The Bio Report

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.

Type 1 diabetes is still a disease we manage day‑to‑day rather than prevent, and today’s approaches do little to stop the immune system from attacking beta cells in the first place. Zag Bio is trying to change that by turning the thymus, the body’s training ground for T cells, into a therapeutic engine for immune tolerance, using thymus‑homing antibodies to program long‑lived, antigen‑specific Tregs against type 1 diabetes and other autoimmune diseases. Zag Bio CEO Jason Cole discusses type 1 diabetes, how the company’s thymic training platform fits into the emerging tolerance landscape alongside cell therapies and nanoparticle approaches, and the potential to extend this strategy to a broader set of autoimmune diseases.

Most small molecule drugs and biologics miss a large group of important receptors in the body. These receptors, known as GPCRs, play big roles in major diseases, but they are unusually hard to target in a precise and safe way. Skape Bio is trying to change that by using artificial intelligence to design an emerging class of therapies known as mini proteins that can fit these receptors snugly and control them in ways traditional drugs often can’t. Christoffer Norn, co‑founder and CEO of Skape Bio, discusses how mini proteins share strengths of both small molecules and biologics while avoiding some of their weaknesses, why the company’s approach could open up new therapeutic opportunities, and how Skape Bio is building a broad pipeline of differentiated GPCR‑targeting therapies.

AI’s promise in drug discovery is being held back by a simple but stubborn problem: the field doesn’t have enough of the right kind of lab-generated data to train good models. Public databases and scattered studies give a patchy view of how proteins interact, mostly showing successful interactions and using different methods and conditions, which makes it hard for AI systems to learn broad rules or understand what doesn’t work. A-Alpha Bio tackles this data gap with AlphaSeq, a lab platform that can test around a million protein pairs in one experiment under the same conditions, producing rich, consistent information on both hits and misses that’s well suited for AI. David Younger, co-founder and CEO of A-Alpha Bio, talks about why far more lab data and infrastructure will be needed than most people expect, why current public datasets fall short, and why the company’s business model is built around providing data and services rather than developing its own drugs.