NEWS NEWS & PRESS RELEASES FDA grants Qualified Infectious Disease Product (QIDP) and Fast-Track Designations for CAL02. June 13, 2023 Combioxin’s licensee, Eagle Pharmaceuticals, announces acceptance of Investigational New Drug application to FDA for CAL02 for the treatment of severe community-acquired bacterial pneumonia. November 14, 2022 Combioxin’s licensee, Eagle Pharmaceuticals, announces submission of Investigational New Drug application to FDA for CAL02 for the treatment of severe community-acquired bacterial pneumonia. October 12, 2022 Combioxin announces worldwide licensing agreement with Eagle Pharmaceuticals for Phase 2b/3, first-in-class anti-virulence agent CAL02 for the treatment of severe pneumonia. August 24, 2021 Combioxin receives positive answers from the FDA on its pre-investigational new drug (PIND) meeting for use of CAL02 in COVID-19 patients at high risk of secondary bacterial infections. May 4, 2020 Publication of a concept paper exposing the parameters that have determined the development of CAL02, in order to overcome the obstacles to achieving market sustainability faced by new anti-infective drugs. February 21, 2020 Positive meeting with EMA Innovation Task Force on CAL02 clinical development plan November 12, 2019 Results of the first CAL02 clinical trial published in The Lancet Infectious Diseases May 2, 2019 Combioxin selected for oral presentation on the results of the first CAL02 clinical trial at the ESICM Annual Congress 2018 in Paris October 24, 2018 Combioxin invited to present CAL02’s clinical data at the FDA’s Workshop on the Development of Non-Traditional Therapies for Bacterial Infections August 21, 2018 Positive Topline Results from First-in-human Trial with CAL02 in the treatment of severe pneumonia April 18, 2018 SELECTED PUBLICATIONS Critical parameters for the development of novel therapies for severe and resistant infections — A Case Study on CAL02, a Non-Traditional Broad-Spectrum Anti-Virulence Drug. Azeredo da Silbeira S and Shorr A. Antibiotics, 2020; 9, 94. CAL02, a novel antitoxin liposomal agent, in severe pneumococcal pneumonia: a first-in-human, double-blind, placebo-controlled, randomised trial. Laterre PF et al. Lancet Infect Dis. 2019; 19(6):620-630. One step closer to precision medicine for infectious diseases. Pletz MW et al. Lancet Infect Dis. 2019; 19(6):564-565. CAL02 liposomes and other anti-toxins: A new generation of anti-infectives. Azeredo da Silveira S and Perez A. Clin Pulm Med 2018; 25(3):84-88. Liposomal therapy attenuates dermonecrosis induced by community-associated methicillin-resistant Staphilococcus aureus by targeting a-type phenol soluble modulins and a-hemolysin. Wolfmeier H et al. EbioMedicine 2018; 33:211-217. Clinical Streptococcus pneumoniae isolates induce differing CXCL8 responses from human nasopharyngeal epithelial cells which are reduced by liposomes. Baumgartner D et al. BMC Microbiology, 2016; 16:154. Precision medicine for the treatment of severe pneumonia in intensive care. Rello J and Perez A. Expert Review of Respiratory Medicine 2016; 10(3):297-316. Liposomes as novel anti-infectives targeting bacterial virulence factors Azeredo da Silveira S and Perez A. Expert Review of Anti-infective Therapy 2015; 13(5):531-3. Engineered liposomes sequester bacterial exotoxins and protect from severe invasive infections in mice. Henry BD et al. Nature Biotechnology 2015; 33(1):81-8. IN THE PRESS & MEDIA «Work, work, and work harder» – The online magazine of the University of Bern February 18, 2021 Un traitement genevois fait des émules aux Etats-Unis – Le Temps May 21, 2020 Une biotech genevoise leurre le coronavirus et prépare des essais cliniques américains – Heidi.news May 5, 2020
