Ultimovacs Announces Updated Positive Results from Phase I Trial
Oslo, 19 October 2020: Ultimovacs ASA ("Ultimovacs", ticker ULTIMO), today
announced five-year overall survival data from the Phase I trial evaluating UV1
as maintenance therapy in patients with non-small cell lung cancer. The results
confirm achievement of the primary endpoints of safety and tolerability and
indicate encouraging initial signals of long-term survival benefit.
"Ultimovacs has established a growing body of clinical data demonstrating a
strong safety and tolerability profile for UV1 and a range of preliminary
efficacy signals in several cancer indications, all of which supports the
further development of our proprietary cancer vaccine candidate," stated Carlos
de Sousa, Chief Executive Officer at Ultimovacs. "The long-term follow-up
results announced today demonstrate that treatment with UV1 is safe both at the
time of administration and throughout the follow-up period of at least 5 years.
Non-small cell lung cancer highly expresses telomerase and remains an indication
in great need of new treatment options for patients."
In the study, a total of 18 non-small cell lung cancer patients whose disease
had not progressed after receiving at least 2nd line treatment with chemotherapy
were enrolled to receive UV1 monotherapy as maintenance treatment. Outcomes of
the study included the safety and tolerability of UV1 as well as initial signs
of clinical response. As per the cut-off date of June 2020, every patient in the
trial reached at least 60-months of follow-up post treatment with UV1. At the
five-years landmark, the Overall Survival (OS) rate was 33% and median
Progression Free Survival (mPFS) was 10.7 months. Throughout the follow-up
period, none of the patients experienced unexpected safety issues related to
UV1. Further, none of the patients alive after 5 years have received other
immunotherapy after the vaccination with UV1.
"At the time of the study initiation, there were no checkpoint inhibitors
available for treatment of this patient population. For patients that received a
second-line of chemotherapy the expected 5-year survival rate was less than 5
percent," stated Jens Bjørheim, Chief Medical Officer at Ultimovacs. "While our
Phase I study is non-randomized and conducted in a small population, it is
promising to see that UV1 was safe and well-tolerated and that using UV1 as a
maintenance therapy could potentially provide benefit to patients in need of
novel approaches."
Ultimovacs presented 48-months of follow-up data at the Society for
Immunotherapy of Cancer's (SITC) 34th Annual Meeting in November of last year.
announced five-year overall survival data from the Phase I trial evaluating UV1
as maintenance therapy in patients with non-small cell lung cancer. The results
confirm achievement of the primary endpoints of safety and tolerability and
indicate encouraging initial signals of long-term survival benefit.
"Ultimovacs has established a growing body of clinical data demonstrating a
strong safety and tolerability profile for UV1 and a range of preliminary
efficacy signals in several cancer indications, all of which supports the
further development of our proprietary cancer vaccine candidate," stated Carlos
de Sousa, Chief Executive Officer at Ultimovacs. "The long-term follow-up
results announced today demonstrate that treatment with UV1 is safe both at the
time of administration and throughout the follow-up period of at least 5 years.
Non-small cell lung cancer highly expresses telomerase and remains an indication
in great need of new treatment options for patients."
In the study, a total of 18 non-small cell lung cancer patients whose disease
had not progressed after receiving at least 2nd line treatment with chemotherapy
were enrolled to receive UV1 monotherapy as maintenance treatment. Outcomes of
the study included the safety and tolerability of UV1 as well as initial signs
of clinical response. As per the cut-off date of June 2020, every patient in the
trial reached at least 60-months of follow-up post treatment with UV1. At the
five-years landmark, the Overall Survival (OS) rate was 33% and median
Progression Free Survival (mPFS) was 10.7 months. Throughout the follow-up
period, none of the patients experienced unexpected safety issues related to
UV1. Further, none of the patients alive after 5 years have received other
immunotherapy after the vaccination with UV1.
"At the time of the study initiation, there were no checkpoint inhibitors
available for treatment of this patient population. For patients that received a
second-line of chemotherapy the expected 5-year survival rate was less than 5
percent," stated Jens Bjørheim, Chief Medical Officer at Ultimovacs. "While our
Phase I study is non-randomized and conducted in a small population, it is
promising to see that UV1 was safe and well-tolerated and that using UV1 as a
maintenance therapy could potentially provide benefit to patients in need of
novel approaches."
Ultimovacs presented 48-months of follow-up data at the Society for
Immunotherapy of Cancer's (SITC) 34th Annual Meeting in November of last year.
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