Anocca AB, a TCR-T cell therapy company, has received a certificate of good manufacturing practice (GMP) compliance from the Swedish Medical Product Agency for its in-house cell therapy manufacturing facility.

The manufacturing license paves the way for Anocca’s near-term path to the clinic and long-term strategy to advance franchises of precision targeted cell therapies for different cancers.

Anocca has built validated asset franchises against cancer targets including KRAS, PRAME and MAGE, with more than 40 preclinical assets in the pipeline.

Anocca’s lead franchise of TCR-T therapies target KRAS driver mutations which are responsible for extremely aggressive forms of cancer. These TCR-T products will be manufactured using a next-generation autologous approach that leverages non-viral gene editing to insert Anocca’s therapeutic TCR into a patient’s own T cells. Anocca will initiate its first clinical program in hard-to-treat solid tumor indications with TCR-T therapies across multiple KRAS mutation forms and patient segments.

“GMP certification of our in-house facility is a crucial milestone that allows us to confidently deploy the first of many TCR-T cell therapies into the clinic,” said Reagan Jarvis, Co-founder and CEO of Anocca, “The patients we are addressing have immense unmet medical need, and TCR-T is a therapeutic modality with the potential to transform patient outcomes.”

Hugh Salter, chief scientific officer, Anocca, said, “Our approach allows us to precisely map high-value but unexploited solid tumour targets such as KRAS and then fine-tune Anocca’s investigational TCR-T products against them. Next generation non-viral gene editing offers the precision and efficiency needed to scale out the manufacture of our broad TCR-T franchises.”