Interview Defence Therapeutics: "The next six months will be trend-setting."

Like many companies that manufacture active ingredients, Orano also has to consider processes of pharmacokinetics and pharmacodynamics. This involves the effects of active ingredients on patients and interactions between active ingredients and patients. The dosage and frequency with which we administer active ingredients play a crucial role. Our Accum™ technology helps all active ingredients or vaccines to get into the cells to work. This opens up new possibilities for companies like Orano in terms of dosages and treatment regimens. Orano had already experimented with Accum™ prior to working with us and then decided to collaborate. In a first step, we successfully linked an active ingredient from Orano to Accum™ and made it usable. The next steps will involve modifications. For example, we have the option of releasing active ingredients directly or gradually. In the coming weeks, we are undertaking further tests and are confident of gaining new, valuable insights.

We share the costs equally. The joint findings will also remain the property of both companies. Judging by the progress to date, we could have achieved all the milestones by mid 2024 and then decide how to proceed based on the data generated. After a GLP study, a Phase I trial is quite conceivable. Whether we continue to conduct these studies as part of our collaboration or whether we license Accum™ for this purpose has not yet been determined. Both options are conceivable. For now, we are focused on achieving our short-term goals.

We conduct the majority of the work but maintain close communication with Orano. The input we receive from our partners is very valuable to us. They not only help us to implement the milestones but also provide new insights and ideas. In return, when it comes to Accum™, we can also contribute our expertise to the collaboration.

We currently have a core team of ten people. We also benefit from research being done at the University of Montreal, as part of a research contract, for example, on projects that complement or deepen the understanding of our technology. For each of our projects, we have project managers who closely supervise the respective topic. However, since all our projects are based on Accum™, a strict separation of projects is neither necessary nor desired. We exchange information on all projects in the core team and continue to work in parallel with different focuses. In October, we will move into our new laboratory and increase our personnel again. We will then centralize some processes that are currently carried out in different laboratories. However, lean structures and flexibility remain important for us.

It is simple: We stay in constant communication and always advance those projects where new developments are possible. Sometimes, we need to wait for results from laboratory actions, or it may involve preparing for new investigations. There is always something to do. The fact that all our projects revolve around Accum™ is a significant advantage for us.

We are continuing to move the work forward. During our investigations, we identified new issues that we want to address directly. For this reason, the comparative study now covers three scenarios. We are interested in gaining detailed knowledge about which combination of Accum™ and an mRNA vaccine also achieves the best results. It is also important for us that we may be able to use certain procedures that have already been approved by the US Food and Drug Administration (FDA). This would make the rest of the process much easier for us and justifies taking a little more time at this point and delving deeper into the details of the investigation.

Specifically, we have several options for how to combine Accum™ and mRNA vaccines, allowing us to derive different use cases. For this reason, the investigation has become more extensive. However, we expect detailed results by the end of the year. We also continue to assume that Accum™ is suitable for improving the efficacy of mRNA vaccines. This holds potential for new vaccines but also for projects that were already considered to have failed and could become competitive again thanks to Accum™.

Yes. We assume that Accum™ is a highly flexible technology. This is shown both by our investigations to date and by the professional assessment of experts. There are no reasons why Accum™ should not be combinable with pseudouridine or other adjuvant technologies. Accum™ can be combined with all active ingredients or vaccines. We offer a technology that makes many biotech projects possible. It is our stated goal to prove it as soon as possible!

Yes, there have been discussions, and we know that several companies are following our work. However, we have not yet had any contact with the large company from Germany mentioned earlier. We expect that once we have published our Accum™ comparative study around mRNA vaccines, the chances for a comprehensive deal, or at least a collaboration with larger companies, will increase rapidly.

We are on schedule. We will have received pending data by the end of July, and then the City of Hope Hospital will finalize the Phase I trial application. That should take another two to three weeks. Subsequently, the FDA will respond and address any further questions. Therefore, we anticipate the study to commence at the City of Hope Hospital later this year. The fact that such experienced partners are handling both the application and the study for us is something we view very positively. The study will include a variety of tumors indications, with a particular focus on melanomas.

We have completely designed the study. It will be a 3+3 design where we will initially test three doses. After identifying the most promising dosage to administer AccuTOX™ as the sole agent, we will combine it with Opdulag, which is already a common cancer therapy. We will initially work with 12 patients and have the option to increase to 18 patients depending on whether or not we consider other dosing options. The study is designed to last up to one year, but patients will be followed beyond that to ensure their best possible care. Once patients are tumor-free, they drop out of the study. However, this is not a disadvantage for our study and does not diminish the data basis. The main focus of the Phase I trial is on safety. However, assuming that everything goes smoothly, we can directly follow up with a Phase IIa study and then investigate efficacy even more closely. Then we will know exactly which dosage of AccuTOX™ also promises the greatest possible success.

We are in the process of having our cellular vaccine manufactured, and as indicated in the question, we expect to start the study later this year. We have already produced the ARM vaccine itself and taken the first samples from patients. It is now just a matter of final details of a regulatory nature until we can start the trial. We will be investigating various types of hard-to-treat cancers, including pancreatic and ovarian cancers. We are conducting part of the study in Canada and the other part in the US. The ARM project is very important to us, and we are moving forward with it decisively. We aim to demonstrate that our technology can yield effects even in the case of hard-to-treat cancer types. In addition, we can easily modulate the vaccine to cover different scenarios.

In Montreal, we will work with the Jewish General Hospital of McGill University, which has everything it takes to complete the study successfully. A partnership is also emerging in the US, although it is not yet ready to be announced. We expect that there will be no significant hurdles on the way to a Phase I study around our ARM vaccines.

The support from CDQM relates to our ARM project and covers most of the costs in this context. Additionally, the cost-sharing arrangement with Orano helps us significantly advance our projects without raising new capital. Furthermore, we still have sufficient funds to bring the Phase I trial of AccuTOX™ to completion. However, as there is now growing interest from professional investors, we are considering broadening our shareholder base. This step could enhance the visibility of our mission to even more potential partners and investors. The good thing in this context is that we are not urgently dependent on a financing round and are, therefore, in a good financial position. Other forms of financing are also conceivable and, based on existing discussions, not unrealistic. By early 2024, we shall announce further financing details for our projects.

We continue to work in parallel on all projects and provide updates on new developments. Results from ongoing studies will offer further indications of how versatile our Accum™ technology is and the potential application areas. In addition, we are working towards two Phase I studies and are pushing ahead with our collaboration with the nuclear medicine company Orano. In the fall, we will move into new premises and hire additional personnel. We are therefore confident that we will be able to accelerate the positive trend of recent years.