On November 9, 2026 Biond Biologics Ltd. ("Biond" or the "Company"), a private clinical-stage biopharmaceutical company developing first-in-class immunotherapies for cancer and immune-mediated diseases, reported that the first patient has been dosed in a first-in-human Phase 1 dose escalation clinical trial in advanced solid tumors evaluating BND-67, a novel antibody-based therapy designed to prevent CD28 shedding.
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The first patient was treated at the Institute of Oncology, Davidoff Center, Rabin Medical Center, Israel, one of multiple clinical sites participating in the study. The trial aims to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of BND-67. The unique clinical design includes a lead-in BND-67 monotherapy treatment followed by combination therapy of BND-67 and anti-PD-1 therapy, in patients relapsing on anti-PD-1 therapy following prior clinical benefit, across selected oncology indications. The first patient completed BND-67 0.3 mg/kg monotherapy without any dose-limiting toxicities or infusion-related reactions and is now receiving BND-67 in combination with nivolumab once every two weeks (MOH_2026-04-14-015766).
"Patients who relapse after responding to immunotherapy represent a significant unmet medical need. BND-67 is based on a compelling biological rationale and targets a previously unexplored mechanism of immune dysfunction like CD28 shedding," said Professor Salomon Stemmer, M.D., Head of Research, Development and Innovation and Deputy Director of Davidoff Center at the Rabin Medical Center, Israel, and a clinical investigator in the trial. "We are pleased to participate in this first-in-human study and investigate its potential to improve outcomes for patients with advanced solid tumors."
"BND-67 opens an entirely new therapeutic avenue for cancer immunotherapy," said Giovanni Selvaggi, MD, Chief Medical Officer at Biond. "CD28 has long been viewed as a cornerstone for T-cell activation, yet no targeted therapy has successfully harnessed it without compromising safety. By preventing CD28 shedding, BND-67 is designed to preserve physiological CD28 signaling and potentiate anti-tumor immune response, without the systemic toxicity associated with CD28 agonism. The BND-67 0.3 mg/kg was shown to be safe and tolerable with sustained receptor occupancy." The Phase 1 lead-in design is intended to establish BND-67’s initial safety and tolerability profile while assessing early signals of clinical activity.
About BND-67 and CD28 Shedding
BND-67 is a first-in-class immunotherapy designed to inhibit pathological CD28 shedding, an immune evasion mechanism found across many types of cancers first described by Biond. CD28 is a critical co-stimulatory receptor required for effective T-cell activation, proliferation, and persistence. In cancer patients, CD28 can be cleaved from the surface of T cells, by specific matrix metalloproteases (MMPs) that are secreted from various cells including T cells and from the cancer cells, leading to impaired immune responses and reduced sensitivity to immunotherapies.
By preventing CD28 shedding, BND-67 is designed to enhance T-cell activation and expansion while selectively inhibiting regulatory T-cell differentiation and suppressive activity. Preclinical studies have demonstrated that BND-67 induces a potent and sustained anti-tumor immune response, both as a monotherapy and in combination with T-cell activating therapies including PD-1 inhibitors and T-cell engagers while demonstrating a favorable safety profile in animal models.
(Press release, Biond Biologics, NOV 9, 2026, View Source [SID1234674509])