We may have forgotten, but in 2019 BioNTech was in its early stages strongly focused on cancer vaccines, before being catapulted to the world stage with its anti-COVID vaccine.
Now, the German company has released a reminder of its original R&D mission with the start of the first phase BNT111 phase 2 test – the first of several cancer vaccine candidates – in skin cancer patients.
Prior to the pandemic, the plan was to launch both phase 2 and phase 3 of BNT111 in 2020, but after the partnership with Pfizer and COVID-19 consumed its attention, the deadlines were extended.
The phase 2 study is testing BNT111 in combination with the Regeneron / Sanofi Libtayo PD-1 inhibitor (cemiplimab) in patients with advanced melanoma who have relapsed or have not responded to treatment with a PD-1 / PD inhibitor. L1.
Since only about one-third of patients are estimated to respond to PD-1 / PD-L1 blockade therapy, there is an incentive in the pharmaceutical industry to develop combined cancer immunotherapies that can increase that proportion.
BNT111 is the main product candidate from BioNTech’s FixVac platform and is based on a combination of four mRNA-encoded antigens, accompanied by the tumor – NY-ESO-1, MAGE-A3, tyrosinase and TPTE – that were created to stimulate a immunity response against a cancer.
The vaccine has already shown preliminary safety and efficacy trials in phase 1, the Lipo-MERIT dose trial reported last year, which included advanced melanoma patients previously treated with PD-1 / PD-L1 inhibitors. Efficacy was evaluated in a subset of 42 patients treated with stroke as monotherapy or in combination with an anti-PD-1 drug.
Among the group of 25 people who were given the vaccine separately, was one patient who had a complete removal of tumors that had spread from the original site. Three others had partial responses with a reduction in tumor size, and seven saw their disease stabilize as tumor growth stopped.
The combined group of 17 patients had six partial responses, including five in 10 patients with a 100 mcg dose of BNT111 plus anti-PD-1. The Phase 2 trial – called BNT111-01 – is enrolling 120 patients and will compare the combination to each of the drugs given alone and is expected to be completed by mid-2022.
BioNTech, meanwhile, aims to begin trials in the mid-term phase of two other cancer vaccines – candidate for FixVac BNT113 for head and neck cancer and neoantigen-specific immunotherapy (iNeST) partnering with Genentech partner in multiple solid tumors – end of the year.
“We were able to demonstrate the potential of mRNA vaccines in addressing COVID-19,” said lemzlem Türeci, co-founder and chief medical officer of BioNTech. “We must not forget that cancer is also a global threat to health, even worse than the current pandemic,” she added.
