AdAlta and Cell Therapies Pty Ltd (CTPL) execute a master services agreement
\nThe deal establishes CTPL as AdAlta\u2019s preferred manufacturer of cellular Immunotherapies
\nMSA also gives AdCella access to deep experience in development and manufacturing of cellular immunotherapies<\/p>\n
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Special Report<\/em>: AdAlta has signed a strategic deal designating Cell Therapies (CTPL) as the preferred manufacturing partner for its cellular immunotherapies, further enhancing its AdCella venture. <\/strong><\/p>\n AdAlta (ASX:1AD)<\/strong><\/a> and CTPL have executed a master services agreement (MSA) with initial work anticipated to focus on technical feasibility assessments of 1AD\u2019s in-licensing candidates.<\/p>\n CTPL is Australia\u2019s leading contract manufacturer of cellular immunotherapies for clinical trials and commercial supply.<\/p>\n 1AD says the MSA provides AdCella with access to deep experience in development and manufacturing of cellular immunotherapies and state-of-the-art facilities.<\/p>\n AdCella is the company\u2019s cellular immunotherapy collaboration with venture capital firm SYNthesis BioVentures (SYNBV), announced in April.<\/a><\/p>\n The jointly owned entity is aimed at facilitating the entry of innovative cellular immunotherapies from Asia into western regulated markets, leveraging 1AD\u2019s i-body technology.<\/p>\n Under the MSA, CTPL and 1AD have agreed to work together on each product that AdCella may in-license, subject to certain limitations and conditions related to capability and commercial competitiveness.<\/p>\n CTPL will provide a range of services, including process development, technology transfer, analytical testing, clinical product manufacturing and supply, and regulatory support.<\/p>\n The MSA establishes service standards, governance mechanisms and customary terms related to starting and ending projects under the MSA.<\/p>\n \u00a0<\/p>\n Cellular immunotherapies are living drugs made from a patient or donor immune cells that have been primed, engineered, or reprogrammed to fight cancer.<\/p>\n 1AD says a specific example is Chimeric Antigen Receptor (CAR) cell therapies which involve modifying a patient\u2019s own immune cells (T cells, NK cells, macrophages, etc) to produce a CAR on the cell surface that enables the patient\u2019s immune system to recognise and kill diseased cells.<\/p>\n The company says as these living drugs are made specifically and just in time for each patient, cellular immunotherapies require highly specialised manufacturing skills.<\/p>\n CTPL is Australia\u2019s leading commercial contract development and manufacturing company, specialising in cell and gene therapy, regenerative medicine, and cellular immunotherapy products.<\/p>\n CTPL\u2019s facilities are co-located with the Peter MacCallum Cancer Centre in Melbourne\u2019s Parkville Precinct and are Australia\u2019s only biomedical manufacturing facility where CAR-T cells and other \u201cliving\u201d cancer therapies can be made at commercial volumes.<\/p>\n Its facility supports both autologous and allogeneic products and includes 10 GMP CTPL has been developing and manufacturing cutting edge treatments for cancer and rare diseases on behalf of local and international clients for more than 20 years and have been approved for commercial CAR-T cell therapy supply to Australia (TGA) and Japan (PMDA).<\/p>\n \u00a0<\/p>\n 1AD says financial costs and timelines of each project will be set out in individual work orders to be agreed as required and are not anticipated to be material prior to AdCella securing rights to its first assets.<\/p>\n Initial work under the MSA is anticipated to include technical feasibility assessments of 1AD\u2019s in-licensing candidates.<\/p>\n The assessments will evaluate the suitability of these products for manufacturing at CTPL under both Australian and US regulatory frameworks and will provide 1AD with If results of the assessments are satisfactory and 1AD successfully in-license any of the product candidates, it will work with CTPL to transfer manufacturing processes into its facilities and manufacture patient doses for Phase 1 clinical trials.<\/p>\n 1AD CEO and managing director Dr Tim Oldham says the collaboration with CTPL is the \u201cnext key building block\u201d in its strategy to bring highly innovative cellular immunotherapies into a western regulated environment.<\/p>\n \u201cCTPL\u2019s demonstrated expertise over many years and multiple clients ensures that we will have access to the skills, experience and facilities needed to realise this goal, and importantly that we can immediately demonstrate this to our in-licensing partners,\u201d he says.<\/p>\n CTPL CEO Dr Bev Menner says the company is \u201cvery pleased\u201d to partner with AdAlta and \u201cWe are impressed by the vision and expertise of AdAlta and SYNBV and we are confident that our experience and networks enable us to provide them with high-quality product development, manufacturing and clinical supply services that meet the expectations of regulators around the world,\u201d she says.<\/p>\n 1AD recently announced<\/a> an institutional investment of up to $3.7m, including up to $3m to be invested by New Life Sciences Capital to support and accelerate its partnership with SYNBV.<\/p>\n \u00a0<\/p>\n\n \ufeff<\/span>\u00a0<\/p>\n This article was developed in collaboration with AdAlta, a Stockhead advertiser at the time of publishing. <\/em><\/p>\n \u00a0<\/em><\/p>\n This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.<\/em><\/p>\n <\/span><\/p>\n The post AdAlta secures Cell Therapies as cellular immunotherapies manufacturer<\/a> appeared first on Stockhead<\/a>.<\/p>","protected":false},"excerpt":{"rendered":"Leader in cellular immunotherapies production<\/strong><\/h2>\n
\ncleanrooms suitable for early to mid-stage clinical trial supply and three large-scale high-throughput GMP manufacturing suites for late-phase and commercial supply with a production capacity of up to 2,000 patient doses annually.<\/p>\nNext building block in strategy<\/strong>\u00a0<\/strong><\/h2>\n
\ncritical data to support its in-licensing decisions.<\/p>\n
\nAdCella to bring the cellular immunotherapy innovation it is seeing in Asia to Australian and global patients in need.<\/p>\n