Swedish biotech company Cantargia recently presented its 2017 Q2 results and it looks like they are ready for their next step, taking them from preclinical to clinical stage.

One of the company’s most recent achievements, after the end of Q2, was the patient recruitment to its CANFOUR study. The phase I/II study has gained approval to start in Norway and Denmark, and review is underway in several other countries. In this trial the antibody CAN04, directed towards the molecular target IL1RAP, will be investigated in patients with cancer. The CAN04 antibody treatment fights cancer by activating the immune system and blocking signals that lead to tumor growth. The indications of primary focus in this trial are non-small cell lung cancer and pancreatic cancer. The primary endpoint will be safety. Other endpoints include pharmacokinetics, efficacy and biomarkers. CAN04 has been shown to have good safety characteristics in two separate GLP studies, a toxicity study and a study looking at how CAN04 binds to tissue from healthy volunteers.

A major milestone

The first part of the trial will be a dose escalation phase, investigating different dose levels of CAN04. This part is expected to take approximately 12 months. After data analysis, a second part is planned to include one monotherapy treatment arm in approximately 20 patients, as well as a combination therapy arm investigating CAN04 with standard therapy in one of the two cancer forms. The exact choice of indication and combination therapy will be decided after completion of the first part of the study. The trial is planned to be conducted as a multi-centre trial in the BeNeLux countries and in Scandinavia.

“Cantargia is in transition from a preclinical stage company to a clinical stage company,” stated Göran Forsberg, CEO of Cantargia at the time of the announcement. “With the regulatory approval, we have passed a milestone of major importance”.

An important business deal

In June, the company’s CANxx, another anti-IL-1RAP antibody, project within autoimmune/inflammatory diseases took a step forward. An agreement was signed with Panorama Research, a California based specialist antibody developer, for the development of an antibody-based drug candidate. In the collaboration project Cantargia’s antibodies against the molecular target IL1RAP will be affinity matured and humanized using Panorama’s technology. In addition, Panorama will generate cell lines optimized for high level GMP production. Cantargia will be responsible for subsequent downstream development. Under the terms of the agreement, Panorama will share risk in the project in exchange for a fraction of future incomes from third parties or future sales. The business deal means lower costs for Cantargia, but even more, they have gained an important collaboration with an established developer of antibodies.

“This partnership is of major importance for Cantargia, it means that our lead project CAN04 for cancer treatment as well as our second project CANxx, are both financed according to plan,” said Göran Forsberg.

Securing the innovation

During the second quarter, Cantargia has also strengthened its patents by receiving preliminary patent approval, which will protect CAN04 both as a substance and specifically for treatment of various forms of cancer in both Europe and the US. The patent is valid until 2035. The company also received patent approval in China for use of IL1RAP as a target molecule for antibody-based therapy of acute lymphoblastic leukemia.

The future shows promise

For Q2 2017 the results were -15.3 million SEK and the cash flow after investments was -17.2 million SEK. The first 6 months ended at -32.5 MSEK, much due to the antibody development, which has gone as planned. At the end of Q2 the company reported a net appropriation of 6.5 (39.7) million SEK.

“Cantargia’s journey is just starting with CAN04 entering the clinical stage. But just like every other clinical project the theory must be proven in practice. Competition in the oncology field is also fierce, and non-small cell lung cancer and leukemia is getting a lot of attention. CAN04 could also see some competition within the anti-IL-1 concept from Novartis as canakinumab is currently being studied in Phase I in combination with the experimental anti-PD1 PDR001, and could enter Phase III trials in NSCLC by 2018,” says Mathias Spinnars, Equity Analyst at Redeye.

The results from Cantargia’s Phase I study with CAN04 will also lead the way for the future development path, says Mathias and continues: “However, it is the Phase II results that will give more color on the potential and can be a real inflection point for the company.” He also believes the industry’s interest in the pathway is growing, and that we could see more deals in the area going forward.

“To complement their pipeline, Cantargia is developing CANxx in autoimmune and inflammatory diseases. This is where the pro-inflammatory IL-1 pathway has been most frequently studied and IL-1 blocking drugs are marketed by Novartis (Ilaris, canakinumab), SOBI (Kineret, anakinra), and Regeneron (Arcalyst, rilonacept). Cantargia’s project is in the very early stages but targeting the pathway has been shown efficacious so far. In sum I believe Cantargia is pursuing an interesting concept and while we will have to wait a while for the big results the future shows promise,” says Mathias Spinnars.

Challenges for the future

Oncology is a tough development area with many failed projects. While the general pre-cautions apply, a specific challenge for Cantargia could be the limited size of the planned studies, according to Mathias Spinnars.

“Phase I will include roughly 15-20 patients and Phase IIa likely more than that. For Cantargia to succeed and for a potential partner to take over the project and expand it in larger pivotal studies, the data likely has to show early and meaningful indications of anti-cancer potential.”

Cantargia’s history

The company was founded in 2009/2010 based on research by professor Thoas Fioretos and Dr Marcus Järås at Lund University. They had discovered that leukemia stem cells expressed a protein called IL1RAP on the cell surface, which is not expressed to the same extent on normal stem cells. They also found that the cancer stem cells could be killed using antibodies against IL1RAP. IL1RAP is important for the cancer cells’ ability to create a favorable environment for proliferation and expansion. Based on these data and a patent application Cantargia was formed together with Lund University Bioscience as financing partner. Since then the company has shown that IL1RAP is also expressed in a range of solid tumor cancers. Cantargia’s product candidate, CAN04, targets IL1RAP and could potentially be used to treat different forms of cancer, with the initial clinical development focused on non-small cell lung cancer (NSCLC) and pancreatic cancer. Cantargia is listed on Nasdaq Stockholm First North.