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Anocca Secures GMP Manufacturing License To Push Novel KRAS TCR-T Cell Therapies Into Clinical Development

January 4, 2024

Largest Facility in Nordics for Clinical Supply of Cell Therapies

SÖDERTALJE, SWEDEN, 4 January 2024 – Anocca AB, a leading TCR-T[1] cell therapy company, today announced it 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[2] of precision targeted cell therapies for different cancers and covering diverse patient populations. Anocca has built validated asset franchises against valuable cancer targets including KRAS, PRAME and MAGE, with more than 40 preclinical assets in the pipeline.

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. The patients we are addressing have immense unmet medical need, and TCR-T is a therapeutic modality with the potential to transform patient outcomes."

Reagan Jarvis, Co-founder, and CEO, Anocca

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 tumour indications with TCR-T therapies across multiple KRAS mutation forms and patient segments.

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

Hugh Salter, Chief Scientific Officer (CSO), Anocca.

– ENDS –

[1] TCR-T therapies: T cell receptor-engineered T cell therapies – a type of cell therapy that uses the natural targeting ability of T cells to identify and eradicate diseased cells like cancer.

[2] Franchises: Several different TCR-T products that serve different population segments but targeting a single cancer mutation.

Media contacts:

Anocca

Mark Farmery, CDO

media@anocca.com

Scius Communications

Katja Stout

+447789435990

katja@sciuscommunications.com

Daniel Gooch

+447747875479

daniel@sciuscommunications.com

About Anocca AB

Anocca is a fully integrated biopharmaceutical company developing libraries of T cell receptor-engineered T cell (TCR-T) therapies to redefine the treatment of solid tumours. Our proprietary technologies have been designed to vastly expand TCR-T development allowing us to systematically generate treatments for the broadest patient populations, equipping the immune system against the most difficult to treat solid cancers. The lead TCR-T candidates from our 40+ preclinical asset library target KRAS driver mutations and will enter clinical development during 2024.

Anocca operates an advanced research and development infrastructure, underpinned by custom software and in-house clinical manufacturing and process development facilities. Our unique discovery platform uses programmable human cells to recreate and manipulate T cell immunity. Follow us on LinkedIn.