Kernal Bio's AI-Driven mRNA Aims to Make CAR T Therapy Off-the-Shelf

BOSTON, MA – April 30, 2026 – A Boston-based biotechnology firm is poised to showcase what it calls a revolutionary approach to cell therapy, one that could transform one of modern medicine’s most powerful cancer treatments from a bespoke, high-cost procedure into an accessible, “off-the-shelf” infusion. Kernal Biologics, Inc. will present compelling new preclinical data for its mRNA 2.0 platform at the upcoming American Society of Gene & Cell Therapy (ASGCT) Annual Meeting in May.

The company’s technology aims to solve the central challenge of CAR T-cell therapy: programming a patient’s immune cells to fight disease without ever removing them from the body. This in vivo approach stands in stark contrast to current methods, which involve a complex, multi-week process of extracting a patient’s T cells, shipping them to a specialized lab for genetic engineering, and reinfusing them after the patient undergoes toxic chemotherapy.

“Our presence at ASGCT 2026 marks a pivotal milestone as we move closer to making in vivo CAR T a reality,” said Yusuf Erkul, M.D., MBA, cofounder and CEO of Kernal Bio, in a press statement. He emphasized the platform's dual-selectivity mechanism as the key to safety and scalability.

This method, if successful in humans, could drastically cut costs, eliminate logistical bottlenecks, and make CAR T therapy available to a much wider patient population for blood cancers and potentially autoimmune diseases.

“By programming T cells in situ, we’re breaking the logistical and toxicological barriers that have kept CAR T therapies out of reach for the vast majority of patients,” added Burak Yilmaz, cofounder and president of Kernal Bio. “We’re moving ahead from the era of bespoke cell therapy to a future with safe and potent molecular programming done with a simple off-the-shelf infusion.”

The 'Two-Check' System: Engineering Precision Inside the Body

At the heart of Kernal Bio's strategy is a proprietary “two checks-and-balances” system designed for unprecedented precision. The first pillar is a highly specialized targeted lipid nanoparticle (tLNP). LNPs are the same technology that enabled the rapid development of COVID-19 vaccines, but Kernal has engineered its version to solve a different problem: targeted delivery. Instead of being absorbed primarily by the liver, these tLNPs are designed to home in on and be absorbed by resting T cells circulating in the body.

Data to be presented at the ASGCT meeting by Manfred Kraus, Kernal’s Head of R&D Therapeutics, will reportedly show these tLNPs achieve effective uptake in T cells while avoiding the liver. In mouse models, a single intravenous dose led to the rapid depletion of peripheral B-cells—a key therapeutic outcome for B-cell malignancies and a strong indicator that the in vivo CAR T programming was successful.

The second pillar is what happens after the LNP reaches its target. The mRNA payload itself is engineered for selectivity using a machine-learning pipeline. The company's AI platform analyzes vast datasets of genetic information to design mRNA sequences that are only translated into the therapeutic CAR protein inside the target T cells. This ensures that even if a nanoparticle were to go astray, the therapeutic action would not be triggered in the wrong cell type, providing a critical layer of safety.

According to an abstract for a poster presentation by Jeff Ozdemir, Kernal's Head of Platform, this AI-driven design process has resulted in up to a 40-fold increase in cell-selective translation in laboratory tests and a 10-fold increase in tumor-selective translation in mouse models.

A Crowded Field and a Stamp of Approval

Kernal Biologics is not alone in the race to develop in vivo cell therapies. The industry has recognized the immense potential in simplifying cell therapy, and other companies like Umoja Biopharma and Interius BioTherapeutics are also advancing their own in vivo programs into early-stage clinical trials. This burgeoning competition underscores the significance of the shift away from traditional ex vivo manufacturing.

However, Kernal has a significant vote of confidence that helps it stand out: major federal funding. The company's work is supported by a grant of up to $48 million from the Advanced Research Projects Agency for Health (ARPA-H), a U.S. government agency created to accelerate high-impact biomedical research. The funding is part of the agency’s Engineering of Immune Cells Inside the Body (EMBODY) program, which was specifically created to overcome the technical complexity, high costs, and poor access that limit current cell therapies.

This substantial, non-dilutive funding not only validates the scientific premise of Kernal’s platform but also provides a crucial financial runway to advance its lead program, KR-402, toward clinical trials. The support from ARPA-H, alongside backing from venture firms like Amgen Ventures and Hummingbird Ventures, signals strong belief from both public and private sectors in the technology's transformative potential.

Beyond Cancer: A New Frontier for Autoimmune Disease

While the initial focus of CAR T therapy has been on aggressive blood cancers, the next frontier is widely seen as the treatment of autoimmune diseases. Conditions like multiple sclerosis, lupus, and rheumatoid arthritis are driven by a dysfunctional immune system attacking the body's own tissues. The ability to selectively eliminate specific rogue immune cells could offer a curative-like treatment for millions of patients.

Kernal's in vivo approach is particularly well-suited for this expansion. The safety and control offered by its dual-selectivity platform could be critical for treating chronic, non-malignant conditions where the risk-benefit calculation is different from that of terminal cancer. The company has already indicated that its KR-402 program is being developed for both B-cell malignancies and multiple sclerosis.

By creating a more controlled, safer, and scalable method for engineering immune cells, Kernal Biologics and its competitors are not just aiming to improve an existing cancer treatment. They are working to unlock a new therapeutic modality with the potential to address a vast range of human diseases, fundamentally changing how medicine harnesses the power of the immune system.