Special Report: AdAlta and SYNthesis BioVentures Fund (SYNBV) are collaborating to form AdCella, a jointly owned entity aimed at facilitating the entry of innovative cellular immunotherapies from Asia into western regulated markets, leveraging AdAlta’s i-body technology.
AdCella, once formed, will aim to identify partners capable of developing multi-functional cellular immunotherapies targeting solid tumours.
It will then license or acquire commercialisation rights for these products outside Asia, in return for conducting initial clinical trials in Australia and integrating AdAlta (ASX:1AD)’s i-body technology into the partner companies’ future product pipeline.
AdAlta says in this way, many of the initial assets would be substantially de-risked because they will have already generated clinical data in their “home” markets.
With AdCella as their bridge to western regulated markets, partner companies will gain access to Australia’s clinical and manufacturing ecosystem, AdAlta’s i-body platform, and capital sources.
Australian patients may also benefit from earlier access to these new therapies than would otherwise be possible without AdCella.
AdAlta says AdCella is the next step in the company’s stated strategy of building out its product development business by securing clinical stage assets that complement the i-body platform. The collaboration with SYNBV is expected to expand AdAlta’s clinical stage pipeline.
SYNBV’s deep expertise in cross border transactions, especially with China, and access to alternative capital sources is highly complementary to AdAlta’s operational and technology skills and enables AdAlta to accelerate execution of its strategy.
“We are delighted to be working with the SYNBV team – their skills, experience and networks in drug development, capital raising and Asia complement ours and significantly strengthens AdCella’s competitive position,” said AdAlta’s CEO, Tim Oldham.
“We will be able to implement this exciting strategy much more rapidly and with greater capital efficiency and reduced risk as a result of this collaboration.”
Prof Andrew Wilks, SYNBV managing director, said the opportunity to work with a quality management and clinical team like AdAlta, while leveraging SYNBV’s extensive experience in China is an appealing prospect.
“We believe that this collaboration will further our fund’s strategy of investing in promising early stage science by leveraging the inherent advantages of the Australian biotech ecosystem.”
Asia-Pacific Opportunity
The Asia-Pacific region, particularly China, is a hub for cellular immunotherapy innovation, as more than half of all cellular immunotherapy clinical trials globally are conducted in China.
Many of these companies are already developing extensive pipelines of sophisticated, multi-functional CAR-cell therapies against novel cancer targets for use in solid tumours and have early clinical efficacy data.
However, they often lack access to advanced technologies, as well as networks and know how to translate this innovation into western regulated markets.
Many companies in the region are also still using traditional scFv technology, limiting the pace and efficiency of their pipeline growth.
Australia meanwhile has world class cellular immunotherapy research, manufacturing and clinical trials capability that is compliant with, and recognised by the US FDA and the European Medicines Agency (EMA).
Australian cell therapy trials also remain at lower cost compared to the US.
AdaAlta says combining Asia Pacific cellular therapy innovation with Australia’s established cellular therapy ecosystem, along with AdAlta and SYNBV’s skills and networks, should provide a pathway for these innovative products to reach a western regulated market as quickly, safely and efficiently as possible.
CAR-T could be the next big thing in treating cancers
CAR-T cell therapies are revolutionising treatment of cancers, showing promise in treating the disease by harnessing the immune system.
The market for CAR cell therapies is projected to grow from US$1 billion in 2020 to more than US$20.3 billion by 2028, with more than 50% of revenues to be derived from CAR-cell therapies against solid tumours by 2030.
CAR-T has been really successful with blood cancers, because it’s relatively easy to find tumour-specific antigens in blood cells.
Solid tumours on the other hand, are much harder to treat.
First, because there’s not as many tumour specific antigens known and the tumour cells don’t necessarily express them all, so it’s much harder to zoom in and target these solid tumour cells.
The second problem is getting the T-cells into the solid tumour, which is much easier to do for blood cancers.
This is where AdAlta’s i-body platform comes in. AdAlta’s i-body technology brings unique properties to the field of CAR cell therapy, and could deliver the same outcomes for patients with solid cancers as has been achieved for blood cancers.
AdAlta’s i-bodies are essentially “next generation antibodies” that are approximately one-tenth the size of monoclonal antibodies.
Their unique targeting capabilities enable them to target novel and difficult to access tumour antigens.
Further, they are small enough to be made and secreted by immune cells to help overcome immune system suppression induced by tumours.
These are significant advantages over scFv fragments, making i-bodies potentially part of the solution to extending these therapies to solid tumours. These advantages underpin AdAlta’s CAR-T collaboration with Carina Biotech in 2021.
What’s next?
Under the MoU, AdAlta and SYNBV will work together over a period of six months (with potential to extend this collaboration for a further six months) to complete due diligence and negotiate final binding agreements and initial asset selection.
This selection will be made from a pipeline of more than ten assets and partners currently identified as suitable candidates for AdCella.
Assuming success in identifying and securing suitable assets, AdAlta will own 75% of AdCella and SYNBV 25% prior to AdCella’s next financing.
The parties will then have the first option to participate in any future financing and will work together to secure third party financing where necessary.
The costs of completing the activities contemplated by the first six months of the MoU are not expected to materially alter AdAlta’s underlying operating cash requirements (after excluding costs of the recently completed Phase I extension clinical study).
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.