As Johnson & Johnson (J&J) made public the launch of a phase III trial with its COVID-19 vaccine, officials from the company and others at the virtual Biopharm America meeting discussed modes of innovation in the pandemic era.
Amy Schulman, managing partner with Polaris, allowed that while “era” might seem to some an extreme word, it’s the right one. “The shifts that we’re seeing are absolute fractures in our health care system and how health care is delivered,” she said. Disparate allocation of resources and absent funding have made a bleak scenario even worse. “It’s those very important truths that are unavoidable, and are underscoring some of the things J&J and other health care companies are responding to,” she said.
Dubbed Ensemble, New Brunswick, N.J.-based J&J’s phase III COVID-19 experiment with JNJ-78436735 follows positive interim results from the company's phase I/IIa study, which showed that the safety profile and immunogenicity after a single vaccination were supportive of further work. The data have been submitted to Medrxiv and are due to appear online soon. Ensemble will enroll up to 60,000 volunteers across three continents and will study the safety and efficacy of a single dose vs. placebo in blocking the virus. J&J has continued scale-up of its manufacturing capacity and remains on track to crank out 1 billion vaccine doses per year.
Though political in-fighting besets the drug development landscape generally, J&J CEO Alex Gorsky said at the Morgan Stanley Healthcare Conference last week that his firm is staying the course. “In spite of much of the noise and sensationalism that we're likely to hear over the next 48, 49 days and even beyond, it’s remarkable that we have more than 200 approaches on a vaccine overall,” aiming to eradicate the virus. “When I say eradicate, I use that [term] loosely, because I think we're going to be dealing with it for years.”
With its COVID-19 bid, J&J deploys the Advac platform, from which also emerged the European Commission-approved Ebola vaccine and the company’s candidates for Zika, respiratory syncytial virus and HIV. More than 100,000 people have been exposed to Advac so far. If the new vaccine works, it’s estimated to stay stable for two years at -20 degrees Celsius and for at least three months at 2-8 degrees C, which makes JNJ-78436735 compatible with standard distribution channels.
Stacy Feld, head of J&J’s collaborative arm, Johnson & Johnson Innovation for western North America, Australia and New Zealand, did not address the vaccine push directly during the Biopharm session, saying the firm has “been rather public about” such efforts already. She spoke about J&J’s ongoing work broadly, “whether it’s supporting entrepreneurs that are pivoting their science to address COVID-19, or continuing to invest in ideas to address urgent and unmet medical needs.” An example is last month’s $47 million series B round by Thirty Madison, a digital health company. The financing was led by Polaris, with J&J participating beside existing investors Maveron and Northzone.
Try again, entrepreneurs
Thirty Madison has raised $70 million since its founding in 2017 by Steven Gutentag and Demetri Karagas. CEO Gutentag was on the Biopharm panel, too. He said his firm “combines specialist-level telemedicine experiences with personalized treatment and ongoing condition management,” tailored to specific chronic health issues – three of them so far: hair loss, migraine, gastrointestinal conditions. More than 40 million people in the U.S. suffer from migraine, yet fewer than 500 doctors specialize in it, he pointed out. “What we’re building is not just a consumer brand within health care,” he said. “A lot of change has to happen, a lot of change that people have known should happen for a long time.” COVID-19 is forcing the issue. “Some of the baseline education, frankly, has been made for you already,” he said. “I no longer have to explain to my parents what telemedicine is.”
Polaris’ Schulman said “a lot of people ask, are you actually funding companies remotely? We are very much investing, [and] not everything has to be in-the-moment, COVID-19-specific.” She conceded that “at the heart of any successful funding venture is the intimacy of the relationship” and that her first meeting with Gutentag was in the flesh, but much can be accomplished via the likes of Zoom. The world’s recognition of the centrality of health care has brought about cooperation that’s “unprecedented, and something that really is [cause for] a moment of celebration,” she said. “People are not being parochial about solutions, but are banding together in a way that’s important. I find this to be a bright spot in an otherwise difficult time for so many.”
J&J’s Feld said that “while we want to act with urgency, we also need to appreciate that the underlying foundation of these partnerships is building relationships and building trust.” It’s happening. Although “the things that are bringing us together look quite different,” she said, negotiators are getting to know each other via screen time.
Gutentag said that “just since we’ve moved to a work-from-home environment earlier this year, we have signed and closed and launched close to half a dozen partnerships” in the pharmaceutical and device manufacturing areas. He advised entrepreneurs in the current climate to persist. “Even if conversations previously took longer or it wasn’t the right time, times are changing. It would be worthwhile to have those conversations again” with an emphasis on value during the pandemic, which he views as a “window to advance health care.”
Biopharm America runs through Sept. 24.