Genentech is tapping into the promise of messenger RNA for building personalized cancer vaccines. The giant Roche subsidiary is partnering with Germany’s BioNTech on its individualized cancer therapies, promising $310 million in near-term payouts to collaborate on a combo with its newly approved checkpoint inhibitor Tecentriq (atezolizumab).
In this deal, BioNTech will contribute its personalized cancer vaccine platform spotlighting unique neoantigens that can be identified in a cancer patient’s tumors, a trendy new target of drug developers like Gritstone, Moderna and Neon Therapeutics. Phase I studies are slated to begin next year.
BioNTech’s work is focused on creating synthetic mRNAs designed to produce therapeutic proteins, turning a patient’s cells into drug factories. Batches of code spur cells to create a therapeutic protein. And the partners are looking to kick up a broad as well as specific immune response to fight cancer. In this case, the tech starts with sequencing a patient’s genome for their tumor, then encoding the neoantigens for that particular tumor into a message delivered by mRNA as a vaccine. Dendritic cells decode the information, and use it to mark tumor cells for destruction by the immune system.
These new personalized cancer vaccines promise to help expand on the effectiveness of checkpoint inhibitors, which dismantle hurdles set up by cancer cells, and hope to succeed where the first wave of off-the-shelf cancer vaccines largely failed.
BioNTech gets rights to co-commercialize new therapies in the US and certain European markets, including Germany. And it will also co-fund the upcoming R&D work.
The deal announcement is characteristically light on financial details. But in light of the upfront and near-term cash in the deal, that sum is likely to be notable.
Founded in 2008, Mainz, Germany-based BioNTech has been largely funded by the Strüngmann group, a family firm led by German billionaires Thomas and Andreas Strüngmann, identical twins who have been fueling a variety of biotechs in Germany.
The company is keeping quiet about the milestones in the deal and isn’t talking about prospective timelines on the work with Genentech, anxious to keep some of its cards close to its vest.
“Immuno-oncology is unbelievably competitive,” says BioNTech COO Sean Marett, and that requires some circumspection on the details.
The company, though, laid out a significant piece of the oncology puzzle it’s been working on in two papers published last year and then last June in Nature. The first outlined its work with sequencing tumors for neoepitopes and in the second paper investigators outlined how they used RNA-lipoplexes to precisely target dendritic cells, overcoming a key hurdle by encoding shared tumor antigens and getting the T cell response they were looking for.
BioNTech has completed one Phase I study in patients, and Marett isn’t reluctant to claim the lead in the field, noting that some U.S. biotechs started after the first publication in 2015. The German biotech now has a staff of 500, even larger than Moderna’s 460, and it’s building its second manufacturing facility in Mainz to back up the expanding clinical plans.
Next steps include taking a close look at how BioNTech will realize its plans, including co-funding the work with Genentech, expanding manufacturing, pushing partnered and in-house programs, with a possible IPO on the table as one real possibility.
Getting a powerhouse U.S. partner like Genentech in their corner moves BioNTech closer to the day it can effectively start selling the therapies they’re now testing in the clinic.
“We’ve got a lot of elements in the company that we need,” says Marett. “The thing we were missing, this ability to be able to not only manufacture but also commercialize. That’s something that this deal will allow us to do.”
The pact marks the latest in a string of Big Pharma tie-ups with the German biotech. Sanofi signed on in a $1.5 billion deal last spring. Both Moderna and CureVac are also elbowing into the mRNA field, with big money deals of their own. And Sanofi followed up after a separate deal BioNTech struck with Eli Lilly, which has its own plans for the oncology field.
Combos are the future of cancer drugs, and BioNTech is acutely aware of the potential the alliance offers with combining its personalized vaccines with Roche’s recently approved PD-L1 checkpoint Tecentriq, or atezolizumab. So is Roche/Genentech.
“Unlike any medicine we have ever developed, virtually all cancer patients may potentially benefit from a custom-built cancer vaccine,” said James Sabry, M.D., Ph.D., Senior Vice President and Global Head of Genentech Partnering, in prepared text. “By collaborating with BioNTech on this cutting edge approach, we hope to truly advance cancer treatments by using a common molecular backbone – mRNA – that is uniquely tailored to an individual patient.”
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