Medivir AB (Nasdaq Stockholm: MVIR) today announced that the first patient with hepatocellular carcinoma (HCC) has been dosed with MIV-818 in a phase 1b/2a combination study with the company's
Medivir AB (Nasdaq Stockholm: MVIR) today announced that the first patient with hepatocellular carcinoma (HCC) has been dosed with MIV-818 in a phase 1b/2a combination study with the company's candidate drug MIV-818. In the study, MIV-818 will be given in combination with two other medicines, either with Lenvima®, a tyrosine kinase inhibitor, or with Keytruda®, an anti-PD-1 checkpoint inhibitor. Lenvima® and Keytruda®, respectively, are currently approved as monotherapy treatments of HCC*.
The purpose of the study is to evaluate safety, tolerability and also to get an indication of the efficacy of MIV-818, which is a completely new mechanism in the treatment of HCC, in combination with two already existing drugs. It is an open-label study starting with a dose escalation part (phase 1b) for each combination to establish the recommended phase 2 dose (RP2D). Once RP2D has been established for each combination, further cohorts of up to in total 30 patients with HCC will be enrolled in the expansion part of the study (phase 2a), for an initial evaluation of safety and efficacy for the combinations of MIV-818 with Lenvima® or Keytruda®.
The study is initiated at clinics in the UK and will also be conducted in Spain and South Korea. It will include patients with HCC for whom current first-line treatment has shown to be ineffective or intolerable.
– " It is very gratifying that we are now moving forward to evaluate MIV-818 in combination with two other treatments with different mechanisms of action" said Magnus Christensen, interim CEO of Medivir.
* Keytruda is approved for the treatment of HCC only in the United States.
For further information, please contact:
Magnus Christensen, Interim CEO, Medivir AB
Phone: +46 (0)8 5468 3100