Dossier - 21/05/2013 No new drugs to be placed on the market without clinical trials New pharmaceuticals are subject to approval by drug authorities. Prior to approval of a new pharmaceutical several hurdles such as preclinical and clinical studies need to be cleared. Clinical trials are performed to ensure the quality efficacy and safety of a medicinal product. Clinical development is a time-consuming and costly process and takes on average ten to fifteen years before a pharmaceutical company can apply for the approval of the…https://www.gesundheitsindustrie-bw.de/en/article/dossier/no-new-drugs-to-be-placed-on-the-market-without-clinical-trials
COVIC-19 clinical trial - 07/04/2022 Convalescent plasma for COVID-19 therapy: clinical trial should bring clarity Does it help to treat COVID-19 sufferers with antibodies from people who have recovered from the disease? It seems an obvious idea and has been tested thousands of times. However, there is not yet enough evidence to prove the clinical efficacy of treating COVID-19 patients with convalescent plasma. The transfusion physician Prof. Dr. Hubert Schrezenmeier from Ulm is planning to carry out a follow-up clinical trial to find the missing evidence.https://www.gesundheitsindustrie-bw.de/en/article/news/convalescent-plasma-covid-19-therapy-clinical-trial-should-bring-clarity
Press release - 18/08/2022 CureVac Starts Phase 1 Clinical Study of Modified, Omicron-Targeting COVID-19 Vaccine Candidate CureVac N.V., a global biopharmaceutical company developing a new class of transformative medicines based on mRNA, today announced the start of a Phase 1 study of the modified COVID-19 mRNA vaccine candidate CV0501, administered as a booster dose to previous COVID-19 vaccination. Developed in collaboration with GSK, CV0501 is based on CureVac’s second-generation mRNA backbone and is designed to specifically protect against the Omicron variant.https://www.gesundheitsindustrie-bw.de/en/article/press-release/curevac-starts-phase-1-clinical-study-modified-omicron-targeting-covid-19-vaccine-candidate
Press release - 10/02/2022 CureVac Doses First Participant in Phase 1 Study with Multivalent Influenza Vaccine Candidate Based on Second-Generation mRNA Backbone Developed in Collaboration with GSK CureVac N.V. (Nasdaq: CVAC), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (“mRNA”), today announced that it has dosed the first participant in a Phase 1 study of its seasonal influenza second-generation mRNA vaccine candidate, CVSQIV, developed in collaboration with GSK.https://www.gesundheitsindustrie-bw.de/en/article/press-release/curevac-doses-first-participant-phase-1-study-multivalent-influenza-vaccine-candidate-based-second-generation-mrna-backbone-deve
Press release - 03/03/2022 Identifying Alzheimer's risks – as early as 17 years before diagnosis In order to develop approaches for the prevention and treatment of Alzheimer's dementia in clinical trials, it would be helpful to be able to identify people with a particularly high risk of developing the disease. But which biomarkers can indicate an increased likelihood of disease early on in symptom-free people who actually develop Alzheimer's later?https://www.gesundheitsindustrie-bw.de/en/article/press-release/identifying-alzheimers-risks-early-17-years-diagnosis
Article - 10/06/2021 New study: vaccine therapy for treating patients with chronic leukaemia Personalised peptide vaccination is expected to improve the treatment of patients with chronic lymphocytic leukaemia. A research team from Tübingen has started a Phase I clinical trial with CLL patients who will undergo ibrutinib treatment. Other leukaemia sufferers as well as cancer patients in general are also expected to benefit in the long term.https://www.gesundheitsindustrie-bw.de/en/article/news/new-study-vaccine-therapy-treating-patients-chronic-leukaemia
Press release - 04/10/2023 Therapeutic option for tumor patients with the rare DNAJB1-PRKACA gene fusion A phase I clinical trial is now starting at Tuebingen University Hospital in the Clinical Collaboration Unit (CCU) Translational Immunology, in collaboration with the Department of Internal Medicine I, which is investigating the therapeutic cancer peptide vaccine Fusion-VAC-XS15 in combination with immune checkpoint blockade by atezolizumab (Tecentriq®). https://www.gesundheitsindustrie-bw.de/en/article/press-release/therapeutic-option-tumor-patients-rare-dnajb1-prkaca-gene-fusion
Press release - 30/08/2021 CureVac Preclinical Data Demonstrates Significant Reduction of Liver Fibrosis with mRNA Therapeutic CureVac N.V. (Nasdaq: CVAC), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (“mRNA”), today announced the publication entitled “Therapeutic HNF4A mRNA attenuates liver fibrosis in a preclinical model” in the peer-reviewed Journal of Hepatology.https://www.gesundheitsindustrie-bw.de/en/article/press-release/curevac-preclinical-data-demonstrates-significant-reduction-liver-fibrosis-mrna-therapeutic
