Biond Biologics Ltd.

MISGAV, Israel, Oct. 29, 2024 /PRNewswire/ -- Biond Biologics Ltd. ("Biond" or the "Company"), is a private clinical-stage biopharmaceutical company focusing on novel immunotherapies for cancer and innovative platforms for the intracellular delivery of biologics. Biond is pleased to announce a clinical trial collaboration and supply agreement with Merck KGaA, Darmstadt, Germany, to evaluate its immunotherapy agent BND-35 in combination with Merck KGaA, Darmstadt, Germany's anti-EGFR monoclonal antibody cetuximab (Erbitux®) in a Phase 1 clinical trial (BND-35-001, NCT06274437) for the treatment of patients with unresectable or metastatic solid tumors. Under the terms of this agreement, Merck KGaA, Darmstadt, Germany will supply Biond Biologics with cetuximab to support Biond's Phase 1 clinical trial, aimed at evaluating the safety and efficacy of BND-35 in combination with cetuximab. Enrollment to the BND-35 dose-escalation monotherapy arm has already begun and several patients have already been dosed. BND-35 is a novel anti-ILT3 (LILRB4) antibody that inhibits the interaction between ILT3 and various extracellular matrix ligands, including fibronectin, a major component of many tumor microenvironments (TME). ILT3 is expressed on myeloid suppressive cells and contributes to a pro-tumorigenic TME. Additionally, ILT3 reduces the effectiveness of targeted antibody therapies that leverage antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), immunological mechanisms known to eliminate tumor cells. BND-35 reprograms the suppressive TME to a more pro-inflammatory one and reverses the inhibitory effects of ILT3 on ADCC and ADCP mechanisms. "We are thrilled to partner with Merck KGaA, Darmstadt, Germany to secure the supply of cetuximab for our clinical trial and thank Merck KGaA, Darmstadt, Germany for their interest in BND-35" said Tal Sines, VP of Business Development at Biond Biologics. "Our preclinical data show that BND-35 can synergize with therapies such as cetuximab, that promote ADCC and ADCP activities. It could provide a potential new treatment option for patients with solid tumors. About BND-35 BND-35, an innovative anti-ILT3/LILRB4 antibody designed to remodel the tumor microenvironment. BND-35 is currently under evaluation as a monotherapy in a Phase 1 clinical trial, which is exploring the safety, tolerability, and potential anti-tumor activity of BND-35 (NCT06274437). BND-35 is being assessed as monotherapy in the BND-35-001 trial, and in combination with established anti-EGFR (cetuximab) and PD-L1 therapies across various indications. About Biond Biologics Biond Biologics stands at the cutting edge of innovative therapies that target novel oncology pathways and enable the intracellular delivery of biologics. The company is dedicated to leverage advanced science and pioneering technologies into transformative drugs for diseases with significant unmet medical needs. Biond Biologics actively seeks synergistic collaborations with leading biopharmaceutical entities to bring novel medicines to patients worldwide. The company's robust pipeline also includes BND-22 (SAR444881), a groundbreaking first-in-class ILT2-blocking antibody in partnership with Sanofi, and BND-67, targeting CD28 shedding, a newly discovered immune evasion mechanism. Additionally, Biond is advancing INspire, a revolutionary platform for the intracellular delivery of protein therapeutics, including antibodies, proteins, or enzymes into cells. Media Contact: Tal Sines VP of Business Development Biond Biologics Ltd. +972-4 884 4337 [email protected] SOURCE Biond Biologics Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

BND-35 is a Novel and Unique Anti-ILT3/LILRB4 Antibody for Remodeling the Tumor Microenvironment BND-35-001 trial includes unique combination arms with anti-EGFR (cetuximab) and anti-PD-1/PD-L1, in selected indications MISGAV, Israel, June 24, 2024 /PRNewswire/ -- Biond Biologics Ltd. ("Biond" or the "Company"), a private clinical-stage biopharmaceutical company developing novel immunotherapies for cancer and a platform for the intracellular delivery of biologics, today announced that the first patient has been dosed in a first-in-human clinical trial testing BND-35, a humanized ILT3/LILRB4 antagonist antibody. The first patient was administered BND-35 as a monotherapy at the Institute of Oncology, Davidoff Center, Rabin Medical Center, Israel, one of the six Israel and US trial study sites. The phase 1, open-label, dose