– Expansion will supply clinical grade cNeT for ongoing Phase I/IIa clinical trials and support future development –
LONDON, April 12, 2022 (GLOBE NEWSWIRE) -- Achilles Therapeutics plc (NASDAQ: ACHL), a clinical-stage biopharmaceutical company developing precision T cell therapies to treat solid tumors, today announced clinical manufacturing expansion in the United Kingdom (UK) and the United States (US). Achilles’ manufacturing facility at the Cell & Gene Therapy Catapult (Catapult) in Stevenage, UK, has received a manufacturing license from the UK 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 advanced non-small cell lung cancer and recurrent or metastatic 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 US 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.
About Achilles Therapeutics
Achilles is a clinical-stage biopharmaceutical company developing precision T cell therapies targeting clonal neoantigens: protein markers unique to the individual that are expressed on the surface of every cancer cell. The Company has two ongoing Phase I/IIa trials, the CHIRON trial in patients with advanced non-small cell lung cancer (NSCLC) and the THETIS trial in patients with recurrent or metastatic melanoma. Achilles uses DNA sequencing data from each patient, together with its proprietary PELEUS™ bioinformatics platform, to identify clonal neoantigens specific to that patient, and then develop precision T cell-based product candidates specifically targeting those clonal neoantigens.
About The Center for Breakthrough Medicines
CBM is a purposefully built advanced therapy contract development and manufacturing organization (CDMO) based in the heart of Philadelphia’s Cellicon Valley. CBM offers pre-clinical through commercial manufacturing capabilities including process development, plasmid DNA, viral vector, cell therapy and a full suite of testing and analytical capabilities. Through a single-source, end-to-end solution, CBM accelerates time to market without compromising quality.
About the Cell and Gene Therapy Catapult
The Cell and Gene Therapy Catapult is an independent innovation and technology organization committed to the advancement of cell and gene therapies with a vision of a thriving industry delivering life-changing advanced therapies to the world. Its aim is to create powerful collaborations which overcome challenges to the advancement of the sector. With over 400 experts covering all aspects of advanced therapies, it applies its unique capabilities and assets, collaborates with academia, industry and healthcare providers to develop new technology and innovation. The Cell and Gene Therapy Catapult works with Innovate UK. For more information, please visit https://www.ukri.org/councils/innovate-uk.
This press release contains express or implied forward-looking statements that are based on our management's belief and assumptions and on information currently available to our management. Although we believe that the expectations reflected in these forward-looking statements are reasonable, these statements relate to future events or our future operational or financial performance, and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. The forward-looking statements in this press release represent our views as of the date of this press release. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we have no current intention of doing so except to the extent required by applicable law. You should therefore not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release.
Lee M. Stern, VP, IR & External Communications
Consilium Strategic Communications
Mary-Jane Elliott, Sukaina Virdi, Melissa Gardiner
+44 (0) 203 709 5000