Archivel Farma’s RUTI® vaccine to start a clinical trial to increase the immunity of healthcare professionals exposed to the risk of COVID-19

  • The clinical trial will be carried out at the Germans Trias i Pujol Hospital in
    Badalona (Can RUTI), and it will include 300 healthy health professionals in
    direct contact with patients affected by COVID-19.
  • RUTI® vaccine is administered by subcutaneous injection, is safe and is in
    advanced clinical stages in India and Ukraine for the treatment of tuberculosis
    and antibiotic-resistant tuberculosis, and also as an enhancer of the anticancer
    response in bladder cancer patients.
  • Archivel Farma began the development of RUTI® in 2005, from Dr. Pere Joan
    Cardona’s research at the Germans Trias i Pujol Research Institute (IGTP). The
    company has invested more than 25 million euros so far. It has a production
    plant in Badalona, which would be prepared to supply the active ingredient of
    the vaccine for a massive demand in case the trial results were positive.


Press release
Badalona, April 7, 2020.- The General Directorate of Research and Innovation in Health of the
Generalitat de Catalunya (DRGIS) will finance a clinical trial to study the protective effect of
RUTI® on COVID-19 in healthcare professionals at high risk of contagion. The trial will consist of
administering RUTI® to 200 professionals and comparing the rate of infection and the clinical
evolution of the infection with a group of 100 untreated professionals. The trial aims to
generate solid clinical evidence of the use of RUTI® for the reduction of the infection rate and
the attenuation of symptoms in professionals with a high degree of exposure to SARS-CoV-2.
There are currently two similar clinical trials underway, one in the Netherlands and one in
Australia. Both use BCG, the only currently available prophylactic vaccine against tuberculosis,
which was discovered more than 100 years ago.

Both the RUTI® and BCG vaccines act as enhancers of the innate immune response, that is,
they help the organism itself to combat its effects more effectively when faced with an
infection. In the case of BCG, its administration has been reported to decrease the load of
different pathogens. Recently, it has also been observed that in those countries where BCG
vaccination is universal, the symptoms and mortality induced by SARS-CoV-2 are lower. The
main differences between BCG and RUTI® are that while BCG contains attenuated bacilli of
Mycobacterium bovis, RUTI® is made from purified fragments of the cell wall of
Mycobacterium tuberculosis, so that as an inactivated vaccine it may present a better safety
profile. . It has also demonstrated in preclinical studies a more potent modulation of the
immune response than BCG.

The RUTI® vaccine has been administered in different human clinical trials, demonstrating
safety and a good immunological response in populations of healthy volunteers, of patients
with latent tuberculosis (some with concomitant HIV) and in elderly patients with bladder
cancer. Studies are currently underway in patients with active tuberculosis and multi-resistant
tuberculosis in Ukraine and India.

For Olga Rué, General Director of the company, “the help given by the Generalitat in this call
will allow this clinical trial to be carried out, and is an enormous recognition of the work of the
entire team over the last 15 years and the potential of RUTI in the management of the COVID-
19 crisis. The opportunity to contribute from Archivel to the fight against the COVID-19
pandemic gives us a lot of energy and at the same time it presents us with a huge professional
and financial challenge to adapt our current manufacturing capacity to the possible demand
that the vaccine may have in the near future in case the clinical trial has good results. We hope
to rise to the challenge, with the support of the Institutions and our investors. ”

Archivel Farma, owner and developer of RUTI®, is a biotechnological R&D company focused on
immunological treatments to respond to unmet medical needs, especially in multi-resistant
tuberculosis (MDR-TB), but also in asthma, allergic rhinitis and some types of cancer. Archivel
Farma manufactures and releases RUTI® from its own manufacturing facilities, located in
Badalona, near Barcelona. The plant obtained the Spanish GMP certification in March 2010. It
has an integrated P3 laboratory that allows the culture and processing of the tuberculosis
bacillus (and other pathogens) to produce the final sterile and lyophilized preparation. Current
manufacturing capabilities allow more than a million treatments to be offered annually, with a
scalable, complete modular process that can facilitate access to the vaccine in neglected areas.
With the scientific advice of Dr. Pere Joan Cardona, the vaccine inventor, Archivel Farma has
invested more than 25 million euros in the development of the vaccine. The reference
shareholders of Archivel Farma, aret he TGT Group and Archivel Technologies (of the
businessman José Martínez, Trifermed Award for Social Impact on Healthcare in 2016, and of
the founding team that invented RUTI®), with a minority stake from Laboratorios Reig Jofré.

For strategic and economic information
Olga Rué, CEO
Tf. +34 687 562 592

For scientific information
Dr. Pere Joan Cardona, through:
Tf. + 34 645 926 619