Atriva Therapeutics - 21/10/2020 COVID-19 pioneer drug in Phase II clinical trial - with double the power The effective treatment of people with severe COVID-19 is a major goal during the corona pandemic. ATR-002, an oral small molecule that targets RNA viruses such as influenza virus and SARS-CoV-2, has a dual effect: it impairs viral propagation and also has an immunomodulatory effect. And what’s more, due to its unique cellular mechanism of action, the efficacy of Atrivia Therapeutics’ drug candidate is not reduced by virus mutations and…https://www.gesundheitsindustrie-bw.de/en/article/news/covid-19-pioneer-drug-phase-ii-clinical-trial-double-power
Inside the fight against COVID-19 - 28/10/2020 A new immunotherapeutic agent for treating severe COVID-19 cases Apogenix, a Heidelberg-based biopharmaceutical company specialising in innovative immunotherapeutics, has initiated a Phase II clinical trial with asunercept, the company’s lead drug candidate for treating severe cases of COVID-19. The fusion protein blocks the CD95-ligand-mediated death of epithelial cells in the lung and thus prevents damage to the organ.https://www.gesundheitsindustrie-bw.de/en/article/news/new-immunotherapeutic-agent-treating-severe-covid-19-cases
Press release - 10/06/2021 Nose2Brain – Active substances without detour through the nose into the brain Effective drugs for the treatment of diseases of the central nervous system do exist. However, the blood-brain barrier, which protects the brain as the body's control center, makes it especially difficult for therapeutic biomolecules to pass through. Thus, researchers from an international consortium coordinated by the Fraunhofer IGB have spent the last four and a half years developing a novel system in the EU project "N2B-patch"…https://www.gesundheitsindustrie-bw.de/en/article/press-release/nose2brain-active-substances-without-detour-through-nose-brain
Press release - 14/12/2022 New drug for metastatic prostate cancer now also approved in Europe On December 13, 2022, the European Commission granted approval to a drug against metastatic prostate cancer whose active ingredient was developed under the leadership of the German Cancer Research Center (DKFZ) in collaboration with Heidelberg University Hospital and Heidelberg University. The drug can significantly improve the survival chances of patients.https://www.gesundheitsindustrie-bw.de/en/article/press-release/neues-medikament-gegen-metastasierten-prostatakrebs-nun-auch-europa-zugelassen
Vaccine development - 02/06/2020 CureVac as a pioneer of mRNA technology - what is behind the novel COVID-19 vaccine? All eyes are on vaccines against the coronavirus. The Tübingen-based company CureVac is doing pioneering work in this field, and intends to initiate clinical testing of its lead vaccine candidate in June. At the same time, Curevac is manufacturing the material for this vaccine candidate. But that’s not all: the novel mRNA technology also has the potential to revolutionise the treatment of cancer and metabolic diseases. What makes the method so…https://www.gesundheitsindustrie-bw.de/en/article/news/curevac-als-pionier-der-mrna-technologie-was-steckt-hinter-dem-neuartigen-covid-19-impfstoff
Press release - 23/11/2021 Multi-peptide vaccine against SARS-CoV-2 shows strong T-cell immune response At the University Hospital Tübingen, clinical evaluation of an in-house developed vaccine (CoVac-1) against SARS-CoV-2 was started in November 2020 under the direction of Prof. Dr. Juliane Walz in the CCU Translational Immunology of the Medical Clinic (Medical Director Prof. Dr. Helmut Salih). Now the results of the Phase I study are available and demonstrate a potent activation of the T-cell response against the coronavirus.https://www.gesundheitsindustrie-bw.de/en/article/press-release/multi-peptide-vaccine-against-sars-cov-2-shows-strong-t-cell-immune-response
Affimed GmbH - 01/07/2020 "Innate cell engager" fighting against cancer In the fight against tumour cells, d Affimed GmbH from Heidelberg relies entirely on the weapons of the innate immune system. Affimed has developed special innate cell engagers, which are bispecific antibodies that recognise tumour cells and bring them together with natural killer cells and macrophages of the innate immune system, which then kill the tumour cells. Clinical trials using the AFM13 molecule are ongoing.https://www.gesundheitsindustrie-bw.de/en/article/news/innate-cell-engager-fighting-against-cancer
Press release - 24/03/2021 Vaccination against mutated protein tested in brain tumor patients for the first time Tumor vaccines can help the body fight cancer. Mutations in the tumor genome often lead to protein changes that are typical of cancer. A vaccine can alert the patients' immune system to these mutated proteins. For the first time, physicians and cancer researchers from Heidelberg and Mannheim have now carried out a clinical trial to test a mutation-specific vaccine against malignant brain tumors.https://www.gesundheitsindustrie-bw.de/en/article/press-release/vaccination-against-mutated-protein-tested-brain-tumor-patients-first-time
