Tor 2 dec / År 39 / Nr 4 2021

Establishing a new and unique method of cancer treatment

The Swedish biopharmaceutical company Immunicum has developed a completely unique set of treatments for cancer. Ilixadencel is so far the company’s main product, and it is a new treatment based on immune cells delivered into the patient’s tumour to treat cancer at the source. What makes it unique is that it comes from healthy donors yet creates a personalized therapy for patients.

Immunicum’s goal is to increase the survival among cancer patients by giving the immune system a head start with a stronger immune response to recognize and fight the cancer. Ilixadencel is the main breakthrough component of this strategy.
Ilixadencel is specific enough to target cancer at its core through injecting it directly into the tumour, and at the same time it can be applied to various types of cancer treatments as it is not limited to any specific type of tumour. Thus, it can be administered to any cancer patient. Cancer cells are generally difficult to be detected by the patient’s immune system, however when ilixadencel is injected into the tumour, an inflammatory reaction is created within the tumour. This treatment reactivates the immune system which causes the tumour cells to be destroyed by the body’s immune response, according to the findings of recent studies.

Gathering clinical data
Illixadencel is an immune activating therapy, or immune primer, that is being studied in kidney cancer, liver cancer, gastrointestinal stromal tumors (GIST), lung cancer, head and neck cancer and gastric cancer, with the next wave of results due in the second half of 2020.
The prospects for the drug candidate have risen over the last year due to the results from the large MERECA trial and smaller GIST trial, previously presented in various articles.
Data from Phase II of the MERECA Renal Cell Carcinoma trial that evaluated the safety and efficacy of ilixadencel in combination with Sutent® (sunitinib) in patients with newly diagnosed mRCC were presented in February at the ASCO-SITC Clinical Immuno-Oncology Symposium 2020 in Orlando, Florida. The data indicates a separation in Kaplan-Meier survival curves in favor of the ilixadencel treatment group and the confirmed objective tumor response rate (ORR) for the ilixadencel treatment group was 42.2% (19/45) versus 24.0% (6/25) for the sunitinib control group. Based on these data Immunicum received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA) In May 2020 for the treatment of metastatic mRCC with ilixadencel. The advantages of the RMAT designation include all the benefits of the Fast Track and Breakthrough Therapy Designation programs including guidance and early interactions with the FDA to discuss potential surrogate or intermediate endpoints to support accelerated approval as well as potential ways to satisfy post-approval requirements.
“We are very excited to have received the RMAT designation for ilixadencel in kidney cancer as it recognizes both the potential of our novel therapeutic approach as well as the clear need for viable therapies to address this difficult-to treat disease. As a designation similar to the FDA’s Breakthrough Therapy Designation, we will now also have the opportunity to receive direct guidance from the FDA which will inform key development decisions and ultimately bring us closer to delivering ilixadencel to patients in need,” commented associate professor Alex Karlsson-Parra, co-founder and Chief Scientific Officer (CSO) of Immunicum.

The next step for ilixadencel is a Phase Ib/II ILIAD trial where it is currently being evaluated for safety in combination with checkpoint inhibitors, another immunotherapy that is becomes the standard-of-care in many indications. This is an important part in advancing Immunicum’s goal of improving the survival of cancer patients.

Advantageous positioning
The Immunicum team strongly believes that ilixadencel will be the first choice of immune primers and is well positioned to align with the future of combination therapies. Whereas current cancer treatments merely reduce cancer’s ability to grow, ilixadencel actively pursues to eliminate cancer cells through the power of the immune system.
The best way to utilise ilixadencel is to pair it with other treatments that help with battling immune suppression. “We are very confident in this combined approach. The current data on ilixadencel is promising in showing more durable immune responses and higher long term survival rates”, Karlsson-Parra underlines.
So far, almost 100 patients have been treated with ilixadencel with only limited side effects, such as fever, which is expected when treated with an immune activating drug. One notable advantage is that it does not seem to add side effects on top of other drugs. Thus far, the signs from the drug candidate are therefore promising in both safety and effects.
The future looks promising for Immunicum, and Alex Karlsson-Parra agrees: ”Looking ahead, we are well-positioned as we have a candidate that is broadly applicable and continues to be validated as a backbone to cancer therapy”.

A market on the rise
Immunicum is not just well positioned with their products. The company is also poised to make a big impact in the fast-growing pharmaceutical industry. According to recent reports, Immunicum’s main pharmaceutical market, immuno-oncology, is rapidly expanding at 13 per cent per year and has an expected valuation of $150 billion dollars by 2025.
High valued acquisitions and licensing deals continue to bring in large amounts of revenue for smaller biotechnology companies such as Immunicum, as well as being in a healthy capitalized industry.
”As the immuno-oncology therapeutic landscape continues to evolve, we aim to consider all strategic options. We will also continue to explore collaboration opportunities for our products and interact with potential partners as we move forward towards the market” states Alex Karlsson-Parra.