VIRSCIO
Breaking Barriers to Successful Preclinical Research

It’s an exciting time in the therapeutic development space as many organizations are exploring emerging therapeutic modalities to bring intractable diseases like Alzheimer’s, dry-age-related macular degeneration (AMD), and other neurodegenerative conditions under active therapeutic management.

To ensure patients are able to realize the true benefits of these advanced treatments, it is imperative that the biotechnology and pharmaceutical industry employ the most advanced research and development capabilities available to de-risk and develop these treatments.

A leader in preclinical and translational research with nonhuman primates (NHP), Virscio is at the forefront of enabling therapeutic innovation.
By developing and providing advanced in vivo models, methods, and technologies, Virscio is accelerating the scientific translation of therapeutic innovation for some of the world’s leading biotechnology and pharmaceutical companies. The company’s primate-centric approach is enabling the development of new-generation drugs that promise higher on-target effects.

“Our focus on NHP in vivo research elevates candidates with safety and efficacy profiles that are more likely to translate to successful clinical trials,” says Matthew Lawrence, CEO and Chief Scientific Officer at Virscio. “We are able to quickly and efficiently test novel, high-impact research concepts that will inform sponsor project and program planning on a continual basis. Our capacity to run a full-time research platform with our unique level of animal access is globally unique.”

Virscio’s preclinical platform is enabled by unique access to African green monkeys, a non-endangered, old-world species that has a shared physiology and anatomy to humans and macaques. The green monkey is a well-characterized and readily available alternative to cynomolgus macaques for both non-GLP and GLP and studies supporting FDA and EMA applications.
With fully integrated preclinical capabilities, Virscio designs and executes studies to reduce the risk of late-stage clinical failures and costly losses that can be avoided with more predictive preclinical data. Definitive, clinically relevant NHP safety and efficacy readouts help sponsors more effectively prioritize their pipelines by accelerating investment in the more promising programs and cutting investment in less compelling ones, driving overall efficiencies.

Bridging the Gaps in the Supply Chain

According to a National Academies of Sciences survey, 64 percent of NIH-supported researchers reported challenges with obtaining nonhuman primates for their research. These challenges have led to a dramatic surge in both cost and wait times as resource availability continues to outpace demand.

Amidst the convergence of compelling development programs that demand human-like test systems and the shifting dynamics of biological resource availability, Virscio is uniquely positioned to meet the demands for preclinical studies to keep therapeutic development timelines on schedule.

“Sponsors looking to start a primate study are presently receiving an indication of 9 to 12 months before study initiation, a delay that can seriously impact research and development timelines,” says Christopher Stanley, CFO and Chief Business Officer. “Our unique preclinical capabilities and ready access to an abundant population of an FDA and EMA-accepted NHP species have positioned Virscio as a globally recognized translational research organization.”

In the 1600s, a subpopulation of African green monkeys, also known as vervets, was introduced to St. Kitts, where they now thrive as an invasive species without natural predators. Biologically isolated and deriving from a limited founding population, vervets are disease-free and have a well-defined genetic background and degree of homozygosity suited to study designs with the minimal necessary sample sizes. In addition to unique biological advantages, Virscio has built world-class research facilities in St. Kitts, West Indies, to eliminate animal welfare concerns associated with international transport while enabling a sustainable long-term solution to the animal shortages created by China’s ban on the export of research monkeys to European and U.S. markets.

Ever mindful of the 3R’s principles, Virscio aims to achieve better translational prediction by elevating the quality and richness of preclinical data with as few animal resources as possible. Substantial investments have been made to improve study design, endpoint measures, and data analysis to ensure study results are definitive and clinically actionable.

The Complete Spectrum of Preclinical Services

Virscio’s preclinical services span in vivo study design and execution and analysis of derived data and specimens within a GLP-compliant environment. Clients can apply Virscio’s in-life models to evaluate critical early questions related to tolerance and achievable distribution of the therapeutic candidate, stepping to GLP safety studies and pharmacodynamic evaluation in induced phenotypes relevant to CNS, ophthalmic, cardiovascular, metabolic, and other disease indications. In all instances, the scientific and technical team are applying clinically relevant endpoints and instrumentation.

Virscio also offers blood biomarker, molecular, and histopathology capabilities, including clinical pathology, H&E histopathology, immunohistochemistry, and pharmacokinetic and toxicokinetic modeling. In addition, Virscio has also invested in developing cutting-edge digital image analysis capabilities, applying AI-enabled software strategies to enhance the data value of acquired medical and histological imaging.

“Our research platform supports clinical molecular and histological endpoints that can be applied to both in-house primate samples and preclinical test systems from other organizations, broadening Virscio’s translational impact,” says Lawrence.

A Holistic Approach to Preclinical Services

Virscio has successfully executed over 750 contract research engagements over the last 15 years, with dozens of programs having moved on into clinical development, reflecting its innovative approach to developing and refining scientific capabilities, resources, and service offerings.

With demand for translational resources continuing to increase, Virscio is investing heavily to meet the biomedical industry’s accelerating adoption of the St. Kitts green monkey.

To deliver the true benefits of its translational platform, Virscio applies a comprehensive yet efficient approach when working with clients. It engages in early collaborative discussions to understand clients’ clinical aims and prior preclinical data generated to enable the development of an integrated preclinical strategy that will ensure an efficient and successful path to IND submission.

Once a client’s program needs are defined, Virscio’s scientists develop custom study designs that will allow for the most efficient path to confirming biodistribution, dose range, and efficacy and safety of the drug candidate. Study designs are captured within a draft protocol format, allowing for efficient review and optimization of a scientific approach with the client. With
alignment on the study protocol, proposals are generated for contracting or further optimization of study design and better aligned to funding availability with study aims.

Ever Mindful Of The 3r’s Principles, Virscio Aims To Achieve Better Translational Prediction By Elevating The Quality And Richness Of Preclinical Data With As Few Animal Resources As Possible

Contracting is followed by the finalization of the protocol and the formation and assignment of the study execution team. Each study is typically initiated within eight to twelve weeks, depending on test article availability, IACUC approval, and other preparatory steps.

When progressing to IND-enabling GLP safety studies, the Virscio team works with clients to align preclinical design with regulatory protocols and clinical plans, engaging in pre-IND meetings and incorporating FDA feedback as required.

Regardless of the scope of research required, Virscio recognizes that every study outcome informs subsequent program investment decisions.

Virscio strives to maximize the achieved scientific gains by employing advanced data analysis and interpretation techniques to enable candidate selection and further development plans.

Advancing Therapeutic Development with Innovative Methods

Virscio specializes in newer-generation therapeutic models that deliver the best results by achieving targeted delivery within the body through less conventional routes of drug administration, supported by clinically relevant imaging, such as MRI and OCT.
In recent years, interest in these delivery routes has grown, fuelled by recognition of the benefits of minimized off-target effects and the ability to work within the constraints of a particular therapeutic modality.

For example, subretinal injections in the eye or intrathecal injections in the thoracic spinal cord rely on administration routes that are challenging to fully model, especially among smaller species with different anatomies. The expertise required to administer these injections adds technical challenge.

Virscio’s surgical team develops methods to address these route of administration challenges, allowing programs to focus on pharmacodynamic and safety results and develop a path toward clinical trials. The company’s tissue-level pharmacodynamic and safety assessments are further enhanced by its extensive histopathology capabilities and experience.

Driving efficiencies in the drug development process, Virscio is committed to providing definitive datasets that facilitate prompt and effective decision-making for the best outcomes. With continued growth, Virscio is on course to fill critical translational gaps and bring expanded efficiencies and impact to drug development and improvements to human health.