Palleon Pharmaceuticals and Henlius Enter into Strategic Collaboration to Develop Bifunctional Sialidase Therapies

- Palleon and Henlius to co-develop Bifunctional HER2-Sialidase and a second bifunctional sialidase to be jointly designed –

- Henlius received exclusive license for two products in China (including Hong Kong, Macau, and Taiwan); Palleon retains all other global rights -

- Palleon receives upfront payment and is eligible for up to $196.5 million in milestone payments -

Palleon Pharmaceuticals, a company pioneering the field of glyco-immunology to treat cancer and inflammatory diseases, today announced a strategic collaboration with Shanghai Henlius Biotech, Inc. (2696.HK) to develop and commercialize two bifunctional sialidase programs from Palleon’s EAGLE (Enzyme-Antibody Glyco-Ligand Editing) immuno-oncology platform, including Palleon’s Bifunctional HER2-Sialidase now in preclinical development and a second bifunctional sialidase to be developed with a proprietary target provided by Henlius.

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Palleon’s EAGLE platform potentiates antitumor immunity by enzymatically removing immunosuppressive sialic acids from tumor and immune cell surfaces. The EAGLE platform is created by genetic fusion of an engineered human sialidase with antibody domains, and includes clinical stage Bi-Sialidase, as well as various bifunctional sialidases comprising a sialidase together with a targeting arm. As one of Palleon’s most advanced bifunctional sialidases, the Bifunctional HER2-Sialidase has shown the potential to treat both HER2-low and HER2-high expressing tumors with modest to high levels of tumor surface sialoglycans, and the candidate is on the verge of entering IND-enabling studies.

Henlius has built a vertically integrated biopharmaceutical platform with core capabilities of high efficiency and innovation embedded throughout the entire product life cycle of R&D, manufacturing, and commercialization, expediting a diversified and robust pipeline covering tumor-associated-antigen (TAA) targets with high market potential. Fully leveraging its experience in biologics development and harnessing the power of innovation, Henlius implements its proprietary antibody and novel conjugating technologies to explore various forms of antibody conjugates to continue building a more diverse innovative pipeline by synergizing its innovation centers in China and the US, as well as its global clinical development teams. Henlius has process development capabilities that span the product lifecycle, starting with cell line development and continuing through commercial manufacturing, effectively supporting the commercialization of its products around the world.

“We’re very pleased to partner with Henlius to develop and expand Palleon’s pipeline to realize the potential of bifunctional sialidases as a treatment option for a wide range of cancer types,” said Jim Broderick, M.D., Chief Executive Officer and Founder of Palleon. “Henlius has a strong track record of providing groundbreaking and cost-effective medicines for patients in China, and the development of these two therapeutic candidates will benefit from their expertise and capabilities.”

Under the terms of the agreement, Palleon will perform research and the parties will then share preclinical and global clinical development responsibilities and costs for the Bifunctional HER2-Sialidase and a second bifunctional sialidase. Henlius has an exclusive license to the two investigational therapies in China (including Hong Kong, Macau, and Taiwan), while Palleon retains all other global rights and, for the second product, receives a royalty-bearing exclusive license to Henlius’ antibody technology outside China. Palleon received an upfront payment and is further eligible to receive up to $196.5 million in certain predetermined R&D and commercial milestones, in addition to royalties upon Henlius commercialization in China.

“We strive to offer innovative and affordable biologics to all patients,” said Wenjie Zhang, Chairman, Executive Director, and CEO of Henlius. “Henlius is currently exploring various forms of antibody conjugates utilizing our proprietary antibody expertise and novel conjugating technologies. Together with Palleon’s cutting-edge EAGLE immuno-oncology platform, we believe that this collaboration will complement Henlius’ innovative early-stage pipeline and accelerate our progress of providing breakthrough treatments for patients with unmet medical needs.”

About Palleon Pharmaceuticals

Palleon Pharmaceuticals is the leading biotechnology company developing drugs that harness glyco-immunology to treat cancer and inflammatory diseases. The company’s proprietary platforms enable new target discovery, patient selection, and the development of novel therapeutics for devastating diseases characterized by immune system dysfunction. Palleon’s lead program in oncology, E-602, is a first-in-class enzymatic degrader of immunosuppressive sialoglycans on tumors and immune cells which is now being evaluated in a Phase 1/2 study (NCT05259696). www.palleonpharma.com

About Henlius

Henlius (2696.HK) is a global biopharmaceutical company with a vision to provide high-quality, affordable, and innovative biologic medicines to patients worldwide, with a specific focus on oncology, autoimmune diseases, and ophthalmic diseases. To date, Henlius has launched five products in China and one in Europe, and has had thirteen indications approved worldwide. In addition, Henlius has had two New Drug Applications (NDA) accepted for review in China.

Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high efficiency and innovation embedded throughout the whole product life cycle, including R&D, manufacturing and commercialization. Henlius has established global innovation centers and Shanghai-based manufacturing facilities aligned with global Good Manufacturing Practice (GMP) standards. These facilities include the Xuhui Plant, which has received Chinese GMP and EU GMP certification, and the Songjiang First Plant, which has received Chinese GMP certification.

Henlius has actively built a diversified and high-quality product pipeline covering over twenty innovative monoclonal antibodies (mAbs). In addition, Henlius has continued to explore immuno-oncology combination therapies with its proprietary HANSIZHUANG (anti-PD-1 mAb) product as the backbone of this pipeline. Henlius has also launched HANLIKANG (rituximab), the first-ever China-developed biosimilar, HANQUYOU (trastuzumab, trade name in Europe: Zercepac®), the first China-developed mAb biosimilar approved in both China and Europe, HANDAYUAN (adalimumab), and HANBEITAI (bevacizumab). In addition, Henlius’ innovative HANSIZHUANG product has been approved by the NMPA for the treatment of MSI-H solid tumors, and its NDAs for the treatment of squamous non-small cell lung cancer and extensive small cell lung cancer (ES-SCLC) are under review. Henlius has conducted over twenty clinical studies for twelve products and ten combination therapies.

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