Defence Therapeutics Interview: 'Accum™ is the most sought-after multi-tool in the pharmaceutical industry.'

Our activities can roughly be divided into two areas. One is the area of immuno-oncology, and the other is the activities against infectious diseases. In the first area, we are working on vaccines against breast and skin cancer as well as antibody-drug conjugates (ADC). The latter primarily address the areas of safety and efficacy and offer significant advantages over other forms of therapy. In the area of infectious diseases, we are working on vaccines against COVID-19 and the human papillomavirus (HPV). At the end of 2022 or the beginning of 2023, we plan to start a Phase I study around each of our activities against breast cancer and skin cancer. Until then, we are undertaking the necessary preliminary work in accordance with the principles of good laboratory practice (GLP) and are already collecting data beyond that in some cases, which we can use in the further course of the approval process.

Our GLP studies are nearing completion. We already know that patients of Dr. Meterissian, Director of the Breast Center of the MUHC in Montreal, will be interested to participate in the study. So the preliminary work for the Phase I study in Canada is very advanced. For the study in Europe, we are working with consultants to help us move our plans into the clinical phase. The last remaining hurdle is funding. These types of studies cost money. Given our encouraging results to date and the versatility of our technology, we are finding receptive ears in discussions with potential funders.

No. The team is familiar with the processes between preclinical and clinical phases. It is also in the interest of our investors that we are extremely thorough in this process and do all the preliminary work conscientiously. Rest assured that we have the time needed in each area to work towards the best possible results.

That is a good point. We do not anticipate any toxicity issues in the planned Phase I trials for two reasons. First, our active ingredients are very small molecules. They do not remain in the organism for long but are rapidly degraded. We also use the active ingredients locally. Therefore negative toxicity is less likely. Second, the dendritic cell (DC) vaccines we use are considered very safe and have been researched for many years.

Because there are good reasons to believe that our vaccines against breast and skin cancer are safe, we are also aiming for a phase I/IIa study. In addition to safety, this study will also provide information on efficacy. In concrete terms, we proceed as follows: Patients at an early stage receive their dose. However, instead of looking only at safety aspects, we also investigate whether tumor regression sets in after administering our vaccine. This type of study is suited to launching collaborations early in the clinical phase.

The approval process is standardized. That means we have to go through Phase II and Phase III until we receive approval. A successful Phase I/IIa trial also opens up the opportunity for us to enter into a partnership or sell the asset at an early stage. In addition, there are accelerated approval processes, as we have seen around COVID-19 vaccines. Since we also have a project around COVID-19, which delivers vaccines nasally and thus may address the transmissibility of the virus more directly, expedited processes are also possible at Defence Therapeutics. Although the pandemic is just flattening out, we believe it is worthwhile to stay on the ball - new variants cannot be ruled out.

As all our projects have a common technological foundation, that is very realistic. The example of Moderna impressively shows the effect that already approved products have on the technologically related pipeline. Thanks to the approved COVID-19 vaccine, the approval process around cancer products is now also faster. Previously, mRNA projects in the fight against cancer had been relatively slow.

Accum™ is very toxic. We have found that cancer cells die when we inject the drug directly into tumors. At the same time, Accum™ provides synergistic effects with other existing therapies. Specifically, this means that Accum™ is effective against cancer cells on the one hand but also supports other known active ingredients on the other. Possible application areas include breast cancer and previously incurable brain tumors, so-called glioblastomas. The important thing is that Accum™ can be injected directly into the tumors. There are already experts who can use active substances in such a targeted manner. We are still a long way from using Accum™ in this way, however, the technology is very versatile. For example, there are plans to use Accum™ as an intelligent antibody-drug conjugate (ADC). In this case, Accum™ could first smuggle a molecule into a tumor cell, as it has done so far as a drug enhancer, then cleave off this molecule and act against cancer cells itself.

Definitely! This form of brain tumor is considered incurable. People die within nine to twelve months. Every scientist's motivation is to make a breakthrough in such an area. Even extending the life span to 14, 16 or 24 months would be a groundbreaking success. However, we are not a large pharmaceutical company that can implement many different projects of this kind. We, therefore, have to focus on existing projects. However, the fight against glioblastoma remains an important concern for us precisely because there are currently no other promising approaches. As a researcher, I am driven by the goal of prolonging or saving patients' lives. From an investor's point of view, the fight against such brain tumors could be promising because there is also the prospect of accelerated approval procedures. However, the first clinical trial in which we give Accum™ to patients will be looking at other types of disease, such as breast cancer. For the simple reason that we have access to these patients.

Almost every pharmaceutical company is working on ADCs - Genentech, Roche, AstraZeneca and many others. Especially in Germany, you may be familiar with the story of CureVac, whose COVID-19 vaccine was unfortunately unsuccessful due to dosing issues. All these companies are potential partners for us, precisely because we can solve problems with dosing effectively and without undesirable side effects.

There are also starting points in the area of our COVID-19 vaccine, which is administered nasally. We have already shown that this vaccine can prevent infections in animals. If we continue with the project and the regulatory authorities suggest accelerating the process and starting a Phase III trial directly, we will reach our limits. Here, Sanofi, for example, could be a suitable partner because they are working on a protein-based COVID-19 vaccine.

There are also links in the field of HPV vaccines, for example, with the market leaders GlaxoSmithKline and Merck. That is when it comes to developing therapeutic vaccines against cervical cancer. We are staying on the ball with our research and continuing to focus on the viral oncogenes E6 and E7, which play a central role in cervical cancer.

Even in gene therapy, there is a use for Accum™. When our technology is combined with the protein Cas9, it becomes 90% more potent in the cell. CRISPR Technology, for example, is working on such methods. Such companies, therefore, offer themselves as licensees of Accum™.

Most definitely, yes! The worst thing that can happen to a biotech is that they invest capital in a project, and suddenly that project is on the brink of failure. Often, the fate of the company in question is closely linked to the projects. Accum™ has the potential to solve many problems related to efficacy and safety, and it has many uses. It is also anything but complicated to add Accum™ to an existing project. I am convinced that our technology can give many projects the positive impetus they need.