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 [email protected] Tf. +34 687 562 592 For scientific information Dr. Pere Joan Cardona , through: [email protected] Tf. + 34 645 926 619

The release as fetched from its publisher. archivelfarma.com ↗