Achilles Therapeutics plc, a clinical-stage biopharmaceutical company developing precision T cell therapies to treat solid tumors, is expanding its clinical manufacturing in the United Kingdom and the United States.
 
Achilles’ manufacturing facility at the Cell & Gene Therapy Catapult (Catapult) in Stevenage, UK, has received a manufacturing license from the Medicines and Healthcare products Regulatory Agency (MHRA) and, separately, the company has entered into a partnership agreement for clinical manufacturing with the Center for Breakthrough Medicines (CBM), a contract development and manufacturing organization in King of Prussia, Pennsylvania.
 
The additional peak annual capacity of up to 600 doses of the company’s personalized clonal neoantigen-reactive T cell product candidates, known as cNeT, will support clinical manufacturing in the two ongoing Phase I/IIa CHIRON and THETIS clinical trials in non-small cell lung cancer and melanoma, respectively.
 
“This significant scale up in annual capacity and expansion of our global clinical manufacturing footprint, with our second site in the UK and our first site to be established in the US, significantly strengthens our global clinical, technical, and supply chain operations,” said Edward Samuel, executive vice president of Technical Operations at Achilles Therapeutics.
 
Following the receipt of a manufacturing license from the MHRA, the Catapult facility is now GMP certified to produce clinical grade doses of cNeT. This second GMP manufacturing site at the Catapult will initially support Achilles’ proprietary VELOS manufacturing process with an annual capacity of 200 cNeT doses at peak production. The company’s first U.S. GMP manufacturing facility to be operated by CBM in King of Prussia, Pennsylvania will have an initial annual capacity of 150-200 doses at peak production.