• Cellevolve�s collaboration with Australia-based QIMR Berghofer will accelerate the development and commercialization of a novel, bioengineered JC virus specific T-cell (VST) therapy for PML, a highly disabling disease of the central nervous system (CNS).
• Off-the-shelf, allogeneic cell therapies may offer many advantages, including faster delivery to patients with rapidly progressing illnesses like PML.
• Additionally, Cellevolve is partnering with BeTheMatch BioTherapies and Cryoport Systems to optimize manufacturing and logistics solutions for this trial and the Cellution^TM platform.

SAN FRANCISCO--(BUSINESS WIRE)--Cellevolve Bio (�the Company� or �Cellevolve�), a development and commercialization company focused on cell therapies, today announced a broad-based collaboration with Australia-based QIMR Berghofer Medical Research Institute and its cell therapy manufacturing facility Q-Gen Cell Therapeutics. The partnership includes manufacturing clinical supply for early-stage development and a research agreement with Professor Rajiv Khanna, PhD on JC and BK virus specific T-cells (VSTs) and allogeneic cell therapies.

The initial therapeutic focus is on progressive multifocal leukoencephalopathy (PML), a demyelinating disease of the central nervous system caused by JC polyomavirus (JCPyV) occurring in immunocompromised patients. Affecting approximately 4,000 individuals annually in the US & Europe, the disease is progressive and often fatal with no currently approved treatment options.¹

�Rapidly progressing illnesses such as PML require safe, efficacious and speedy treatments since the longer patients wait, the more debilitating the outcome thus promptly halting disease progression is critical,� said Derrell Porter, MD, MBA, Founder and Chief Executive Officer, Cellevolve. �We are honored to partner with leading VST researcher Professor Khanna and his team at QIMR Berghofer to advance a novel, bioengineered, JCV-specific off-the-shelf T-cell therapy to the clinic in this first randomized cell therapy clinical trial.�

Cellevolve has received initial FDA feedback for its clinical development plan for the JCPyV VST (CE-VST01-JC) and IND submission is planned for the first half of 2022.

�We are at a transformative stage in science and discovery, where we are able to harness the power of the body�s immune response to treat diseases caused by viral infections�, said Rajiv Khanna, PhD, Professor and Senior Scientist and Coordinator of Immunology Department and Centre for Immunotherapy and Vaccine Development, QIMR Berghofer. �We are thrilled to partner with Derrell and the Cellevolve team on a shared goal to take our JC Virus Specific T Cells (JC-VST) into clinical development and hopefully create a new treatment paradigm for PML.�

To support the CE-VST01-JC pivotal trial and the Company�s proprietary Cellution^TM platform, Cellevolve has established a multi-year partnership with Be The Match BioTherapies^� to provide clinically consented, cellular starting material for the development of the final therapeutic. With 30+ years of experience, Be The Match BioTherapies sources internationally compliant, human leukocyte antigen (HLA)-typed starting material from the Be The Match Registry^�, the world�s most diverse registry of more than 22 million potential volunteer donors.

�There is a huge unmet medical need for a novel, FDA-approved, PML treatment based on the gravity of this disease and the overall patient burden,� said David B. Clifford, M.D., Melba and Forest Seay Professor of Clinical Neuropharmacology in Neurology, Washington University School of Medicine. �Additionally, off-the-shelf cell therapies by design will enable faster delivery and therapeutic access, which is integral to addressing this progressive disease for patients all over the world.�

Cellevolve will also partner with Cryoport Systems (Cryoport: NASDAQ CYRX) to provide storage, packaging, labelling, distribution and logistics support for the Company�s clinical trials in the US and EU. Cryoport is the trusted global provider of temperature-controlled logistics and supply chain solutions for life sciences. Cryoport has unparalleled experience and expertise in supporting regenerative medicine clinical trials and commercially approved products.

These partnerships mark the start of Cellevolve�s quest to accelerate the revolution in cell therapy by translating innovation into commercially available treatments. Several additional partnerships are in development and will be the subject of future announcements.

Reference

1. NORD (2021). Progressive Multifocal Leukoencephalopathy . Retrieved from https://rarediseases.org/rare-diseases/progressive-multifocal-leukoencephalopathy/. Accessed on September 28, 2021.

About Cellevolve

Cellevolve Bio is a development and commercialization company focused on cell therapies. The Company�s mission is to accelerate the revolution in cell therapy by translating innovation into commercially available treatments. Founded by leaders with extensive experience developing and launching therapeutics, Cellevolve understands that cell therapy innovations require unique and specialized capabilities to advance them to approval and beyond. The Company is addressing this need with its integrated Cellution^TM clinical development and commercialization platform that translates breakthrough science from the world�s leading innovators into powerful new therapies for patients.

For more information, please visit: www.cellevolve.com.

Follow Cellevolve on social media: https://www.linkedin.com/company/cellevolve/

Contacts

Sadie Whittaker, PhD

Chief External Affairs Officer, Cellevolve

+1-805-410-0651

[email protected]

Sophia Ononye-Onyia, PhD MPH MBA

Founder & CEO, The Sophia Consulting Firm

+1-347-851-8641

[email protected]