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Solupore® - Enabling the Manufacture of Affordable New Treatments to Cure Cancer

Periodic Reporting for period 1 - SOLUPORE (Solupore® - Enabling the Manufacture of Affordable New Treatments to Cure Cancer)

Reporting period: 2018-05-01 to 2019-04-30

Cancer is a global challenge but there is positive news for cancer patients, particularly those for whom the current treatments such as chemotherapy are not effective. A new game-changing treatment, cell immunotherapy, has been delivering spectacular results and is an entirely new approach to treating cancer. It arms the body’s defenses into fighting the cancer cells from within.

In summary, immune cells are removed from the patient’s blood and “engineered” in such a way that the cells identify and attack the disease when they are re-introduced to the patient. Whilst the performance of these new approaches has been outstanding in treating various types of cancer, the challenge is, they are not cost efficient. Swiss pharma giant, Novartis, made history by being the first company to get FDA approval (August 2017) to market its immunotherapy treatment drug, Kymriah™. However, the price tag for this single dose treatment of $475,000 makes it virtually inaccessible to wider patient communities. The predominant cost critical component lies in the very complex manufacturing process which uses virus based transfection to develop cancer-killing cells. In addition, the inherent complexities of treating sick patients using viruses, pharma companies must queue for as long as multiple years before the virus is available. When the virus becomes available, it can take up to 22 days to complete the cell engineering phase. Every day of the cell engineering process counts as the manufacturing takes place in expensive production facilities (typically costing €1,000 per hour).

At Avectas, our highly-trained team of scientists has developed Solupore® an innovative, rapid and gentle cell engineering technology. The unique selling point of Solupore® is that it eliminates the need for viruses in the manufacturing process. This removes the significant bottleneck faced by the pharma companies in getting these transformative therapies to market AND it allows for a much simpler regulatory pathway enabling the availability of these lifesaving treatments for European patients. In addition, Solupore® reduces the manufacturing time from 22 days to 16 days. In comparison with today’s state of the art, Kymriah™, it is estimated (Reuters August 2017) that the current manufacturing costs of Kymriah™ is about €200k. Solupore® reduces these manufacturing costs to €115,000. This >40% reduction in the cost of goods combined with the elimination of the queueing time for virus production and the simpler regulatory pathway renders these life-changing therapies economically viable thus making them available to a wider patient community. Avectas has already commercialised a suite of products in the regenerative medicine field under the brand name Spraybase® and is now focused entirely on solving the manufacturing challenges in the immunotherapy space.

The overall objectives for this project are to
- To develop a scaled prototype of the Solupore technology.
- To carry out a demonstration (pilot) study with a target customer
- To sign a commercial partnership agreement with a cell immunotherapy company
The work completed to date has been focused on the development of the technology that will enable Solupore to be used in a Clinical setting. The main results in this period include but are not limited to the following:

1. Successful scaling of cell production to enable scientists to work with larger volumes of ‘typical’ patient material to develop and ultimately validate the technology.
2. Selection of critical key components to scale up the process including filters and nebulizer head to administer our proprietary solution.
3. Development of software to run the Solupore® device.
4. Design and development of the scaled Solupore® device needed to enable the development of the clinically relevant Solupore® process. Validating our design concepts with external expertise.
5. Selection of key consumables required for use with the device such as filters for the cells and defining the formulation of the delivery buffers.
6. Appointed external partners on computational fluid dynamics to fully elucidate our Solupore® technology, allow for a more rapid method for optimisation of soluporation and examine the impact changes in scaling and/or design of our system impacts on soluporation.
7. Completed external review of the end to end process with subject matter expert from the Center for Commercialisation of Regenerative Medicine (CCRM).
8. Working with Key Opinion Leaders with a focus on the best solution for their clinical unmet needs and to get input into the design of the device and the process to meet this need.
9. Generating data to show the benefits of Solupore® on cell health and manufacturing time versus our competitors, allowing us to define our USP in the marketplace.
10. Further validation of our technology through preclinical studies have been planned, enabling in vivo examination of data generated in vitro to date.
11. Key hires including Head of Project Management, Head of Process Development and engineers.
12. Agreements in place to carry out development studies with two leading cell therapy companies using their proprietary cargos.
13. Generation of ~40 leads for potential new customers.
At this stage of the project, Avectas has demonstrated that its Solupore technology can be scaled up to successfully engineer cells efficiently. Crucially, the engineering step will be substantially simpler and shorter than that required for virus-mediated engineering. This will significantly reduce the cost of cell therapy manufacturing because processes will be shorter and simpler. In addition, the bottleneck currently in place regarding access to stocks of virus will be avoided.

To date, we have demonstrated the scaling of our technology and shown that the cells are highly functional post the Solupore cell engineering process. The expected results for the coming year will include the design and build of our scaled technology to align with good manufacturing processes (GMP) and regulatory standards whilst in parallel carrying out further functionality data to confirm the gentleness and effectiveness of our technology in comparison to other cell engineering methods. We will also read out results on our animal study. The ultimate goal is to tech transfer our Solupore technology to a 3rd party and sign a commercial deal with a customer for the use of the Solupore technology.

It has been well documented that the cost of these life-saving cell therapies is a real challenge. With our Solupore technology, we believe we will significantly reduce the manufacturing cost which will have a real impact on the cost and make this a real economic alternative for the industry. The industry feedback to date confirms that Solupore® will have an enormous impact on the delivery of affordable immunotherapy cancer treatments to patients throughout Europe and globally. Additionally, the reagent and device are made from common, inexpensive components adding to the economic viability of the technology.
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