Decoy Therapeutics Engages hVIVO as CRO Partner to Advance D-MAV Antivirals Toward Phase 1

• Decoy Therapeutics Inc. (Nasdaq: DCOY), a preclinical-stage biotechnology company pioneering Designable Multi-Antivirals (D-MAVs), has engaged hVIVO plc (AIM: HVO), a purpose-built full-service CRO and global leader in human challenge trials, under a consultancy agreement to support the clinical advancement of its lead respiratory antiviral candidate.

• Under the agreement, hVIVO will provide services spanning translational modeling, regulatory strategy, CMC consulting, non-clinical development support, and preparation of clinical and regulatory documentation for European and UK submissions — with the outputs designed to serve as a reusable development template across Decoy’s broader D-MAV pipeline.

Decoy Therapeutics Inc. (Nasdaq: DCOY) announced on June 1, 2026, from Cambridge, Massachusetts, that it has engaged hVIVO plc as its CRO development partner to support the clinical advancement of its lead Designable Multi-Antiviral (D-MAV) candidate toward Phase 1 first-in-human and Phase 2a human proof-of-concept studies. The collaboration brings together Decoy’s proprietary IMP³ACT platform — which uses AI-enabled peptide design running on Google Cloud — with hVIVO’s integrated preclinical strategy, regulatory, CMC, and clinical execution capabilities.

Under the consultancy agreement, hVIVO will deliver services across translational modeling, regulatory strategy, scientific advice preparation, CMC consulting, non-clinical development support, and preparation of key clinical and regulatory documentation required for European and UK clinical trial submissions. The engagement includes regulatory interaction support with both the European Medicines Agency and the UK Medicines and Healthcare products Regulatory Agency. Decoy also plans to pursue U.S. registration with the FDA and intends to conduct early proof-of-concept and likely follow-on studies with hVIVO given its established track record in human challenge trials.

A key design objective of the collaboration is reusability. Decoy intends for the outputs generated through hVIVO’s consultancy program — covering first-in-human dose selection, translational pharmacology planning, challenge study design, and Phase 2a readiness — to serve as a rapid development template applicable across multiple future D-MAV candidates. Decoy’s platform architecture is designed to enable similar clinical trial designs across its pipeline, subject to regulatory feedback, which positions the hVIVO engagement as a foundational investment rather than a program-specific outsourcing relationship.

Decoy’s D-MAV candidates are built on the concept of targeting shared viral mechanisms conserved across multiple respiratory viruses, enabling a single adaptable therapeutic to address multiple pathogens rather than requiring individual drugs for each viral threat. The company’s lead programs focus on respiratory viral infections including pan-coronavirus and broad-spectrum respiratory indications, with Phase 1 clinical trials expected in 2027. hVIVO, which serves seven of the world’s ten largest biopharma companies, operates an integrated platform spanning consulting, Phase I/II CRO services, human challenge trials at its London quarantine facility, and specialist virology and immunology laboratory services.

“The antiviral landscape continues to evolve as sponsors seek new approaches to address respiratory viruses and strengthen pandemic preparedness. Decoy’s programmes represent a differentiated approach, and we are pleased to be supporting the company as it progresses towards the clinic. This collaboration highlights the growing demand for integrated development partners that can support biotechnology companies from early development strategy through to clinical execution.”

Yamin ‘Mo’ Khan, Chief Executive Officer, hVIVO