Biond Biologics Launches Phase 2 Study for Innovative Cancer Treatment BND-22

Biond Biologics Launches Phase 2 Clinical Trial for BND-22

Biond Biologics Ltd., a private biopharmaceutical firm focused on developing advanced immunotherapies for cancer and autoimmune conditions, has unveiled the commencement of a Phase 2 clinical study for its innovative BND-22 treatment. This trial will assess the efficacy of BND-22 (also recognized as SAR444881) in conjunction with anti-PD-1 therapy, specifically targeting patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have either previously undergone immune-oncology treatments or are naïve to anti-PD-1/PD-L1 therapies, especially those with mismatch repair proficient colorectal cancer (MSS-CRC) or ovarian cancer. This information is cataloged under ClinicalTrials.gov identifier NCT06651593.

The clinical study is headed by Dr. Aung Naing from The University of Texas MD Anderson Cancer Center. This Phase 2 trial aims to include participants whose tumors exhibit expression of HLA-G, known to be linked to the ILT2 receptor. Identifying these biomarkers is crucial, as they are anticipated to provide insights into the treatment's action mechanisms and to help predict patient responses, thereby informing future therapeutic directions.

The primary goals are multifaceted: to explore biomarkers associated with the efficacy of BND-22 as a standalone treatment and in tandem with anti-PD-1 therapy, and to evaluate predictors of response, survival, and treatment resistance. Secondary aims include assessing the safety, tolerability, and overall effectiveness of this drug combination. Importantly, Biond Biologics maintains exclusive rights to develop and commercialize BND-22 globally.

Dr. Natalia Ashtamker, the Vice President of Clinical Development at Biond, emphasized that the launch of this biomarker study stems from encouraging results observed in the initial Phase 1/2 dose-escalation evaluations of BND-22. These earlier studies indicated a favorable safety profile and notable anti-tumor responses, both as a standalone treatment and in combination with other approved therapies. Observations included dose-dependent activation of immune responses in ILT2-expressing T cells, natural killer (NK) cells, and monocytes, corroborated by several confirmed clinical responses in patients deemed heavily pre-treated.

Dr. Ashtamker commented, "The biomarker-rich nature of this study is essential for advancing our understanding of BND-22 and its capabilities as a multi-cell checkpoint inhibitor. By integrating it with PD-1 blockade and performing thorough profiling of patient samples, we hope to expedite BND-22's progression into registration trials. Our ultimate goal is to serve the patients who stand to gain the most from this innovative treatment. Additionally, we continue to provide care for patients from the Phase 1/2 trial who have shown sustained responses to BND-22."

A Deeper Look at BND-22

BND-22 represents a groundbreaking humanized IgG4 antagonist antibody targeting the ILT2 receptor, crucial for the treatment of solid tumors. The ILT2 receptor plays a vital role in modulating immune responses, inhibiting immune cell activity by binding to major histocompatibility complex (MHC) class I molecules, including HLA-G, a protein linked to various tumor types.

Through preclinical studies, BND-22 has displayed promise in thwarting ILT2-mediated immunosuppressive signals that deter macrophage activity while simultaneously activating NK cells and CD8+ T lymphocytes, thereby prompting significant anti-tumor responses.

The previous Phase 1/2 study of BND-22 confirmed its safety and tolerability when administered as a monotherapy or in conjunction with other anti-cancer agents like cetuximab and pembrolizumab. This critical study encompassed evaluations of BND-22 as a standalone treatment, particularly focusing on cholangiocarcinoma, and as an adjunct therapy in NSCLC and MSS-CRC.

Biond Biologics, founded in 2016 by Dr. Tehila Ben Moshe, Dr. Ori Shilo, and a dedicated team of scientists from Israel's biopharmaceutical realm, continues to push the envelope in drug discovery and development. The company is committed to addressing unmet medical needs in oncology, with BND-22 functioning as a premier candidate within their clinical pipeline. They are also concentrating on their other promising lead, BND-35, an innovative anti-ILT3/LILRB4 blocking antibody to further enhance therapeutic options for patients battling solid tumors.

For more detailed information about Biond Biologics and its initiatives, visit Biond Biologics Official Website.