#Israel #Cancer Immunotherapy #Biond Biologics #Misgav #BND-67

Biond Biologics Launches Phase 1 Trial for Novel Immunotherapy BND-67

Biond Biologics Ltd., a promising player in the field of cancer immunotherapies, has officially dosed the first patient in their exciting Phase 1 clinical trial for BND-67. This noteworthy study targets advanced solid tumors and is an innovative approach to enhance anti-tumor immunity by preventing CD28 shedding. In clinical research, CD28 shedding has been identified as an immune evasion mechanism, making this therapy groundbreaking in its potential effectiveness against cancer.

The trial is taking place at the prestigious Institute of Oncology at Davidoff Center, Rabin Medical Center in Israel, where the first patient underwent treatment. The design of this trial includes a BND-67 monotherapy lead-in, which will be followed by a combination therapy with an anti-PD-1 agent for patients who have previously experienced a relapse after responding to immune checkpoint therapy.

Professor Salomon Stemmer, M.D., a key investigator in this trial and the Deputy Director at the Davidoff Center, emphasized the unmet medical need for patients who relapse after showing responses to immunotherapy. He stated, "BND-67 is based on a compelling biological rationale and targets a previously unexplored immune dysfunction mechanism like CD28 shedding. We are pleased to explore its potential benefits for patients with advanced solid tumors."

Understanding BND-67's Mechanism of Action

What sets BND-67 apart from other therapies is its dual mechanism of action: it enhances effector T-cell activity while reducing the differentiation of regulatory T-cells. This approach aims to reinstate robust anti-tumor immunity, an area that has been a challenge in oncology treatments. Giovanni Selvaggi, M.D., Chief Medical Officer of Biond, elaborated on the significance of targeting CD28 shedding, indicating that preserving the physiological CD28 signaling is crucial for optimal anti-tumor immune responses without the adverse effects usually associated with CD28 agonism.

Preliminary results from the trial have also shown that BND-67 at a dose of 0.3 mg/kg is safe and well-tolerated, with the first participant completing the monotherapy phase without any dose-limiting toxicities or adverse infusion reactions. Following this step, they will receive the drug in combination with nivolumab, an established anti-PD-1 therapy.

The Impact of BND-67 on the Future of Cancer Treatment

The development of BND-67 marks a significant advancement in cancer immunotherapy, as it aims to address the challenge of CD28 shedding that hinders T-cell activation—a critical component in the immune response against tumors. In cancer patients, specific matrix metalloproteases (MMPs) potentially cleave CD28 from the T-cell surface, leading to diminished immune responses and decreasing effectiveness of tumor therapies. By preventing this shedding, BND-67 is poised to enhance T-cell activation and inhibit regulatory T-cell differentiation, thereby potentially wielding a powerful anti-tumor response.

Biond Biologics aims to make significant strides not only in oncology but also in immune-mediated diseases with an expanding portfolio of pipeline programs. Their commitment to leveraging novel pathways is reflected in their active projects, including BND-22, another antibody targeting the ILT2 receptor to enhance anti-tumor activity in solid tumors.

Founded in 2016 by accomplished scientists and drug developers from the Israeli biopharmaceutical landscape, Biond Biologics stands at the forefront of this crucial battle against cancer. As they progress through their clinical trials, the scientific community and patients alike are eagerly awaiting further findings regarding BND-67 and its potential as a new standard therapy.

In a landscape where innovative solutions are urgently needed, Biond Biologics continues to pave the way for groundbreaking therapies that could revolutionize cancer treatment and bring hope to numerous patients battling advanced solid tumors.