Misgav, Israel, November 9, 2026
Biond Biologics Ltd., a clinical-stage biotechnology company developing innovative immunotherapies, has announced that the first patient has been dosed in a first-in-human Phase 1 clinical trial of BND-67, an investigational antibody-based treatment for advanced solid tumors. BND-67 is designed to prevent the pathological shedding of CD28, a key co-stimulatory receptor required for effective T-cell activation and anti-tumor immune responses. The clinical program will initially evaluate BND-67 as a monotherapy before introducing combination treatment with an anti-programmed cell death protein 1 (PD-1) therapy. The study is designed for patients whose cancers have relapsed after previously benefiting from immune checkpoint inhibitor treatment, representing a population with significant unmet medical needs. The first participant was treated at the Institute of Oncology, Davidoff Center, Rabin Medical Center, Israel, one of several participating clinical sites. According to Biond, the patient completed the initial 0.3 mg/kg BND-67 monotherapy dose without dose-limiting toxicities or infusion-related reactions and subsequently began combination treatment with nivolumab administered once every two weeks. The milestone marks the transition of BND-67 from preclinical research into human clinical evaluation.
BND-67 Targets CD28 Shedding to Restore T-Cell Activity
The investigational antibody uses a novel approach to cancer immunotherapy by targeting CD28 shedding, a process that can weaken the immune system’s ability to recognize and attack cancer cells. CD28 is an important co-stimulatory receptor expressed on T cells and plays a central role in their activation, proliferation and persistence. In certain cancer settings, enzymes known as matrix metalloproteases (MMPs) can cleave CD28 from the surface of T cells. This process reduces the availability of the receptor and may impair the immune response against tumors, potentially contributing to resistance to immunotherapy. Biond developed BND-67 to block this pathological cleavage and preserve CD28 on the T-cell surface. The candidate is designed to produce a dual immunological effect by enhancing effector T-cell activity while reducing regulatory T-cell differentiation and suppressive function. Effector T cells help identify and destroy abnormal cells, whereas regulatory T cells normally control immune responses but can also contribute to an immunosuppressive tumor environment. By influencing both populations, BND-67 aims to strengthen anti-tumor immunity without directly stimulating CD28 through conventional receptor agonism. This distinction is important because previous attempts to activate CD28 directly have raised concerns about systemic immune toxicity. BND-67 is designed to preserve physiological CD28 signaling rather than broadly activating the receptor.
Phase 1 Trial Evaluates Safety and Combination With Nivolumab
The first-in-human Phase 1 dose-escalation study is an open-label clinical trial designed to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of BND-67, along with preliminary evidence of anti-tumor activity. The trial includes a lead-in period in which participants receive BND-67 alone, followed by combination treatment with an anti-PD-1 agent. The study focuses on patients with selected advanced solid tumors who previously experienced clinical benefit from immune checkpoint therapy but subsequently relapsed. The first participant completed the initial 0.3 mg/kg monotherapy treatment without reported dose-limiting toxicity or infusion-related reactions and moved on to receive BND-67 in combination with nivolumab every two weeks. Biond also reported sustained receptor occupancy at the initial dose, indicating that the antibody continued to engage its intended biological target. However, these observations from the first treated participant are preliminary and cannot establish the treatment’s overall safety or effectiveness. The dose-escalation phase will provide additional information as more participants receive increasing dose levels. Researchers will also assess pharmacodynamic biomarkers and tumor responses to understand whether the proposed mechanism translates into measurable biological and clinical activity.
Advertisement
Preclinical Research Supports Further Oncology Development
Before entering clinical development, BND-67 demonstrated anti-tumor activity in preclinical studies, both as a standalone treatment and in combination with other immune-activating therapies. According to Biond, experimental findings showed potential activity when combined with PD-1 inhibitors and T-cell engagers, supporting the company’s strategy of evaluating the antibody alongside existing immunotherapy approaches. Animal studies also indicated a favorable safety profile, although these results do not predict human outcomes with certainty. The company believes that targeting CD28 shedding could provide a new therapeutic strategy for patients whose tumors have developed resistance to immune checkpoint inhibitors. Professor Salomon Stemmer, a clinical investigator at Rabin Medical Center, highlighted the unmet need among patients who relapse after initially responding to immunotherapy. Giovanni Selvaggi, Chief Medical Officer at Biond, emphasized the potential of preserving CD28 signaling to strengthen anti-tumor immune responses. Biond also has another clinical-stage oncology candidate, BND-22, an antibody targeting the ILT2 receptor that is being evaluated in Phase 2 research. The advancement of BND-67 into human testing expands the company’s oncology pipeline. Further clinical investigation will determine whether this first-in-class approach can offer meaningful benefits to patients with advanced solid tumors.
Source: Biond Biologics press release
