Sanofi and Biond Biologics Enter $1.1 Billion Global Collaboration to Develop ILT2 Antibody Inhibitor BND-22 for Solid Tumors

Compiled by Hemingway

On January 12, Biond Biologics, a company developing a platform for cancer immunotherapy, announced that it had entered into an exclusive global licensing agreement with Sanofi (SNY) to develop and commercialize BND-22.

BND-22 is a humanized IgG4 antibody antagonist targeting the immunoglobulin-like transcript 2 (ILT2) receptor, indicated for the treatment of solid tumors. ILT2 is a member of the ILT family of immunomodulatory receptors and functions as an inhibitory receptor expressed on both innate and adaptive immune cells. It binds to MHC class I molecules, including HLA-G, an immunosuppressive protein expressed by various tumor types.

Under the terms of the agreement, Biond will receive a $125 million upfront cash payment and is entitled to over $1 billion in development, regulatory, and commercial milestone payments, as well as tiered royalties in the double digits. In the course of implementation, Biond will lead the Phase Ia clinical studies of BND-22 to evaluate its safety and tolerability both as a monotherapy and in combination with approved cancer therapies, and to explore potential correlations between the antitumor activity of BND-22 and selected tumor and hematologic biomarkers. Thereafter, Sanofi will assume responsibility for clinical development and commercialization.

Previous preclinical studies have demonstrated that BND-22 exerts broad antitumor effects by activating natural killer (NK) cells and CD8+ T lymphocytes through targeting ILT2-mediated “don’t eat me” signaling in macrophages. The Investigational New Drug (IND) application for BND-22 has recently been submitted to the U.S. Food and Drug Administration (FDA), with Phase I clinical trials planned to commence in mid-2021 to evaluate the safety, tolerability, and preliminary antitumor activity of BND-22 in patients with advanced cancer.

To date, the development of cancer immunotherapy has primarily focused on drugs that stimulate the adaptive immune system to attack malignant cells, particularly T lymphocytes. However, a limitation of this strategy is that many patients with advanced-stage cancer do not achieve durable benefits from these agents. In contrast, BND-22, as a novel immunotherapeutic agent, targets both adaptive and innate immune cells. It leverages not only T cells but also the antitumor activities of other immune cells, such as natural killer (NK) cells and macrophages.

Biond Biologics is a drug discovery and development company dedicated to developing innovative therapies for novel oncology targets by discovering immune modulation pathways and enabling intracellular delivery of biologics. Biond’s pipeline is built on internal research into newly discovered immune checkpoints and immune evasion mechanisms. Its leading development programs include BND-22, a multi-cell checkpoint inhibitor targeting ILT2, and BION-206, a novel agent that overcomes resistance to PD-1 blockade by targeting soluble CD28.

In addition to its immunotherapy drug production line, Biond has developed INspire, an innovative technology platform capable of delivering biologics intracellularly. INspire is based on chemically modified carrier proteins that can be conjugated with protein therapeutics (such as antibodies or enzymes) and is designed to deliver these conjugated therapeutics into cells, thereby enabling access to many key disease targets currently considered “undruggable.”

Reference Source: Biond Biologics and Sanofi Enter into Global Licensing Agreement for BND-22, a Novel Immune Checkpoint Inhibitor Targeting the ILT2 Receptor