It’s been a tough year for biotech, so how about a little good news? In between all the layoffs, restructurings and last-ditch strategic option hunting, we wanted to take a moment to shine a spotlight on 15 innovative and truly fierce biotechs.
That didn't surprise us, because everyone we talk to in the Fierce Biotech universe tells us that science doesn't stop for the markets. Financing might be a little tough right now, but innovation, breakthroughs and discoveries are all still being made.
The latest crop of Fierce 15 honorees consists of companies pushing the envelope not only in the lab, in the clinic or on the conference circuit: They are also defining what it means to be a modern biotech company, with modalities ranging from radiopharmaceuticals to cell therapy. Indications as diverse as oncology, neurodegenerative disorders, Pompe disease and even pregnancy complications made the list this year.
We have also turned a greater focus toward celebrating diverse teams. We asked for you to nominate companies pushing boundaries not only in the clinic but in the C-suite and beyond. We wanted to see the best of the best, the biotechs fiercely redefining expectations culturally, ethically and in their pipelines.
And here they are. We examined hundreds of nominations for the Fierce 15 this year. When we say we look at them all, we really truly do. These are the 15 companies that really stood out for us this year and we’re proud to call them the industry’s fiercest biotechs for 2023.
— Senior Editor Annalee Armstrong
Adaptive Phage Therapeutics
CEO: Greg Merril
Founded: 2016
Based: Gaithersburg, Maryland
Clinical focus: Bacterial infections
What makes Adaptive Phage Fierce: “Resistance evolves. We adapt.” That’s the motto of the biotech working to tackle antibiotic resistance with bacteriophages—antimicrobial therapeutics designed to be safe, effective and durable.
“The issue is basic biology. Bacteria evolved to survive,” CEO and co-founder Greg Merril told Fierce Biotech. As bacteria evolve to resist antibiotics, the industry has struggled to keep up. Big Pharmas have, of course, developed drugs designed to kill bacteria that exist at that moment in time. But bacteria resistance has evolved so quickly that companies often aren't able to even get a return on their investment for development, Merril explained. This has led to low investment in the area and a broken antibiotics pipeline.
To tackle the problem and treat ever-evolving bacterial infections, Adaptive Phage is ditching antibiotics all together. The biotech instead aims to channel the diversity and specificity of curated bacteriophages from its phage bank to treat infections. The approach matches a phage from its growing library through a proprietary phage susceptibility test that Adaptive is working to commercialize globally via a partnership with Mayo Clinic Laboratories.
“If we don't have phage or if a patient develops resistance to the phage that we've got, we can then use the bacteria to find new phage and add that to the collection,” Greg explained. “Phage are the most diverse bacteria killers on earth so you're always going to be able to find phage that's able to kill a bacteria.”
While other phage-focused biotechs exist, no other company was founded by world-renowned bacteriophage scientist Carl Merril, M.D. Carl—Greg’s father—currently serves as Adaptive’s chief scientific officer and has been conducting research in phage since the 1960s.
Things came to a head in 2003 when the National Institutes of Health (NIH) researcher had an article published in Nature about previous limitations in phage therapy—which were mainly related to the narrow range of bacteria that phage would kill—and the promise newer efforts showed in the area. Carl believed using a large library of phage to match to the bacterial strain could tackle how selective phage was.
A few years later, the U.S. Navy’s Biological Defense Research Directorate (BDRD) launched a project to test Carl’s ideas as a potential way to manage biodefense threats tied to multidrug-resistant superbugs.
Things really picked up steam in 2016, after a man got sick from an antibiotic-resistant bacteria, becoming so gravely ill he fell into a coma. The man—Tom Patterson—survived, awaking from his coma shortly after receiving phage therapy, as detailed in "The Perfect Predator: A Scientist's Race to Save Her Husband from a Deadly Superbug: A Memoir," written by his wife and epidemiologist Steffanie Strathdee, Ph.D.
The story shared in the book is the “genesis” of Adaptive, Greg explained, adding that the BDRD experienced further successes with the therapy. On the heels of these events, the father-son duo launched Adaptive and acquired exclusive global rights to BDRD’s phage tech.
Since then, nearly 60 patients have been treated with Adaptive’s phage therapy on an early-access, compassionate basis, the CEO said.
The biotech also has three candidates in clinical trials, all in midstage development. The first program is testing bacteriophage therapies in patients with diabetic foot osteomyelitis in a phase 2a study. This is the biotech’s first clinical trial in the indication, with Adaptive able to skip a phase 1 because phage therapies are widely known as well tolerated with few—if any—drug-related adverse events, according to Greg.
A second program is evaluating phage for patients with prosthetic joint infections in a phase 1/2 trial. The program was introduced through the compassionate emergency-use program, Greg said, because such infections are very difficult to treat with standard of care. The CEO said standard-of-care treatment is expensive and has high mortality and morbidity rates, so the space offers “a great market opportunity.”
The third trial is run by the NIH’s National Institute of Allergies and Infectious Diseases and the NIH-funded Antibacterial Resistance Leadership Group. The placebo-controlled, phase 1b/2 trial assesses Adaptive’s bacteriophage therapies among patients suffering from cystic-fibrosis-related lung infections.
“We don't suffer from the problems that have driven the antibiotic market to be a failure. We address that directly by having an adaptive approach to how we deal with bacteria,” the CEO concluded. “The traditional drug development process for antibiotics is a failed business model, and we have a totally different business model. So, that's why this is going to succeed.”
Investors: Deerfield Management, the AMR Action Fund, Mayo Clinic, Tedco, Alexandria Venture Investments, Hackensack Meridian Health
Click here to read the entire list.