Over the past decade, research and drug development have focused on immunotherapies – drugs that have the ability to strengthen the body's own immune system to fight a number of deadly diseases, with cancer being a main focus.
Immunotherapies in oncology are known as immuno-oncology (IO), an area that has increasingly come into focus over the past decade. Pharmaceutical and biotechnology companies have great confidence in IO's capacity to make a difference for cancer patients, and large sums are being invested in developing new effective drugs and combination therapies in the field.
One of the most common and promising methods of IO is checkpoint inhibitors (CPIs) – antibodies that have the ability to prevent cancer cells from hiding from T cells, i.e. the cells of the immune system with the best ability to kill cancer cells. Unfortunately, CPIs are not a perfect solution, as they can cause serious side effects in some patients and are sometimes ineffective. Therefore, other IO alternatives are being explored.
Elicera Therapeutics develops new solutions in immuno-oncology
In Sweden, the cell and gene therapy company is developing Elicera Therapeutics IO solutions mainly based on two IO technologies: oncolytic viruses (OV) and CAR-T cells (chimeric antigen receptor-T cells) – two technologies that are still in the starting blocks and that have created great interest in the cancer field with their promising treatment potential.
Oncolytic viruses and CAR-T cells
In short, OVs are viruses that replicate in and kill cancer cells. One of the advantages of OVs is that they not only destroy tumor cells but also stimulate the patient's immune system's anti-tumor response, which has the potential to prevent the tumor from coming back.
The idea of using OV is not new. The pharmaceutical industry has been interested in its possibilities for more than a century. Despite this long-standing interest, it has only been in recent years that its properties have been put to practical use. To date, only one OV treatment has been approved by the FDA, although research into the technology has intensified.
Meanwhile, CAR-T therapies have attracted a lot of attention by using the latest gene modification technology. In fact, American Society of Clinical Oncology (ASCO) named CAR-T cell therapy as the most important advancement of 2018. In this case, T cells are taken from the patient's cancer cells, which are then put back into the patient so that they can then destroy the cancer cells. The FDA has approved three CAR-T therapies so far: Novartis Kymriah for the treatment of diffuse acute lymphoblastic B-cell leukemia, a variant of non-Hodgkin's lymphoma and acute lymphoblastic B-cell leukemia, and Gilead Sciences Yescarta and Tecartus, which treats diffuse large B-cell lymphoma and mantle cell lymphoma, respectively, also variants of non-Hodgkin's lymphoma.
Elicera's broad development pipeline
Elicera was founded in 2014 under the name Virex based on well-validated preclinical research led by professor Magnus Essand vid Uppsala UniversityThe research work led to the company's first clinical study in 2016, testing the oncolytic virus ELC-001 in the treatment of neuroendocrine tumors (NETs).
Elicera currently has four ongoing projects in its pipeline. In addition to ELC-001, the company is working on another OV project called ELC-201, which is in early development and has broad potential against most tumors. ELC-201 has three mechanisms of action that combined could lead to a broader and more effective target profile.
Regarding CAR-T cells, Elicera is working on optimized versions of the fourth generation CAR-T cells and has two projects underway, ELC-301 which is being developed for the treatment of non-Hodgkin's lymphoma and ELC-401 which has glioblastoma multiforme (GBM) as its primary indication, but which has the potential to also treat other solid tumors.
In 2016, Elicera filed patent applications for their iTANK platform, a technology designed to optimize CAR-T cells. The idea behind this technology is to give CAR-T cells the ability to also activate endogenous CD8+ T cells against cancer, thereby using two mechanisms of action. The technology is applicable to all CAR-T cell therapies and can circumvent several of the major problems that can arise in CAR-T cell therapy in solid tumors, such as antigen heterogeneity, local immunosuppression and CAR-T cell exhaustion. Preclinical data indicate that the iTANK platform facilitates CAR-T cells to inhibit tumor growth and prolong patient survival compared to conventional CAR-T therapies, and may thereby attract co-development and out-licensing opportunities.
»Elicera is a clinical-stage biotechnology company and we have a broad portfolio of exciting drug candidates. From an investor's perspective, I believe we offer an opportunity to invest in the development of cancer immunotherapies with enormous potential and completely unique approaches, not only in Sweden but also in a global perspective. Added to this is our iTANK platform, which enables optimization of not only our own CAR T cells but in theory all CAR T cells under development« — Jamal El-Mosleh, CEO Elicera Therapeutics
Shifting focus from R&D to market
In 2020, as more patents were approved and new avenues for patient studies opened up, Virex saw the opportunity to grow from an R&D-based organization to a more market-oriented company. Virex changed its name to Elicera Therapeutics and hired Jamal El-Mosleh as CEO, a recruitment that brought significant business development experience in the immuno-oncology area.
