The Bio Report

Cardiovascular disease remains the world's leading cause of death, yet many patients still face substantial risks even after conventional factors such as LDL cholesterol and blood pressure are controlled. Rezera is developing its experimental therapy ruvonoflast, an NLRP3 inhibitor, to address this residual inflammatory risk. The therapy is designed to suppress chronic, tissue-based inflammation while preserving the immune system's ability to respond to infection. Rezera CEO Geoff McDonough discusses the role of inflammation in heart disease, the company’s phase 3 trial of ruvonoflast in peripheral artery disease, and its next-generation, brain-penetrant NLRP3 inhibitor in development for neuroinflammatory conditions.

Many cancer treatments fail not because immune cells can’t recognize a tumor, but because the hostile environment surrounding it can prevent them from doing their job. Dyve Biosciences is seeking to address that problem by targeting tumor acidity, which the company says can suppress T-cell activity, promote immune evasion, and contribute to resistance to checkpoint inhibitors and other therapies. Its solution is a transdermal drug-delivery platform designed to move a buffering agent through the skin and into systemic circulation. The company’s lead oncology candidate, DYV 800, is intended to raise extracellular tumor pH and thereby make the tumor microenvironment more hospitable to immune attack. Ryan Beal, CEO of Dyve Biosciences, discusses why the company sees acidity as an overlooked but foundational target in oncology, how its delivery technology may overcome the limitations of oral bicarbonate dosing, and indications beyond cancer that the company is pursuing.

For people with non-muscle-invasive bladder cancer, treatment can involve repeated procedures, a high risk of tumor recurrence, toxic therapies and, in some cases, removal of the bladder. Hamlet Biopharma is developing Alpha1H, a synthetic peptide inspired by a protein complex found in human breast milk. Catharina Svanborg, chair of Hamlet Biopharma, discusses how Alpha1H is designed to selectively target bladder tumor cells while sparing healthy tissue, the science that led to the program, and the clinical-development path ahead.  

GLP-1 therapies have dramatically reshaped obesity care, but the next generation of medicines may be judged by more than how much weight patients lose. A central question is whether treatments can selectively reduce the visceral fat associated with cardiometabolic disease while maintaining the muscle needed for physical function, metabolic health, and durable weight management. Erik Ingelsson, chief scientific officer of Wave Life Sciences, discusses the biology behind a new RNA-based approach designed to remove a natural brake on fat breakdown, how the company is thinking about clinical endpoints and patient populations, and why precision approaches to fat loss could change the definition of success in obesity treatment.

T-cell engagers have delivered important advances in blood cancers, but extending their success to solid tumors has proved considerably more difficult. Physical barriers, immunosuppressive tumor microenvironments, and the risk of attacking healthy tissue have constrained the field. Deck Bio is developing multi-target T-cell engagers to address these limitations. Jack Silberstein, the company’s CEO, discusses Deck Bio’s efforts to create therapies that reach more cancer cells, reduce the likelihood that tumors will evade treatment, and minimize harm to healthy tissue.

For people with severe allergies and mast cell diseases, the risk of a dangerous reaction can shape everyday decisions about food, activities, and family routines. Current treatments generally manage symptoms or lower the likelihood of a reaction, rather than directly targeting the immune cells thought to drive the disease. Allergene AI Therapeutics is developing an in vivo mRNA CAR-T therapy intended to address that underlying biology. The approach aims to temporarily program a patient’s own T cells to target mast cells, with the goal of eliminating sensitized cells and enabling the immune system to rebuild a less reactive mast cell population. Sid Kerkar, founder and CEO of Allergene AI Therapeutics, discusses the scientific rationale for this proposed immune reset, the potential for mRNA and lipid nanoparticle delivery to simplify and broaden access to CAR-T therapy, and the work needed to move the approach from early research into clinical testing.

Antibody-drug conjugates have established themselves as an important cancer-treatment modality, but their effectiveness and tolerability in solid tumors can be constrained by inadequate tumor delivery, incomplete internalization, and off-target toxicity. NEOK Bio is seeking to overcome those challenges with its bispecific ADC platform that uses dual-antigen targeting, engineered antibodies, and next-generation linker technology. Mayank Gandhi, co-founder and CEO of NEOK Bio, discusses the company’s bispecific ADC platform, its two clinical programs, and its strategy to develop more selective therapies for patients with advanced solid tumors.

Alzheimer’s disease remains one of medicine’s most intractable challenges. While existing therapies may address individual features of the disease, such as amyloid or tau, they have yet to reverse the progressive cognitive decline, inflammation, and neurodegeneration that characterize it. Evinco Therapeutics is developing nanoscale, natural killer cell-derived particles that carry proteins and microRNAs to target the neuroinflammation underlying Alzheimer’s. Alan Trounson, founder and CEO of Evinco Therapeutics, discusses the company’s multifaceted therapeutic approach, how these particles are designed to cross the blood-brain barrier, and their potential to modulate neuroinflammation, support the brain’s immune cells, and promote amyloid clearance.

Gilead today stands at an inflection point. Its HIV and broader virology business still account for roughly two-thirds of total revenue, even as oncology has grown into a mid–single-digit billion-dollar franchise and inflammation and immunology remain earlier-stage bets. The company is tackling the strategic challenge of diversifying beyond HIV while preserving its leadership in virology. Chief Medical Officer Dietmar Berger discusses how the company is raising the bar for mechanistic understanding before making major investments, using targeted acquisitions to build platform-based franchises, and bringing in differentiated therapies and platforms that can be applied across solid tumors, autoimmune diseases, and even future viral threats.

Ischemic stroke remains one of the most devastating and resource‑intensive emergencies in medicine, with the physical removal of a clot, the current gold-standard care, still leaving more than half of patients with poor outcomes at 90 days. Revalesio is developing a next‑generation, oxygenated saline infusion designed to protect the brain during and after clot removal by stimulating mitochondrial function, reducing reperfusion injury, and limiting the spread of damage to surrounding tissue. Revalesio president Greg Archambeau discusses how the company’s experimental therapy may reshape the trajectory of stroke recovery, shorten hospital stays, and change the economics of stroke centers.