Home Intervjuer ExpreS2ion CEO: “Compelling preclinical package gives us confidence”

ExpreS2ion CEO: “Compelling preclinical package gives us confidence”

Bent U. Frandsen, CEO ExpreS2ion Biotechnologies

ExpreS2ion CEO: “Compelling preclinical package gives us confidence”

12 juni, 2024

Based on its proprietary protein expression platform, ExpreS2ion Biotech advances its ES2B-C001 breast cancer vaccine candidate toward clinical studies. A SEK 60 million rights issue is underway to fund this pivotal step. CEO Bent U. Frandsen discussed the current development and the future plans ahead with BioStock.

Originally, ExpreS2ion developed the ExpreS2 platform to support companies and scientists with the discovery and development of recombinant protein material, primarily for vaccines in early research stages. Four years ago, the company made a strategic pivot. Following the new strategy, the company is now developing its own pipeline of vaccine candidates, using the ExpreS2 system as the underlying platform technology.

ExpreS2ion’s lead candidate ES2B-C001 is a treatment for HER2 positive breast cancer. The current standard of care is dominated by monoclonal antibodies (mAbs) and antibody drug conjugates, therapies that, despite their popularity, have their limitations.

Efficacious alternative to the current standard of care

One of the biggest challenges with mAbs is that patients develop resistance over time, making the treatment ineffective. Additionally, these treatments need to be administered repeatedly via intravenous infusion, which is neither comfortable nor convenient for patients and very costly for the healthcare system. Simply put, there is a medical need for alternative therapies, which is where ES2B-C001 comes into play.

In preclinical testing, the candidate has shown effectiveness against HER2 positive breast cancer cells that have built a tolerance against mAbs. ExpreS2ion aims to provide an efficacious alternative to the current standard of care, with ES2B-C001 breaking this tolerance. Furthermore, ExpreS2ion has completed the regulatory required preclinical safety studies to initiate human clinical trials and has shown to be a cost-effective solution in the healthcare system. With a promising preclinical package to support their claim, the next step will be to confirm these findings in a human setting.

Validated platform

The ExpreS2 platform has already proven valuable, with a positive phase III readout in Covid-19. However, that project has been shelved by the exclusive licensee Bavarian Nordic, who sees no commercial opportunity in the wake of the declining pandemic.

Currently, the company is carrying out a rights issue of units, aiming to raise SEK 60 million. The funds are primarily intended for a phase I study with ES2B-C001 and will also support the preclinical development of a cytomegalovirus vaccine project run in collaboration with Evaxion Biotech and further development of the platform.

In December 2024 and October 2025, respectively, the company may raise additional capital if the warrants of series TO 10 and TO 11 issued in the current rights issue are exercised for subscription of shares. The capital raised from the warrants are intended to be used for the same activities as listed above.

Comments from the CEO

BioStock reached out to ExpreS2ion CEO Bent U. Frandsen to discuss the ongoing rights issue and the next steps in the development.

With breast cancer being one of the larger cancer indications, what is the market potential for a candidate like ES2B-C001?

– Breast cancer unfortunately has a high occurrence – we know that 1 in 8 women may be diagnosed with breast cancer during their lifetime. About a quarter of those diagnosed will experience high expression of HER2, which is a protein that we all carry, but in the case of overexpression may lead to tumor development and high mortality.

– HER2 is what we target with ES2B-C001. Today’s therapeutic treatments are estimated to grow to a market value of 32 billion EUR by 2026. ExpreS2ion estimates that the market potential for ES2B-C001 is blockbuster-level and could reach almost 3 billion EUR in annual sales.

How do you intend to position ES2B-C001 in the breast cancer treatment landscape?

– ES2B-C001 is a HER2-VLP therapeutic vaccine. Specifically, our vaccine attaches ExpreS2-produced antigens to a virus-like particle (VLP), creating a molecule that mimics a virus without its harmful contents. This approach is similar to the proven Covid-19 vaccine ABNCoV2, which offered strong safety, efficacy, and a more durable immune response than prevailing Covid-19 vaccines.