escalation study aims to explore the safety, tolerability, anti-tumor activity, pharmacokinetics and exploratory biomarkers for BND-35 as a monotherapy and in combination with two approved drugs, a PD-1/PD-L1 inhibitor or the anti-EGFR drug, cetuximab. The decision to test the combination of BND-35 with cetuximab was driven by supportive pre-clinical data and a deep understanding of the BND-35 mechanism of action. BND-35 augments antibody-dependent cellular phagocytosis and antibody-dependent cellular cytotoxicity, which are mediated by binding of Fc receptors (FcR) on immune cells to antibodies as cetuximab and additional tumor targeting antibodies. Each arm of the trial includes the patient populations most likely to benefit from ILT3/LILRB4 blockade based on translational research findings. "The BND-35 trial design introduces a novel combination therapy that targets the immunosuppressive cell milieu within the tumor microenvironment (TME)," commented Professor Salomon Stemmer, M.D., Head of Research, Development and Innovation and Deputy Director of Davidoff Center at the Rabin Medical Center, and a clinical investigator in the trial. "There's a pressing need for innovative treatments for cancers that are resistant to existing therapies. Given its promising preclinical efficacy, we're eager to assess BND-35's potential in overcoming ILT3/LILRB4-mediated immunosuppression." "ILT3 is a unique receptor expressed on various suppressive myeloid cells within the TME and the binding of various ligands to ILT3 maintains the TME in an immunosuppressive state. BND-35 has been demonstrated to effectively block the interaction between ILT3 and its various ligands, thereby enhancing the immune system's ability to fight tumors, resulting in increased physiological anti-tumor responses and enhanced tumor cell destruction by immune cells," stated Tsuri Peretz, project manager for the BND-35 program. About ILT3/LILRB4/LILRB4 BND-35 is a novel anti-ILT3/LILRB4 antagonist antibody developed for the treatment of solid tumors. BND-35 binds ILT3/LILRB4 with high affinity and blocks its interaction with ligands present in the TME In vitro and ex vivo studies have demonstrated that BND-35 as monotherapy or in combination with anti-PD-1/PD-L1 pathway inhibitors as well as with anti-EGFR agents, enhances the pro-inflammatory activity of various myeloid cells and inhibits the immunosuppressive activity of suppressive myeloid cells, thereby restoring T cell and NK cell activity. BND-35-induced immune activity enhancement was demonstrated in a unique system of patient-derived tumoroids. In vivo, blocking ILT3/LILRB4 activity with BND-35, as monotherapy or in combination therapy, resulted in decreased tumor growth and induced a pro-inflammatory phenotype in tumor-resident T cells and myeloid cell populations. Further information about the trial is available in (Trial Identifier: NCT06274437). About Biond Biologics Biond Biologics is at the forefront of developing cutting-edge therapies targeting novel oncology pathways and enabling the intracellular delivery of biologics. By exploring immunoregulatory pathways and pioneering intracellular delivery platforms, Biond Biologics aims to translate advanced science and innovative technologies into transformative drugs for diseases with significant unmet needs. The company fosters synergistic collaborations with leading biopharmaceutical entities to formulate groundbreaking medicines to patients worldwide. In addition to BND-35, Biond Biologics' programs include BND-22 (SAR444881), a multi-cell checkpoint first-in-class ILT2 blocking antibody that was partnered with Sanofi. In addition, it is developing BND-67, a novel agent for attenuation of CD28 shedding, an immune-evasion mechanism discovered by Biond's scientists, which could overcome PD-1 pathway blockade resistance. Biond Biologics is also developing INspire – an innovative technological platform that enables the intracellular delivery of protein therapeutics, such as antibodies, proteins or enzymes, into cells. This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities described herein, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction. Company contact: Tal Sines VP of Business Development Biond Biologics Ltd. +972-4 884 4337 tal.sines@biondbio.com

