Dosing has commenced in BioNTech's BNT111 Phase II cancer vaccine trial in advanced melanoma.
The first patient has been treated in a Phase II cancer vaccine trial by BioNTech, evaluating its mRNA-based therapy BNT111 in combination with Libtayo (cemiplimab) in patients with anti-PD1-refractory/relapsed unresectable Stage III or IV melanoma.
The open-label randomised trial will assess the efficacy, tolerability and safety of BNT111 in combination with Libtayo. It will enrol 120 patients and will evaluate the effects of the combination, as well as stand-alone individual agents.
BNT111 is the lead product candidate from BioNTech’s FixVac platform and targets a fixed combination of mRNA-encoded, tumour-associated antigens, with the aim of activating a strong and precise immune response against cancer.
The candidate is fully owned by BioNTech while Libtayo, an anti-PD-1 monoclonal antibody, is being co-developed by Regeneron and Sanofi.
“BNT111 is an intravenous therapeutic cancer vaccine candidate encoding for a fixed set of four cancer-specific antigens optimised for immunogenicity and delivered as RNA-lipoplex formulation,” says BIoNTech. According to the firm, more than 90% of melanomas in patients express at least one of the four tumour-associated antigens encoded in BNT11; NY-ESO-1, MAGE-A3, tyrosinase and TPTE.
The BNT111-01 trial, which is being carried out in collaboration with Regeneron, was reviewed and approved by the regulatory authorities in EU countries Spain, Germany, Italy and Poland as well as in the UK, the US and Australia. The first patient has been dosed in the EU.
The primary endpoint of the study is to assess the overall response rate of BNT111 in combination with Libtayo. Secondary endpoints include overall response rate in the single-agent arms, duration of response and safety.
The first patient has been treated in a Phase II cancer vaccine trial by BioNTech, evaluating its mRNA-based therapy BNT111 in combination with Libtayo (cemiplimab) in patients with anti-PD1-refractory/relapsed unresectable Stage III or IV melanoma.
The open-label randomised trial will assess the efficacy, tolerability and safety of BNT111 in combination with Libtayo. It will enrol 120 patients and will evaluate the effects of the combination, as well as stand-alone individual agents.
BNT111 is the lead product candidate from BioNTech’s FixVac platform and targets a fixed combination of mRNA-encoded, tumour-associated antigens, with the aim of activating a strong and precise immune response against cancer.
The candidate is fully owned by BioNTech while Libtayo, an anti-PD-1 monoclonal antibody, is being co-developed by Regeneron and Sanofi.
“BNT111 is an intravenous therapeutic cancer vaccine candidate encoding for a fixed set of four cancer-specific antigens optimised for immunogenicity and delivered as RNA-lipoplex formulation,” says BIoNTech. According to the firm, more than 90% of melanomas in patients express at least one of the four tumour-associated antigens encoded in BNT11; NY-ESO-1, MAGE-A3, tyrosinase and TPTE.
The BNT111-01 trial, which is being carried out in collaboration with Regeneron, was reviewed and approved by the regulatory authorities in EU countries Spain, Germany, Italy and Poland as well as in the UK, the US and Australia. The first patient has been dosed in the EU.
The primary endpoint of the study is to assess the overall response rate of BNT111 in combination with Libtayo. Secondary endpoints include overall response rate in the single-agent arms, duration of response and safety.
