AdAlta and Cell Therapies Pty Ltd have executed a MSA. Pic: Getty Images
Health & Biotech
Special Report: AdAlta has signed a strategic deal designating Cell Therapies (CTPL) as the preferred manufacturing partner for its cellular immunotherapies, further enhancing its AdCella venture.
AdAlta (ASX:1AD) and CTPL have executed a master services agreement (MSA) with initial work anticipated to focus on technical feasibility assessments of 1AD’s in-licensing candidates.
CTPL is Australia’s leading contract manufacturer of cellular immunotherapies for clinical trials and commercial supply.
1AD says the MSA provides AdCella with access to deep experience in development and manufacturing of cellular immunotherapies and state-of-the-art facilities.
AdCella is the company’s cellular immunotherapy collaboration with venture capital firm SYNthesis BioVentures (SYNBV), announced in April.
The jointly owned entity is aimed at facilitating the entry of innovative cellular immunotherapies from Asia into western regulated markets, leveraging 1AD’s i-body technology.
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.
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 starting and ending projects under the MSA.
Cellular immunotherapies are living drugs made from a patient or donor immune cells that have been primed, engineered, or reprogrammed to fight cancer.
1AD says a specific example is Chimeric Antigen Receptor (CAR) cell therapies which involve modifying 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.
The company says 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, specialising in cell and 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.
Its facility supports both autologous and allogeneic products and includes 10 GMP
cleanrooms 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.
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).
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.
Initial work under the MSA is anticipated to include technical feasibility assessments of 1AD’s in-licensing candidates.
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
critical data to support its in-licensing decisions.
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.
1AD CEO and managing director Dr Tim Oldham says the collaboration with CTPL is the “next key building block” in its 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,” he says.
CTPL CEO Dr Bev Menner says the company is “very pleased” to partner with AdAlta and
AdCella to bring the cellular immunotherapy innovation it is seeing 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,” she says.
1AD recently announced 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.
This article was developed in collaboration with AdAlta, a Stockhead advertiser at the time of publishing.
This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.
Health & Biotech
Health & Biotech
Health & Biotech
