Cellevolve Announces Global Partnership with QIMR Berghofer Medical Research Institute to Advance Ready-to-Use T Cell Therapy in First Randomized Cell Therapy Trial for Progressive Multifocal Leukoencephalopathy (PML)
Cellevolve’s collaboration with Australian company QIMR Berghofer will accelerate the development and commercialization of a novel JC virus-specific T cell therapy (VST) for PML, a highly disabling disease of the central nervous system (CNS).
Standard allogeneic cell therapies can offer many benefits, including faster delivery to patients with rapidly progressive diseases like PML.
In addition, Cellevolve partners with BeTheMatch BioTherapies and Cryoport Systems to optimize manufacturing and logistics solutions for this assay and Cellution.MT Platform.
SAN FRANCISCO, December 01, 2021– (BUSINESS WIRE) – Cellevolve Bio (âthe Companyâ or âCellevolveâ), a development and commercialization company focused on cell therapy, today announced a large-scale collaboration with QIMR Berghofer Medical Research Institute based in Australia and its cell manufacturing plant for Q-Gen Cell Therapeutics. The partnership includes the manufacture of clinical supplies for early stage development and a research agreement with Prof. Rajiv Khanna, PhD on JC and BK virus specific T cells (VST) and allogeneic cell therapies.
The initial treatment goal is progressive multifocal leukoencephalopathy (PML), a demyelinating disease of the central nervous system caused by the JC polyomavirus (JCPyV) occurring in immunocompromised patients. Affecting approximately 4,000 people per year in the United States and Europe, the disease is progressive and often fatal with no currently approved treatment options.1
“Rapidly progressive diseases such as PML require safe, effective and timely treatments because the longer patients wait, the more debilitating the outcome, so it is essential to stop the progression of the disease quickly,” said Derrell Porter, MD, MBA, Founder and CEO of Cellevolve. “We are honored to partner with Professor Khanna, a leading researcher at VST, and his team at QIMR Berghofer to advance a novel, ready-to-use, bioengineered, JCV-specific T cell therapy at the clinic. in this first randomized clinical trial of cell therapy. “
Cellevolve has received initial feedback from the FDA for its clinical development plan for JCPyV VST (CE-VST01-JC) and IND submission is expected in the first half of 2022.
âWe are at a transformative stage of science and discovery, where we are able to harness the power of the body’s immune response to treat diseases caused by viral infections,â said Rajiv Khanna, PhD, professor and Principal Scientist and Coordinator of the Department of Immunology and the Center for Immunotherapy and Vaccine Development, QIMR Berghofer. “We are delighted to partner with Derrell and the Cellevolve team in the common goal of bringing our JC virus specific T cells (JC-VST) into clinical development and, hopefully, creating a new paradigm of treatment for PML. “
To support the CE-VST01-JC pivotal trial and the Company’s exclusive CellutionMT platform, Cellevolve has established a multi-year partnership with Be The Match BioTherapiesÂ® to provide clinically accepted cellular starting material for the development of final therapeutics. With over 30 years of experience, Be The Match BioTherapies sources human leukocyte antigen (HLA) -type starting material in accordance with international standards from the Be The Match registry.Â®, the world’s most diverse registry of over 22 million potential voluntary donors.
âThere is a huge unmet medical need for a new, FDA-approved treatment for PML based on the severity of the disease and the overall patient burden,â said David B. Clifford, MD, Melba and Forest Seay , professor of clinical neuropharmacology in neurology, University of Washington School of Medicine. âIn addition, ready-to-use cell therapies by design will enable faster delivery and therapeutic access, which is integral to the fight against this progressive disease for patients around the world. “
Cellevolve will also partner with Cryoport Systems (Cryoport: NASDAQ CYRX) to provide storage, packaging, labeling, 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 the life sciences. Cryoport has unparalleled experience and expertise in supporting regenerative medicine clinical trials and commercially approved products.
These partnerships mark the beginning of Cellevolve’s quest to accelerate the cell therapy revolution by translating innovation into commercially available treatments. Several additional partnerships are under development and will be the subject of future announcements.
NORTH (2021). Progressive multifocal leukoencephalopathy. Retrieved from https://rarediseases.org/rare-diseases/progressive-multifocal-leukoencephalopathy/. Accessed September 28, 2021.
Cellevolve Bio is a development and commercialization company focused on cell therapy. The Company’s mission is to accelerate the cell therapy revolution by translating innovation into commercially available treatments. Founded by leaders with extensive experience developing and launching therapies, Cellevolve understands that cell therapy innovations require unique and specialized capabilities to advance them to approval and beyond. The Company responds to this need with its Integrated CellutionMT clinical development and commercialization platform that translates the scientific breakthrough of the world’s leading innovators into powerful new therapies for patients.
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Sadie Whittaker, PhD
Director of External Affairs, Cellevolve
Sophia Ononye-Onyia, PhD MPH MBA
Founder & CEO, The Sophia Consulting Firm