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KANCERA EVALUATES IMMUNO-ONCOLOGY DRUG CANDIDATE.

Kancera has entered into an agreement with Acturum Life Science AB in order to evaluate and further develop the unique Fractalkine inhibitor AZD8797. Published research points to that Fractalkine signaling probably contributes to the growth and spread of tumors and the pain that often affects cancer patients. In addition, the presence of Fractalkine has been proposed to be associated with a lack of efficacy of immuno-oncology drugs. Taken together, these findings provide a new perspective of Fractalkine signaling as a target for cancer drug development. Kancera will now evaluate how efficiently the Fractalkine inhibitor AZD8797 may stop tumor growth and relieve severe pain.

Originally, the candidate drug AZD8797 was successfully developed by AstraZeneca in Sodertalje as an effective inhibitor of Fractalkine signaling. The present documentation of AZD8797 includes drug properties, safety, toxicology, and production. Kancera's assessment is that this documentation is likely to meet requirements for an application to undertake clinical trials against cancer. AstraZeneca originally developed AZD8797 against multiple sclerosis and showed effect of AZD8797 in a preclinical model of the disease (see the publication in PNAS April 8, 2014 vol. 111, no. 14, p 5409). Acturum Life Science acquired the rights to the Fractalkine project from AstraZeneca as part of Acturum's acquisition of the research facility in Sodertalje. However, AstraZeneca has retained the rights to develop Fractalkine inhibitors against respiratory diseases.

The agreement with Acturum Life Science gives Kancera right to evaluate AZD8797 in preclinical studies and then to acquire the project. This agreement entails no expenses for Kancera apart from investments in the patent portfolio and in the scientific evaluation.

If Kancera chooses to acquire the Fractalkine project, following the preclinical evaluation phase, the total payment to Acturum will consist of 6 million Kancera shares divided into three tranches, which are due at pre-defined success-milestones. Accordingly, the two companies share the risk in the product development through the first study in man. Kancera intends to apply for orphan drug designation, covering the Fractalkine inhibitor, in order to ensure at least 10 years of exclusivity on the market in Europe and 7 years in the United States.

Since AZD8797 already meets the pharmaceutical properties Kancera considers necessary for the biological evaluation of the effect against cancer, the project can be run without significantly affecting the resource allocation to Kancera's other projects.

About the Fractalkine project

Fractalkine is an immune regulatory factor that sends signals via the CX3CR1 receptor, also called G-protein coupled receptor 13 (GPCR13). In the healthy individual, Fractalkine and its receptor regulate migration of immune cells from the blood capillary wall into areas where the immune system is needed. Animal studies show that Fractalkine and its receptor are not essential for survival and that important immune functions remain intact indicating that inhibition of the Fractalkine signaling by a drug probably will be tolerated without significant adverse effects. Fractalkine and its receptor have been linked to the growth and proliferation of pancreatic, breast and prostate cancer. Also, cancer cells that have the Fractalkine receptor on their surface migrate towards nerve ends that have Fractalkine on their surface. Thus, cancer cells are led to surround and apply pressure on nerves and thereby cancer pain may arise. Another proposed mechanism for how Fractalkine and its receptor affect the development of tumors is that they contribute to the transformation of the body's macrophages from being a threat against the cancer (the M1 form) to supporting the cancer (the M2 form). This mechanism is also suggested as a predictive factor for responsiveness to the new immuno- oncology drugs that act through PD-1 and PD-L1 such as nivolumab, pembrolizumab and pidilizumab. During 2014 and 2015 studies have been published demonstrating that the absence of Fractalkine in tumor cells is a significant marker for how successful the immuno-oncology treatment is expected to be (see e.g. the publication in Nature on November 27, 2014, Vol. 515, pp 563). In the light of these observations, there are good reasons to further study if inhibition of the Fractalkine signaling with AZD8797 has the potential to increase the proportion of patients responding to the new immuno-oncology drugs that act through PD-1 and PD-L1.

About Kancera AB

Kancera develops the basis for new therapeutics, starting with new treatment concepts and ending with the sale of a drug candidate to international pharmaceutical companies. Kancera is currently developing drugs for the treatment of leukemia and solid tumors, based on blocking survival signals in the cancer cell and on addressing cancer metabolism. Kancera's operations are based in the Karolinska Institutet Science Park in Stockholm and the company employs around 12 people. Remium Nordic AB is Kancera's Certified Adviser.

About Acturum Life Science AB

The development company Acturum Life Science is a subsidiary of Acturum, which is jointly owned by FAM, the Wallenberg Foundations investment company, and the construction company PEAB. The company was formed in 2013 in order to operate Biovation Park by utilizing and developing the high-class research environment built up by AstraZeneca in Sodertalje. For more information, visit www.biovationpark.com.

For more information, visit www.kancera.com or call +46 735 20 40 01.
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Publication:Worldwide Biotech
Date:Nov 1, 2015
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