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Freya Pharma Solutions to start pivotal Phase III study with CR2O as clinical operational partner

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22

Apr

2022

Author: admin

  • Press Releases, Project Updates
  • Freya, FSIAD, Lybrido, Phase III

Freya Pharma Solutions, a late clinical stage company focusing on the development of effective pharmaceutical therapies for women who have been diagnosed with Female Sexual Interest/Arousal Disorder (FSIAD).


Freya Pharma Solutions plans to conduct the pivotal Phase III clinical trial with its therapy Lybrido in 516 patients across Europe to confirm the efficacy of Lybrido in women suffering from female sexual interest/arousal disorder (FSIAD).

CR2O BV is leading the preparation, execution and reporting of this Phase III clinical trial.

Curious to learn more about CR2O’s full-service global CRO activities, or experience?
Please, contact Ellemieke von Mauw:

Ellemieke von Mauw
Director Clinical Programs | Business Development
CR2O B.V.

T +31 (0)85 071 74 65 | M +31 (0)6 57 76 61 45 | E ellemieke.vonmauw@cr2o.nl

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Citryll to start first-in-human studies with CR2O as clinical operations partner

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First clinical trial authorisation under ECTR is a fact

Citryll to start first-in-human studies with CR2O as clinical operations partner

Posted on by admin

19

Apr

2021

Author: admin

  • Press Releases, Project Updates
  • autoimmune, CIT-013, Citryll, inflammatory, NET, neutrophil extracellular trap

Citryll has planned the start of first in human studies for its development candidate CIT-013 for July 2021. CR2O is proud to be a part of Citryll’s exiting journey offering their services and operational expertise in early clinical development.

Citryll is a private pharmaceutical company based in Oss, the Netherlands that is dedicated to the development and commercialization of therapeutics that target NETosis and NETs. Citryll was founded by Helmuth van Es, CEO Citryll, ModiQuest B.V., originator of the tACPA patents, and Renato Chirivi, CSO Citryll and co-inventor of tACPA.

Citryll, is taking a new approach to treat autoimmune and chronic inflammatory diseases including lupus, vasculitis, rheumatoid arthritis and respiratory diseases, by targeting and inhibiting the source of auto-antigens and/or neutrophil extracellular trap (NET) derived proinflammatory and toxic molecules instead of broadly targeting acquired immunity or inflammation.

Curious to learn more about CR2O’s full-service global CRO activities, or experience with early-stage clinical trials?
Please, contact Ellemieke von Mauw:

Ellemieke von Mauw
Director Clinical Programs | Business Development
CR2O B.V.

T    +31 (0)85 071 74 65    |    M     +31 (0)6 57 76 61 45 E    |    Ellemieke.vonmauw@cr2o.nl

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CR2O to manage First-in-Human trial with Dyadic’s SARS-CoV-2-S-RBD vaccine candidate DYAI-100

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Freya Pharma Solutions to start pivotal Phase III study with CR2O as clinical operational partner

CR2O to manage First-in-Human trial with Dyadic’s SARS-CoV-2-S-RBD vaccine candidate DYAI-100

Posted on by admin

21

May

2023

Author: admin

  • Press Releases
  • C1, COVID-19, Dyadic, DYAI-100, SARS-CoV-2, Vaccines

CR2O is proud to announce today it will manage and further support the clinical and preclinical development of DYAI-100, Dyadic’s C1 produced SARS-CoV-2-S-RBD vaccine candidate.

The first-in-human trial with DYAI-100 is expected to begin in H2 2021. 

Dyadic International Inc., a global biotechnology company focused on further improving, applying and deploying its proprietary C1-cell protein production platform to accelerate development, lower production costs and improve the performance of biologic vaccines and drugs at flexible commercial scales, announced on March 18 2021 that the company’s initial C1 produced SARS-CoV-2-S-RBD vaccine candidate, DYAI-100,  is moving towards an anticipated safety and preliminary efficacy first-in-human Phase I clinical trial. Dyadic has entered into a master services agreement with CR2O, as full-service global contract research organization specializing in vaccinology, to manage preclinical and clinical development of DYAI-100.

CR2O’s Chief Scientific Officer, Prof. Dr. Albert Osterhaus commented, “In response to the COVID-19 pandemic, pharmaceutical companies have developed vaccines within the unprecedented period of less than one year. To this end, and in close collaboration with strategic partners, they have implemented state-of-the-art technologies including the use of mRNA, viral vectors, and novel adjuvants. To effectively combat the COVID-19 pandemic worldwide, second generation variants of concern vaccines, produced at low cost and in large scale, are now urgently needed. The collaboration with Dyadic to use their highly-productive fungal C1-cell protein manufacturing system for this purpose appears to be a logical and promising way forward.”

CR2O’s CEO, Hadil Es-Sbai, added: “We are honoured to partner with Dyadic and its strategic partners in developing an affordable, scalable, protective and safe vaccine to combat this disease that continues to impact our everyday life”

For Dyadic’s original press release, please refer to Yahoo Finance.

