This year marks the 17th time we’ve sought out the best of the best when it comes to private biotech companies, and as we blow out the candles and look forward to officially becoming an adult next year, we thought it high time to see how our alumni are getting on.
Picking the ultimate winners each year is a monumental task; under my editorship for the past three Fierce 15s (the fourth will be with you very soon) and John Carroll’s for the 13 years before that, we at FierceBiotech pick only who we see as the best.
We want them to be major success stories in 10 or 20 years’ time, and we have picked some of these big, long-term winners in the past—but some too have fallen by the wayside or failed to deliver on early promises.
This is always the balancing act with Fierce 15: We often have little data to go on, with most being preclinical or very early-stage clinical. We seek out clues via interviews with management and VCs as well as how strongly they are being backed in dollar terms and their science and attempts at innovation.
We know, too, that moving from a clinical-stage biotech to a commercial biotech, especially when you’re doing this on your own, is a new and complex shift internally and also one that some have not managed to pull off. Add ever-increasing manufacturing complexities to that list, and we begin to feel what it must be like to be an investor or an exec in one of these companies.
Check out our alumni and their journeys, and check back very soon to see 2019's Fierce 15 winners.
BIND – 2008 winner
We have to go back more than a decade to the glory days of BIND, one of the winners of the 2008 Fierce 15, which was co-founded by MIT superstar Bob Langer.
The Cambridge, Massachusetts-based company was at the cutting-edge of targeted and programmable therapeutics called Accurins to combat cancer using nanoparticles. It caught the interests of Amgen, Pfizer, Roche and Merck; later, it went public to the tune of $70 million.
But, fast-forward to 2016, and the picture became bleak, given that it had the dubious honor of being one of only a handful of biotechs to file for bankruptcy.
This came after a series of trial failures, dropped deals and major staff cuts, which prompted the biotech into Chapter 11, and its assets were sold off to Pfizer for just $40 million. That was a big comedown for the company, which had been valued at more than $200 million just four years before.
Tesaro – 2011 winner
Tesaro has had a mixed few years. When it won the Fierce 15 award back in 2011, it had got off a major $101 million series B on the promise of its cancer work using PARP inhibitors. Its leading light, niraparib, scored a major trial win back in 2016—Tesaro posted positive top-line results for the drug in patients who express BRCA, as well as those who don’t, and saw its shares jump 106% on the day.
That drug was speedily approved as Zejula by the FDA in the spring of 2017 and looked set to rival other PARP inhibitors from the likes of AstraZeneca and Clovis Oncology. This added to the green light the biotech got back in 2015 to start marketing its other major drug, rolapitant (now Varubi), to help prevent some of the common side effects of chemotherapy.
Varubi had a setback last year, however, when an injectable form of the drug saw safety issues. Tesaro had to reach out to doctors to update them with a safety warning for the drug, specifically over the risk of anaphylaxis and anaphylactic shock shortly after getting a shot of the med.
AstraZeneca and partner Merck have also been looking to dominate the PARP market with their Lynparza, with recent data out showing it to be the first PARP inhibitor to deliver a success in newly diagnosed ovarian cancer, adding to a string of firsts for the drug. It was first to market in its class, ahead of Zejula and Clovis Oncology’s Rubraca, and was the first in the field to win a breast cancer green light.
After its phase 3 data readout back in 2016, speculation snowballed that it would be bought out, but that never came off. Its stock price has also been going in just one direction: south, since the dizzying highs of $190 a share in early 2017 to around $40 in the autumn of 2018 as the battle for market share intensifies.
But buyout rumors wouldn’t die; in the end, GlaxoSmithKline was its white knight, snapping up the biotech in a deal worth more than $5 billion in late 2018, as the U.K.-based Big Pharma looked to bolster its own cancer credentials.
Seaside Therapeutics – 2012 winner
Seaside was probably the most tumultuous flop of Fierce 15 history, given that, just six months after its win, it posted devastating trial results which all but sunk the company.
At the start, it all looked very promising: The small company had raised a considerable sum of money from a key backer, was collaborating with Roche and was nearing what could have been breakthrough human data on Fragile X, an incredibly challenging target. But then the trial failed, Roche pulled out and the work came to an abrupt halt.
