FibroGen Exercises Exclusive License Option for HiFiBiO’s CCR8 Program

Rhea-AI Summary

FibroGen (FGEN) has extended its partnership with HiFiBiO Therapeutics by exercising an exclusive license for the anti-CCR8 monoclonal antibody program, HFB1011. This agreement involves a $35 million upfront payment plus potential milestones and royalty payments based on net sales. FibroGen gains exclusive global rights to develop products from this program, which targets CCR8, a receptor implicated in tumor immune suppression. The HFB1011 development candidate is expected to enter clinical trials in 2023, reinforcing FibroGen's focus on expanding its immuno-oncology pipeline.

Positive

• FibroGen exercises exclusive license for anti-CCR8 program, enhancing its pipeline.
• Agreement includes $35 million upfront payment and potential future milestones.
• HFB1011 candidate expected to enter clinical trials in 2023.

Negative

• None.

• Exclusive license 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 and CAMBRIDGE, Mass., Dec. 20, 2021 (GLOBE NEWSWIRE) -- 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.

Forward-Looking Statements
This release contains forward-looking statements regarding our strategy, future plans and prospects, including statements regarding the development and commercialization of the company’s product candidates, our development programs and regulatory events and related timelines and potential future payments to be made. These forward-looking statements include, but are not limited to, statements about our plans, objectives, representations and contentions and are not historical facts and typically are identified by use of terms such as “may,” “will”, “should,” “on track,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. Our actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties related to the continued progress and timing of our various programs, including the enrollment and results from ongoing and potential future clinical trials, and other matters that are described in our Annual Report on Form 10-K for the fiscal year ended December 31, 2020 and our Quarterly Report on Form 10-Q for quarter ended September 30, 2021 filed with the Securities and Exchange Commission (SEC), including the risk factors set forth therein. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and we undertake no obligation to update any forward-looking statement in this press release, except as required by law.

Contacts:
FibroGen, Inc.

Investors:
Michael Tung, M.D.
Corporate Strategy / Investor Relations
415.978.1434
mtung@fibrogen.com

Media:
Meichiel Keenan
Associate Director, Public Affairs
mkeenan@fibrogen.com

Contacts:
HiFiBiO Therapeutics

Investors/Media:
Vincent Tse
617.395.1212
media@hifibio.com

 

FAQ

What is the significance of FibroGen's exclusive license for the anti-CCR8 program (FGEN)?

The exclusive license enhances FibroGen's preclinical development pipeline in immuno-oncology and provides a $35 million upfront payment plus potential milestones.

When is the clinical development for the HFB1011 candidate expected to begin?

The clinical development for the HFB1011 candidate is expected to begin in 2023.

How does the anti-CCR8 monoclonal antibody program benefit FibroGen (FGEN)?

The anti-CCR8 program strengthens FibroGen's position in the immuno-oncology space, targeting immunosuppressive T cells in tumors.

What financial benefits could FibroGen receive from the HiFiBiO partnership (FGEN)?

FibroGen could receive clinical, regulatory, and commercial milestone payments, as well as royalties based on net sales from the partnership.