• APB-A1 targets the clinically validated CD40L/CD40 biology which is central to a wide range of attractive neuroimmune indications
  • APB-A1 is a novel and differentiated biotherapeutic with strong preclinical evidence 
  • Deal accelerates the Lundbeck strategy to expand R&D activities within neuroimmunology
  • Follows the Lundbeck strategy of tractable and biomarker driven development programs in diseases of high unmet need

VALBY, Denmark I October 14, 2021 I H. Lundbeck A/S (Lundbeck) announced that it has entered into a definitive agreement with AprilBio Co., Ltd. (AprilBio), a biopharmaceutical company based in South Korea dedicated to developing specialized biologics and antibody drugs.

Under the agreement between the two companies, Lundbeck receives exclusive, worldwide rights to research, develop and commercialize APB-A1, a novel and well-differentiated anti-CD40 ligand (CD40L) antibody-like drug candidate, ready for phase I testing around the beginning of 2022. This novel drug candidate offers significant potential across a wide array of neuroimmune diseases.

Dr. Johan Luthman, EVP and Head of Research & Development in Lundbeck, said:

I am excited to announce this partnership with AprilBio around their interesting novel anti-CD40L antibody-like molecule that accelerates our R&D strategy within neuroimmunology, one of our four strategic biological focus areas. Based on promising preclinical data, this project has the potential to offer new, potent and differentiated therapies for several different types of neuroimmune diseases”.

The agreement enables Lundbeck to initiate clinical activities targeting the neuroimmune system. The concept is built on a biology that has proven its ability to therapeutically target diseases of the central nervous system. APB-A1 will accelerate internal experience and expertise that in turn will enable building a broader pipeline for Lundbeck in this area.

“We are also glad to join hands with Lundbeck, which leads the global brain disease treatment industry,” AprilBio CEO Dr. Sang-hoon Cha said in a statement. “We expect that possibilities to successfully develop a new drug for treating multiple neuroimmune diseases will increase through this partnership.”

Under the terms of the license agreement, Lundbeck will make a one-time payment to AprilBio of USD 16 million in cash. In addition, Lundbeck will pay AprilBio success-based development, regulatory, and sales milestone payments of up to USD 432 million related to APB-A1. Lundbeck will also pay AprilBio tiered royalty payments with the highest tier reaching low double-digit percentage of net sales. Lundbeck will be responsible for all future development activities and expenses related to the project.

About APB-A1
APB-A1 is a neutralizing anti-CD40L antibody-like drug candidate with an innovative molecular design blocking the essential CD40L/CD40 co-stimulatory interaction. The activation of the CD40L/CD40 signaling cascade is essential for the initiation of cellular and humoral immune responses. It is an established and clinically validated immune pathway through its ability to trigger activation, differentiation and proliferation of B-cells, T-cells, and several other immunes cells (such as monocytes, macrophages, dendritic cells, natural killer cells) to mediate immune responses. Modulating the CD40L/CD40 interaction therefore holds great promise for treatment of a wide range of autoimmune related CNS disorders and neurological diseases.

APB-A1 is a human, high affinity, anti-CD40L antibody-like fusion protein that is designed to inhibit the CD40L/CD40 pathway through neutralization of CD40L presented on activated T-cells, and consequently significantly attenuating the initiated immune response. In preclinical studies, APB-A1 has demonstrated engagement with CD40L leading to decreased antibody response and circulating inflammatory markers. One of the differentiating aspects of the APB-A1 design is its ability to utilize human serum albumin for half-life extension translating into superior clinical features.

About AprilBio
AprilBio Co., Ltd. is a biopharmaceutical company in South Korea founded in 2013. The company is specialized in development of specialized biologics and antibody drugs. The company’s platform technologies include a human phage-display Ab library and Anti-Serum Albumin Fab-Associated (SAFA) technology (versatile building block for half-life extension and generation of novel biological therapeutics). AprilBio is focused on rare diseases, oncology, autoimmune and inflammatory diseases.

About H. Lundbeck A/S
H. Lundbeck A/S (LUN.CO, LUN DC, HLUYY) is a global pharmaceutical company specialized in brain diseases. For more than 70 years, we have been at the forefront of neuroscience research. We are tirelessly dedicated to restoring brain health, so every person can be their best.

Too many people worldwide live with brain diseases – complex conditions often invisible to others that nonetheless take a tremendous toll on individuals, families and societies. We are committed to fighting stigma and discrimination against people living with brain diseases and advocating for broader social acceptance of people with brain health conditions. Every day, we strive for improved treatment and a better life for people living with brain disease.

We have approximately 5,600 employees in more than 50 countries, and our products are available in more than 100 countries. Our research programs tackle some of the most complex challenges in neuroscience, and our pipeline is focused on bringing forward transformative treatments for brain diseases for which there are few, if any therapeutic options. We have research facilities in Denmark and the United States, and our production facilities are located in Denmark, France, and Italy. Lundbeck generated revenue of DKK 17.7 billion in 2020 (EUR 2.4 billion; USD 2.7 billion).

For additional information, we encourage you to visit our corporate site www.lundbeck.com and connect with us on Instagram (h_lundbeck), Twitter at @Lundbeck and via LinkedIn.

SOURCE: Lundbeck