Curious to learn more about CR2O’s full-service global CRO activities, or experience with vaccine trials?
Please, contact Ellemieke von Mauw:

Ellemieke von Mauw
Director Clinical Programs | Business Development
CR2O B.V.

T    +31 (0)85 071 74 65    |    M     +31 (0)6 57 76 61 45 E    |    Ellemieke.vonmauw@cr2o.nl

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CR2O profiled in Biotech NEWS and Life Sciences

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Citryll to start first-in-human studies with CR2O as clinical operations partner

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CR2O profiled in Biotech NEWS and Life Sciences

Posted on by admin

01

Dec

2020

Author: admin

  • Company Updates
  • Biotech NEWS, Interview, Magazine, Winter 2020

Dutch industry magazine Biotech NEWS and Life Sciences has profiled CR2O in their 2020 Winter edition.

Biotech NEWS and Life Sciences is a national magazine reporting on trends and news within health and life sciences in The Netherlands. During the interview with CR2O, management team members Cari, Ellemieke, and Nick explain how CR2O has seen considerable growth over the past years, and why CR2O is an early phase clinical trial expert that is ‘big enough to deliver, small enough to care’.

To read the full article and learn more on CR2O’s background, recent clinical trials, and core expertise, you can find the November edition of Biotech News and Life Sciences magazine by clicking here.

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H2020 awards contract to ENDFLU, CR2O coordinated vaccine trial

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CR2O to manage First-in-Human trial with Dyadic’s SARS-CoV-2-S-RBD vaccine candidate DYAI-100

H2020 awards contract to ENDFLU, CR2O coordinated vaccine trial

Posted on by admin

07

Nov

2020

Author: admin

  • Press Releases, Project Updates
  • ENDFLU, EU, Hannover, Horizon2020, India, Influenza, Vaccines

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.

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

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CR2O profiled in Biotech NEWS and Life Sciences

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

Posted on by admin

10

Jun

2020

Author: admin

  • Press Releases, Project Updates
  • Amsterdam UMC, GLORIA, Glucocorticoids, Horizon2020, Rheumatoid Arthritis

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.

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

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H2020 awards contract to ENDFLU, CR2O coordinated vaccine trial

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

Posted on by admin

09

Apr

2020

Author: admin

  • Press Releases, Project Updates
  • COVID-19, ErasmusMC, Harbour, Horizon2020, Immunology, MANCO, SARS-CoV-2, Vaccines

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.

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Update COVID-19: Safeguarding health and safety

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

Update COVID-19: Safeguarding health and safety

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COVID 19 virus

5 MAR 2020

Update COVID-19: Safeguarding Health and Safety

As a result of the COVID-19 pandemic, CR2O has adapted its contingency plan aimed to guarantee the safety and well-being of patients, employees, clients and continuity of our services. By following recommendations from Regulatory Authorities (local, EMA and FDA), CR2O continues to focus on patient safety and maintaining compliance with GCP under the current restrictive circumstances.

CR2O will remain fully operational during the COVID-19 pandemic. If you have any question, please contact us on: info@CR2O.nl / +31 (0)85-071 74 01.

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

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Isolda

09

Jan

2020

Author: admin

  • Press Releases, Project Updates
  • Horizon2020, Immunology, ISOLDA, TiHo, Vaccines

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.

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CEPI awards contract worth up to US$12.5 million to consortium led by Wageningen Bioveterinary Research to develop a human vaccine against Rift Valley fever

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Update COVID-19: Safeguarding health and safety

CEPI awards contract worth up to US$12.5 million to consortium led by Wageningen Bioveterinary Research to develop a human vaccine against Rift Valley fever

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Rift Valley Fever

5 AUG 2019

CEPI awards contract worth up to US$12.5 million to consortium led by Wageningen Bioveterinary Research to develop a human vaccine against Rift Valley fever

Wageningen Bioveterinary Research (WBVR), part of Wageningen University & Research, and the Coalition for Epidemic Preparedness Innovations (CEPI) have announced a new partnering agreement. With support from the European Union’s (EU’s) Horizon 2020 programme, CEPI will provide up to US$12.5 million for vaccine manufacturing, preclinical research, and a phase 1 study to assess the safety, tolerability, and immunogenicity of a single-dose vaccine candidate (RVFV-4s) against Rift Valley fever virus for use in humans.

About the Vaccine Development Consortium

WBVR will lead the preclinical safety and efficacy evaluation of RVFV-4s vaccine candidate; BunyaVax BV will provide the vaccine technology, undertake project management and enabling science; IDT Biologika GmbH will manufacture the vaccine; TiHo RIZ, University of Veterinary Medicine Foundation, Research Centre for Emerging Infections and Zoonoses will undertake studies to establish correlates of protection. CR2O BV will coordinate the clinical trial; CEVAC Clinical Trial Unit of Ghent University Hospital will implement and sponsor the clinical trial; and CEVAC Immunomonitoring Laboratory of Ghent University will handle biological material.

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