Biond Biologics Announces First Patient Received BND-22 Assay in Phase 1 Clinical Trial of BND-22, a New Immune Checkpoint Inhibitor Targeting the ILT2 Receptor
MISGAV, Israel, April 26, 2021 / PRNewswire / – Biond Biologics Ltd. (“Biond” or the “Company”), a privately-held, clinical-stage biopharmaceutical company developing novel cancer immunotherapies and a platform for intracellular delivery of biologics, today announced that the first patient received a phase 1 clinical trial of BND-22 (SAR444881), an antibody blocking the Ig-Like Transcript 2 (ILT2) receptor.
The first patient received BND-22 at the oncology research unit at Sourasky Medical Center in Tel Aviv, Tel Aviv, Israel, one of six United States and Israel trial sites initially planned to participate in the phase 1, open-label, dose-escalating study exploring safety, tolerability, pharmacokinetics (PK), antitumor activity and biomarkers BND-22 activity in patients with certain advanced solid tumors.
“BND-22 represents a novel approach to cancer immunotherapy targeting both adaptive and innate immune cells, ”said Geva delights, MD, research unit head and deputy director, oncology division at Sourasky Medical Center in Tel Aviv, and clinical researcher in the trial. “There is still an urgent need to develop new treatments for patients with cancers refractory to standard treatment. BND-22 has demonstrated compelling preclinical activity, and we look forward to further investigating the potential for ILT2 blockade in this Phase 1 study.
“The entrance to BND-22 clinical trial is an important milestone for Biond as it represents the achievement of an important aspect of the company’s vision to advance our new drugs in clinical evaluation while utilizing our drug discovery, development and translation capabilities ” , said Tehila Ben Moshe, Ph.D., co-founder and CEO of Biond. “BND-22, a multicellular checkpoint inhibitor, has been studied extensively by our scientific team for several years and has been shown to have the potential to improve current treatment paradigms, either as monotherapy or in combination. Based on extensive translational studies of real-world patient samples, we designed the Phase 1 trial to focus on the patient populations that we believe are most likely to respond to blockade. ILT2. We look forward to the results of the BND-22-001 as we strive to improve the treatment of cancer patients in urgent need of new therapies. “
Biond announced on January 12e, 2021 an exclusive worldwide license agreement with Sanofi, for the development and commercialization of BND-22. Under the terms of the agreement, Biond will lead the first Phase 1 human study of BND-22, evaluating its safety and tolerability in monotherapy and in combination with approved anticancer treatments and exploring the association between BND-22 anti-tumor activity and selection of tumor and blood biomarkers; Sanofi will then assume clinical development and commercialization responsibilities.
BND-22 is a humanized IgG4, antagonist antibody targeting the ILT2 receptor under development for the treatment of solid tumors. ILT2, a member of the ILT family of immunomodulatory receptors, is an inhibitory receptor expressed on both innate and adaptive immune cells that binds to major histocompatibility complex (MHC) class I molecules, including HLA- G, an immunosuppressive protein expressed by several types of tumors.
BND-22 has been shown in preclinical studies to have a broad anti-tumor effect by targeting ILT2-mediated “don’t eat me” signals in macrophages and by activating NK and CD8+ lymphocyte. The program is supported by a comprehensive biomarker strategy designed to guide patient recruitment into advanced clinical trials.
BND-22-001 is the first human clinical trial of BND-22. This is a phase 1/2, open-label, dose-escalating, multicenter study of advanced cancer patients with solid tumor types known to express HLA-G. Following dose escalation and determination of the recommended phase 2 dose of BND-22, the study design allows for the expansion of patient cohorts to assess the anti-tumor activity of BND-22 in specific tumor types. BND-22-001 is planned to be extended to also assess the safety and anti-tumor activity of BND-22 in combination with other therapies. For more information about the trial, including participating medical centers, please visit https://clinicaltrials.gov/ (Test ID: NCT04717375).
About Biond Biologics
Biond Biologics is a drug discovery and development company focused on developing innovative therapies for novel oncology targets by discovering immunoregulatory pathways and enabling intracellular delivery of biologics. Biond aims to translate high-quality science and out-of-the-box disruptive thinking into transformational medicines for diseases with high unmet need. The company’s vision is to deliver innovative drugs to patients while fostering long-term synergistic collaborations with leading biopharmaceutical companies.
Biond’s main development programs include BND-22, a multicellular checkpoint inhibitor targeting ILT2, and BION-206, a novel agent developed to overcome resistance to PD-1 blockade by targeting soluble CD28; an immune escape mechanism discovered by scientists at Biond. The company is also developing BND-35 – an antibody blocking ILT3, which targets myeloid suppressor cells in the tumor microenvironment.
In addition to its pipeline of immunotherapy agents, Biond is developing INspire – an innovative technology platform that enables the intracellular delivery of therapeutic proteins, such as antibodies or enzymes, into cells.
Biond was founded in 2016, by Tehila Ben Moshe, Ph.D., Ori shilo, and a team of accomplished scientists and drug developers from Israel biopharmaceutical industry. The main investors in the company are the Israel Biotech Fund (“IBF”) and Harel Insurance. For more information visit www.biondbio.com.
Company details :
Itay Friedman, MD
VP Clinical Development
Biond Biologics Ltd.
+ 972-4 884 4337
SOURCE Biond Biologics Ltd.