By Melane Sampson
Adaptin Bio (OTCQB: APTN) is advancing a novel strategy to overcome one of the most persistent challenges in neuro-oncology—delivering effective therapies across the blood-brain barrier. By leveraging the natural trafficking ability of immune cells, the company’s proprietary bispecific T-cell engager platform is designed to transport therapeutic agents directly to intracerebral tumors.
“Our novel approach has demonstrated high specificity for EGFRvIII-expressing glioma cells, dose-responsive efficacy across diverse patient-derived glioma cell lines, and a favorable safety profile,” Michael J. Roberts, PhD, CEO and co-founder of Adaptin Bio, says in an interview with BioTuesdays.
Dr. Roberts explains that at the core of Adaptin’s approach is its proprietary brain-specific T-cell engager (BRiTE) platform, a technology developed at Duke University by Dr. John Sampson, renowned neurosurgeon-scientist and chair of Adaptin’s scientific advisory board. The platform combines engineered T cells with bispecific antibodies, aiming to enhance the delivery of therapeutics into the brain while simultaneously activating immune-mediated tumor destruction. The company’s lead candidate, APTN-101, has received FDA clearance to enter a Phase 1 clinical trial in glioblastoma (GBM), with additional indications under consideration.
“Our mission is to break through major challenges in medicine by pioneering a new treatment paradigm for cancer and central nervous system (CNS) diseases—the ability to deliver drugs precisely where they are needed,” he says. “In many of these conditions, that means crossing biological barriers that have historically limited therapeutic efficacy.”
The blood-brain barrier remains an obstacle in treating CNS diseases, Dr. Roberts notes. While small molecule drugs can sometimes penetrate this barrier, larger biologics—including many promising immunotherapies—are typically excluded. Adaptin’s solution is to harness the natural mobility of the immune system.
“We utilize immune cells, particularly T cells, which naturally travel throughout the body, to transport therapies across barriers. By training these cells, we aim to enhance their ability to cross the blood-brain barrier and deliver treatments directly to the tumor site,” he says.
He points out that this “hitchhiking” mechanism involves extracting T cells from patients via leukapheresis—a medical procedure used to separate white blood cells from a patient’s blood—engineering them ex vivo to express specific receptors that facilitate brain entry, and reintroducing them into the body. These modified cells can carry bispecific T-cell engagers on their surface, effectively acting as delivery vehicles.
“When these engineered T cells cross into the brain, the therapeutic agents go with them,” Dr. Roberts says. “That allows us to significantly increase drug concentrations at the tumor site.”
The dual mechanism of action is key to Adaptin’s approach. APTN-101 combines adoptive cell therapy (ACT) with a bispecific antibody that binds both CD3 receptors on T cells and the EGFRvIII mutation commonly expressed in GBM.
“The T cells are not just delivery vehicles, they are also active participants in the therapy,” he says. “The engager directs the T cells to the tumor, and the T cells execute the anti-tumor response.”
The company’s preclinical data suggest the combination is critical. In animal models, administration of either the T-cell engager or engineered T cells alone produced limited survival benefits. However, Dr. Roberts emphasizes that, when combined, the therapy resulted in long-term survival of approximately 80% of treated animals.
“We observed a more than sevenfold increase in delivery of the therapeutic agent to the brain when using the combined approach. Importantly, that translated into meaningful anti-tumor activity,” he says.
GBM is one of the most aggressive and difficult-to-treat cancers, with a median survival typically ranging from 18 to 20 months after diagnosis. Despite decades of research, the standard of care—which includes surgery, chemotherapy, and radiation—has seen little improvement in patient outcomes.
“Nothing has meaningfully changed in GBM treatment in more than 20 years. The main issue is that we have not been able to get enough effective drug into the brain to make a difference,” Dr. Roberts contends.
Adaptin Bio believes its platform could address this fundamental limitation while also enabling a more dynamic and personalized treatment approach. By profiling tumor antigens following surgical resection, the company aims to deploy a library of bispecific engagers targeting multiple tumor markers over time.
“We envision a toolbox of T-cell engagers that can be matched to a patient’s tumor profile,” Dr. Roberts explains. “As the tumor evolves, we can adapt the therapy—potentially extending survival through repeated treatment cycles.”
He adds that this strategy could transform GBM from a rapidly fatal disease to a more manageable chronic condition. “Our goal is not just incremental improvement. We want to give patients meaningful time—potentially years or even decades—by managing the disease over the long-term.”
Looking beyond oncology, the company sees broader applications for its platform across CNS disorders—a market projected to grow significantly in the coming decade. CNS diseases represent a large economic burden, with hundreds of billions in annual healthcare costs and limited disease-modifying treatment options.
“There is a global need for therapies that can effectively target CNS conditions. Our platform is designed to address that by solving the drug delivery problem,” Dr. Roberts says.
He adds that Adaptin’s Phase 1 trial, initiating soon, is a two-part dose-escalation study evaluating APTN-101 both as a standalone therapy and in combination with engineered T cells in patients with newly diagnosed or recurrent EGFRvIII-positive GBM.
“Part one of the study is primarily focused on safety. The second part is where we expect to see the full impact of our technology by combining the engager with activated T cells,” Dr. Roberts says.
The trial will assess safety, response rates, and early signs of efficacy, with initial data from Phase 1 in 2027. The company expects to report full Phase 1 results by the end of 2027 or early 2028 and is targeting a potential Nasdaq uplisting in the same timeframe.
Dr. Roberts highlights several advantages of the BRiTE platform relative to other immunotherapy approaches. Unlike CAR-T therapies, which can be limited by tumor heterogeneity, BRiTE’s modular design allows for rapid adaptation to different tumor antigens. Additionally, the platform may help overcome the immunosuppressive tumor microenvironment commonly seen in GBM.
“In some cases, we’ve observed that even immunosuppressive cells can be redirected to attack tumors. That could further enhance the overall immune response,” he adds.
The broader market opportunity for bispecific antibodies and T-cell engagers continues to expand, Dr. Roberts asserts, with significant deal activity across the biopharma sector. Many such programs are in early clinical stages, positioning Adaptin within a highly competitive but potentially lucrative landscape.
“We are at a similar stage to many other companies in this space, but we believe our combined delivery and activation approach differentiates us in a meaningful way,” he says.
With a current market capitalization of approximately $50 million following a reverse merger and financing completed in 2025, Adaptin sees substantial upside as it advances its clinical pipeline.
“We’ve brought together a highly experienced team with a track record of successful innovation, and we’re applying that experience to a significant unmet need,” Dr. Roberts concludes. “If we can demonstrate clinical success, we believe this platform has the potential to fundamentally change how we treat brain cancers.”
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