• Exclusive license option to anti-CCR8 monoclonal antibody program further strengthens FibroGen’s preclinical development pipeline
  • HiFiBiO to receive $35 million option exercise payment, potential milestones and royalties

SAN FRANCISCO, CA and CAMBRIDGE, MA, USA I December 20, 2021 I FibroGen, Inc. (Nasdaq: FGEN), a leading biopharmaceutical company discovering, developing, and commercializing first-in-class therapeutics, and HiFiBiO Therapeutics, a private, multinational clinical-stage biotherapeutics company with expertise in immune modulation and single cell science, today announced an extension of their partnership with FibroGen’s exercise of an exclusive license option for HiFiBiO’s anti-CCR8 monoclonal antibody program (HFB1011).

“We are pleased to add the HiFiBiO CCR8 program and the HFB101110 molecule to our preclinical development pipeline,” said John Hunter, Chief Scientific Officer, FibroGen. “With this addition in the immuno-oncology space, we have the exciting opportunity to further expand our early development pipeline.”

“We are excited to strengthen our FibroGen partnership with the license of HFB1011, a unique program targeting CCR8, a GPCR majorly expressed on regulatory T cells in the tumor microenvironment. Our antibody, identified by using our single B cell cloning platform, is another demonstration of our Drug Intelligent Science (DIS®) approach for novel drug discovery and development. Together with the Galectin-9 program (HFB2009), we expand our collaboration with FibroGen to develop transformative medicines in immuno-oncology”, said Liang Schweizer, Ph.D., Chief Executive Officer, HiFiBiO.

Under the terms of the agreement, HiFiBiO will receive a $35 million upfront payment from FibroGen in addition to potential clinical, regulatory, and commercial milestones. HiFiBiO will also be eligible to receive royalties based upon net sales.

FibroGen will have the sole right to develop all products in the CCR8 program worldwide. The development candidate is expected to enter clinical development in 2023.

About CCR8

CCR8 is a GPCR with prevalent and highly specific expression on immunosuppressive tumor infiltrating regulatory T cells (Tregs) across different tumor types. Stimulation of CCR8 by its ligand results in proliferation of Tregs and immune-suppression in the tumor microenvironment. Targeting CCR8 with an antibody able to mediate cell killing through antibody-dependent cellular cytotoxicity (ADCC) offers the potential to selectively deplete highly immunosuppressive Tregs in the tumor microenvironment and promote anti-tumor immunity.

About FibroGen
FibroGen, Inc. is a biopharmaceutical company committed to discovering, developing, and commercializing a pipeline of first-in-class therapeutics. The Company applies its pioneering expertise in hypoxia-inducible factor (HIF) and connective tissue growth factor (CTGF) biology to advance innovative medicines for the treatment of unmet needs. The Company is currently developing and commercializing roxadustat, an oral small molecule inhibitor of HIF prolyl hydroxylase activity for anemia associated with chronic kidney disease (CKD), anemia associated with myelodysplastic syndromes (MDS), and for chemotherapy-induced anemia (CIA). Pamrevlumab, an anti-CTGF human monoclonal antibody, is in clinical development for the treatment of idiopathic pulmonary fibrosis (IPF), locally advanced unresectable pancreatic cancer (LAPC), and Duchenne muscular dystrophy (DMD). FibroGen recently expanded its research and development portfolio to include product candidates in the immuno-oncology and autoimmune space. For more information, please visit www.fibrogen.com.

About HiFiBiO Therapeutics

HiFiBiO Therapeutics is transforming the field of immunotherapy by combining proprietary single-cell profiling technologies with advanced data intelligence and deep knowledge of immune system biology. This approach enables the development of novel antibody therapies that are paired with biomarkers to predict patient response. HiFiBiO Therapeutics is working actively to address unmet medical needs around the world through its own innovative pipeline programs and open-innovation partnerships with world-renowned industry and academic researchers. The company’s strong global footprint features cutting-edge laboratories on three continents, in Cambridge, Mass., Paris, Shanghai, Hangzhou and Hong Kong. To learn more, please visit www.hifibio.com.

SOURCE: HiFiBiO Therapeutics