BETHESDA, MD, USA & PANGYO, South Korea I February 15, 2022 I ValenzaBio, Inc., a biopharmaceutical company developing monoclonal antibody (mAb) therapeutics for autoimmune and inflammatory indications, and Novelty Nobility Inc, a biotechnology company specializing in the design, discovery, optimization, and early stage development of next generation antibodies, today announced an exclusive worldwide license agreement for the development and commercialization of VB517, a potentially best-in-class anti-c-KIT mAb for mast cell-driven autoimmune diseases. c-KIT is a receptor tyrosine kinase critical to the survival and activation of mast cells. Blocking c-KIT has been shown to reduce mast cell degranulation and induce mast cell depletion in clinical studies. VB517 is a fully human mAb with low-picomolar affinity for c-KIT and has demonstrated potent suppression of human mast cell activation in preclinical models. ValenzaBio plans to initiate clinical studies of VB517 in 2023.

“We are thrilled to expand our pipeline of mAb therapeutics for the treatment of autoimmune and inflammatory diseases with the addition of VB517,” said William Bonificio, Ph.D., chief strategy officer of ValenzaBio. “The impressive preclinical package assembled to date by Novelty Nobility suggests VB517 may offer best-in-class potential for the treatment of mast cell-driven diseases, including chronic urticaria. We’re privileged to partner with Novelty Nobility as we seek to rapidly advance VB517 through an IND-enabling program and into clinical studies next year.”

“ValenzaBio has an established pipeline of potentially best-in-class therapies for autoimmune diseases, making them an ideal partner for our anti-c-KIT program”, said Jin Cho, MBA, chief finance and business officer of Novelty Nobility. “As Novelty Nobility remains focused on ocular diseases with our intravitreal formulation of the anti-c-KIT mAb, we believe the team at ValenzaBio is capable of unlocking the huge potential of this modality in autoimmune diseases.”

Under the terms of the agreement, Novelty Nobility received an undisclosed upfront payment from ValenzaBio and is eligible to receive certain sales royalties and additional development and sales milestones.

About ValenzaBio, Inc.
ValenzaBio is a privately held biopharmaceutical company developing safe and effective therapies for autoimmune and inflammatory diseases. The company is advancing a pipeline of differentiated monoclonal antibodies with best-in-class properties, targeting clinically validated mechanisms of action, to provide improved treatment options for patients. VB517 joins ValenzaBio’s clinical stage program, VB119, currently enrolling trials in renal autoimmune indications, and VB421, which is expected to begin clinical trials in thyroid eye disease this year. ValenzaBio is based in Bethesda, MD.

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About Novelty Nobility Inc.
Novelty Nobility is a private biotech company with a mission to improve the lives of patients with underserved medical needs. Novelty Nobility has built a humice-based, unique fit-for-purpose antibody discovery engine (PREXISE-D) and develops monoclonal and bispecific antibodies and antibody-drug conjugates (ADCs), as well as a next-generation, site-specific ADC linker technology (PREXISE-L). The company primarily focuses on oncology, but is brave enough to dive deeply into other areas such as ophthalmology or autoimmune disease where its scientific novelty can make an impact on patients’ lives.

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SOURCE: Valenza Bio