Prepare for a game-changing collaboration! InnoSer and CR2O unveil their strategic partnership, bridging the gap between pre-clinical and clinical research. Join us as we revolutionize drug discovery and development with an integrated platform poised to accelerate groundbreaking treatments to market.
Read the full press release unveiling this transformative alliance!
Driving more efficient and accelerated results from pre-clinical trials to commercialisation of new therapies for Australian, European and U.S. firms.
The full innovation journey offering for Biointelect, a strategic life science consulting company, and CR2O, a leading contract research organisation, has reached new heights, with Australian, European and U.S. clients now able to tap into world-class strategic advice and full-service clinical trial capabilities following the announcement of Biointelect’s and CR2O’s new strategic partnership.
Biointelect and CR2O will work to provide our clients solutions across geographical boundaries and rapidly navigate an increasingly complex regulatory, access, policy and clinical landscape. Based in the Netherlands, CR2O is expanding Biointelect’s existing capability to include clinical trial capabilities across the European Union and Australia. The partnership will give CR2O access to Biointelect’s strategic product development consultancy and commercialisation capabilities.
The transformational move puts Biointelect and CR2O at the forefront for providing world-class innovative end-to-end commercialisation solutions to streamline project work across every phase of the development cycle.
Biointelect CEO Leah Goodman said ultimately this collaborative partnership will mean strengthened confidence for clients in reaching their goals and an enhanced customer experience with a focus on performance.
“We are delighted that our partnership with CR2O enhances the full value Biointelect brings to our clients, completing our partnership capability from early research right through to commercialisation.”
“The alliance with CR2O will generate even greater returns to clients across the full innovation journey via a consolidated service offer with a trusted partner.”
“Biointelect’s reputation for quality is a common value with CR2O, and we are confident that together this global expansion will continue to enable our collaboration with Life science partners in enhancing the ecosystem and bringing innovation to patients,” Goodman added.
Trusted connections
The strategic partnership harnesses the deep insights, ground support and local presence of both CR2O and Biointelect for Australian, European and U.S. clients across the pharmaceutical and biotechnology industries.
Core to the advancement strategy is an understanding of the macroeconomic and geopolitical tensions that often impact the sector, to deliver fit-for-purpose clinical development solutions that de-risk the pathway to patient care settings.
CR2O CEO Hadil Es-Sbai believes the partnership with Biointelect will strengthen strategic capabilities by leveraging established relationships with stakeholders to provide advanced end-to-end commercialisation solutions for clients.
“We are very pleased to strengthen our collaboration with Biointelect by leveraging their world-class strategic planning and commercialisation capabilities for the benefit of our pharmaceutical and biotechnology clients. Together we offer integrated, fit-for-purpose clinical development solutions that de-risk the complex journey from bench to bedside,” said Es Sbai.
Performance driven
The new partnership has ushered in a wave of enquiries from universities, government, biotechnology and pharmaceutical companies seeking a wholistic, one-stop-shop for tailored solutions across the full innovation journey. With a synergy in values underpinning the partnership’s success, both will leverage their proven track records to continue a trajectory of bringing life science innovations to market.
“At the end of the day, our aim is to deliver outstanding results for our clients through an efficient and accelerated approach with a focus on reliability and credibility. Our partnership with CR2O enhances our ability to provide value to our now shared clients.” Goodman said.
SpokespeopleAustralia: Biointelect CEO Leah Goodman
With a career spanning executive leadership roles at Bristol-Myers Squibb, Merck Healthcare, and Sanofi, Leah has excelled in diverse therapeutic areas, from immunooncology to primary care. She has significant experience successfully leading Multinational company business transformation and growth in Australia and across Asia including South East Asia, Korea, and Japan. In November 2023, Leah commenced as Chief Executive Officer at Biointelect. Drawing on her extensive leadership background, she has embarked on successfully engaging the company to a this new strategic vision and long term success.
The Coalition for Epidemic Preparedness Innovations (CEPI) is expanding its partnership with Wageningen Bioveterinary Research (WBVR) to advance WBVR’s vaccine candidate against Rift Valley fever (RVF) through a multi-site Phase I/IIa clinical trial. Subject to regulatory and ethical approvals, the anticipated trials are scheduled to begin in 2025 in Kenya and Uganda, two countries where the mosquito-borne disease poses a significant threat to the lives and livelihoods of people in rural communities. Backed with up to US$25.9 million in funding from CEPI, with support from the European Union’s Horizon Europe programme, the studies will be the first to assess the safety and immunogenicity of WBVR’s RVF vaccine in countries where RVF is endemic.
WBVR’s live-attenuated vaccine known as hRVFV-4s, and being further developed under Wageningen spin-off Bunyavax, is currently being evaluated in a Phase I clinical trial in Belgium under a previous CEPI/ EU grant. In addition to the anticipated trials in Kenya and Uganda, CEPI will fund an extension of the ongoing Phase I study to assess immunogenicity up to 24 months; manufacturing of clinical trial materials; epidemiological research to assess the burden of infection and the risk of ‘spillover’ transmission from animals to humans in Kenya and Uganda; and regulatory engagement, including a strategy for achieving licensure of the vaccine. The work will be a combined effort of WBVR with consortium partners Batavia Biosciences BV, Bunyavax BV, CR2O BV, University of Veterinary Medicine Hannover, and Integrum Scientific, LLC.
The official CEPI and WBVR Press Release can be found here.
CR2O is happy to announce that the First-in-Human trial with Dyadic’s SARS-CoV-2-RBD vaccine candidate DYAI-100 has started in South Africa.
Dyadic International Inc. is 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. 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 Dyadic’s SARS-CoV-2–RBD vaccine candidate DYAI-100.
In July 2022, CR2O (on behalf of Dyadic) submitted a Clinical Trial Application (CTA) to the South African Health Products Regulatory Authority (SAHPRA) and the Witwatersrand Human Research Ethics Committee (WHREC) in order to gain approval to initiate a Phase I study with DYAI-100, a C1-SARS-CoV-2 recombinant protein RBD vaccine and clearance to start the trial was provided in October 2022.
The Phase I randomized, double blind, placebo-controlled trial is designed to demonstrate clinical safety and preliminary efficacy of DYAI-100.
Following the regulatory approval from the South African Health Products Regulatory Authority (SAHPRA) and the Witwatersrand Human Research Ethics Committee (WHREC), site preparations and recruitment was commenced and the first dosing for subjects began during the week of January 9th, 2023.
The Chief Scientific Officer of CR2O, Prof. Albert Osterhaus, applauds the collaborative efforts of Dyadic and CR2O. These have led to the approval and execution of this first in human Phase I trial with a candidate COVID-19 booster vaccine, produced with the novel C1-cell protein production platform. The use of this platform may well pave the way for faster, cheaper and easier production of vaccines and other biologicals to combat emerging viruses.
For Dyadic’s original press release, please refer to GlobeNewswire.
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
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
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
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
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.
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.
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.
