Biond Biologics Announces First Patients Dosed with BND-22 (SAR444881) Combinations in Phase 1 Clinical Trial

First patients dosed in study sub-part evaluating BND-22 in combination with pembrolizumab or with cetuximab

In April 2021, Biond initiated a phase 1 study to evaluate the safety, tolerability, and anti-tumor activity of BND-22 in advanced cancer patients with tumor types known to express the immunosuppressive protein HLA-G

BND-22 is being developed as part of an exclusive worldwide license agreement with Sanofi

MISGAV, Israel, May 23, 2022 /PRNewswire/ -- Biond Biologics Ltd. ("Biond" or the "Company"), a private clinical-stage biopharmaceutical company, developing novel immunotherapies for cancer and a platform enabling the intracellular delivery of biologics, today announced that first patients have been dosed in the first-in-human, phase 1 clinical trial's sub-part evaluating BND-22 (SAR444881), an Ig-Like Transcript 2 (ILT2) receptor blocking antibody, in combination with pembrolizumab or with cetuximab.

The phase 1 trial is an open-label, dose escalation and expansion study exploring the safety, tolerability, pharmacokinetics (PK), anti-tumor activity, and exploratory biomarkers for BND-22 activity in patients with select advanced solid tumors. The trial is enrolling participants in medical centers in the USA and Israel.

"Immune checkpoint inhibitor-based therapeutic combinations have demonstrated improvement over existing standards of care in multiple tumor types," said Salomon M. Stemmer, M.D., Research Unit Head, Head of Research, Innovation and Development and Deputy Head Davidoff Center, Rabin Medical Center, and a clinical investigator in the trial. "We look forward to continuing the investigation of BND-22, an immunotherapy targeting both adaptive and innate immune cells, both as a single agent and as part of novel combinations."

"While approved immunotherapies and tumor targeting antibodies have transformed cancer care, an urgent need to develop new approaches for the treatment of advanced cancer patients remains," said Itay Friedman, M.D., VP of Clinical Development at Biond. "Concurrently targeting different immune pathways, dysregulated in tumors may result in an enhanced anti-tumor effect. We are excited to initiate the next part of BND-22' phase 1 trial exploring the inhibition of ILT2 in combination with potentially complementing therapeutics."

In January 2021, Biond announced 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-in-human, phase 1 study of BND-22, evaluating its safety and tolerability as a single agent and in combination with approved cancer therapeutics as well as exploring the association between BND-22 anti-tumor activity and select tumor and blood-based biomarkers; Sanofi will assume clinical development and commercialization responsibilities thereafter.

About BND-22 (SAR444881)

BND-22 is a humanized IgG4, antagonist antibody targeting the ILT2 receptor in development for the treatment of solid tumors. ILT2, a member of the ILT family of immuno-modulating receptors, is an inhibitory receptor expressed on both innate and adaptive immune cells that binds major histocompatibility complex (MHC) class I molecules including HLA-G, an immunosuppressive protein expressed by multiple tumor types. BND-22 has been shown in preclinical studies to have a broad anti-tumor effect by targeting ILT2-mediated "do not eat me" signals in macrophages and by activating NK and CD8+ lymphocytes. The program is supported by a comprehensive biomarker strategy designed to guide patient enrollment in advanced clinical trials. BND-22-001 is the first-in-human clinical trial of BND-22. It is a Phase 1/2 multicenter, open label, dose escalation and expansion study enrolling advanced cancer patients with solid tumor types known to express HLA-G. For more information about the trial, including participating medical centers, please visit https://clinicaltrials.gov/

(Trial Identifier: NCT04717375).

About Biond Biologics

Biond Biologics is a drug discovery and development company focused on developing innovative therapies for novel oncology targets by uncovering immunoregulatory pathways and by enabling the intracellular delivery of biologics. Biond aims to translate high quality science and out-of-the-box, disruptive thinking into transformational drugs for diseases with high unmet needs. The company's vision is to deliver innovative medicines to patients while fostering synergistic long-term collaborations with leading biopharmaceutical companies. Biond's leading development programs include BND-22, a multi-cell checkpoint inhibitor targeting ILT2, and BND-67, a novel agent developed for overcoming PD-1 blockade resistance by targeting soluble CD28; an immune evasion mechanism discovered by Biond 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 or enzymes, into cells.

Biond was founded in 2016, by Tehila Ben Moshe, Ph.D., Ori Shilo, and other accomplished scientists and drug developers from the Israel biopharmaceutical industry. Israel Biotech fund, Harel Insurance, Deep Insight and Bristol Myers Squibb (BMS) are among Biond shareholders. For more information, visit www.biondbio.com.

Company contact:
Tal Sines, PhD
Biond Biologics Ltd.
+972-53 952 0493
[email protected]

SOURCE Biond Biologics Ltd.