Press release - 21/04/2021 Atriva Therapeutics to Speed up Development of COVID-19 Drug with Federal Funding Atriva Therapeutics GmbH, a company that is pioneering the development of therapies for the treatment of viral infections, has secured up to €11.4 million in federal funding. The company, founded in 2015, announced today that it was selected for research funding from the German Federal Ministry of Education and Research (BMBF). Atriva will use the funds to advance its drug ATR-002 towards market maturity as quickly as possible.https://www.gesundheitsindustrie-bw.de/en/article/press-release/atriva-therapeutics-kann-dank-foerdermitteln-covid-19-medikament-schneller-entwickeln
Vaccine development - 25/05/2021 Vaccines - a beacon of hope in the fight against pandemics https://www.gesundheitsindustrie-bw.de/en/article/dossier/vaccines-beacon-hope-fight-against-pandemics
Press release - 21/09/2021 Antibiotic levels measurable in breath for first time A team of engineers and biotechnologists at the University of Freiburg has for the first time shown in mammals that the concentration of antibiotics in the body can be determined using breath samples. The breath measurements also corresponded to the antibiotic concentrations in the blood. The team’s biosensor – a multiplex chip – will in future enable personalized dosing of medicines against infectious diseases on-site.https://www.gesundheitsindustrie-bw.de/en/article/press-release/antibiotic-levels-measurable-breath-first-time
Press release - 24/10/2022 How tumors suppress the development of metastases Why do metastases often only appear after the original tumor has been surgically removed? Scientists from the German Cancer Research Center (Deutsches Krebsforschungszentrum, DKFZ) and the Mannheim Medical Faculty of Heidelberg University have now published an explanation for this phenomenon. They were able to identify a messenger substance of the cancer cells that locally promotes the growth of the primary tumor.https://www.gesundheitsindustrie-bw.de/en/article/press-release/wie-tumoren-die-entstehung-von-metastasen-unterdruecken
Press release - 19/10/2022 Apogenix’ Asunercept Demonstrates Efficacy in Phase II Trial for the Treatment of Hospitalized COVID-19 Patients Apogenix, a biopharmaceutical company developing next generation immunotherapeutics, announced today that asunercept showed statistically significant benefits for hospitalized COVID-19 patients in the ASUNCTIS trial. The open-label multi-center phase II trial investigated efficacy and safety of asunercept in 435 patients with moderate to severe COVID-19 disease.https://www.gesundheitsindustrie-bw.de/en/article/press-release/apogenixs-asunercept-zeigt-wirksamkeit-phase-ii-studie-zur-behandlung-von-covid-19-patienten-im-krankenhaus
Press release - 20/06/2023 CureVac Doses First Patient in Phase 1 Study of Cancer Vaccine Candidate for Surgically Resected Glioblastoma CureVac N.V. today announced that it has dosed the first patient with its investigational cancer vaccine CVGBM in a Phase 1 study. CVGBM is based on CureVac’s proprietary second-generation mRNA backbone and features a single mRNA, encoding eight epitopes derived from known tumor-associated antigens with demonstrated relevance in glioblastoma. A first data readout is expected in the second half of 2024.https://www.gesundheitsindustrie-bw.de/en/article/press-release/curevac-doses-first-patient-phase-1-study-cancer-vaccine-candidate-surgically-resected-glioblastoma
Press release - 30/03/2022 CureVac and GSK Start Clinical Development of Second-Generation COVID-19 Vaccine Candidate, CV2CoV CureVac N.V. a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (“mRNA”), today announced that the first participant was dosed in a Phase 1 study of COVID-19 second-generation mRNA vaccine candidate, CV2CoV, developed in collaboration with GSK.https://www.gesundheitsindustrie-bw.de/en/article/press-release/curevac-and-gsk-start-clinical-development-second-generation-covid-19-vaccine-candidate-cv2cov
Press release - 23/06/2022 Cancer patients receiving immunotherapy: no evidence of increased risk for severe immune complication after COVID-19 vaccination Does COVID-19 vaccination increase the risk of cancer patients undergoing therapy with immune checkpoint inhibitors to suffer a dangerous immune complication known as a "cytokine release syndrome"? A team of Heidelberg physicians and scientists has now shown in a clinical study: Increased serum levels of the characteristic cytokines occur frequently in cancer patients, but clinically relevant cases of the dreaded syndrome were not…https://www.gesundheitsindustrie-bw.de/en/article/press-release/cancer-patients-receiving-immunotherapy-no-evidence-increased-risk-severe-immune-complication-after-covid-19-vaccination