CEO presents the company
After a first round of financing last year, with an oversubscribed new share issue that raised SEK 13,2 million, the company is now ready to be listed and is planning an introduction in 2021. BioStock contacted Elicera's CEO to find out more about the company and its strategy.
Jamal El-Mosleh, what is Elicera's overall vision as a biotechnology company?
– In short, our vision is to extend survival and increase the quality of life of cancer patients through innovative immunotherapies.
What are some of the main challenges on the way to this goal?
– Cancer immunotherapy has shown promise in treating tumors, with many patients achieving disease control for years. However, not all patients benefit from this type of treatment and the most effective treatments likely require combinations of different approaches. We do not claim to have all the answers, but we believe that we may be able to provide important pieces of the puzzle in combination with other therapies. In terms of challenges ahead, there are clearly several and I believe that we share the same challenges as many other biotech companies. Most biotech companies do not have the resources to take a drug candidate all the way to market and need to find a partner who can take over the later stages of development, marketing and sales. I would say that the most important challenges ahead of us are generating promising clinical data from well-designed studies, creating efficient manufacturing and securing the necessary financial resources to implement our plans, with the right expertise tied to the company.
Today, one of the most popular forms of immuno-oncology is checkpoint inhibitors. Why is Elicera focusing on other types of IO such as oncolytic viruses and CAR-T cells?
– Immuno-oncology is a term used to describe a wide range of different treatments that use the immune system in a variety of ways. Checkpoint inhibitors focus primarily on limiting the natural immunosuppression of tumors but do not work unless there is already an active immune response against cancer. Oncolytic viruses and CAR-T cells are promising fields in immuno-oncology that activate the immune defense against cancer and should therefore work in synergy with checkpoint inhibitors. Our scientific expertise lies in gene modification and tumor immunology and we use this expertise to not only develop oncolytic viruses and CAR-T cells but also give them immune-stimulating properties through specific gene insertions. This means that all of our products give rise to a multifaceted attack on cancer with several different mechanisms of action and we see broad potential to combine our therapies with other treatments to achieve synergistic effects.
There is still a lot to learn about OV and CAR-Ts. What makes you confident that these technologies are the future of cancer therapy?
– CAR-T cells have achieved significant proof-of-concept from treating patients with various types of blood cancer. We know that these therapies can be extremely effective as they have a proven ability to eradicate all tumors in blood cancer patients who have exhausted all other treatment options. The most important challenges for CAR T cells lie in the solid tumor area, and here I believe we can make an important contribution in the form of our iTANK platform and our own CAR T cells that are under development. What makes OVs and CAR T cells such exciting technologies, I would say, is that they can be genetically modified to elicit tailored immune responses based on the most current scientific knowledge in immuno-oncology.
You are planning to go public later this year. What makes Elicera ready for listing?
– Elicera is a clinical-stage biotechnology company and we have a broad portfolio of exciting drug candidates. From an investor's perspective, I believe we offer an opportunity to invest in the development of cancer immunotherapies with enormous potential and completely unique approaches, not only in Sweden but also in a global perspective. Added to this is our iTANK platform, which enables optimization of not only our own CAR T cells but in theory all CAR T cells under development.
– Management and the board also have previous experience from publicly traded biotech companies. I was previously CEO of Immunicum, another immuno-oncology company, for almost ten years and was responsible for their IPO in 2013. In addition, my current chairwoman, Agneta Edberg, was also chairwoman of Immunicum during my time there. So I have been on this journey to some extent and have gained important and valuable experiences that I believe Elicera can benefit from. We closed an oversubscribed financing round in 2020 and have since then prepared the company for the upcoming IPO, so I believe we are in a very good position to make this transition now.
Finally, as a small company, does Elicera have what it takes to be a successful biotech company in the competitive IO landscape?
– Yes, I think we have. We have developed the iTANK platform and four drug candidates with unique approaches in two promising immuno-oncology areas.
– I also believe that we have the scientific and commercial drug development expertise required to take the projects to the point where we can divest them to commercial partners and generate returns for our owners.
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