTI®, will add Chief Medical Officer responsibilities to its current Chief Scientific Officer role. Isabel Amat, co-inventor of the vaccine, will serve as COO and Ramon Bosser, from Janus Developments, former Project Director, will support operations as an advisor to the CEO.The financial partners that supported the company in successive rounds since 2005 exited the company with an upside.
Archivel Farma presented the first analysis of the results of the phase II clinical trial run from June 2010 to June 2011 in three clinical sites in South Africa at the 7th European Congress on Tropical Medicine & International Health in Barcelona. The trial involved 96 individuals with latent tuberculosis infection (LTBI), half of them with concomitant HIV infection.
The primary goal was to evaluate the safety, tolerability and immunogenicity of RUTI®, Archivel’s proprietary therapeutic vaccine made with detoxified cellular fragments from Mycobacterium tuberculosis, the causal agent of tuberculosis. RUTI® elicited a bell-shaped, poly-antigenic response against secreted (ESAT-6, Ag85B) and structural (16 kDa, 38 kDa) antigens that were stimulated in the three doses tested. A single inoculation of the 25 ug dose showed the best safety, tolerability and immunogenicity profiles. At this dose RUTI® elicited also a long-term memory response (evaluated by a validated WHO test), compatible with a prophylactic effect.
The results of the trial were reviewed at the end of July by an independent Advisory Board that concluded that the results allow proceeding to phase III. On the basis of the results, Archivel Farma plans to start a phase III clinical trial in around 1300 HIV+ individuals with latent tuberculosis infection, who are at serious risk to develop active tuberculosis if left unattended. Archivel aims to show a significant reduction of the incidence of active tuberculosis in this target population over a period of two years after injection of a single dose of RUTI® in combination with standard chemotherapy.
Archivel Farma manufactures and releases RUTI® from its own manufacturing facilities, located in Badalona, close to Barcelona. The plant obtained the Spanish GMP certification in March 2010. It has a built-in P3 lab that enables the culture and processing of the tuberculosis bacillus (and other pathogenic agents) in order to produce the final sterile, lyophilized preparation. Current manufacturing capabilities allow delivering more than a million treatments per year, with a full scalable modular process that may facilitate the access to the vaccine of neglected areas. In its final pharmaceutical form RUTI® is stable at room temperature, adding to its attributes the advantage of being a logistics-friendly product.
The company aims to clear regulatory permits in South Africa by the first quarter of 2013. The first indication (prevention of active tuberculosis in HIV+, LTBI individuals) may be commercially available by 2016. Other indications, as prevention of active tuberculosis relapse after standard chemotherapy, may be pursued with the help of appropriate partners in different territories.
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