BND-35 Receives IND Clearance, and First in Human Phase 1 Trial is Expected to Begin in April 2024 MISGAV, Israel, March 26, 2024 /PRNewswire/ -- Biond Biologics Ltd., a pioneering clinical-stage biopharmaceutical company, developing innovative immunotherapies for cancer and a transformative platform for the intracellular delivery of biologics, is excited to announce that our BND-35 program has been selected for presentation at the esteemed American Association for Cancer Research (AACR) Annual Meeting, scheduled for April 5 - 10, 2024, in San Diego Convention Center, San Diego, CA, USA. BND-35 is distinguished as a humanized IgG4, ILT3 (LILRB4) antagonist antibody, designed to modulate the tumor microenvironment (TME) from immunosuppressive to pro-inflammatory, thereby counteracting tumor growth. BND-35 phase 1 trial includes a unique clinical design, that will be presented in the ACCR, and is based on Biond's extensive pre-clinical work and the ability of BND-35 to block interactions with the various ligands of ILT3. The presentation, titled "BND-35, a novel anti-ILT3 antibody for remodulation of the tumor microenvironment", will be part of the session on "Immune Targets and Therapies." It is scheduled for Monday, Apr 8th, 2024, at 4:05 PM. The session will highlight Biond Biologics' comprehensive preclinical characterization of BND-35, emphasizing its potential as a transformative treatment for solid tumors. BND-35 Oral Presentation Highlights at 2024 AACR Annual Meeting Biond Biologics' pivotal research on BND-35 demonstrates its specificity in binding ILT3 with high affinity, without affecting other ILT-family receptors. The specific blocking of ILT3's interaction with key ligands significantly enhances the pro-inflammatory activity of myeloid cells and effectively reverses ILT3-mediated immune suppression of T cells. The presentation will detail how BND-35, as a standalone therapy and in combination with anti-PD-1 and anti EGFR agents, has shown promising results in restoring T and NK cell activity and inducing a pro-inflammatory TME in various in vitro, ex vivo, and in vivo models. "ILT3 is a clinically validated target that in the past several years have been the focus of several clinical programs. The findings we're presenting at AACR 2024 represent the unique features of BND-35 and why we believe it has the potential to surpass other ILT3 targeting agents," said Motti Hakim, Ph.D., VP R&D at Biond Biologics. "BND-35's ability to remodel the immunosuppressive environment into a pro-inflammatory one, opens new doors for treating solid tumors and our research in this field brings a significant leap forward in our understanding of immune regulation within the TME," Tsuri Peretz, BND-35 project manager at Biond Biologics, added, "We are eager to share our latest advancements with the scientific community. BND-35's compelling preclinical results pave the way for its upcoming first-in-human clinical trial, marking a pivotal step in our quest to provide innovative solutions for patients with solid tumors." In addition to the spotlight on BND-35, Biond Biologics continues to advance its Immuno-Oncology pipeline, including the pre-clinical-stage BND-67 program, and the innovative INspire platform for intracellular delivery of biologics. The presentation will underscore Biond's commitment to groundbreaking research and development, aiming to unlock new pathways for cancer treatment. About Biond Biologics Biond Biologics is at the forefront of developing cutting-edge therapies targeting novel oncology pathways and enabling the intracellular delivery of biologics. By exploring immunoregulatory pathways and pioneering technological platforms, Biond aims to translate advanced science and innovative thinking into transformative drugs for diseases with significant unmet needs. Biond's programs include BND-22 that was partnered with Sanofi, a multi-cell checkpoint first in class ILT2 blocking antibody, and BND-67, a novel agent developed for attenuating CD28 shedding, overcoming PD-1 blockade resistance; an immune evasion mechanism discovered by Biond's scientists. The company is also developing BND-35 – an ILT3 blocking antibody, that targets suppressive myeloid cells in the tumor microenvironment. In addition to its pipeline of immunotherapy agents, Biond is developing INspire – an innovative technological platform that enables the intracellular delivery of protein therapeutics, such as antibodies, proteins or enzymes, into cells. Using INspire, Biond targets, for example, the RAS-RAF signaling pathway, which is a driver in many cancers. Company contact: Tal Sines VP of Business Development Biond Biologics Ltd. +972-4 884 4337 tal.sines@biondbio.com