RQ Bio welcomes positive CHMP opinion on Kavigale for prevention of COVID-19 in immunocompromised individuals

RQ Bio welcomes positive CHMP opinion on Kavigale for prevention of COVID-19 in immunocompromised individuals

• Kavigale (sipavibart; AZD3152) is a monoclonal antibody discovered by RQ Bio and licensed to AstraZeneca in 2022.
• Advancing from discovery to positive CHMP opinion in three years illustrates the speed with which long-acting monoclonal antibodies can be developed as a drug class to protect vulnerable populations against serious viral diseases.
• Further validates RQ Bio’s antiviral drug discovery expertise and model for early partnership with the pharmaceutical industry.

London, England, 09 January 2025 – RQ Biotechnology Ltd. (“RQ Bio”), a leader in the discovery of preventative medicines for infectious diseases, today welcomes the decision by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) to recommend the granting of marketing authorisation for the medicinal product Kavigale. Kavigale is intended for the prevention of COVID-19 in immunocompromised individuals- aged 12 years and older and was reviewed under the EMA’s accelerated assessment programme.

“This welcome news is further validation of our expertise in antiviral drug discovery and our model for early partnership with the pharmaceutical industry to rapidly advance potentially important new medicines,” RQ Bio CEO Mike Westby said. “The programme has transitioned from discovery to positive regulatory opinion in three years. This is truly remarkable and highlights the pace with which long-acting prophylactic antibodies can now advance through pre-clinical and clinical development.”

The active substance of Kavigale is sipavibart, an antiviral human IgG1 monoclonal antibody discovered by RQ Bio in partnership with The University of Oxford. Sipavibart provides passive protection against SARS-CoV 2 by binding its spike protein receptor binding domain.

AstraZeneca exclusively licenced sipavibart (formerly AZD3152) from RQ Bio in May 2022.

Hayden Selvadurai, Head of Portfolio Management at RQ Bio, commented, “This positive opinion from the CHMP highlights the productive relationship we have with a trusted pharma partner. We’re excited about the opportunity to build on this experience and are advancing assets from our other programmes, including seasonal influenza, to provide protection for vulnerable individuals that are unable to build an optimal immune response from vaccination.”

ENDS

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ABOUT KAVIGALE
Kavigale is indicated for the preexposure prophylaxis of COVID-19 in adults and adolescents 12 years of age and older, weighing at least 40 kg and who are immunocompromised due to a medical condition or receipt of immunosuppressive treatments.

ABOUT RQ BIO
RQ Bio’s mission is to develop preventative medicines to provide instant immunity and protect vulnerable people from life threatening viral diseases. RQ Bio has achieved this by combining expertise in virology and drug development with deep academic collaborations, including the University of Oxford, to create an innovative discovery platform delivering multiple sources of leads. RQ Bio was founded by scientific experts previously involved with the UK’s COVID Antibody Taskforce, which worked to build a community of infectious disease experts focussed on the rapid delivery of highly potent neutralising antibodies to support the UK COVID-19 response. In April 2024, RQ Bio Covid Ltd was formed to manage RQ Bio’s licensed COVID assets, including sipavibart.

Attachment

• RQ Bio CHMP Positive Opinion Final