adivo receives limited market authorization status from European Medicines Agency (EMA) for lead oncology program

Dr. Kathrin Ladetzki-Baehs and Dr. Markus Waldhuber, both founder and CEO of adivo GmbH © Adivo GmbH

adivo GmbH, a Martinsried-based company focussed on discovering species-specific therapeutic antibodies for pets, today announced that the company has been granted the limited market authorization status by the Committee for Veterinary Medicinal Products (CVMP) of the European Medicines Agency (EMA) for its most advanced proprietary pipeline program. adivo’s CAESAR-derived cancer immunotherapy could benefit from a significantly shortened development path to a first market entry.

The adivo technology platforms allows de-novo identification of species-specific antibody panels to select drug candidates with optimal functionality, developability and low risk of immunogenicity. adivo has established CAESAR, the first fully canine phage display platform in the veterinary medicines market for selecting therapeutic candidates against a broad range of diseases.

The cancer antibody addresses a well-established immune-oncology pathway in dogs and may now benefit from an accelerated approval pathway toward a first market approval in a specific oncology subsegment. The cancer program is one of two proprietary assets progressing towards first-in- animal studies within the next 12 months, driving the transformation of adivo into a clinical-stage biopharmaceutical company in the companion animal therapeutics space.

Early 2022, the Veterinary Medicinal Products Regulation introduced a specific authorization route for medicines intended for veterinary limited markets in the European Union. The regulatory pathway aims to stimulate the development of veterinary medicines for serious or life-threatening animal diseases and unmet veterinary medical needs. It enables the regulatory authorities to recommend granting a marketing authorization based on less comprehensive data than normally required.

The benefits for applicants, such as adivo, comprise shortened go to market timelines due to the reduced data requirements and enhanced regulatory assistance.