Harbour BioMed Announces License Agreement with Windward Bio for HBM9378/SKB378, an Anti-TSLP Fully Human Antibody for Immunological Diseases

CAMBRIDGE, Mass., ROTTERDAM, Netherlands and SHANGHAI, Jan. 10, 2025 /PRNewswire/ -- Harbour BioMed (HKEX: 02142, the "Company"), a global biopharmaceutical company committed to the discovery, development and commercialization of novel antibody therapeutics focusing on immune-oncology and immunology, today announced that the Company and Sichuan Kelun Biotech BioPharmaceutical (HKEX: 06990, "Kelun-Biotech") have entered into a license agreement with Windward Bio AG ("Windward Bio") for HBM9378/SKB378, an anti-thymic stromal lymphopoietin (TSLP) fully human monoclonal antibody co-developed by Harbour BioMed and Kelun-Biotech.

Under the terms of the agreement, Windward Bio is granted an exclusive license to research, develop, manufacture, and commercialize HBM9378/SKB378 globally, excluding Greater China and several Southeast and West Asian countries. In return, Harbour BioMed and Kelun-Biotech are eligible to receive a total of up to $970 million upfront and milestone payments, as well as tiered royalties ranging from single to double digits on net sales. The $45 million upfront and near-term milestone payments include both cash payment and an equity interest in Windward Bio's parent company. Furthermore, Harbour BioMed and Kelun-Biotech are eligible to receive additional payments if Windward Bio undergoes a near-term change of control or enters into a sublicense agreement with a third party. All payments under the license agreement shall be paid in equal amounts to Harbour BioMed and Kelun-Biotech.

In connection with the license agreement, Windward Bio announced a $200 million Series A financing round led by OrbiMed, Novo Holdings, and Blue Owl Healthcare Opportunities, along with co-investors SR One, Omega Funds, RTW Investments, Qiming Venture Partners, Quan Capital, and Pivotal bioVenture Partners.

"We are delighted to partner with Windward Bio to advance the development of HBM9378/SKB378, a promising TSLP-targeted fully human antibody with significant potential to address immunological diseases," said Dr. Jingsong Wang, Founder, Chairman & CEO of Harbour BioMed. "This collaboration demonstrates the value of our Harbour Mice^® technology platform and reflects our commitment to bring transformative treatments to patients worldwide."

About HBM9378/SKB378

HBM9378/SKB378 (now also known as WIN378) is a co-development project jointly conducted by Harbour BioMed and Kelun-Biotech, with both parties equally sharing the global rights. It is a fully human monoclonal antibody targeting TSLP, generated from the two heavy chains and two light chains (H2L2) Harbour Mice^® platform. It inhibits the TSLP-mediated signaling pathway by blocking the interaction between TSLP and its receptor, which is a well-validated cytokine plays a key role in the development and progression of various immunological conditions, including asthma and chronic obstructive pulmonary disease (COPD). Inhibition of this pathway has shown benefits across multiple inflammatory phenotypes. The antibody's long half-life optimization and outstanding biophysical properties provide a favorable dosing advantage.

Prior to the execution of the license agreement, Harbour BioMed submitted an Investigational New Drug (IND) application to the Centre for Drug Evaluation of the National Medical Products Administration (NMPA) in China for HBM9378/SKB378 for the treatment of COPD in November 2024. The company has also completed a phase I clinical trial in China under an IND for the treatment of moderate-to-severe asthma.

About Harbour BioMed

Harbour BioMed (HKEX: 02142) is a global biopharmaceutical company committed to the discovery, development, and commercialization of novel antibody therapeutics focusing on immunology and oncology. The Company is building its robust portfolio and differentiated pipeline through internal R&D capability, collaborations with co-discovery and co-development partners, and select acquisitions.

The proprietary antibody technology platform Harbour Mice^® generates fully human monoclonal antibodies in two heavy and two light chains (H2L2) format, as well as heavy chain only (HCAb) format. Building upon the HCAb antibodies, the HCAb-based immune cell engagers (HBICE^®) bispecific antibody technology is capable of delivering tumor-killing effects unachievable by traditional combination therapies. Integrating Harbour Mice^®, and HBICE^® with a single B cell cloning platform, our antibody discovery engine is highly unique and efficient for the development of next-generation therapeutic antibodies. For further information, please refer to www.harbourbiomed.com.

About Windward Bio AG

Windward Bio is a clinical-stage, drug development company committed to improving outcomes for people living with advanced immunological conditions with an initial focus on severe respiratory conditions. It is led by a highly experienced team of biopharmaceutical executives with deep discovery, development expertise and with repeated success in bringing compounds from target identification through commercialization. Collectively, they have contributed to more than 15 product launches and executed two Nasdaq IPOs and two sales.