Interim Report for Kancera AB (publ) Q4 2015, January 1 – December 31, 2015
The period January to December 2015 and the fourth quarter 2015 in brief
Significant events during the period
– The ROR project reported that Kancera’s candidate drug KAN0439834 is effective against both leukemic cells circulating in the blood and leukemic cells that have invaded the lymph nodes in humans.
– Recent studies of clinical samples from leukemia patients underscore that ROR inhibitors mainly target the white blood cells causing cancer while the healthy white blood cells, including T cells, are spared. These results are of significance for the possibility to combine ROR inhibitors with the new generation of immuno-stimulating cancer drugs that have been developed since the effect of those requires functional T-cells.
– A new generation of ROR inhibitors is being developed against solid tumors.
– The PFKFB3 project reported a new discovery showing that Kancera’s PFKFB3 inhibitor KAN0438757 kills cancer cells by preventing them to repair their DNA. The discovery indicates that KAN0438757 could be an efficient complement to radiation for the treatment of advanced cancer.
– The HDAC6 project reported that Kancera’s HDAC6 inhibitors counteract the migration of cancer-associated fibroblast cells and that an international patent application was filed in May.
– In the ROR project, Kancera reported that follow-up studies of the pharmaceutical properties of KAN0439834 show that they probably are better than previously assumed with respect to uptake and penetration of the substance to the cancer. The new studies indicate that dosing 2-3 times a day at 65-300 mg gives a concentration in the body that may be sufficient to exert an effect on solid tumors. Against this background, ROR inhibitors will be tested in animal models of solid tumors. It was further reported that ROR inhibitors have shown effect against leukemic cells from bone marrow which is a capacity wanted since the existing drugs are not sufficiently effective against cancer cells in the bone marrow.
– In the Fractalkine project, Kancera reported that a network of leading cancer and pain scientists that has been established that will evaluate the drug candidate KAN0440567 (AZD8797) in an advanced animal model closely resembling the human form of pancreatic cancer. Kancera has synthesized and quality controlled the salt form of the drug candidate that will be used in this study and has conducted a successful peroral dosing study in mice.
– From the collaboration with Prof. Thomas Helleday, Kancera reported that Kancera’s PFKFB3 inhibitor significantly reduces the size of a tumor formed by aggressive human breast cancer cells (so-called triple negative breast cancer) transplanted in zebrafish. The results from the study support that Kancera’s PFKFB3 inhibitor is effective against these aggressive cancer cells if the substance reaches the tumor in sufficient concentration, which is easier to achieve in zebrafish than e.g. in mice.
– Kancera has developed several chemical families of potent and selective HDAC6 inhibitors based on a common scaffold, and Kancera reported the decision to withdraw the original patent application from 2014 in order to postpone the publication of the structures at least 12 months. This is done in order to prevent Kancera’s existing patent application to become an obstacle to a new patent application covering the recently developed HDAC6 inhibitors.
– Vinnova announced in June 2015 that Kancera has been awarded a grant to support the further development of HDAC6 inhibitors against cancer. The first part of the grant was paid in July. VINNOVA decided to bring forward the second payment (SEK 750, 000) to the HDAC6 project to December 2015.
– In February 2014 Kancera received an initial payment from the EU amounting to € 523,655 (about SEK 4.6m) for the execution of the A-PARADDISE project. The project has now delivered a midterm report which has been approved by the EU. This means that a second installment of the grant was paid to Kancera at year-end according to plan. This payment amounted to € 300,000 (about SEK 2.8m).
Significant events after the end of the reporting period
– A patent covering small molecule PFKFB3 inhibitors has been approved in the USA.
– A patent application covering new chemical series in the HDAC6 project has been filed.
– The patent application covering ROR inhibitors filed in February 2015 has been strengthened by adding examples of additional highly potent ROR inhibitors.
Statement from the CEO
2016 began as usual with an intense biotech week in San Francisco where Kancera and most of the Pharmaceutical and Biotech industry gathered to discuss cooperation opportunities in individual meetings. During the week in San Francisco, Thomson Reuters also presented its retrospection of 2015 which was a strong year for the industry with more and larger acquisitions than ever and a strong interest in preclinical drug development projects. The generally high interest from major pharmaceutical and biotech companies to acquire pharmaceutical project continues, which is reflected partly in the increasing level of payment upon signature of the acquisition or licensing agreements and partly in increasing total price tags for pharmaceutical projects. Cancer, by virtue of the great medical need, continues to be the therapeutic area in which most agreements are reached (for more information, see the Market Outlook section).
In the third quarterly report in 2015, I described the challenge in the ROR-project to achieve a sufficiently high concentration of the drug candidate in the blood to enable studies of efficacy against more cancer diseases, in addition to chronic lymphocytic leukemia, such as solid tumors. During the fourth quarter we have succeeded to develop a new series of compounds in the ROR project that can be maintained in an active concentration in the blood for 10 hours in mice. This can be compared with the approximately 2.5 hours shown by Kancera’s first drug candidate KAN0439834 in the same type of measurement. This progress now provides us with new opportunities to test the effect of ROR inhibitors in several preclinical models of severe human cancers.
During the fourth quarter we have also been able to show that oral administration of the Fractalkine receptor antagonist KAN0440567 to mice effectively blocks the function of the Fractalkine receptor. This is a first step in the ongoing studies to examine the effect of this substance against cancer of the pancreas in a preclinical model of the disease.
Furthermore, in January we reported several reinforcements of Kancera’s portfolio of patents and patent applications, including a new application from the HDAC6 project, a granted patent from the PFKFB3 project and a completion of the international patent application from the ROR project including new substances showing up to 20 times higher effect against leukemia cells compared to Kancera’s first drug candidate.
Overall, we see progress in Kancera’s entire project portfolio which further strengthens the company's competitiveness and business development efforts.
About Kancera AB (publ)
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’s operations are based in the Karolinska Institutet Science Park in Stockholm and the company employs around 13 people. The Kancera shares are traded on NASDAQ OMX First North and the number of shareholders was around 7300 as of December 16, 2016. Remium Nordic AB is Kancera’s Certified Adviser. Professor Carl-Henrik Heldin and Professor Håkan Mellstedt are board members and Kancera´s scientific advisors.
In 2006, Pharmacia’s and Biovitrum’s unit for the development of drug candidates was spun-out to create iNovacia AB. In 2008, iNovacia started the development of the ROR project in collaboration with the Karolinska Institute. In May 2010, Kancera AB was formed by scientists from Cancer Center Karolinska, iNovacia AB and a group of private investors through capital contributions and two developed drug projects focusing on cancer: the ROR project and the PFKFB3 project, the latter had been initiated by Biovitrum AB. NASDAQ OMX approved Kancera’s listing on First North with the first day of trading being February 25, 2011. In March 2013 Kancera acquired a complete drug development laboratory from its former subsidiary iNovacia AB and the drug development is since then performed within Kancera AB at the Karolinska Institutet Science Park, Stockholm.