FGEN FibroGen Inc

FibroGen, Inc. (NASDAQ: FGEN) today announced a clinical trial supply agreement with Regeneron Pharmaceuticals to evaluate FibroGen’s immuno-oncology assets, FG-3165 and FG-3175, in combination with Regeneron’s anti-PD-1 therapy, LIBTAYO® (cemiplimab), in patients with solid tumors.

“We are very excited to collaborate with Regeneron Pharmaceuticals to evaluate two separate novel combination approaches to treat patients with select solid tumors,” said Deyaa Adib, M.D., Chief Medical Officer of FibroGen. “We believe that the mechanisms of action for both FG-3165 (anti-Gal9) and FG-3175 (anti-CCR8) have the potential to be synergistic with cemiplimab, providing the possibility for an improvement in clinical outcomes for patients. We look forward to building a collaborative relationship with Regeneron, who is a leader in oncology therapeutic products development and commercialization.”

FG-3165 targets Gal9, which binds multiple immune checkpoints on lymphocytes that suppress T and natural killer (NK) cell activation. FG-3175 targets CCR8, a receptor frequently over-expressed on T regulatory cells in solid tumors. Both FG-3165 and FG-3175 have demonstrated complementary mechanisms of action with PD-1 inhibitors preclinically, and the Company believes that combining LIBTAYO® with either FG-3165 or FG-3175 may result in added clinical benefit for patients.

Under the clinical study collaboration and supply agreement, Regeneron will provide drug supply to FibroGen, who will be the sponsor of each Phase 1 monotherapy and combination trial. Each company retains all rights to their respective compounds, including as a monotherapy or as combination therapies.

Earlier today, FibroGen separately announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for FG-3165 in patients with solid tumors. An IND submission for FG-3175 is anticipated in 2025.

About FG-3165FG-3165 is a galectin-9 (Gal9) targeted antibody under development for treatment of solid tumors and potentially hematologic malignancies characterized by high Gal9 levels of expression. Gal9 has been reported to signal through multiple immune checkpoints on lymphocytes, including TIM3, VISTA, and PD-1, suppressing T and natural killer cell activation. FG-3165 selectively binds to Gal9 with high affinity and inhibits its ability to induce lymphocyte cell death, resulting in enhanced tumor cell killing. The Company plans to initiate a Phase 1 trial in select solid tumors in the second half of 2024.

About FG-3175FG-3175 is a c-c motif chemokine receptor 8 (CCR8) targeted antibody under development for treatment of solid tumors highly infiltrated by CCR8-positive T regulatory cells (Tregs). CCR8 is a GPCR with prevalent and highly specific expression on immunosuppressive tumor infiltrating Tregs across different tumor types. FG-3175 is designed to deplete CCR8 Tregs via antibody dependent cellular cytotoxicity (ADCC) in the tumor microenvironment and enhance anti-tumor T cell responses, leading to enhanced anti-tumor activity and potentially improved clinical outcomes for patients in tumors such as Breast, Colorectal, Ovarian and Melanoma. In addition to its ADCC activity FG-3175 also disrupts CCR8 signaling, potentially providing additional benefit by disrupting Treg proliferation and migration into the tumor. The Company plans to submit an Investigational New Drug (IND) application for FG-3175 in 2025.

About FibroGen FibroGen, Inc. is a biopharmaceutical company focused on accelerating the development of novel therapies at the frontiers of cancer biology. Pamrevlumab, a fully human anti-CTGF monoclonal antibody, is in clinical development for the treatment of metastatic pancreatic cancer and locally advanced unresectable pancreatic cancer (LAPC). Roxadustat (爱瑞卓®, EVRENZOTM) is currently approved in China, Europe, Japan, and numerous other countries for the treatment of anemia in chronic kidney disease (CKD) patients on dialysis and not on dialysis. Roxadustat is in clinical development for chemotherapy-induced anemia (CIA) and a Supplemental New Drug Application (sNDA) has been accepted for review by the China Health Authority. FG-3246 (also known as FOR46), a first-in-class antibody-drug conjugate (ADC) targeting CD46 is in development for the treatment of metastatic castration-resistant prostate cancer. This program also includes the development of an associated CD46-targeted PET biomarker. In addition, FibroGen has expanded its research and development portfolio to include two immuno-oncology product candidates for the treatment of solid tumors. For more information, please visit www.fibrogen.com.

Forward-Looking Statements This release contains forward-looking statements regarding FibroGen’s strategy, future plans and prospects, including statements regarding its clinical programs for FG-3165 and FG-3175. These forward-looking statements include, but are not limited to, statements regarding the efficacy, safety, and potential success of FibroGen product candidates, and statements about FibroGen’s plans and objectives 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. FibroGen’s 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 its various programs, including the enrollment and results from ongoing and potential future clinical trials, and other matters that are described in FibroGen’s most recent quarterly and annual reports on Form 10-Q and Form 10-K, respectively, as 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 FibroGen undertakes no obligation to update any forward-looking statement in this press release, except as required by law.

For Investor Inquiries:David DeLucia, CFAVice President, Head of Investor Relations and Corporate FP&Air@fibrogen.com

For Media Inquiries:Simon MillerVice President, Marketing and Corporate Communicationsmedia@fibrogen.com