Ultimovacs, the Norwegian biotech company, has staged a remarkable comeback for its cancer vaccine candidate. Despite encountering a setback earlier this year when it failed to meet the primary objective, the company has now presented compelling data illustrating the enhanced survival benefits achieved when combining its vaccine with two Bristol Myers Squibb (BMS) drugs in lung lining cancer patients.
Back in June, investors had a moment of doubt when Ultimovacs reported the disappointing outcome of its cancer vaccine in second-line malignant pleural mesothelioma patients, failing to demonstrate an improvement in progression-free survival (PFS). The addition of UV1 to BMS’ Opdivo and Yervoy had seemingly yielded no statistically significant effect on PFS, resulting in the trial falling short of its primary endpoint.
Undaunted, Ultimovacs persisted in tracking study participants, and this determination has been rewarded with data that casts a more favorable light on UV1. Patients receiving UV1 in combination with Opdivo and Yervoy exhibited a median overall survival (OS) of 15.4 months, in stark contrast to the 11.1 months observed in the control arm, where patients received solely the BMS drugs. However, questions linger about whether this OS improvement will maintain its robustness in a more extensive clinical trial, as the 95% confidence intervals in the phase 2 study are wide and overlap. In the treatment arm, OS spans from 11.1 months to 22.6 months, while the control group’s range is from 8.8 months to 18.1 months.
The data abstract also highlights the initial shortfall in the primary endpoint, with PFS being numerically inferior in the treatment arm, at 4.2 months, compared to the control group’s 4.7 months, as per blinded independent central review. Nevertheless, assessments by local investigators tell a different story, showing a PFS of 4.3 months for the study drug, outperforming the control’s 2.9 months.
Ultimovacs is optimistic about the overall data set, emphasizing the potential for further clinical development. The coming months are poised to be pivotal, with top-line results from phase 2 trials in melanoma and head and neck cancer expected in the upcoming year.
The positive update has propelled Ultimovacs’ shares, with a notable surge of approximately 25% to 141 Norwegian kroner ($13). This surge has pushed the stock above the price point it held before news of the primary endpoint setback in June, reflecting renewed investor confidence in the company’s prospects.
