Another cancer vaccine play out of Geneva shoots for 'hard endpoint' in PhII head and neck cancer test
After quietly plowing the arid cancer vaccine field for a decade, a low profile Swiss biotech is throwing itself in the ring as a player to watch in the frenetic race to extend the benefits of immunotherapies to solid tumors.
Co-founded by biotech vet Bernard Mach — who was involved in the creation of Biogen and Novimmune — and his son Nicolas, MaxiVAX is laser-focused on developing a two-part cancer vaccine that activates the immune system to attack cancer. And it has been awarded a €2.785 million ($3.07 million) grant from the European Commission — on top of CHF 5 million ($5.01 million) from a Series B2 round — to push through a Phase II study in head and neck cancer in Switzerland and kick off a US study for an undisclosed rare tumor.
Much has been made of cancer vaccines’ potential to complement immune checkpoint inhibitors, which can be incredibly effective in subsets of patients, sometimes as few as 20%. But the first generation of cancer vaccines, largely made of peptides derived from cancer cells, has failed to induce the immune effects needed to make a difference on their own.
A key issue, MaxiVAX CEO Dimitrios Goundis said, is that peptides carry mutations that vary from patient to patient. Their solution: Isolate the whole tumor cells, containing the complete antigenic repertoire for the immune cells to profile and target, inactivate them, then implant them subcutaneously next to an adjuvant meant to sustain the immune response.
“So our therapy basically is a vaccine, which is patient specific, and an immune boosting agent (GM-CSF) which is delivered by encapsulated genetically modified cells, which allow continued delivery of GM-CSF over several days at the site of vaccination,” he told Endpoints News. “And with that we address we think all the weaknesses that we’ve identified over the course of the last 20, 30 years when people start to look at vaccines against cancers in a more systematic way.”
GM-CSF, or granulocyte-macrophage colony-stimulating factor, is a naturally occurring immune modulator that has a relatively short half life, normally disappearing within a couple hours in the bloodstream. To keep it flowing, MaxiVAX is inserting a gene into hundreds of thousands of cells to produce a steady supply of GM-CSF such as immune cells that can stay energized as they get familiarized with irradiated tumor cells.
The improvement should be clear cut, he said. While checkpoints have extended median survival in advanced and refractory head and neck cancer from three to six months, that still means half of the patients don’t live that long. For the ongoing Phase II, for which they are recruiting around 40 patients across six sites, MaxiVAX will be monitoring the number of patients who pass the 6-month survival threshold as the main efficacy measure.
“It’s a hard endpoint,” he said. “So we’re not only looking at whether or not the tumor is reduced in size or disappears, but also what is the effect of that in prolonging the life of the patients.”
He expects the final results from the open-label trial to be in around 2021. Before that, MaxiVAX’s small team of 10 will also initiate a Phase II for which they have already obtained an IND in the US.
The new funds from private investors — MaxiVAX has managed to stay away from venture capitalists in raising over $15 million so far — will also go toward building out manufacturing.
Right now the biotech relies on the Geneva Hospital, where Nicolas Mach is head of oncology, to isolate the tumor cells and to generate and fill the capsules with GM-CSF producing cells. Its offices are located in the neighborhood, which also houses AMAL Therapeutics, another next-gen cancer vaccine player recently bought out by Boehringer Ingelheim.