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2020-02-14 08:00:00
Oslo, 14 February 2020: Ultimovacs ASA ("Ultimovacs", ticker ULTIMO), a pharmaceutical company developing novel immunotherapies against cancer, announces its fourth quarter 2019 results today. A presentation by the company's management team will take place today in meeting room Nyland at Thon Hotel Vika Atrium (Munkedamsveien 45, 0250 Oslo) at 09:00 CET. The presentation can be followed as a live webcast (access through link https://channel.royalcast.com/webcast/hegnarmedia/20200214_10/) which will also be available on our website. It will be possible to post questions during the presentation through the webcast. Highlights for the fourth quarter of 2019: o The process of starting up the randomized phase II trial in malignant melanoma (named INITIUM) is progressing according to plan towards inclusion of the first patient in Q1-20. The trial will include 154 patients. o UV1 will be investigated in a randomized, multi-center phase II trial in mesothelioma (named NIPU), sponsored by Oslo University Hospital and supported by Ultimovacs and Bristol-Myers Squibb. The trial is expected to commence in Q1-20 and will include a total of 118 patients. o The initiation of the NIPU trial implies that UV1 will be tested in two large randomized phase II trials in different cancer types with a total of 272 patients. This represents a major step forward for Ultimovacs and the development of UV1. Being engaged in two such trials in parallel will enhance the opportunities for successful clinical results and support that UV1 may be broadly applicable across cancer types. o In the US based phase I trial in malignant melanoma, in which UV1 is given in combination with a PD-1 checkpoint inhibitor, all 20 of the initially planned patients have been successfully included (cohort 1 – safety pembrolizumab/UV1). No unexpected safety issues related to UV1 have been observed to date. In this study, a group of 10 patients (cohort 2 – dose finding GM-CSF) will be added in order to investigate an increased dosage of the adjuvant GM-CSF. In this second cohort, three of the ten patients have been included to date and Ultimovacs expects that the remaining patients will be fully enrolled during 2020. This trial gives supporting data for future filing applications. The progress of this trial does not dictate timelines for the randomized phase II trials. o Ultimovacs has obtained data on overall survival after 4 years in the metastatic malignant melanoma cancer trial. In this completed phase I/IIa trial, UV1 was given in combination with ipilimumab. The trial was conducted at the Oslo University Hospital. Treatment was generally well-tolerated. Immune responses towards the UV1 peptides occurred very early and 10/11 (91%) of evaluable patients showed an immune response. With 4 years of follow-up, one patient obtained a complete tumor response and three patients obtained a partial response, resulting in an objective response rate of 44% based on 9 evaluable patients. The median progression free survival (mPFS) was 6.7 months. Overall survival after 4 years was 50%. Although this study did not have a direct comparator arm, the results compare favorably to the ipilimumab monotherapy phase IV study at the Oslo University Hospital (the ‘IPI4 study’). The hospital enrolled 69 patients in the IPI4 study, with the same investigators, during the same time period and with similar inclusion criteria as Ultimovacs’ phase I study. The IPI4 study had a 4-year overall survival of 27.5%, which is consistent with survival data in the major historical ipilimumab studies. o On 7 February 2020, the abstract “A Phase I/IIa Clinical Trial Investigating the Therapeutic Cancer Vaccine UV1 in Combination with Ipilimumab in Patients with Malignant Melanoma: 4-year Survival Update” was presented during a poster session at the 2020 ASCO-SITC Clinical Immuno-Oncology Symposium in Florida. o Total operating expenses for the period amounted to MNOK 27.8, total operating loss was MNOK 25.4, negative cash flow from operations was MNOK 13.3 and net decrease in cash and cash equivalents was MNOK 12.4. Total cash and cash equivalents per 31 December 2019 amounted to MNOK 399.6. o As presented in a separate stock exchange announcement on 13 February 2020, Ultimovacs has appointed Carlos de Sousa as new Chief Executive Officer. Mr. de Sousa will join Ultimovacs as new CEO on 1 June 2020. Until then, Øyvind Kongstun Arnesen will continue in his position as CEO. The report and presentation are also available on the company website. For further information, please see www.ultimovacs.com or contact: Øyvind Kongstun Arnesen, CEO oeyvind.arnesen@ultimovacs.com, +47 469 33 810 Hans Vassgård Eid, CFO hans.eid@ultimovacs.com, +47 469 19 822