Pharma Focus Europe

Anocca Secures GMP Manufacturing License for Advancing Innovative KRAS TCR-T Cell Therapies in Clinical Development

Friday, January 05, 2024

Anocca AB, a prominent company specializing in T cell receptor-engineered T cell therapies (TCR-T), has announced that it has received a certificate of good manufacturing practice (GMP) compliance from the Swedish Medical Product Agency for its internal cell therapy manufacturing facility.

This manufacturing license is a significant achievement for Anocca, enabling its immediate entry into clinical trials and supporting its long-term strategy to advance multiple franchises of precision-targeted cell therapies designed for diverse cancer types and patient populations. Anocca has successfully developed validated asset franchises focusing on crucial cancer targets such as KRAS, PRAME, and MAGE, boasting a robust pipeline with over 40 preclinical assets.

Reagan Jarvis, Co-founder, and CEO of Anocca, emphasized the importance of the GMP certification, stating, "The certification of our in-house facility is a crucial milestone that enables us to confidently progress the first of many TCR-T cell therapies into clinical trials. The patients we aim to help have significant unmet medical needs, and TCR-T represents a therapeutic modality with the potential to revolutionize patient outcomes."

Anocca's primary franchise of TCR-T therapies is designed to target KRAS driver mutations, which are associated with highly aggressive forms of cancer. These TCR-T products will be manufactured using an advanced autologous approach, employing non-viral gene editing to integrate Anocca's therapeutic TCR into the patient's own T cells. The company plans to initiate its initial clinical program focusing on challenging solid tumor indications with TCR-T therapies addressing multiple KRAS mutation forms and patient segments.

Hugh Salter, Chief Scientific Officer (CSO) at Anocca, explained the company's approach, stating, "Our strategy allows us to precisely identify high-value yet untapped solid tumor targets, such as KRAS, and then tailor Anocca's investigational TCR-T products to address them. The next-generation non-viral gene editing technology provides the precision and efficiency required to scale up the production of our extensive TCR-T franchises."

In this context, TCR-T therapies refer to T cell receptor-engineered T cell therapies, a type of cell therapy utilizing the inherent targeting capabilities of T cells to identify and eliminate diseased cells, particularly cancerous ones. The term "franchises" refers to various TCR-T products serving distinct population segments while targeting a common cancer mutation.



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