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 a leading European clinical CRO, specialised in managing and operating early-stage infectious disease clinical trials. Artemis Bioservices is a specialty lab, evaluating viral vaccines and antiviral therapeutics, in particular against emerging, zoonotic and vector-borne diseases.
For several years, CR2O and Artemis Bioservices have teamed up to advance industry- and public partners’ compounds from bench to various stages of clinical development. Together we offer more value to our partners by combining scientific expertise and operational excellence, under strict regulatory and quality requirements.
“We are very pleased with the successful collaboration with Artemis Biosciences lab in the recently concluded Phase-I studies investigating novel vaccines against Rift Valley Fever and SARS-CoV-2.” – Hadil Es-Sbai, CEO CR2O
“Our scientists and operational experts in virology, immunology and vaccinology, work hand-in-glove with our partners to deliver their projects within specifications.” – Byron Martina, CEO Artemis Biosciences
A successful drug development strategy is a well-designed and dynamic process. Making sure regulatory requirements are embedded from the start, is key. From pre-clinical all the way to registration, a well-organized set of action plans needs to be in place that guides and accelerates the client’s vision on how to support their targeted therapeutic area.
CR2O (cr2o.nl) and 3D-PharmXchange (3d-pxc.com) are celebrating 2 years of successful ongoing collaboration on a number of pre- and clinical development programs for Biotech/Pharma SMEs. Together we designed, planned, oversaw and optimized multiple clinical-stage development programs. Amongst others our partnership has led to a well-defined CMC, regulatory and clinical development strategy for a new drug treating Female Sexual Disfunction including obtaining scientific and technical advice at EMA and FDA paving the way for the start of confirmatory trials in Europe and US.
Both companies also joined forces in delivering CMC, clinical development and clinical operational expertise allowing a vaccine produced on a new innovative yeast based production platform to be tested in a First-in-Human study. The use of this novel platform will lead to affordable, scalable, protective and safe vaccines.
Our highly qualified and experienced Life Sciences professionals are supported by CR2O’s rigorous clinical quality management system and continuous training programs, enabling delivery of top-quality clinical services. Senior experts were selected based on their ability to answer to the client’s development program’s specific requirements. The combined teams of Non-Clinical, Clinical, CMC and Regulatory experts all had hands-on experience from leading Big Pharma company teams.
Going from bench to the patient’s bedside is the dream of any scientist. Working smarter can make this goal a reality. Having a clear plan and guidance from the first tests all the way to the final drug product is crucial. Being able to combine CR2O’s operational clinical expertise with Clinical Science, CMC, Regulatory Affairs and Non-Clinical expertise was shown to be vital in those projects.
CR2O and 3D-PharmXchange remain committed with enthusiasm to the responsibilities that we assumed together towards customers and partners. We have successfully inspired difficult projects with novel ideas and insights, thereby significantly increasing the chance of success. We are constantly developing and stimulating ourselves to be able to take on the challenges of our complex field with pride.
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
The first healthy volunteer was dosed with hRVFV-4s, a novel live-attenuated Rift Valley fever vaccine. A clinical trial, run by the LARISSA[1] consortium and which started this week, will assess the safety, tolerability and immunogenicity of the vaccine candidate. “We are very proud and excited to have reached this milestone,” says Carine Punt, CEO of WUR Spin-out BunyaVax, the company managing the LARISSA consortium.
In this First-in-Human Clinical trial, designed as a dose escalation study, standard Phase I safety parameters as well as immunogenicity of the hRVFV-4s vaccine will be assessed in healthy adult volunteers. Following a single dose administration, the candidate vaccine is expected to generate a long-lasting immune response against Rift Valley fever, a severe and deadly disease predominantly transmitted by mosquitoes. The study will be performed at the Centre of Vaccinology in Belgium with CR2O as clinical operations partner.
Project
Currently, the only Rift Valley fever vaccines available are for use in livestock and none have been licensed for use in humans. The LARISSA consortium aims to address this deficiency. The consortium led by Wageningen Bioveterinary Research (WBVR), part of Wageningen University & Research, consists of six partners[2] and is financed by the Coalition for Epidemic Preparedness Innovations (CEPI), with support from the EU Horizon 2020 program.
One Health
“The vaccine virus, initially constructed by genetic engineering back in 2014, was found highly safe and efficacious in ruminants. Following years of optimizing production and developing a viable regulatory path for human use we can now make the first steps to protect humans from this emerging pathogen by a true One Health approach, in which a combination of human, animal and climatic variables are considered” states Paul Wichgers Schreur, Project Lead of the LARISSA consortium (WBVR).
“Our globally connected world has made us vulnerable to the rapid spread of zoonoses and the emergence of another pandemic disease is just a matter of time. Climate change, too, is also further compounding this risk, leading to an expansion of the range of disease-carrying animals, like mosquitoes, which can spread deadly diseases including Rift Valley fever”, said Dr Melanie Saville, Executive Director of Vaccine R&D at CEPI. “Given the potential for Rift Valley fever to cause significant disruption to health, economies and societies across sub-Saharan Africa and other regions, we can, and must, develop a safe and effective human vaccine against this viral threat to protect those people who are most at-risk and to improve global epidemic preparedness.”
About Rift Valley fever
Rift Valley fever virus was first identified in 1931 during an investigation into an outbreak among sheep on a farm in the Rift Valley of Kenya. Multiple outbreaks have since been reported across the African continent and on the Arabian Peninsula. Rift Valley fever virus mainly affects ruminants, leading to high mortalities among young animals and abortion storms in pregnant herds.
Humans become infected through close contact with infected animals or via mosquito bite. Despite the majority of infected humans present with mild flu-like symptoms the infection may develop into a life-threatening disease in about 1-2% of infections. As susceptible mosquitoes are expanding their territory, there is a concern that the virus will spread to naive regions in the near future. In view of the epidemic threat posed by this disease, the WHO has classified it as a priority pathogen in need of urgent R&D investment.
[1] LARISSA is the acronym for Live-attenuated Rift Valley fever vaccine for single-shot application
[2] Partners of LARISSA are: WBVR/WUR, IDT Biologika GmbH, Research Centre for Emerging Infections and Zoonoses (RIZ)/TiHo, CR2O BV, CEVAC-CTU UZGent/CEVAC-LAB UGent, BunyaVax BV.
The clinical trial application of the LARISSA study is the first application submitted successfully by CR2O under the new European Clinical Trial Regulation (ECTR).
The ECTR is the new regulation for receiving ethical and regulatory approval in the European Union and European Economic Area by using the Clinical Trial Information System (CTIS) centralized portal to submit clinical trial applications.
LARISSA is a first in human Phase 1 study to assess the safety, tolerability, and immunogenicity of a single-dose vaccine candidate against Rift Valley fever (RVF) virus in healthy adult subjects. The vaccine is a novel live-attenuated RVF vaccine virus to generate a lasting immune response against the disease. The study will be performed at the Centre of Vaccinology in Belgium and first subject randomized is expected in August 2022.
Official approval was obtained on July 26th, which made CR2O one of the first successful users of the new ECTR regulation!
Please refer to https://www.larissa.online/ for more information.
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