FUJIFILM Diosynth Biotechnologies and NeuExcell Therapeutics enter manufacturing agreement to rapidly advance NXL-001, a potential neuro-regeneration gene therapy to treat ischemic cortical stroke

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Sep 13, 2021, 06:00 ET

STATE COLLEGE, Pa., Sept. 13, 2021 /PRNewswire/ --

FUJIFILM Diosynth Biotechnologies (FDB) will provide essential drug substance and drug product manufacturing, under accelerated timelines, for NeuExcell's first-in-human clinical studies
Drug substance manufacturing will be carried out in FUJIFILM Diosynth Biotechnologie's state-of-the-art cGMP mammalian manufacturing facility in College Station, Texas

"The signing of the manufacturing agreement with NeuExcell showcases our flexibility in supporting biotech companies of all sizes, and our focused commitment to enabling NeuExcell to reach the full potential of their innovative gene technology platform on accelerated timelines," said Gerry Farrell, chief operating officer, FUJIFILM Diosynth Biotechnologies, Texas site. "We are proud and delighted to have been selected by NeuExcell as the manufacturing partner for their NXL-001 candidate. It is an honor for FDB to play a role helping to bring a treatment to patients around the world who suffer from ischemic cortical stroke."

"As we prepare to advance NXL-001 into clinical studies, we are pleased to have FUJIFILM Diosynth Biotechnologies, an industry-leading Biologics CDMO, as our trusted partner," remarked Jie Xu, Co-Founder and Head of Discovery, NeuExcell. "Securing reliable biomanufacturing is essential and we are grateful to be able to advance the NXL-001 program immediately in FUJIFILM Diosynth Biotechnologies' state-of-the-art manufacturing facility."

About NeuExcell Therapeutics

NeuExcell is a privately held early-stage gene technology company headquartered in Pennsylvania, USA. Its mission is to improve the lives of patients suffering from neuro-degenerative diseases and CNS injuries. Based upon the scientific work of Prof. Gong Chen, the Company has developed a potentially disruptive neural repair technology through astrocyte-to-neuron conversion in-vivo by introducing neural transcription factor(s) through adeno-associated virus (AAV)-based gene therapy. NeuExcell's pipeline covers major neurodegenerative diseases such as Stroke, Huntington's Disease, Amyotrophic Lateral Sclerosis, Alzheimer's Disease, Parkinson's Disease, Traumatic Brain Injury, Spinal Cord Injury, and Glioma.

About FUJIFILM Diosynth Biotechnologies

FUJIFILM Diosynth Biotechnologies an industry-leading Biologics Contract Development and Manufacturing Organization (CDMO) with locations in Teesside, UK, RTP, North Carolina, College Station, Texas, and Hillerød, Denmark. FUJIFILM Diosynth Biotechnologies has over thirty years of experience in the development and manufacturing of recombinant proteins, vaccines, monoclonal antibodies, among other large molecules, viral products and medical countermeasures expressed in a wide array of microbial, mammalian, and host/virus systems. The company offers a comprehensive list of services from cell line development using its proprietary pAVEway™ microbial and Apollo™ cell line systems to process development, analytical development, clinical and FDA-approved commercial manufacturing. FUJIFILM Diosynth Biotechnologies is a partnership between FUJIFILM Corporation and Mitsubishi Corporation. For more information, go to: www.fujifilmdiosynth.com

SOURCE NeuExcell Therapeutics