On June 11, 2024 Asgard Therapeutics, a privately held biotech company pioneering in vivo direct cell reprogramming for cancer immunotherapy, reported that it selected Exothera S.A. ("Exothera"), a leading provider of nucleic acids and viral vector development and manufacturing services, for process development up to clinical Phases I/II manufacturing of its candidate AT-108, based on viral vector technology (Press release, Asgard Therapeutics, JUN 11, 2024, View Source [SID1234644248]).
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AT-108 is a first-in-class, off-the-shelf gene therapy that leads to personalized and potent anti-cancer immune responses. AT-108 reprograms cancer cells inside the patient’s body to become conventional Type 1 Dendritic Cells (cDC1s), a rare subset of immune cells, which are critical for effective anti-tumor immunity. These induced cDC1s present the individual’s specific cancer antigens to the immune system, triggering personalized and systemic anti-cancer immune responses.
Exothera will be entrusted with the development and scale-up of a manufacturing process for the drug candidate, including development of analytical methods, GMP-grade material production, and aseptic filling.
Exothera offers a full-service model for viral vector-based biotherapeutics thanks to state-of-the-art technologies, and one of the largest viral vector facilities in Europe (15 000 m² – 161 500 ft²).
Cristiana Pires, Co-founder and Chief Executive Officer of Asgard Therapeutics, said: Following our proof-of-concept studies supporting the lead candidate AT-108, we are very happy to reach process development phase and start CMC activities. We are looking forward to work with the very knowledgeable and skilled technical team at Exothera to progress our pioneering AT-108 towards clinical development.
Hanna Lesch, Chief Technology Officer at Exothera, mentioned: We are proud to support Asgard Therapeutics in bringing these revolutionary therapeutics closer to the patients. Over the years we gained extensive experience with virus-based therapeutics production – both in suspension and in fixed bed bioreactors – and we are confident that we will use this expertise to help Asgard Therapeutics achieve clinical phase success.