After the trial failure, Carroll said: “I don't regret singling the company out, not even a little bit. Honest people in this business can be wrong about what they're trying to do, or how they're trying to do it. The key for me is that there is a passionate and committed team working with a solid scientific understanding of their target disease while trying to achieve an ambitious goal, with enough money in the bank to give it all a serious chance of success.”
Juno Therapeutics – 2014 winner
A biotech that has had arguably the largest roller coaster ride of any of our winners, Juno Therapeutics was also a winner of the (less auspicious) and inaugural FierceBiotech "Rotten Tomatoes" award after a group of young people died in its tests of a new CAR-T medicine—a therapy that was later ditched, although too late for some.
Deaths can happen in experimental science, of course, whether from the disease itself or from the drugs trying to treat it, but when the first round of deaths happened on Juno’s watch, the company appeared to blame other factors for the fatalities and was given a quick turnaround on an FDA halt. A few months later, several more patients died, and with a sense of inevitability, the drug itself was later nixed.
Juno had been up there with Novartis and Kite Pharma in the fight to get the first CAR-T med to approval, but the biotech was hit hard by those deaths—and the decision to abandon its first-in-line drug. It had to reach further back in its pipeline for a new CAR-T that works differently from the now-ditched JCAR015. Its stock took a big hit, and some thought that might be the end.
But 2017 saw Juno become the phoenix from the ashes, rising up with the new drug JCAR017 that has since come up with some encouraging new data. Juno kept going, didn’t lose focus on its goal, and then in January 2018 won a $9 billion buyout from long-term partner Celgene (itself now subsumed by Bristol-Myers Squibb).
Many biotechs could have shriveled up and shuffled away after these fatalities, especially after the approvals for its rivals and the hits Juno took from the media (myself included). But Juno should be commended for its ability to keep going, gain that buyout and, hopefully, create a better, safer drug for blood cancer patients.
Vir Biotechnology – 2017 winner
When Vir Biotechnology launched in California in January 2017, it didn’t say much about what was in its pipeline—but it picked up plenty of buzz anyway, thanks to the big names involved in the company.
George Scangos, the former Biogen frontman, signed on to head the new California company as the Bill & Melinda Gates Foundation and ARCH Venture Partners delivered $150 million in startup capital. Not a bad place to start.
Then in 2017, it emerged from the shadows and outlined the details of a pipeline focused on infectious disease. And true to form, the company has signed on more big names in biotech to allow Vir to become "a major company in the treatment of infectious disease," Scangos told FierceBiotech at the time.
It then went about penning collabs with RNAi biotech Alnylam Pharmaceuticals, another Fierce 15 alum, and the infectious disease company Visterra, as well as four academic research labs including groups at Stanford and Harvard.
But it wasn’t done there: Despite such a short time in the spotlight, Vir saw its funding exceed $500 million by the end of 2017 and included contributions from its initial investors as well as a slate of new supporters. They include SoftBank Vision Fund (which led a $1.1 billion injection into Vivek Ramaswamy’s Roivant Sciences), the Alaska Permanent Fund and other private and institutional investors.
The biotech industry has charted plenty of advances in fighting infectious diseases over the last few years—Gilead Sciences' Sovaldi and other cures for hepatitis C among them—but there is still more work to be done, Scangos told us after winning the Fierce 15 award back in 2017.
Now that journey, perhaps inevitability, will look to bring Vir from a quiet, private biotech into the public domain with a $100 million IPO attempt announced in August.
Moderna Therapeutics – 2013 winner
When Moderna Therapeutics raised $474 million in 2016, its next step was widely expected to be—finally—an IPO. The company got there eventually last December, but not before it grabbed another mammoth VC round of $500 million and $125 million on top of that from an expanded cancer vaccines pact with Merck.
Then came its eye-watering $600 million IPO, as it now turns to the business of making good on its science. This revolves around its mRNA platform. It had been criticized for many years over its stealthy approach to scientific updates, while at the same time raising tons of cash.
In the last few years, however, it’s been more open (clearly as a result of heading onto the public markets). On its most recent second-quarter earnings call, the biotech said it was pushing on with its 21 pipeline programs, moving another four into phase 1 and starting a phase 2 study of its Merck-partnered personalized cancer vaccine for patients with melanoma.
The cancer vaccine, dubbed mRNA-4157, joins an AstraZeneca-partnered VEGF-A drug for myocardial ischemia in phase 2. It remains firmly early- to midstage, but the future will tell if its mighty cash hauls have created a profit-turning pipeline.