Apertura Gene Therapy and Viralgen Announce Strategic Collaboration to Manufacture TfR1 CapX, a Next-Generation Capsid for Gene Therapies Designed to Treat Central Nervous System Diseases

NEW YORK and SAN SEBASTIÁN, Spain, March 17, 2026 /PRNewswire/ -- Apertura Gene Therapy, a biotechnology company developing next-generation AAV capsids for delivering genetic medicines, and Viralgen, a leading contract development and manufacturing organization (CDMO) specializing in recombinant adeno-associated virus (rAAV) gene therapies, today announced a strategic manufacturing collaboration to support gene therapy programs using Apertura's TfR1 CapX, a novel AAV capsid that targets human Transferrin Receptor 1 (hTfR1) to cross the blood-brain barrier.

Through this collaboration, Apertura licensees can efficiently access the TfR1 CapX plasmid through Viralgen's integrated AAV manufacturing platform by leveraging its technical expertise. This collaboration aims to facilitate the scale-up process and ensure a seamless transition from research to clinical development.

"We expect to see multiple Apertura partners advance programs using TfR1 CapX into the clinic this year and next, and this collaboration with Viralgen is designed to facilitate the advancement of novel therapies leveraging TfR1 CapX," said Diego Garzón, Ph.D., Chief Business Officer at Apertura.

TfR1 CapX is an intravenously (IV) dosed AAV capsid that is designed to bind to human TfR1, cross the blood-brain barrier, and broadly transduce tissues in the CNS while administered at low doses. TfR1 CapX has demonstrated selectivity to the CNS compared to other tissues, with robust transduction of neurons and astrocytes across different brain regions, as shown in extensive preclinical testing conducted independently by several groups.

"We believe having a well-characterized production framework in place enables gene therapy programs to progress more efficiently toward clinical development and supports the development of more effective and scalable gene therapies," said Jimmy Vanhove, Chief Executive Officer at Viralgen.

Viralgen has scaled up TfR1 CapX manufacturing and is ready to support research and clinical development programs. The established AAV platform manufacturing process has been successfully deployed across more than 1.500 batches.

Viralgen provides CMC services, including essential starting materials such as Master Cell Bank (MCB) creation and plasmid supply as part of its integrated AAV manufacturing services. Currently, these capabilities are utilized to generate MCBs and plasmids for the TfR1 CapX partnership.

"Through this collaboration, Apertura licensees can benefit from an efficient and fast supply of TfR1 CapX plasmid to support clinical production of investigational gene therapies using a scalable and established manufacturing process," said Jorge Santiago-Ortiz, Ph.D., Vice President of CMC and Regulatory Affairs at Apertura. "The collaboration is structured to support clinical manufacturing planning and regulatory engagement as Apertura advances its gene therapy programs."

About Viralgen

Viralgen is a leading Contract Development and Manufacturing Organization (CDMO) specializing exclusively in adeno-associated virus (AAV)-based gene therapies. Founded in 2017 as a subsidiary of AskBio, Inc. within the Bayer AG group, Viralgen delivers end-to-end support from early development to large-scale commercial manufacturing. Leveraging their proprietary Pro10™ suspension cell line and Aava™ manufacturing platform, Viralgen achieves industry-leading, high-yield, scalable manufacturing across all AAV serotypes. Located in San Sebastian, Spain, its state-of-the-art facility features three cGMP suites with 2,000-liter capacities each, certified by the AEMPS/EMA, and integrates services including plasmid production, process optimization, fill-finish, and in-house QC testing. With over 1,500 AAV batches produced, Viralgen provides reliable, efficient solutions bringing life-changing gene therapies to patients with greater speed and consistency. Learn more at viralgen.com and follow us on LinkedIn.

About Apertura Gene Therapy

Apertura Gene Therapy develops genetic medicines and next-generation AAV capsids that engage human-relevant receptors, aiming to enable more effective and selective gene delivery. The company's lead capsid, TfR1 CapX, leverages human transferrin receptor 1 to enable intravenous delivery to the brain and spinal cord. This established transport mechanism has a strong clinical track record in pediatric and geriatric populations, expanding its potential to treat serious neurological and genetic diseases. Apertura has licensed its next-generation capsids to multiple partners, with programs expected to enter clinical trials this year and next year. Founded in 2021 on technology from the Broad Institute and supported by Deerfield Management Company, Apertura Gene Therapy is headquartered in New York City. Learn more at aperturagtx.com and follow us on LinkedIn.

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