Posted: 14 May 2024
AdAlta Limited (ASX:1AD) (AdAlta) and Cell Therapies Pty Ltd (CTPL) are pleased to announce that they have executed a Master Services Agreement (MSA) establishing CTPL as AdAlta’s preferred manufacturing partner of cellular immunotherapies. This agreement provides AdCella, AdAlta’s cellular immunotherapy collaboration with SYNthesis BioVentures (SYNBV),1 with key product development, manufacturing and supply chain capabilities. CTPL will support AdCella in delivering AdCella’s objective of providing innovative cellular immunotherapies originating in Asia with access to AdAlta’s i-body® technology and a pathway to western regulated markets.
MSA establishes CTPL as AdAlta and AdCella’s preferred cellular immunotherapy manufacturer CTPL is now AdAlta and AdCella’s preferred manufacturer of cellular immunotherapies. CTPL Chief Executive Officer, Dr Bev Menner said: “We are very pleased to partner with AdAlta and AdCella to bring the cellular immunotherapy innovation we see in Asia to Australian and global patients in need. We 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.”
Under the MSA, CTPL and AdAlta 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. CTPL will provide a range of services, including process development, technology transfer, analytical testing, clinical product manufacturing and supply, and regulatory support. The MSA establishes service standards, governance mechanisms and customary terms related to commencing and ending projects under the MSA. AdAlta CEO and Managing Director, Dr Tim Oldham said: “This collaboration with CTPL is the next key building block in our strategy to bring highly innovative cellular immunotherapies into a western regulated environment. CTPL’s 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. “
The 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. Initial work under the MSA is anticipated to include Technical Feasibility Assessments of AdCella’s in-licensing candidates. The Technical Feasibility Assessments will evaluate the suitability of these products for manufacturing at CTPL under both Australian and US regulatory frameworks and will provide AdCella with critical data to support its in-licensing decisions. Should the results of Technical Feasibility Assessments be satisfactory and if AdCella successfully in-license any of these product candidates, AdCella and CTPL will work together to transfer manufacturing processes into CTPL facilities and manufacture patient doses for Phase I clinical trials.
CTPL provides AdAlta and AdCella with leading cellular immunotherapy manufacturing expertise
Cellular immunotherapies are living drugs made from a patient or donor immune cells that have been primed, engineered or reprogrammed to fight cancer. A specific example is Chimeric Antigen Receptor (CAR) cell therapies which involve modification of a patient’s own immune cells (T cells, NK cells, macrophages, etc) to produce a CAR on the cell surface that enables the patient’s immune system to recognise and kill diseased cells such as cancer. As these living drugs are made specifically and just in time for each patient, cellular immunotherapies require highly specialised manufacturing skills.
CTPL is Australia’s leading commercial contract development and manufacturing company, specializing in cell therapy, gene therapy, regenerative medicine, and cellular immunotherapy products. CTPL’s facilities are co-located with the Peter MacCallum Cancer Centre in Melbourne’s Parkville Precinct and are Australia’s only biomedical manufacturing facility where CAR T-cells and other “living” cancer therapies can be made at commercial volumes. The facility supports both autologous and allogeneic products and includes 10 GMP cleanrooms suitable for early to mid-stage clinical trial supply and 3 large-scale high-throughput GMP manufacturing suites for late-phase and commercial supply with a production capacity of up to 2,000 patient doses per year. CTPL’s expert team and world-class facilities have been developing and manufacturing cutting edge treatments for cancer and rare diseases on behalf of local and international clients for more than twenty years and have been approved for commercial CAR-T cell therapy supply to Australia (TGA) and Japan (PMDA).
