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The CDMO will perform tech transfer, analytical development, and scale-up to initiate manufacturing at its GMP facility in Jumet, Belgium.
January 11, 2023
By: Tim Wright
Editor, Contract Pharma
Valo Therapeutics (ValoTx), a developer of immunotherapy platforms for cancer and infectious diseases, has selected Exothera, a full service contract development and manufacturing organization (CDMO) specialized in gene therapy, vaccines, and oncolytic viruses, to develop a large-scale manufacturing process for clinical development of its oncolytic adenovirus, VALO-D102. ValoTx’s VALO-D102 oncolytic adenovirus is a fundamental component of the company’s proprietary PeptiCRAd (Peptide-coated Conditionally Replicating Adenovirus) immuno-oncology platform. The platform utilizes a unique technology which creates electrostatic interactions between positively charged, tumor-specific peptides and the negatively charged surface of oncolytic adenoviruses. This allows an adenovirus to be used as an immunogenic carrier for the tumor-specific peptides, creating systemic tumor-targeted killer T-cell responses. Exothera brings expertise in adenovector and A549 cells with a deep knowledge of state-of-the-art manufacturing technology and DoE-based development tools. Exothera will perform tech transfer, analytical development, and scale-up to initiate manufacturing of clinical material for EU Phase II clinical trials in its GMP facility in Jumet, Belgium—one of the biggest dedicated viral vector manufacturing facilities in Europe. The facility can accommodate projects from development to manufacturing scale. “ValoTx’s platform has the potential to turn the tide in the fight against cancer,” said Hanna Lesch, chief technology officer, Exothera. “At Exothera, we are excited to put our extensive viral vector expertise at Valo’s service for the process development and manufacturing of such a revolutionary oncolytic virus-based immunotherapy. We’re proud to be one of the leaders laying down the roadmap for viral vector production to deliver exciting new cancer therapies like PeptiCRAd-1.” Petri Priha, vice president of CMC, Valo Therapeutics, said, “We are reinventing cancer immunotherapy to make it more effective and accessible to cancer patients. This important work with Exothera will enable us to develop a large-scale manufacturing process for VALO-D102 to support our future clinical development plans and pave the way for future commercial-scale manufacturing.”
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