Partnership with National Resilience, Inc. (Resilience) on Cell Therapy Manufacturing
Cellevolve has established an expansive collaboration with Resilience, a biopharmaceutical manufacturing company:
Exclusive manufacturing partner
Collaboration on asset selection
Board Observer Seat
May elect to contribute manufacturing services in exchange for equity in future financings
Partnership with Australia’s QIMR Berghofer to develop virus-specific T-cells
Cellevolve has also secured a broad-based collaboration with QIMR Berghofer and its cell therapy manufacturing facility Q-Gen Cell Therapeutics. The partnership includes manufacturing clinical supply for early-stage development, and a research agreement.
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 5,000 individuals annually, the disease is progressive and often fatal; no currently approved treatment options exist.
Cellevolve has developed its clinical program for the JCPyV virus-specific T cell (VST), CE-VST01-JC, and has received initial FDA feedback. IND submission was submitted in September 2022.
Rajiv Khanna, PhD
The collaboration with QIMR Berghofer also includes a BK polyomavirus (BKPyV) specific VST. BK virus reactivation may occur in immunocompromised hosts, with significant effects seen in kidney and hematopoietic stem cell transplant recipients.
The VST program is led by Professor Rajiv Khanna, PhD, Senior Scientist and Coordinator of the Immunology Department and Centre for Immunotherapy and Vaccine Development, QIMR Berghofer. Professor Khanna is an industry leader in VSTs who has dedicated his career to harnessing the power of the body’s immune response to treat diseases caused by viral infections.
Be The Match BioTherapies®
Cellevolve has established a multi-year partnership with BeTheMatch BioTherapies to provide clinically consented, cellular starting material to support the development of the final drug products. With 30+ years of experience, BeTheMatch BioTherapies sources internationally compliant, HLA-typed starting material from the Be The Match Registry®, the world’s most diverse registry of more than 22 million potential volunteer donors.
Cryoport Systems, LLC
Cellevolve has partnered with Cryoport to provide storage and cold chain logistical support in the US and EU for our clinical trials.
They have unparalleled experience and expertise in supporting critical regenerative medicine clinical trials and commercially approved products.