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Details:
First patient dosed with MIV-818 currently in the phase 1b/2a for the treatment of hepatocellular carcinoma, the purpose of the study is to evaluate safety, tolerability and also to get an indication of the efficacy.
Lead Product(s): MIV-818,Lenvatinib
Therapeutic Area: Oncology Product Name: MIV-818
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 14, 2021
Details:
In the study, MIV-818 will be administered in two combinations, either with lenvatinib, a tyrosine kinase inhibitor or pembrolizumab, an anti-PD-1 check-point inhibitor.
Lead Product(s): MIV-818,Lenvatinib
Therapeutic Area: Oncology Product Name: MIV-818
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 31, 2021
Details:
MIV-818 is a pro-drug designed to selectively treat liver cancers and to minimize side effects. It has the potential to become the first liver-targeted and orally administered drug for patients with HCC and other forms of liver cancer.
Lead Product(s): MIV-818
Therapeutic Area: Oncology Product Name: MIV-818
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 05, 2021
Details:
The results continue to be promising and show a good safety and tolerability profile. The study is proceeding according to plan and now the recommended starting dose has been set for the next study where we combine MIV-818 with standard treatment.
Lead Product(s): MIV-818
Therapeutic Area: Oncology Product Name: MIV-818
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 19, 2021
Details:
The results from the completed phase Ia intra-patient dose escalation part of the study show that MIV-818 has an acceptable safety and tolerability profile and a selective effect on liver cancer cells.
Lead Product(s): MIV-818
Therapeutic Area: Oncology Product Name: MIV-818
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 12, 2021
Details:
European Medicines Agency (EMA), has granted orphan medicinal product designation in the EU for MIV-818 for the treatment of patients with hepatocellular carcinoma (HCC), the most common type of primary liver cancer.
Lead Product(s): MIV-818
Therapeutic Area: Oncology Product Name: MIV-818
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 25, 2020
Details:
U.S FDA has granted orphan drug designation (ODD) to MIV-818 for the treatment of patients with hepatocellular carcinoma (HCC), the most common type of primary liver cancer.
Lead Product(s): MIV-818
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 06, 2020
Details:
The U.S FDA has granted orphan drug designation to MIV-818, a pro-drug designed to selectively treat liver cancer cells and to minimize side effects, for the treatment of hepatocellular carcinoma.
Lead Product(s): MIV-818
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 06, 2020
Details:
Medivir AB received notice of allowance for MIV-818 from the European Patent Office and the Japanese Patent Office for the MIV-818 composition-of-matter and liver cancer treatment claims.
Lead Product(s): MIV-818
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 30, 2020
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