– This means less dosing and thus a very cost-effective treatment as well. We expect it to start as a second or third line option for patients already undergoing chemo- or radiotherapy and treatment with monoclonal antibodies. Our vaccine approach has significant potential, which could position it as a leading first-line therapeutic treatment option in the future.

Looking to enter phase I with ES2B-C001, you are already looking for a potential partnership. Why is that?

– Our compelling preclinical package gives us confidence regarding our future clinical development goals. That said, developing a novel therapeutic vaccine is a costly, lengthy, and risky affair. Therefore, we believe that by establishing a partnership this would enable us to share the risk and reach value inflection points at a lower cost to our investors, albeit at the cost of some upside.

What interest have you seen in the project, and your platform, so far?

– Over the past year, we have increased our presence at scientific congresses to promote the ES2B-C001 project and highlight ExpreS2ion’s capabilities in advancing the project to this late preclinical stage. Simultaneously, the ExpreS2 platform’s validation in Phase III clinical trials for Covid-19 has further garnered attention. As ES2B-C001 enters clinical development, we anticipate heightened awareness of our unique therapeutic breast cancer vaccine.

You indicated that the positive results in Covid-19 can be seen as a validation of your vaccine platform. Turning to BioStock’s investor readers, could you please explain the meaning of these results in other settings, such as breast cancer or cytomegalovirus?

– The great thing about the late-stage clinical validation of our vaccine platform is that we apply exactly the same technologies, a patented method for making antigens coupled with a proprietary technology to a virus-like particle (VLP) structure, across both the Covid-19 project, and the breast cancer vaccine project.

– A major benefit of applying these technologies in the breast cancer treatment space is that the active ingredient in ES2B-C001 is a non-mutating self-antigen, which means we have the target fully validated both production-wise and functionally.

– With regards to our cytomegalovirus vaccine research project, we apply ExpreS2ion’s production system, ExpreS2, to make antigens that have been selected using an AI technology from our CMV discovery partner Evaxion Biotech. Here we are also progressing, albeit admittedly in an earlier research phase.

Speaking of the cytomegalovirus project – how is that progressing?

– Well, we have looked into various designs of the CMV antigen and have found targets that are potentially innovative and therefore patentable. So far, we have generated some interesting preliminary animal data, that indicates to us that we may have an edge in making a competitive CMV vaccine. The CMV vaccine research field has for decades tried to make an approved CMV vaccine but even big pharma has struggled, and we see in early discovery that we potentially can overcome these challenges.

Your platform is also used in several projects within academia, most notably four within malaria. What are the latest updates?

– That is correct. University of Oxford under a clinical license agreement develops four different ExpreS2-made malaria vaccine projects, and currently 6 – 7 different clinical studies are ongoing, both in Europe and Africa, to investigate safety and efficacy of these.

– Our partners at University of Oxford build their main malaria vaccine research on the already documented clinical evidence that our ExpreS2-made antigen has shown the highest level of antibody generation in vaccinated humans to-date. It seems that University of Oxford post-pandemic times has been very good in winning grant funding for this important malaria clinical research, where ExpreS2ion continues to be the source of the antigens under development.

You are currently aiming to raise SEK 60 million. In your opinion, what makes ExpreS2ion a good investment right now?

– ExpreS2ion is reaching one of its most important milestones since we embarked on our pipeline-focused strategy four years ago. We are sponsoring a first in human clinical trial in a key cancer area of high unmet medical need, with a unique therapeutic breast cancer vaccine, that has the potential to be a first-in-class breakthrough treatment.

– The funding will allow us to generate the clinical data that we need to further meet value inflection points for our investors and raise the likelihood of reaching a valuable license partner scenario in the years to come.

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This material has been created for marketing purposes and is not and should not be considered a prospectus under applicable laws and regulations. The complete terms and conditions for the rights issue and more information about the company have been presented in an prospectus published on the above-mentioned company’s website.

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