#Israel #Biond Biologics #BND-22 #ILT2 receptor #Misgav

Biond Biologics Regains Full Rights to BND-22

In an exciting development from Biond Biologics Ltd., the company has announced the full reacquisition of rights to BND-22 (SAR444881) from Sanofi, marking a pivotal moment in its mission to innovate cancer therapies. This agreement follows a successful Phase 1 dose-escalation trial that demonstrated the drug's favorable safety profile and anti-tumor effects. BND-22 is an immune checkpoint inhibitor specifically designed to target the ILT2 receptor, which plays a crucial role in modulating immune system responses against solid tumors.

Since entering an exclusive global licensing agreement with Sanofi in January 2021, Biond collaborated with the pharmaceutical giant to advance BND-22 through initial clinical investigations. Together, they initiated a Phase 1 study (BND-22-001, NCT04717375) that explored the safety and tolerability of BND-22 utilized both as a stand-alone treatment and in conjunction with existing therapies like cetuximab and pembrolizumab. The results were incredibly promising, with numerous patients showing positive responses, especially those who had already undergone extensive prior treatments.

The Phase 1 study not only confirmed safety but also indicated a noteworthy immune response; specifically, it showed a dose-dependent increase in activation markers in immune cell subsets. This exciting data has set the stage for BND-22 to transition into Phase 2 trials, where its effectiveness is currently being evaluated as a monotherapy for cholangiocarcinoma and in combination with cetuximab for patients with non-small cell lung cancer (NSCLC) and colorectal cancer (CRC).

Dr. Tehila Ben Moshe, CEO and co-founder of Biond, expressed her enthusiasm about the reacquisition, stating, "Sanofi has been an outstanding partner, and together, we have made remarkable progress in advancing the clinical development of BND-22. As we regain full rights to the drug, we are committed to pushing forward with its development, either independently or through strategic collaborations."

The Phase 2 study initiated by Sanofi aims to optimize dosing and expand treatment options for BND-22, addressing significant unmet medical needs in oncology. Additionally, there are plans for a future biomarker study that will examine the combination of BND-22 with anti-PD-1 therapies in various cancers, a further testament to its potential.

BND-22 itself is a humanized IgG4 antagonist antibody targeting the inhibitory ILT2 receptor, which is found both on innate and adaptive immune cells. By interrupting the interactions of this receptor with MHC class I molecules, including the immunosuppressive protein HLA-G commonly found in tumors, BND-22 aims to reactivate the immune system's ability to recognize and destroy cancer cells. Notably, prior preclinical studies have indicated that BND-22's mechanism can disrupt the 'do not eat me' signals that protect cancer cells from immune targeting, a breakthrough in treatment strategy.

As Biond Biologics continues to make strides in developing innovative therapies, their pipeline isn't solely limited to BND-22. They are also working on BND-35, an antibody that targets ILT3/LILRB4, enhancing the immune response against cancerous cells. Moreover, BND-67, another promising candidate, aims to maintain T cell activation by preventing the shedding of CD28, significantly improving immune response durability against tumors.

With a prescribed focus on leveraging immunoregulatory pathways for oncology, Biond Biologics demonstrates significant potential not only in improving treatment outcomes for patients but also in innovating the future of cancer therapy. The successful reacquisition of BND-22 and the promising results from the ongoing studies underscore their commitment to addressing the urgent needs within the oncology sector.

For more information about the Phase 2 study, interested individuals can visit ClinicalTrials.gov with the trial identifier NCT04717375.

Biond Biologics continues to pave the way for advancements in cancer therapy and remains a key player in the biopharmaceutical landscape, showcasing their dedication to innovation, research, and patient care.