More than a decade after the approval of a curative therapy for hepatitis C, hepatitis B has proven more challenging to tackle. Vir Biotechnology, in collaboration with Alnylam Pharmaceuticals, is developing a promising combination approach that marries Vir’s monoclonal antibody tobivibart with Alnylam’s siRNA elebsiran. We spoke to Mark Eisner, chief medical officer of Vir, about hepatitis B, the company’s combination therapy in development with Alnylam, and its platform technologies for developing treatments for infectious disease and oncology.

While GLP-1 agonists have been all the rage in treating obesity, Coya Therapeutics sees potential for these therapies to address inflammatory diseases. In fact, Coya is developing its low-dose interleukin 2 in combination with several different agents. The belief is that its approach will address inflammation by targeting dysfunctional regulatory T cells. The company is pursuing multiple neurodegenerative conditions, as well as autoimmune and metabolic diseases. We spoke to Arun Swaminathan, CEO of Coya Therapeutics, about its pipeline-in-a-product strategy to treat neurodegenerative and other inflammatory diseases, its pursuit of a GLP-1 combination therapy for these conditions, and the challenges of being a newly minted public company in the current financial environment.

Though cancer vaccines have been an area of great promise, in practice they have faced several challenges because of the heterogeneity of tumors, the ability of the tumor microenvironment to suppress the immune system, and the challenges of producing a strong and sustained T-cell response. OSE Immunotherapeutics’ off-the-shelf cancer vaccine Tedopi has shown promising results in a phase 3 study in patients with non-small cell lung cancer and the company is now conducting a confirmatory phase 3 study. We spoke to Nicolas Poirier, CEO of OSE Immunotherapeutics, about the company’s off-the-shelf cancer vaccine, non-small cell lung cancer, and how it is leveraging its immune system expertise through partnerships with leading pharmaceutical companies.

One of the challenges in treating brain cancer and other diseases of the central nervous system is delivering therapeutics beyond the blood-brain barrier. NeOnc Technologies using a natural compound derived from essential oils in plants that not only can kill cancer cells, but can cross the blood-brain barrier. What’s more, it can transport other therapies as well. We spoke to Thomas Chen, founder and CEO of NeOnc, about brain cancer, how the blood-brain barrier complicates the delivery of therapies to treat the condition, and how its experimental candidate that is delivered intranasally works.

Some 70 percent of potential therapeutic targets are believed to be beyond the reach of conventional small molecule therapies or biologics. Macrocyclic peptides offer a way to get at elusive targets while providing desirable characteristics of both small molecule drugs and biologics. They offer oral bioavailability, can permeate cells, and engage complex targets with specificity. Unnatural Products is harnessing AI to create synthetic macrocyclic peptides to pursue previously undruggable targets. We spoke to Cameron Pye, CEO and co-founder of Unnatural Products, about how these peptides can target proteins that traditional therapies cannot reach, the engineering process for the company’s synthetic macrocyclic peptides, and their potential to lead to new innovative therapies for a range of conditions from cancer to obesity.

Through the creation of a chemical programming language, Chemify said it has been able to expand the chemical space it can explore. Chemify is combining this unique programming language with robotics and AI to digitize chemistry. The company, though, has much grander ambitions than being a drug developer. It wants to be the infrastructure for the industry. We spoke to Lee Cronin, founder and CEO of Chemify, about the company’s platform technology for digitizing chemistry, how its chemical programming language expands the chemical space it can explore, and how the integration of robotics into its platform accelerates drug discovery.

Prescription digital therapies, the use of software to treat disease, are growing in number. Already there have been 140 prescription digital therapies that have been granted market access through national regulatory and reimbursement pathways. That represents a five-fold increase in the since 2021, according to the IQVIA Digital Health Trends 2024 report. We spoke to Murray Aitken, executive director of the IQVIA Institute for Human Data Science, about the report, why digital health companies faced challenging times in recent years, and why your next prescription may be in the form of an app. 

There has been growing interest in the potential of psychedelics to treat a variety of mental health conditions. While some focus has been put on synthesizing compounds that can target the receptors psychedelics bind to without inducing their hallucinatory effects, Filament Health is taking a notably different approach. The company, co-founded by Ben Lightburn who previously ran a firm specializing in natural extraction technologies, is focusing on developing pharmaceutical grade botanical drugs that may benefit from multiple active compounds rather than an isolated active ingredient. We spoke to Ben Lightburn, founder and CEO of Filament Health, about the company’s approach to psychedelic medicine, the case for natural botanical extracts rather than synthetic compounds, and its lead experimental therapy that targets methamphetamine use disorder. 

Gain Therapeutics' platform technology Magellan leverages AI, structural biology, and physics-based models to identify novel binding sites on otherwise undruggable proteins implicated in diseases. The company’s experimental Parkinson’s disease therapy has the potential to slow or stop progression of the neurodegenerative condition by stabilizing a lysosomal enzyme implicated in the disease. We spoke to Gene Mack, interim CEO of Gain, about the company’s platform technology, how its experimental therapy for Parkinson’s disease works, and what other conditions might be good candidates for its platform technology to target.

We continue our holiday tradition by welcoming STAT News Senior Biotech Writer Adam Feuerstein for our annual look back at the year that was in biotech and what’s ahead for the industry with the JPMorgan Healthcare conference and beyond in 2025. Feuerstein offers his view on finance and dealmaking in 2024, new drug approvals, and his annual take on the best and worst CEOs of the year. We also discuss what Trump 2.0 may look like for the industry, changes coming to the FDA and other agencies, and what hot technologies to watch in the year ahead.