Clinical development partner

H2020 awards contract to ENDFLU, CR2O coordinated vaccine trial

07

Nov

2020

The EU Research and Innovation programme HORIZON 2020 has awarded a contract to a consortium that aims towards a next generation influenza vaccine to protect citizens worldwide (an EU-India collaboration).

The ENDFLU consortium gathers seven European partners from five countries (NL, DE, BE, SE and CH) and seven Indian partners. As one of the partners CR2O BV will coordinate the clinical trial and will offer project office support.

Influenza claims high morbidity, disability and mortality burdens worldwide. Seasonal influenza viruses cause recurring annual epidemics, with an estimated 3 to 5 million cases of severe illness and up to 650,000 deaths every year. Individuals at risk of developing severe disease and complications, such as viral and (secondary) bacterial pneumonia and cardio-vascular disease, include the very young (below one year of age), older adults above 65, pregnant women, and individuals with underlying (chronic) illnesses, such as metabolic, respiratory and cardiac conditions. A large proportion of severe influenza burden occurs in resource-poor communities and in LMICs. In addition, zoonotic and often fatal cases of infection with animal strains of influenza A viruses are increasingly reported.

Zoonotic influenza viruses tend to remain inefficient at human-to-human transmission. However, occasionally, they develop the ability to readily transmit among humans, and may trigger global influenza pandemics, as with H1N1 virus strains in 1918 and 2009, H2N2 in 1957 and H3N2 in 1968. Influenza pandemics can yield devastating morbidity and mortality burdens, including in otherwise healthy children and young adults (which are typically spared from severe disease during seasonal epidemics).

Next generation, broadly-protective influenza vaccines are urgently needed in order to address seasonal influenza antigenic drift and contribute to better pandemic preparedness.

GLORIA aims to prove chronic low dose glucocorticoids are highly effective and safe in elderly patients

10

Jun

2020

The EU Research and Innovation programme HORIZON 2020 has awarded contract worth up to 6 million euro’s to consortium led by Amsterdam Medical Center under grant agreement No 634886.

GLORIA aims to prove that the addition of chronic low dose glucocorticoids (GC) to current antirheumatic therapy is highly cost-effective and safe in elderly patients with rheumatoid arthritis (RA). RA is a frequent (affecting > 2% of the elderly population), painful and disabling chronic disease with high societal costs. RA is associated with multiple comorbidities, polypharmacy and adverse events; these problems, together with challenges in compliance (adherence) are dramatically increased in the elderly population. About 50% of patients are chronically treated with low-dose glucocorticoids (GC) in combination with other antirheumatic drugs, but without good evidence on the balance of benefit and harm. Thus, existing guidelines and information on safety and efficacy of GC are inadequate. GLORIA will address these problems by conducting a large pragmatic trial: 800 elderly (>65y) RA patients receiving standard of care will be randomized to additionally receive 5 mg prednisolone daily or placebo for 2 years. Very liberal eligibility criteria will ensure representativeness to the target population, and most data will be collected from routine clinical practice, minimizing patient and physician load, and operating costs. A novel tool will monitor compliance; it can send personalized reminders to a patient’s smart device. The efficacy of this technology will be tested in a nested trial.

Compliance and other characteristics will be entered into a model that will allow personalized risk and benefit assessment in the future.

In this consortium 10 partners have joined to gather safety and efficacy data during the chronic use of low dose glucocorticoids. As one of the partners CR2O BV coordinates the clinical trial.

H2020 awards contract to develop a monoclonal antibody against COVID-19

09

Apr

2020

The EU Research and Innovation programme HORIZON 2020 has awarded a contract worth up to 3 million euro’s to a European consortium led by ErasmusMC in collaboration with Harbour Antibodies BV to develop a monoclonal antibody against SARS-CoV 2.

This project “MANCO” aims at the development of contributing to the rapid international public health preparedness and response against the novel coronavirus SARS CoV 2 that emerged in China at the end of 2019. Coronavirus disease (COVID-19) is an infectious disease caused by this newly discovered coronavirus SARS CoV 2.

Most people infected with the SARS CoV 2 virus will experience mild to moderate respiratory illness and recover without requiring special treatment.  Older people, and those with underlying medical problems like cardiovascular disease, diabetes, chronic respiratory disease, and cancer are more likely to develop serious illness.

At this time, there are no specific vaccines or treatments for COVID-19.

Lessons learned and intervention efforts against SARS coronavirus (CoV), MERS-CoV and other emerging viruses provide invaluable information to accelerate the coordinated response against SARS-CoV 2 and the rapid development and manufacture of new diagnostic, prophylactic and therapeutic intervention strategies for COVID 19. A much-promising approach to both patient management of emerging viral infections and to better preparedness and response to emerging epidemics is the use of monoclonal antibodies. The consortium aims at contributing to the rapid international response against COVID 19, through preclinical and clinical evaluation of monoclonal antibodies against SARS-CoV 2.

In this consortium 8 partners have joined to develop a monoclonal antibody against Sars-CoV 2. As one of the partners CR2O BV will coordinate the phase I clinical trial and assume the role of the sponsor of the clinical trial.

ISOLDA aims at the development of improved vaccines against viral infections for older adults

Isolda

09

Jan

2020

The EU Research and Innovation programme HORIZON 2020 has awarded a contract worth up to 6 million euro’s to a consortium led by Stiftung Tieraerztliche Hochschule Hannover (TiHo), aimed at developing improved vaccines against viral infections for older adults.

The average age of citizens of the European Union (EU) is increasing, with currently 20% aged over 65. Ageing is one of the main health-related challenges within the EU, and promoting healthy ageing is a key priority. Increased susceptibility to infectious diseases and their associated complications, related to altered immune responses, threatens the health of older adults. In addition, senescence-related reduced immune function negatively affects the effectiveness of vaccination and contributes to lower protection provided by current vaccines in older adults. Another challenge is related to increased risk of adverse reactions in individuals over 60 following vaccination, in particular with live-attenuated vaccines. Identifying key factors causing poor and/or adverse responses to vaccination in older adults, and devising counter-strategies to circumvent these issues, are essential to improve vaccine-induced immune responses and achieve better vaccination-mediated protection against viral infections in this expanding vulnerable population.

In this consortium, 7 partners have joined to develop improved vaccines against viral infections for older adults. As one of the partners CR2O BV will coordinate the clinical trial and will offer project office support.